Written by CadmiumCD Project Manager, George Heitzmann
In December 2020, The Accreditation Council for Continuing Medical Education (ACCME®) released new Standards for Integrity and Independence in Accredited Continuing Education which includes updates to key aspects of the financial disclosure process.
The standards were updated based on industry recommendations to make them easier to understand, clearer to follow, and more useful for Accredited Education Providers. The updated standards are meant to ensure high-quality scientific learning and protection from industry bias.
ACCME is allowing a one-year transition phase from January 1, 2021 to January 1, 2022 for accredited providers to comply with new requirements. This article will briefly explain these changes and how they will affect your planning and event workflows.
One of the major changes relates to how the disclosures are handled. Previously, speakers were asked to disclose relevant financial relationships within the past twelve months. Now, faculty and planners need to disclose all financial relationships with ineligible companies (defined by ACCME as companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients) within the prior 24 months with no minimum threshold.
The disclosure should include the name and nature of the financial relationship with the ineligible company. However, faculty no longer need to disclose spouse or partner financial relationships.
The disclosure review committee is now responsible for reviewing all disclosures submitted by speakers and planners. This change is intended to make the process easier for faculty and planners by putting the onus of determining which financial relationships are relevant on disclosure reviewers, rather than on faculty themselves.
Planners also need to exclude owners and employees of ineligible companies from participating unless they’re presenting on items unrelated to their product, when content is limited to basic scientific research, or when they participate as technicians to teach safe and proper use of medical devices.
Any relevant financial relationships found by disclosure reviewers need to be mitigated. Common mitigation strategies include peer review, recusal, or divestment from the financial relationship.
The mitigation steps taken must be documented and disclosed to learners including the name of the individual, ineligible company, nature of the relationship, and a statement on how the relationship has been mitigated.
There are several updated terms in the new standards. “Commercial interests” was replaced with “ineligible company”; “disclosure resolution” was replaced with “disclosure mitigation” and Accredited Medical Education was replaced with Accredited Continuing Education. These changes are intended to make the language more clear and inclusive. Providers should review all ACCME policy statements and replace these terms in all documentation.
ACCME provided a one-year transition phase for accredited providers to comply with new requirements by January 1st, 2022. However, It would be wise for education managers and planners to start implementing many of these changes immediately to assist with the transition.
Further ACCME resources on the updated standards are provided below.
George Heitzmann manages software projects focusing on events and continuing education management. Originally from South Africa, he graduated from the University of Cape Town with a Bachelor of Business Science Degree in Marketing and received a Project Management Professional (PMP) Certification from the Project Management Institute. At CadmiumCD, George is project manager for the Survey Magnet.