Overview
The Accreditation Council for Continuing Medical Education (ACCME) released its approved Standards for Integrity and Independence in Accredited CE on December 10, 2020. These standards, which replace the ACCME’s previous Standards for Commercial Support (SCS), seek to provide greater clarity for ensuring independence in accredited continuing education (CE). As stated in the ACCME’s Preamble, “independence is the cornerstone of accredited continuing education.” The original standards were adopted in 1992 and had not seen updates since 2004, apart from some policy and FAQ updates that had been made over the past 16 years.
As the name suggests, these new standards seek to maintain the integrity of accredited CE by providing updates to terms and requirements and streamlining requirements into five (5) standards for providers. Standards 1-3 apply to all accredited organizations. Standard 4 applies “only to accredited continuing education receiving financial or in-kind support from ineligible companies.” Standard 5 applies “only when there is marketing by ineligible companies or nonaccredited education associated with the accredited continuing education.”
Accredited organizations have a transition period of one year to implement needed updates and changes to process within their respective accredited programs. It is the ACCME’s expectation that all accredited programs will be fully compliant by January 1, 2022. In addition to the ACCME, the following accredited programs have adopted these new standards:
- Accreditation Council for Pharmacy Education (ACPE)
- American Academy of Family Physicians (AAFP)
- American Nurses Credentialing Center (ANCC)
- Association of Regulatory Boards of Optometry’s Council on Optometric Practitioner Education (ARBO/COPE)
- Joint Accreditation for Interprofessional Continuing Education™
Terms
Many of the proposed changes aim to clarify definitions and set forth new terms, such as:
- The term “continuing medical education” has been replaced by the term “accredited continuing education.”
- Instead of requiring accredited providers to “resolve” relevant financial relationships that pose a conflict of interest, the term “mitigate” has been adopted regarding financial relationships.
- 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 those organizations focused on serving the needs of patients (not the interests of industry), from those organizations whose primary business is “producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.”
Standard 1: Ensure Content is Valid
Standard 1 encompasses the ACCME’s Policy on Clinical Content Validation and elements of what had previously been SCS 5. Updated language in this standard would appear to address new/emerging therapies and/or the field of complementary and alternative medicine. Revised language states: “Although accredited continuing education is an appropriate place to discuss, debate, and explore new and evolving topics, these areas need to be clearly identified as such within the program and individual presentations. It is the responsibility of accredited providers to facilitate engagement with these topics without advocating for, or promoting, practices that are not, or not yet, adequately based on current science, evidence, and clinical reasoning.”
Standard 2: Prevent Commercial Bias and Marketing in Accredited Continuing Education
Standard 2 expands upon independence in accredited CE, addressing what was previously SCS 1. This standard provides greater instruction on how to ensure independence in accredited CE and includes a couple of new requirements. First, accredited education must be free of any marketing or sales of products or services, regardless of whether the education is being financially supported by an ineligible entity. Faculty cannot actively promote or sell products or services that serve their professional or financial interests during accredited CE, which includes consulting services, books, software, etc. Second, accredited providers may not share the names or contact information of learners with any ineligible company or its agents without the explicit consent of individual learners. Effectively, providers must implement a learner-consent mechanism if they wish to share such information.
Standard 3: Identify, Mitigate and Disclose Relevant Financial Relationship
Standard 3 addresses what was previously SCS 2 & 6 and has incorporated as official language within the standard, what had been clarifying policies and FAQs. Several noteworthy updates have been made to expectations set forth by this standard regarding identification and mitigation of relevant financial relationships, as well. The ACCME now makes explicit that all individuals in a position to control content must disclose all financial relationships with an ineligible entity (not just those they deem relevant to the activity). It is the accredited provider’s responsibility to determine relevance, based on the nature of the content. In addition, financial relationships with an ineligible entity must now be disclosed for the previous 24 months (vs. 12 months).
Standard 4: Manage Commercial Support Appropriately
Standard 4 addresses what was previously SCS 3 and a component of SCS 6, and it only applies if commercial support is accepted to support an accredited CE activity. There are not significant changes to the requirements outlined with this standard; language sets forth that the accredited provider must make all decisions regarding the receipt and disbursement of the commercial support. The language in this standard also outlines specific parameters regarding the commercial support agreement, provider accountability and disclosure to learners.
Standard 5: Manage Ancillary Activities Offered in Conjunction with Accredited Continuing Education
Standard 5 expands upon elements of the previous SCS 4 and only applies if marketing by ineligible companies or nonaccredited education is associated with the accredited CE. One specific update to managing “ancillary activities” that occurs with accredited CE is that within the live setting there must be distinct separation from content that is accredited and that which is not. “Marketing, exhibits, and nonaccredited education developed by or with influence from an ineligible company or with planners or faculty with unmitigated financial relationships must not occur in the educational space within 30 minutes before or after an accredited education activity. Activities that are part of the event but are not accredited for continuing education must be clearly labeled and communicated as such.” For items such as conference bags and lanyards that often are “sponsored” with marketing messages, Standard 5 requires that such ancillary marketing “not influence any decisions related to the planning, delivery, and evaluation of the education.”
Summary
These newly released standards aim to streamline and provide greater clarity when it comes to ensuring integrity and managing independence of accredited CE. And, while accredited providers will need to make updates and adjustment to processes, it’s apparent that the ACCME did take stakeholder feedback into account, as a handful of proposed revisions were not included in the final set of standards (e.g. disallowing joint providers from receiving commercial support funding, requiring providers communicate to learners the name of the entity with which learner data would be shared and how that entity intended to use the information, etc. ). It remains to be seen if the term “ineligible entity” will be uniformly adopted across stakeholder groups (i.e. funders), but this terminology update falls in line with the ACCME’s attempt to draw a clear distinction between various entities. To download a complete copy of the ACCME’s Standards for Integrity and Independence in Accredited CE, please click here.
About AOE
AOE is a CE consulting and services company. Our deliverable is your accredited CE success story. We offer accreditation and reaccreditation support services; outsourced, extension-of-staff accreditation compliance management services; and accredited CE compliance trainings on the Standards, the new menu of commendation criteria, maintenance-of-certification, accredited CE basics and other tailored trainings.
Contact AOE’s Managing Director, Annika Borvansky, at 303-557-0859 Ext. 82 or annika@aoeconsulting.com for more information on how AOE can support your team, or if you’re interested in AOE’s comprehensive training on the new ACCME Standards.
