AOE Compliance Connection – October 2018 Newsletter

Welcome to the October edition of AOE Compliance Connection, AOE’s monthly newsletter.  We trust that this monthly publication assists you and your team in your work towards success, compliance and peace of mind.

Amazon Alexa is front and center this month as the app is now being used for accredited CME!  Read more in our first feature article below.  Additionally, this month we’re taking a look at disclosure and some compliance-related key points, along with our monthly ACCME, ACPE and ANCC board bulletin updates.    

Connect with us on social media to stay current with our weekly Compliance Tips – we are partway through a series of Commendation Criteria tips where we address each criterion from the new Menu for Accreditation with Commendation from the ACCME.  You can follow the series on Twitter, Facebook, or find the Compliance Tip series on our webpage as well.

Amazon’s Alexa can do more than tell jokes and play music:  Now, it offers CME-accredited courses for physicians.  Last month, Rockpointe launched the first ever Alexa CME-accredited course utilizing the AudioEducate platform.  Along with two educational partners (Potomac Center for Medical Education (PCME) and the Academy of Physicians in Clinical Research (APCR)), Rockpointe designed and produced a three-part series surrounding the topic of patient-informed consent:

1. “Human Experimentation Part 1: What Entitles Physicians to Experiment on Fellow Humans?” 
2. In “Part 2: Pathway to the Medicine Industrial Compliance Complex” 
3. “Part 3: Informed Consent: The Cornerstone of Medical Ethics”

(Activity summaries can be accessed on this Policy & Medicine blog entry.)

This education series is a great example of compliance with ACCME Criterion 35, in terms of implementing innovations in areas such as education approaches, design, assessment, or use of technology.

ACCME Criterion 7 continues to be one of the highest areas of non-compliance for CME providers. This month’s feature highlights some key points for collecting disclosure information, appropriately managing this information to identify conflicts-of-interest and reporting relevant financial relationships to learners.

Collecting Disclosure

• Disclosure must be collected for anyone in a position to influence or affect the content of CME. This includes planners and managers, faculty, authors and content developers, moderators and content reviewers amongst others. Carefully consider all individuals who may have an opportunity to influence the content of the CME activity, such as those serving a planning or managing role.
• Ensure the following when collecting information about financial relationships from individuals in a position to control CME content: 
  • Disclosure information is collected before the individual’s engagement in the CME activity.
  • Disclosure information is collected for financial relationships occurring in the past 12-months.
  • Individuals in a position to control content are reporting financial relationships for themselves and their spouse/partner.
• The ACCME does not require that a disclosure form is utilized, however, this is a best practice to ensure standardization and consistent communication of the appropriate ACCME-definition of a commercial interest, along with other useful information. 
• If an individual discloses that he/she is an employee of a commercial interest, STOP and assess the situation. As a rule, employees of a commercial interest can have no role in CME activities, except in the case of very specific circumstances as outlined here on the ACCME’s website.  

Reviewing Disclosure

• Carefully review the disclosure information submitted by all individuals in a position to influence CME content to confirm relevance of each financial relationship. 
• A financial relationship is relevant, and poses a conflict-of-interest if:
  • It is with an ACCME-defined commercial interest
  • It occurred in the past 12 months
  • It is any amount
  • The products/services of the ACCME-defined commercial interest are related to the content of the CME activity

Appropriately Resolve all Conflicts-of-Interest

• Once relevant conflicts-of-interest have been correctly identified, they must be appropriately resolved.  
  • Providers should select a resolution mechanism that is appropriate for the role of the individual, whether a steering committee member, a faculty speaker, a planner, a manager, or another role.  
  • Resolution should be documented clearly. 
  • Some examples of possible resolution mechanisms that may resolve content, dependent on role, include:
    • Recusal
    • Peer-Review of planning decisions by person(s) that do not have conflicts of interest
    • Peer-Review of content by person(s) that do not have conflicts of interest
    • Independent Clinical Content Review

Report Relevant Financial Relationships to Learners

• Report relevant financial relationships to learners. You must ensure the following:
  • Information is provided to learners before engagement in the CME activity.
  • The name of the individual, the commercial interest(s), and the nature of the financial relationship(s) is reported.
  • Even if an individual has “nothing to disclose” this must be disclosed to learners as well. 

As multi-accredited providers can attest to, each board features different requirements along the various elements of CE activity design.  One of the ACPE’s defining differences from other boards is some of their specific evaluation requirements.  

In Standard 11, the ACPE explains that providers must “develop and conduct evaluations which allow pharmacists and technicians to provide feedback on CPE activities”. The specific elements of the evaluation should relate to the intended outcome of each initiative, and may vary from activity to activity.  Providers should note that the ACPE requires that learner feedback be summarized for pharmacists and technicians, separately.  Once separated and summarized, the data should be used constructively to improve and progress the overall CPE program.  

In each evaluation, providers should gather feedback from pharmacists and technicians in each of the following areas:    

• Applicability of the CPE activity to meet their educational needs  
• Achievement of each stated objective  
• Quality of faculty  
• Usefulness of educational material  
• Effectiveness of teaching and learning methods, including active learning  
• Appropriateness of learning assessment activities  
• Perceptions of bias or commercialism  

Additional evaluation components may be used, in addition to the above list.  

For more information about the ACPE evaluation requirements, click here.