Compliance Corner: Standard 3 – Are you implementing all requirements?

January 22, 2024

Standard 3: Identification, Mitigation and Disclosure of Relevant Financial Relationships is the most common noncompliance seen by California Medical Association (CMA) continuing medical education (CME) staff. Here we will discuss key components of this standard, and some of the common mistakes that are seen.

The Accreditation Council for Continuing Medical Education (ACCME) released the new Standards for Integrity and Independence (SII) in December 2020 along with an information packet, toolkit and resources. The new standards became effective January 1, 2022, and all CME providers are expected to have implemented them.

Standard 3 includes five separate and distinct elements. A common error is not addressing each separately, or assuming that one step takes the place of another.

Step 3.1 – Collect information.

  • 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.
  • Remember that the definition of an ineligible company has changed and must be used verbatim in your collection mechanism.
  • The definition of an Ineligible Company is “those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.” This definition must be used verbatim.
  • Who are examples of individuals in control of content? Find out more here.
  • CMA strongly encourages you to use the ACCME SII toolkit template, which includes all required elements. Please note that any additional information beyond the template may put you in noncompliance.

Step 3.2 – Exclude owners or employees of ineligible companies.

  • Always start with exclusion of owners or employees of ineligible companies.
  • Accredited CME must be evidence-based, balanced and have no bias or promotion. An owner or employee has a fiduciary responsibility to promote their company.

Step 3.3 – Identify relevant financial relationships.

  • Review the information you collected in step 3.1 to determine if the individual has relationship(s), and if the relationship(s) are relevant to the content of the activity.
  • Consider if the educational content that the individual can control is related to the business lines or products of the ineligible company.
  • Important – ONLY you as the accredited provider organization can determine relevancy. It is never up to the individual to self-identify if they feel their relationship is relevant to the education they may be involved with.

Step 3.4 – Mitigate relevant financial relationships.

  • Take steps to prevent all those with relevant financial relationships from inserting commercial bias into content.
  • You as the accredited provider must mitigate all financial relationships that you have determined are relevant.
  • Mitigation must occur prior to the individual assuming their role, and be appropriate to the person’s role in the activity (i.e., steps for planners will likely be different than for speakers and occur before planning begins).
  • Document the steps taken to mitigate relevant financial relationships. You should be able to share your strategies and documentation with CMA if needed.
  • Common errors include not separately mitigating once a relationship is identified as relevant, or to use incorrect mitigation strategies for the individual’s role.
  • Mitigation strategies for planners:
    • Recusal from controlling aspects of planning and content with which there is a financial relationship.
    • Peer review of planning decisions by persons without relevant financial relationships.
  • Mitigation strategies for speakers:
    • Peer review of content by persons without relevant financial relationships.
    • Attest that clinical recommendations are evidence-based and free of commercial bias.
  • See both the planning guide and toolkit template resource links below for more information on mitigation steps for each role.

Step 3.5 – Disclosure to Learners.

  • Disclosure to learners must include both the presence and absence of relevant financial relationships.  
  • Disclose the presence of relevant financial relationships. This includes the name of the individual, the name of the ineligible company and the nature of the relationship.
  • If there is a relevant financial relationship, disclosure to learners must also include that the relationship has been mitigated.
  • Disclose the absence of relevant financial relationships. For other individuals in control of content, you must disclose when there is no relevant financial relationship.
  • For those with no relevant financial relationships, the disclosure to learners can be a group message.
  • Disclosure must be provided to learners before engaging with the accredited education and must be in a format that CMA can verify at the time of accreditation.
  • A common error is considering that disclosure to learner is sufficient. Note that the steps of Identification (step 3.3) and Mitigation (step 3.4) must occur.
  • See the toolkit template resource link below for sample language.

If you have not already updated your processes and mechanisms to implement the new standards, the below ACCME resources will be helpful.

As your accreditor, CMA is here to help! Reach out with questions to cme@cmadocs.org.


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