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As with any transition to new or revised requirements, we understand that planning for some activities will pre-date the opportunity to implement changes in your organization’s processes. For those activities, (planned in 2021 but taking place or released in 2022), we would not expect to see compliance with the new requirements. Please note that, for those activities, we would expect compliance with applicable aspects of the Standards for Commercial Support and related policies. We encourage you to add a note to the relevant activity files indicating that your organization’s transition to the new Standards was in process, and the planning actions, for example, obtaining disclosures from those in control of content, occurred prior to your organization's full implementation of the new Standards. For activities planned on or after January 1, 2022, you will need to demonstrate compliance with the new Standards. 

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As described in the Standards’ section on eligibility, a biomedical startup is considered an ineligible company if it has begun a governmental regulatory approval process. 

  • Drugs: The ACCME considers the submission of the Investigational New Drug Application (IND), which must be approved before clinical trials can begin, as the point of entry into the government regulatory approval process.  This graphic published on the FDA website shows where in the drug development cycle the IND is submitted. Once a company makes this submission, it would be considered an ineligible company.
  • Medical devices: When a company initiates a premarket approval (PMA) process submission, as described on the FDA website here, it would then be considered an ineligible company.
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Individuals who may be in a position to control accredited continuing education are expected to disclose all their financial relationships with ineligible companies within the past 24 months to the provider.  

  • Individuals who own stock (not through a mutual fund or pension plan) in privately held ineligible companies are considered owners or employees and therefore must be excluded from controlling content or participating as planners or faculty in accredited CE, unless they meet the exceptions to the exclusion described in Standard 3.2.
  • Individuals who own stock in publicly traded ineligible companies are not considered owners or employees.  As described in Standard 3, the provider is expected to determine if the relationship is relevant to the educational content. If so, the provider needs to take steps to mitigate the relationship and disclose the relationship to learners.
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No. Individuals who receive patent royalties from ineligible companies are not considered owners or employees of those companies. Those individuals may control content in accredited continuing education, if the appropriate steps are taken:  

  • As described in Standard 3, individuals who may be in a position to control accredited continuing education are expected to disclose all their financial relationships with ineligible companies within the past 24 months to the provider, including royalty payments.
  • Providers must then determine if the relationship, in this case, royalty payments, is relevant to the educational content.
  • If so, the provider needs to take steps to mitigate the relationship and disclose the relationship to learners.

 

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Individuals who may be in a position to control accredited continuing education are expected to disclose all their financial relationships with ineligible companies within the past 24 months to the provider, including contracts to purchase stock at an agreed-upon price (stock options).  

  • As described in Standard 3, the provider is expected to determine if the relationship, in this case, stock options, is relevant to the educational content. If so, the provider needs to take steps to mitigate the relationship and disclose the relationship to learners.
  • An individual who holds stock options in an ineligible company is not considered an owner or employee of that ineligible company.  
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Yes. Providers may accept verbal disclosure of financial information from those in control of content in accredited CE. Providers must be able to verify for the ACCME that the individual was given the ACCME definition of an ineligible company and was informed that they must disclose all financial relationships with ineligible companies over the 24-month period prior to their involvement in accredited CE. 

Published Revised

No. You are not expected to comply with new disclosure requirements or obtain new disclosure information from those in control of content for a previously released activity, even if the activity is available to learners in 2022 or beyond.  Please note that the activity is subject to the Content Validity of Enduring Materials policy, so you must ensure that the content is still up-to-date and accurate at least every three years or earlier if the content warrants review.

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As is always the case when accreditation requirements change, our goal is to be flexible and allow accredited providers time to transition to the new expectation. We expect accredited providers to take reasonable steps to comply with the Standards for Integrity and Independence for activities taking place in 2021 that will continue to be available in 2022 and beyond.

You are expected to demonstrate compliance with the Standards for Integrity and Independence with any activities that take place beginning January 1, 2022, or later. We encourage you to begin the transition now, especially with activities that will be released in 2022.

For activities that were planned or released prior to 2021, we do not expect you to make changes to or obtain new disclosure information from the individuals who were in control of content.

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No changes have been made to the Accreditation Statement or the Accreditation Statement Policy. The ACCME has chosen to use the term accredited continuing education in the Standards for Integrity and Independence in Accredited Continuing Education to be inclusive of all health professions. There is no expectation that providers will change their terminology. You may continue to use the terms "continuing medical education" or "CME" as appropriate.

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The accredited provider is expected to explain to learners that you intend to share their information with an ineligible company. You can do that at registration; however, the learner must have the ability to opt out and still register for your activity. The consent statement must be clearly visible. If the statement is hidden in a long list of terms and conditions, that would not meet the expectation.

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No. The exception does not apply to conferences or rounds that have set times and dates and have traditionally been planned as accredited CE. Activities such as regularly scheduled series, department rounds, morbidity and mortality rounds, and tumor boards do not fall under the exceptions. Providers are expected to comply with Standard 3 when planning those activities.

The exception is meant to apply to spontaneous learning opportunities that previously might not have been considered accredited CE. A few examples are team huddles, well-being check-ins, and impromptu leadership-learning discussions. In those cases, with the guidance of the CME/CE department, learners can describe the learning opportunity (problem-in-practice and change that resulted) without having to take the steps outlined in Standard 3. The Quick Tool provides a good framework for spontaneous learning opportunities.

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You can choose whether to collect disclosure information when planning each activity or on a periodic basis, such as annually or biannually. If you choose to collect the information periodically, it is important to ask the person to update the disclosure if anything changes to ensure you have up-to-date, accurate information.     

Remember that you 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 of their involvement with an accredited CE activity.  

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As part of the accreditation process, the ACCME will select a sample of your accredited education to verify that learners received the appropriate disclosure information. Because the ACCME is not present at the time the disclosure occurs, we ask that you save documentation that will allow us to verify it took place – in whatever format disclosure is made. Specifically, we will want to verify that disclosure to learners included:

a. The names of the individuals with relevant financial relationships.

b. The names of the ineligible companies with which they have relationships.

c. The nature of the relationships. 

d. A statement that all relevant financial relationships have been mitigated.

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Yes. There needs to be a 30-minute interval between an accredited and nonaccredited session or activity regardless of whether the nonaccredited activity is before, after, or both. As noted in Standard 5.2, this time interval is required if the nonaccredited activity is either developed by or with an ineligible company, or if individuals with unmitigated, relevant financial relationships with ineligible companies are in control of content.

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No. Nonaccredited education (or sessions) as described in the question, would not need to be separated from accredited education by 30-minute intervals because those sessions are not “controlled by ineligible companies or include individuals with unmitigated, relevant financial relationships.” An example might be a legislative briefing or an awards ceremony. 

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The 30-minute interval is required for all live activities, whether the activity takes place in-person or online. For live, online activities, if the learner will remain in the same "virtual space" for a nonaccredited session, then the provider must ensure that there is a 30-minute interval before or after accredited education.  

If the learner is required to leave the virtual space to transition between accredited and nonaccredited activities, and will need to take an action, such as clicking a link that clearly communicates that they are leaving the accredited education, then there is no time-interval requirement.

 

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No. The exception does not apply to conferences or rounds that have set times and dates and have traditionally been planned as accredited CE. Activities such as regularly scheduled series, department rounds, morbidity and mortality rounds, and tumor boards do not fall under the exceptions. Providers are expected to comply with Standard 3 when planning those activities.

The exception is meant to apply to spontaneous learning opportunities that previously might not have been considered accredited CE. A few examples are team huddles, well-being check-ins, and impromptu leadership-learning discussions. In those cases, with the guidance of the CME/CE department, learners can describe the learning opportunity (problem-in-practice and change that resulted) without having to take the steps outlined in Standard 3. The Quick Tool provides a good framework for spontaneous learning opportunities.

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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.

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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.

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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.
Published

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.

Published

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.

Published

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.

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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.  

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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.

 

Published

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):

  • Planners
  • Faculty
  • Authors
  • Committee members
  • Content reviewers
  • Editors
  • 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.

Published

No. The provider cannot delegate the responsibility for identifying relevant financial relationship solely to the person with the financial relationship.

Published

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.

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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.

Published

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.

Published

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. 

Published

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.

Published

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
Published

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.

Published

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.

Published

Yes, only in the circumstances permitted by the ACCME as described in Standard 3.2.

Published

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.

Published

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.

Published

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. 

Published

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.

Published

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.

Published

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.

Published

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.

Published

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

  1. Does your organization, or a part of your organization, produce, market, re-sell, or distribute healthcare products used by or on patients?
  2. Does your organization advocate for, or on behalf of, an ineligible company?
  3. 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.)
  4. 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 info@accme.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.

Published

No. If you are creating a journal-based CME activity, the ACCME does not expect you to identify, mitigate, and disclose to learners the relevant financial relationships of the article's authors and editors. That process is handled by the journal editors. Disclosure by authors is a standard component of published articles, and the editorial review process manages the mitigation of relevant financial relationships. The accredited provider does, however, need to identify, mitigate, and disclose relevant financial relationships for those involved in planning the journal-based CME activity, e.g., the person(s) choosing the article(s) and/or writing the evaluation mechanism.

The ACCME has two expectations about the publication that issued the article:

  • The publication cannot be owned by an ACCME-defined ineligible company.
  • The publication must have in place a process that manages the disclosure of authors, editors, and peer reviewers involved in the process of reviewing and publishing the article. The process must be accepted within the scientific publication community. For example, the publication follows the International Committee of Medical Journal Editors' (ICMJE) Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (http://www.icmje.org/recommendations/).
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