In January 2019, the Accreditation Council for Continuing Medical Education (ACCME) issued a call for feedback to review the rules that protect the integrity and independence of accredited continuing medical education (CME) for healthcare professionals. The ACCME developed an open process and has asked for recommendations about potential revisions to the ACCME Standards for Commercial Support: Standards to Ensure Independence in CME Activities to ensure their relevance and effectiveness in the evolving healthcare environment.
Recently, the ACCME released an Executive Summary and Survey Responses from the call for feedback. The Summary notes that the ACCME received a total of 141 responses from a variety of backgrounds and received feedback it plans to review and continue to work towards issuing a revised version of the Standards for comment in early 2020.
Of the 141 responses, most were from CME providers (75%), though ACCME also received responses from several clinicians and healthcare professionals, several medical and healthcare associations, an advocacy organization and a patient/caregiver/member of the public.
Each of the six Standards received responses outlining challenges and recommendations.
For Standard 1 “independence”, ACCME asked about new or existing challenges related to the separation of accredited CME from commercial influence that the ACCME should address. Comments touched upon the following topics:
- Many doctors in teaching hospitals have relationships with industry, which makes it difficult to provide education “devoid of commercially connected physicians”
- The importance of conflict of interests being properly reported and/or resolved;
- The difficulty of poster sessions and the inability to have commercial support for meals and receptions – it is difficult to get learners to attend poster sessions with the required separation;
- That the Standards have removed too much control from the providers in how to best keep promotion out of education;
- The ambiguity of the commercial interest definition as it relates to health technology companies and digital platforms that host and/or deliver content; and
- The difficulty with being able to determine if a company is from industry as technology and the industry change and evolve.
Some of the recommendations for Standard 1 include the following:
- Disclosing levels/ranges of commercial support to learners and/or the percentage of total activity cost provided by a commercial supporter;
- Allowing accredited providers more latitude in determining whether content or potential involvement represents a true COI and/or whether the proposed content has value for learners;
- Consider updating the definition of commercial interest with input from accredited providers;
- Reexamine the requirement that no employee of a commercial interest can be in control of content;
- Provide an option for providers to work with industry and demonstrate that there is no bias;
- Consider disallowing any for-profit entities (including hospitals, rehab centers, etc.) from controlling CME credit; and
- Require universal disclosure of all financial and non-financial relationships with commercial and non-commercial healthcare-related interests, not just “relevant” financial relationships.
For Standard 2, ACCME asked about new or existing challenges respondents have seen related to the identification and resolution of conflicts of interest in accredited CME that the ACCME should address. Some of the challenges respondents noted include the following:
- Getting all faculty to submit their content for review prior to an activity;
- “Substantial” resentment from speakers about repeated redundant disclosures that need to be collected and stored in a variety of institutional systems;
- The vague nature of the standard, especially as it relates to determining relevance;
- Tough on financial resources of smaller organizations to collect and resolve conflicts of interest;
- The lack of a definition or delineation of what elements of financial relationships are to be disclosed; and
- No clear definition of who is considered to be “in control of content,” and therefore who needs to disclose.
Some of the recommendations for Standard 2 include:
- Create a national database that houses conflict of interest information;
- Create guidance on how to determine if a conflict is relevant;
- Allow the accredited providers more leeway in determining whether content or potential involvement represents a true conflict of interest;
- Participate and help to create a universal disclosure definition that could be adopted by societies, journals, and academic institutions across science and medicine; and
- Define and possibly update the definition of a commercial interest to include entities involved in new and innovative healthcare practices.
For Standard 3, ACCME asked about new or existing challenges related to the appropriate management of commercial support of accredited CME that the ACCME should address. Some challenges respondents mentioned include:
- Different, non-standardized, budget templates for each grantor;
- A variance in the way providers accept and apply the rules regarding commercial support;
- How to handle exhibitors who are renaming exhibit fees into commercial support and then trying to dictate how the funds should be spent;
- Not enough of an emphasis placed on creating an environment in which learners can learn; and
- Confusion around what is considered commercial support.
Recommendations for Standard 3 include the following:
- Look at whether guidelines should be different for online content in some way;
- Require that any commercial supporter who provides CME support in a given year report all CME support provided in dollar levels and recipient accredited providers, both case and in-kind values;
- Provide a standard agreement for use with commercial supporters;
- Change the “must sign” requirement to something that also encompasses electronic signatures and acceptance of agreements; and
- Allow providers to reimburse expenses and/or pay honoraria to teachers/authors if they choose to participate in the remainder of an educational event as a learner.
For Standard 4, the ACCME was interested in hearing about new or existing challenges related to the appropriate management of associated commercial promotion that the ACCME should address. Challenges included:
- An unclear understanding of what is meant by separation of promotion;
- What is permitted to be in the “conference bag” attendees receive at the registration area of conferences;
- The requirement that meeting rooms used for certified education must be totally separated from rooms used for promotional sessions is a financial burden for some organizations;
- A conflict between Standard 4.4 and Standard 5 as to the prohibition/allowance of using trade names in educational materials;
- Managing the increasing use of in-kind products/devices in a growing simulation-based education program;
- Needing further guidance for providers who offer dinner/breakfast CME programs in which the meal portion of the activity is promotional; and
- Balancing the need to bring additional revenue to meetings with the reality of limited space.
Some of the recommendations for Standard 4 included:
- Requiring all grant portals to separate grant application processes from exhibit transaction processes entirely;
- Allow product theaters prior to or after CME activity in the same meeting room as long as the change in activity is stated in advance to the learner, is labeled as non-CME, and the learner has the ability to leave the room prior to the start of the non-CME program;
- Consider adding a category for CME delivered via social media;
- Clarify the positioning of ads or acknowledgement of commercial support in electronic applications;
- Provide more current examples of compliance and noncompliance;
- Creating a publicly available list of prohibited sponsorship assets (i.e., general wifi within a CME meeting); and
- Update the standards around online content to provide clear guidance about where promotion is acceptable and to allow flexibility for new online formats.
For Standard 5, the ACCME asked for challenges relating to accredited CME content and format without commercial bias. Responses included:
- Confusion over what to do when the drug or device is unique;
- Confusion about medical device CME, as it is difficult to report on evidence without reference to the actual brand name of the device to distinguish it from other similar devices;
- How to provide education on controversial topics when there is limited evidence for clinical recommendations;
- Additional guidance needed regarding the use of agents for off-label purposes; and
- Difficulty understanding support requirements and expectations as they relate to medical marijuana.
Recommendations for Standard 5 included:
- Provide clarifications on the “special exceptions”;
- Consider allowing employees/owners of ACCME-defined commercial interests to present accredited CME related to the commercial interest’s business lines or products provided that the content promotes improvements or quality in healthcare and not a specific proprietary business interest;
- Allowing the use of a medical device name/photo when used for a specific procedure;
- Provide greater clarity on when the use of proprietary names (when necessary) is acceptable;
- Drawing a bright line between promotional and non-promotional speakers; and
- Consider relaxing some of the restrictions on logos, etc.
For Standard 6, the ACCME wanted to hear about challenges related to disclosures relevant to potential commercial bias in accredited CME that the ACCME should address. Responses included:
- Interpretation and assurance of compliance with Standard 6 are left to the discretion of the provider, which leads to the double-edged sword of flexibility and ambiguity;
- Confusion over how to disclose financial support without using a trade name if they are not known by anything else;
- Confusion over the definition of an employee of commercial interest;
- The difficulty of getting disclosures from faculty in a timely manner;
- Whether there is a way to handle identification and disclosure of relevant financial relationships during a live CME event, for example, by a last-minute presenter or when they discuss a case without prior notice; and
- Confusion over what is commercial support and what is personal conflict of interest.
Recommendations for Standard 6 include;
- Providing more guidance as to the length of time after a relationship has been terminated that it still must be disclosed;
- Removing the “trade name” piece of Standard 6.4;
- Modernizing the requirements about disclosures relevant to potential commercial bias to reflect the changing environment, expand the definition of commercial interest to include EHR vendors and other health technology companies that have the potential to risk patient or population health;
- Providing specific expectations and examples; and
- Moving toward general disclosure by asking providers to collect a disclosure of all relationships with commercial interests as defined by the ACCME.
Additional feedback in general included suggestions about: making the language of the Standards more direct; narrowing the current regulations; considering and reviewing the policies and standards with their potential impact on all healthcare professions and interprofessional CME; adding a policy statement, FAQ, or new section of the SCS that addresses the separation of promotion from education on platforms such as apps, digital devices, or EHRs; and commissioning independent research studies to examine whether declarations to learners mitigate bias or the perception of bias.