AOE Compliance Connection – June 2021 Newsletter

Welcome to the June edition of AOE Compliance Connection, AOE’s monthly newsletter. As we step into summer, we remain committed to equipping you and your team with the latest CE news and updates! In this month’s newsletter, you will find a special focus on the new Standards for Integrity and Independence in Accredited Continuing Education: a new ACCME resource as your organization transitions, a recently published JAMA article about the changes in Standards, and a deeper dive into Standard 3. You’ll also find a quick link to AOE’s analysis of the ACCME’s 2020 Annual Report Data for more insight into this past year of CE! As always, we keep our site up to date with CE in the news updates and helpful weekly compliance tips. Reach out to us at inquire@aoeconsulting.com!

Accredited providers are expected to be in compliance with the new Standards for Integrity and Independence in Accredited Continuing Education by January 1, 2022. The ACCME’s latest resource to aid the transition plan is a “Transition Checklist” that providers can use to ensure that they are in compliance on time.

Here is a quick overview of each section of the checklist:

Standard 1: There is nothing new/different in the ACCME’s approach to ensuring content validity, but providers will find helpful steps in this section of the checklist to ensure that their current processes meet requirements.

Standard 2: Pertaining to the prevention of commercial bias and marketing, these checklist items will help providers understand what needs to be communicated to faculty members, as well as tips on obtaining explicit consent of each learner.

Standard 3: Identification/Mitigation/Disclosure of relevant financial relationships can be a tricky area for many providers and this section of the checklist includes helpful reminders on how and when each required step should take place.

Standard 4: Like Standard 1, there is nothing new to the requirements for managing commercial support. This section of the checklist will help providers ensure that their current practices meet ACCME requirements.

Standard 5: The checklist items in this section encourage providers to review their processes to make sure that learners can easily distinguish between accredited CE and other activities.

Click here to download the full Transition Checklist as a word document (here for a PDF) and here for other resources related to the new Standards.

The Standards for Integrity and Independence in Accredited Continuing Education were released in December 2020, officially replacing the established Standards for Commercial Support. As providers will be required to comply with the new Standards by January 1, 2022, now is an advantageous time for a deep dive into each of the 5 new Standards.  AOE is poised to help your organization make this transition and train your team in achieving (and documenting) compliance with the new Standards – connect with us to find out more. As part of that service, over the next few months, AOE is featuring one standard per newsletter, to offer readers insight and tools beyond a surface level. Previous AOE newsletters feature in-depth information about Standard 1 and Standard 2.

Standard 3 pertains to the identification, mitigation, and disclosure of relevant financial relationships. The entire standard deals with steps providers are required to take to prevent the influence of ineligible companies on accredited CE.

The five components of the standard flesh out the action steps required of all accredited CE providers:

1. Collect Information: The accredited provider must collect information regarding all financial relationships (any amount) with ineligible companies from ALL individuals in control of educational content (inclusive of planners, faculty, and others) within the prior 24 months. The collected information should include the name of the ineligible company with which the person has a financial relationship AND the nature of the financial relationship.The ACCME clarifies that the collection of financial disclosure can happen on an annual OR activity-by-activity basis. If an organization chooses to collect annually or biannually, they should instruct the individual to communicate with them when updates to disclosure occur to ensure up-to-date information.One additional area of frequent confusion regarding this portion of Standard 3 is the method of information collection. While the ACCME doesn’t require that providers use a disclosure form to collect financial information, it is a commonly used mechanism by many providers. Other options include verbal collection (and subsequent recording of the information in a spreadsheet, etc.) or electronic collection (e-mail, web-forms, etc.).
2. Exclusion of Owners or Employees of Ineligible Companies: An important and often overlooked requirement of this standard is the consideration of those employed by ineligible companies or owners of said companies. Per the ACCME, these individuals must be excluded from controlling content in any way, with three, special-use exceptions:
   • When the content of the activity is not related to the business lines or products of their employer/company.
   • When the content of the accredited activity is limited to basic science research.
   • When they are participating as technicians to teach the safe and proper use of medical devices, and do not recommend whether or when a device is used.
3. Identification of Relevant Financial Relationships: Accredited providers are responsible for reviewing the submitted financial relationship information to determine if a financial relationship(s) is relevant (occurring in the past 24 months with an ineligible company and when the educational content that the individual can control is related to the business lines/products of the ineligible company).
4. Mitigation of Relevant Financial Relationships: Accredited providers must then take steps to protect the integrity of CE content from commercial bias by mitigating the relevant financial relationships that are identified. Mitigation must occur PRIOR to the individual assuming their role, and the steps taken must be appropriate to the role of the individual (steps for planners will differ from steps for faculty). All steps and actions taken must be documented.
5. Disclosure of all Relevant Financial Relationships to Learners: The final step in Standard 3 is for the accredited provider to disclose to the learners the following four components:
   • The names of individuals with relevant financial relationships
   • The names of the ineligible company (but only the name – not the logo or other company/product information)
   • The nature of the relationships
   • A statement that the relationship(s) has been mitigated

   Learners at any given activity must receive this disclosure information in a format that allows for them to engage with the disclosures BEFORE they engage with the CE content. An important note: The accredited providers must disclose the absence of relevant financial relationships, as well.

The ACCME provides only three exceptions to Standard 3. Accredited providers do NOT need to complete the above 5 steps (collection, exclusion, identification, mitigation, disclosure) when the accredited education is non-clinical, when the learner is in control of content, and when the learner controls their educational goals and reports on the resulting changes.

More information about the new Standards can be found here.