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No, in this scenario the commercial interest is giving commercial support and buying promotional and sales opportunities. The commercial interest should buy advertising and promotion opportunities with resources designated for that purpose. If an agreement for advertising or promotion is struck between the two parties it must be outside the written agreement for commercial support described in Standard 3 of the SCS. With respect to commercial support, the terms and conditions of the support must be described in a written agreement between the accredited provider and the commercial supporter, as delineated in Standard 3 of the SCS. Any event or product that contains advertising or promotional opportunities must not be part of the educational CME activity and must not be paid for by commercial support. Normally these are assigned to the "exhibit hall," advertising pages or screens or promotional receptions or meals, all of which are clearly identified as such by the learner.

Relevant financial relationships are financial relationships in any amount, which occurred in the twelve-month period preceding the time that an individual was asked to assume a role controlling content of the CME activity, and which relate to the content of the educational activity, causing a conflict of interest. The ACCME considers financial relationships to create conflicts 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. The potential for maintaining or increasing the value of the financial relationship with the commercial interest creates an incentive to influence the content of the CME—an incentive to insert commercial bias. The ACCME has not set a minimum dollar amount for relationships to be considered relevant and does not use the term significant to describe financial relationships. Inherent in any amount is the incentive to maintain or increase the value of the relationship. ACCME considers relationships of the person involved in the CME activity to also include financial relationships of a spouse or partner.

The 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.” See ACCME’s Definition of Commercial Interest or ACCME's Corporate Structure Review Process for more information.

In August of 2009, the ACCME issued a ‘Letter to providers regarding restructuring for new commercial interest definition’ which includes six questions that have been developed by the ACCME in order to determine whether or not an organization falls under the definition of an ACCME-defined commercial interest.  Those six questions are listed below:

Structured Self-Assessment Related to ACCME’s Definition of a Commercial Interest

  1. Does your organization, or a part of your organization, produce, market, re-sell, or distribute health care goods or services consumed by or used on patients?
  2. Does your organization have a parent company that produces, markets, re-sells, or distributes health care goods or services consumed by, or used on, patients? (A "parent company" is a separate legal entitiy that owns or fiscally controls an accredited provider or non-accredited organization.)
  3. Does your organization have a sister company that produces, markets, re-sells, or distributes health care goods or services consumed by, or used on, patients? (A "sister company" is a separate legal entity which is a subsidiary of the parent company and which maintains a governance structure and activities separate from both the parent company and the accredited provider or nonaccredited joint provider.  The sister company does not control or direct, in whole or in part, the operations of the accredited provider or non-accredited organization.)
  4. Does your organization advocate for an ACCME-defined commercial interest?
  5. Does your organization have a parent company that advocates for an ACCME-defined commercial interest?
  6. Does your organization have a sister company that advocates for an ACCME-defined commercial interest?

If an organization answers yes to any of these questions, they would be defined by ACCME as a commercial interest.  If after answering these questions, the organization still has questions regarding its status, it 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 pursue having ACCME perform a corporate structure review. There is a fee ($4,000) for organizations that wish to have a corporate structure review conducted. 

It would depend on what the program book, 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 program book. If the abstracts are not referenced as part of the CME content, and appear in the program book with all other logistical information about the activity, then there can be advertising.

The ACCME offered several alternatives for corporate restructuring that met its requirements. For example, the ACCME determined that an accredited CME provider can have a sister corporation that is a commercial interest, as well as a parent corporation that is not a commercial interest, as long as each corporation is a separate legal entity and there are proper firewalls in place. The corporation that is the CME provider:

  1. is not owned or controlled by a commercial interest;
  2. has separate management;
  3. is the employer of record;
  4. has a governance structure separate from the governance structure of the commercial interest; and
  5. receives any funds from a commercial interest only as commercial support.

A diagnostic laboratory is not considered an ACCME-defined commercial interest if its business is limited to the provision of diagnostic services that provide clinical results or information to healthcare professionals for their treatment of patients.

A diagnostic laboratory is considered an ACCME-defined commercial interest if it produces, markets, distributes, or re-sells proprietary diagnostic products or devices to other entities or individuals, such as other laboratories, clinics, clinicians, or patients for the provision of clinical service—for example, providing on-site or in-home clinical results.

A diagnostic laboratory that is owned or controlled by an ACCME-defined commercial interest is considered an ACCME-defined commercial interest.

No. Communication or distribution mechanisms that are owned or controlled by a commercial interest cannot be used to transmit or distribute continuing medical education activities to learners (e.g., a cable TV network or website owned and controlled by a commercial interest).

Yes. An accredited provider can fulfill the expectations of SCS 3.4 to 3.6 by adopting a previously executed agreement between an accredited provider and a commercial supporter and indicating in writing their acceptance of the terms and conditions specified and the amount of commercial support they will receive.

The ACCME considers financial relationships to create actual conflicts 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.

No. If you are creating a journal-based CME activity, the ACCME does not expect you to identify and disclose to learners the relevant financial relationships of the article’s authors and editors or to resolve their conflicts of interest. 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 resolution of any conflicts of interest. The accredited provider does, however, need to identify, resolve, 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:

SCS 2.1 requires that the accredited provider “must be able to show that everyone who is in a position to control the content of an education activity has disclosed all relevant financial relationships with any commercial interest to the provider.” 

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)

A common area of noncompliance with SCS 2 is that providers only collect information about relevant 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.

No. There is no reason for the CME provider to request suggestions for speakers or topics from commercial interests, since it is unacceptable to act upon their suggestions. CME providers can receive commercial support from industry. CME providers cannot receive guidance, either nuanced or direct, from an ACCME-defined commercial interest on the content of the activity or on who should deliver that content. If the provider implements the suggestions of the commercial interest then this creates a situation where the independence of CME from the commercial interest is seriously undermined. The provider must ensure that the content of the CME remains beyond the control of any commercial interest. The process to develop the CME must be independent of any commercial interest. Accredited providers must not allow commercial interests to directly (SCS 1.1) or indirectly (SCS 3.2) control the content of CME.

No. The ACCME does not require that providers use a disclosure form to gather information about relevant financial relationships of all persons in control of the 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 relevant financial relationships of all persons in control of content. The obtaining of this information must be a key component of several processes in order to ensure the independence of educational activities (see Criterion 7). 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.

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 (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 Commercial Support. 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. ACCME does not find providers out of compliance with SCS 3 for providing scholarships to Residents and Fellows through their academic institutions, residency or fellowship programs as part of their medical training.  

Yes. Some mechanism(s) that providers employ to resolve conflicts of interest 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 resolve conflicts for planners with relevant financial relationships, 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.

Educational materials are those materials used by the accredited provider in the transfer of education to learners (for example, handouts, slides, educational content, abstracts that are part of the education itself) as well as materials that contain information required by the ACCME to be made known to the learner as part of Criterion 7, ACCME Standards for Commercial SupportSM: Standards to Ensure Independence in CME Activities, Standard 6.

The April 2014 modifications added “corporate logo” to Criterion 9, Standards for Commercial Support: Standards to Ensure Independence in CME Activities, Standard 4.3. There was no change to the intent of the Standard or the ACCME’s expectation that educational materials should be free of any advertising or promotion.

Yes. The new CME activity, must demonstrate compliance with all applicable ACCME accreditation requirements, including faculty disclosure and acknowledgement of any commercial support (SCS 6).

 

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 (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 Commercial Support. 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. ACCME does not find providers out of compliance with SCS 3 for providing scholarships to Residents and Fellows through their academic institutions, residency or fellowship programs as part of their medical training.  

Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria for promotional speakers’ bureau, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as ownership, employment, management position, independent contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels, board membership, and other activities from which remuneration is received, or expected. ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner.

The ACCME has not set a minimum dollar amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship.

With respect to personal financial relationships, contracted research includes research funding where the institution gets the grant and manages the funds and the person is the principal or named investigator on the grant.

Note: Standard 2.1 requires the disclosure of relevant financial relationships.  Providers may choose to collect all financial relationships from an individual, and make the decision which would be relevant to the content of the activity, or, they may ask the person disclosing to limit their disclosures to those which are relevant to the content of the activity.

Commercial support underwrites 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 working for the provider on the activity.

  • In journal-based CME there cannot be an advertisement within the pages of the article on which the activity is based. There can be advertisements between articles.
  • In a print enduring material there can be advertisement at the end and the beginning of the CME content but nowhere else in the enduring material.

 

Yes - but 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 8.061 of the Council on Ethical and Judicial Affairs 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.

Commercial Support for an activity is financial, or in-kind, contributions given by a commercial interest, which is used to pay all or part of the costs of an activity. The definition of roles and requirements when commercial support is received are outlined in the ACCME Standards for Commercial Support (SM).

ACCME expects to be able to review income and expense statements for all CME activities. These statements must reflect:

Significant sources of income: Including income from commercial support, advertising and exhibit fees, tuition and registration fees, internal budget allocations and any other source that represents greater than 20% of total income.

Significant expenses: Including staff salaries, meeting costs, honoraria, faculty travel expenses and any other item that represents greater than 20% of total expense.

Commercial support is financial, or in-kind, contributions given by a commercial interest, which is used to pay all or part of the costs of a CME activity.

All funds that originate from ACCME-defined commercial interests 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 (Standards for Commercial Support and related policies).

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 ACCME-defined commercial interest, 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 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.

The use of employees of ACCME-defined commercial interests as faculty and planners or in other roles where they are in a position to control the content of accredited CME is prohibited, except in the specific situations specified here. The ACCME has identified 3  special-use cases where employees of ACCME-defined commercial interests can have a specific, limited role in accredited CME activities. In each scenario—as in every accredited CME activity—the expectations of ACCME’s Accreditation Requirements, including the Standards for Commercial Support, must be met.

  1. Employees of ACCME-defined commercial interests can control the content of accredited CME activities when the content of the CME activity is not related to the business lines or products of their employer.
  2. Employees of ACCME-defined commercial interests can control the content of accredited CME activities (e.g., as planners, authors, or speakers [including poster presentations]) when the content of the accredited CME activity is limited to basic science research (e.g., pre-clinical research, drug discovery) or the processes/methodologies of research, themselves unrelated to a specific disease or compound/drug. In these circumstances, the accredited provider must be able to demonstrate that it has implemented processes to ensure employees of ACCME-defined commercial interests have no control of CME activity content that is related to clinical applications of the research/discovery or clinical recommendations concerning the business lines or products of their employer.
  3. Employees of ACCME-defined commercial interests can participate as technicians in accredited CME activities that teach the safe and proper use of medical devices. In this circumstance, the accredited provider must demonstrate that it implements processes to ensure that employees of ACCME-defined commercial interests have no control of CME activity content that is related to clinical recommendations concerning the business lines or products of their employer. 

Yes. Effective April 2015, providers can use tabs, links, or other electronic mechanisms to make disclosure information available to learners, just as they have always been able to make disclosure available via a tabbed section in a printed syllabus. Regardless of the method of disclosure, all required ACCME information specified in Standard for Commercial Support 6: Disclosures Relevant to Potential Commercial Bias must be transmitted to the learner prior to the learner beginning the CME activity and should be clearly marked, accessible, and useful for learners. 

No. The ACCME cannot control what a commercial interest asks of an accredited provider but there is no CME reason for the provider to share the names of speakers/authors with commercial supporters.  An accredited provider that submits to the requirement of a commercial supporter to supply the names of speakers and authors could be participating in a process whereby the commercial supporter is controlling the selection of speakers and authors in accredited CME. The provider may be found in noncompliance with the ACCME Standards for Commercial SupportSM: Standards to Ensure Independence in CME Activities.

 

Yes. Distributing promotional material such as save the date cards, and not distributing the actual educational activity, would not be restricted by the ACCME's Standards for Commercial Support.

ACCME insists on 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 ACCME-defined commercial interest associated with them.

No. ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner.  The ACCME expects that providers will communicate to everyone who is in a position to control of content of an educational activity that the individual’s disclosure of relevant financial relationships must include:

  • financial relationships in any amount,

  • including financial relationships of their spouse or partner,

  • within the 12 months prior to the educational activity,

  • with an ACCME-defined commercial interest, and

  • that relate to the content of the educational activity

 

CME must be free of commercial bias. CME must not promote products or services. 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.

Yes. Verbal disclosure to the provider is acceptable as long as the provider can verify for the ACCME at accreditation what information was collected for the conflict of interest identification and resolution processes.

Yes. Resolving conflicts of interest means individuals taking explicit actions prior to the educational activity to create CME content that is valid and free of commercial bias -- even in the presence of relevant financial relationships. In the construct of the current CME system, the development and presentation of CME content is most often the responsibility of teachers/authors. Therefore, the ACCME considers teachers/authors to be a part of the accredited provider. So, when the provider directs teachers/authors to take actions to assist in the identification and resolution of conflict of interest, a provider's mechanism is being implemented. The provider might then monitor the effectiveness of the actions taken by the teachers/authors to resolve conflicts of interest. Keep in mind that simply monitoring the CME content at the time of presentation is not and cannot be the resolution mechanism.

No. The provider cannot delegate the responsibility for resolving the conflict of interest to the person with the conflict of interest. However, an individual who controls CME content can be involved in the mechanism by being expected to take specific actions to resolve his/her conflict (ex: removing bias, using an evidence-based approach) under the supervision of the provider.

The ACCME expects that written agreements for commercial support will:

  • be between the accredited provider and commercial supporter. (This means that the accredited provider's name and commercial supporter's name must be included in the written agreement as the parties entering into the agreement for commercial support.)
  • include the name of the joint provider or third party that would be receiving and disbursing the funds (when applicable).
  • be signed by both the accredited provider and the commercial interest providing the commercial support. Third parties and/or joint providers may also sign the written agreement but may not sign it instead of the accredited provider.
  • be signed prior to the activity taking place.

The nature of the relationship means the role they play or service they provide in exchange for some form of compensation (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 relevant. 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.

Financial relationships are those relationships in which the individual benefits by receiving, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as independent contractor (including contracted research), consulting, promotional speaking and teaching, membership on advisory committees or review panels, board membership, and other activities for which remuneration is received or expected. The ACCME considers relationships of the person involved in the CME activity to also include financial relationships of a spouse or partner.

Relevant financial relationships are financial relationships in any amount, which occurred in the twelve-month period preceding the time that the individual was asked to assume a role controlling content of the CME activity, and which relate to the content of the educational activity, causing a conflict of interest. The ACCME considers financial relationships to create conflicts 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. The potential for maintaining or increasing the value of the financial relationship with the commercial interest creates an incentive to influence the content of the CME—an incentive to insert commercial bias. The ACCME has not set a minimum dollar amount for relationships to be considered relevant and does not use the term significant to describe financial relationships. Inherent in any amount is the incentive to maintain or increase the value of the relationship.

Informed learners are the final safeguards in assuring that a CME activity is independent from commercial influence. Regarding personal conflicts of interest, CME providers are to have in place mechanisms to identify and resolve conflicts of interest. While these mechanisms should greatly reduce the potential for conflicts of interest to affect CME content, a potential for influence remains. Disclosing to learners the relevant financial relationships that were present and resolved assists learners in assessing the potential for bias in information that is presented. ACCME believes this disclosure contributes to the transparency and accountability of the system.

Yes. That documentation would verify that the first step of a mechanism for identifying conflicts of interest is in place. That would document for ACCME that the Provider knew the relevant financial relationships of the Committee members. However, keep in mind that the provider would need to be able to show that there was an assessment of whether or not the information disclosed caused a conflict of interest and if so, what was done to resolve the conflict.

No. Standard 2.1 requires the provider to identify relevant financial relationships of those who control the content of a CME activity in order to identify conflicts of interest. Two things must be present for there to be a conflict of interest: financial relationship(s) with an ACCME-defined commercial interest(s) and the ability to control content related to products/services of the commercial interest(s).  If no financial relationships exist, or the content of the CME activity is not related to the products or services of a commercial interest, there are no relevant financial relationships to identify and no conflicts of interest to identify or resolve.

Please note: Providers must determine that there are no potential conflicts of interest, as described above, during the planning process. You need to have evidence showing that you made the decision to not gather information about financial relationships during the planning process and why you made that decision. You cannot make the determination retroactively.

Also note that Standard 6 (SCS 6) still applies because the learner must be informed that those in control of the content of the activity have no relevant financial relationships.