AOE Consulting Synopsis: Proposed Revisions to ACCME Standards and Definitions

AOE Consulting Synopsis: 

Proposed Revisions to ACCME Standards and Definitions

January 8, 2020

Summary

On January 7, 2020, the ACCME announced proposed updates, clarifications, and revisions to its Standards, definitions, and policies regarding how accredited organizations operate. The stated purposes for these proposed changes were to “streamline, clarify, and modernize the Standards” and to ensure independence of accredited medical education from commercial influence.

The ACCME will accept comments about the proposed changes via an electronic survey until February 21, 2020. The ACCME Board will address the proposed changes and potentially ratify them at its March 2020 meeting. All approved changes will be made over a transition period that will allow accredited providers and other stakeholders to adjust/alter practices.

Analysis

Many of the proposed changes attempt to clarify definitions and set forth new terms, such as:

  • The term “continuing medical education” would be replaced by the term “accredited continuing education (ACE).”
  • Instead of requiring accredited providers to “resolve” relevant conflicts of interest among those planning/controlling ACE content, the new Standards would require providers to “mitigate” the potential effect of financial relationships on ACE.
  • New terms of “eligible entities” (organizations eligible for accreditation) and “ineligible entities” (those not eligible for accreditation) are set forth in an attempt to demonstrate the separation of commercial interests from organizations developing accredited continuing education.

Some of the proposed changes seem to go further in separating ACE content from non-ACE messages. The proposed changes:

  • Require accredited providers to manage “ancillary marketing” that occurs around ACE. For example, completely separating advertising, exhibits, marketing and promotion from ACE. For items such as conference bags and lanyards that often are “sponsored” with marketing messages, the proposed updates to Standard 5 state that arrangements to allow ancillary marketing “must not influence any decisions related to the planning, delivery, and evaluation of the education,” among other requirements. 
  • Make explicit that nonaccredited education, even if not promotional, cannot be interleafed within accredited education. 
  • Clarify that owners/employees of “ineligible entities” have unresolvable financial relationships and must be excluded from participating as planners, faculty, or in the delivery of ACE, except in a very limited set of circumstances.
  • Clarify that most of the Standards are applicable to all accredited providers, while the Standards directly addressing commercial influence and support only apply to commercially supported ACE.
  • Require accredited providers to obtain consent from learners before they can share learner contact information with any “ineligible entities.”

One proposed change appears to address new/emerging therapies and/or the field of complementary and alternative medicine. Under Standard 1 (Ensure Content is Valid), the ACCME proposes: “Accredited education may inform learners about approaches to diagnosis or treatment that are controversial or not generally accepted but must not include advocacy for these approaches or teach healthcare professionals how or when to use them.”

Another proposed change requires accredited providers directly disperse all commercial support associated with honoraria payments and/or reimbursements to individuals. This limits the role of the joint provider somewhat.  Related to this change, no longer are education partners, when applicable, required for inclusion on letters of agreement. 

Overall, many of the changes help clarify previous language. Some continuing education grant funding organizations could take issue with the new term “ineligible entity.” But given that the ACCME has never had jurisdiction over commercial organizations, the proposed change from “commercial interests” to “ineligible entities” as it relates to the ability of those organizations to become accredited or be involved in the planning and delivery of accredited continuing education, seems to be ACCME’s attempt at further clarification.  

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Weekly Compliance Tip

How do I know if the activity content is or isn’t related to the business lines of an ineligible company? 

Standard 3 states that an activity is considered related to the business lines when…

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