On January 7, 2020, the Accreditation Council for Continuing Medical Education (ACCME) announced a call for comment about its proposed revisions to the Standards for Integrity and Independence in Accredited Continuing Education. The revised standards are expected to continue to promote the independence and integrity of accredited continuing education for healthcare professionals.
Overview
One of the first changes is changing the title of the documents from Standards for Commercial Support to Standards for Integrity and Independence in Accredited Continuing Education.
Among the proposed changes are replacing the term “continuing medical education” with the term “accredited continuing education (ACE)” and instead of requiring accredited providers to resolve relevant conflicts of interest among those planning/controlling ACE content, the new standards would require providers to mitigate the potential effect of financial relationships on ACE.
Eligible and Ineligible Entities
The proposal defines eligible entities as organizations whose primary mission and function are: (1) providing clinical services directly to patients; or (2) the education of health care professionals; or (3) serving as fiduciary to patients, the public or population health; and other organizations that are not otherwise ineligible. The below image includes examples of eligible entities.
Ineligible entities, on the other hand, are organizations whose primary business is producing, marketing, selling, reselling, or distributing health care products used either by or on patients. The below image includes examples of ineligible entities.
Standard 1: Ensure Content is Valid
Standard 1 incorporates the current CME Clinical Content Validation Policy and further clarifies that while education may inform learners about approaches that are not generally accepted, the education must not advocate for those approaches or teach how or when to use them.
All scientific research that is referred to, reported, or used in accredited education in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection, and analysis. Organizations will be unable to be accredited if they advocate for unscientific modalities of diagnosis or therapy or if their education promotes recommendations, treatment, or manners of practicing health care that are determined to have risks or dangers that outweigh the benefits or are known to be ineffective in the treatment of patients.
Standard 2: Preventing Marketing or Sales in Accredited Continuing Education
The proposed revision to Standard 2 updates and simplifies the guidance for independence, including prohibiting faculty from marketing or selling their products or services during accredited education. Additionally, accredited providers must receive consent from learners before sharing their names or contact information with ineligible entities or their agents.
Standard 3.1: Identify, Mitigate, and Disclose Relevant Financial Relationships with Ineligible Entities
The proposed revision also requires that accredited providers must collect disclosure information from those in control of content about all their financial relationships with ineligible entities for the prior twelve months. It is the accredited providers responsibility to determine which relationships are relevant.
There is no minimum financial threshold – individuals are required to disclose all financial relationships, regardless of the amount, with ineligible entities, and must disclose regardless of their view of the relevance of the relationship to the education. This goes beyond just the individual involved, but also includes the known financial relationships of their spouse or partner.
Standard 3: Ownership
Employees of ineligible entities will not be able to participate as planners or faculties unless one of these specific situations applies:
- When the content of the activity is not related to the business lines or products of their employer;
- When the content of the accredited activity is limited to basic science research, such as pre-clinical research and drug discovery, or the methodologies of research, and they do not make care recommendations; or
- 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.
Standard 3.5: Disclosure
The proposal requires that in the disclosure to learners, a statement must be made that all relevant financial relationships have been mitigated and learners must receive that information prior to engaging with the accredited education.
The absence of relevant financial relationships shall also be disclosed. Learners shall be told when planners, faculty, and others that are in control of the content have no relevant financial relationships with ineligible entities.
Standard 3.4 – Self Directed Learning
Self-directed accredited continuing education has a carveout which allows for when the learner is in control of the content and there are no planners or faculty, accredited providers do not need to identify, mitigate, or disclose relevant financial relationships. However, when accredited providers serve as a source of information for the self-directed learner, they should direct learners only to resources and methods for learning that are not controlled by ineligible entities.
Standard 4: Manage Commercial Support Appropriately
The purpose of Standard 4 is to simplify guidance about decision-making and the disbursement, agreements, accountability and disclosure to learners. The accredited provider is responsible for dispersing the commercial support and ineligible entities are not permitted to directly pay for any of the expenses related to the education or the learners.
The accredited provider is permitted to use commercial support to fund honoraria or travel expenses of planners, faculty, and others who are in control of content. However, those expenses must be paid or reimbursed directly to the individual by the accredited provider, not by the ineligible entity or by a joint provider. Further, the accredited provider is not allowed to use commercial support to pay for travel, lodging, honoraria, or personal expenses for individuals or groups of learners in accredited education. However, the accredited provider may use commercial support to defray or eliminate the cost of the education for all learners.
Additionally, when it comes to disclosing commercial support, the accredited provider must disclose to learners the name of the ineligible entities that provided commercial support, as well as the nature of the support if it was in kind, prior to the learners engaging in the education. The disclosure may not include the ineligible entities corporate or product logos, trade names, or product group messages.
Standard 5: Manage Ancillary Marketing around Accredited Continuing Education
Standard 5 includes simplified and updated guidance about the separation of accredited education and marketing by ineligible entities. It clarifies that learners must be able to easily distinguish between accredited education and other activities, such as non-accredited continuing education and marketing. Further, those other activities must not be interwoven with the accredited education, nor can they occur in the physical space immediately before or after an accredited education activity.
When it comes to print, online, or digital continuing education activities, learners must not be presented with marketing while engaged in the accredited education activity. They must be able to engage with the accredited education without having to click through, watch, listen to, or be presented with product promotion or product-specific advertisement.
Potential Problems
While many of the changes clarify previous language, there are some potential issues in the proposed changes.
In Standard 1, by allowing the education to talk about treatment that is not generally accepted but not advocate for it, it puts the onus on the CME provider to determine the difference between a simple “discussion” of the idea and “advocating” for it.
Additionally, by requiring accredited providers to disperse all commercial support under Standard 4, the role of the joint provider is limited and suggests that only the accredited provider can be the direct recipient of commercial support. Often, continuing education programs are done with multiple accredited providers working together. There are also practical payment processing issues, such as situation where the accredited provider (i.e., a smaller specialty or state medical society) does not have the staff to process payments to faculty and expenses or in the case of universities, which have to set up each speaker as a vendor in their systems and can take up to two years to secure authority to hire additional personnel. Perhaps a better alternative may be to require the accredited provider to keep records of faculty payments.
Comments?
All comments are due to the ACCME by 5pm CST on February 21, 2020. Comments can be submitted through the ACCME website here.