By Thomas Sullivan, Jan Schultz and Michael Lemon
On Jan. 23, 2020, the CME Coalition held a webinar on the proposed changes to the ACCME Standards for Commercial Support, which were released on Jan. 7, 2020. The webinar discussed the changes, opportunities and challenges with the proposed new Standards by the ACCME.
Panelists on the webinar included: Thomas Sullivan, President of Rockpointe, Founder of the CME Coalition, and Editor of Policy & Medicine; Michael Lemon, MBA, FACEHP, CHCP, President of the Postgraduate Institute for Medicine (PIM); and Jan Schultz, MSN, RN, FACEHP, CHCP, Principal of Jan Schultz Associates.
Background on ACCME Standards for Commercial Support
The ACCME Standards for Commercial Support: Standards to Ensure Independence in CME ActivitiesSM were initially published in 1992, with a full revision taking place in 2004 and partial changes in 2008 and 2014. ACCME Standards have been adopted by other accrediting organizations, such as the ANCC, the ACPE and Joint Accreditation, thereby making the ACCME Standards the “gold standard.”
The Proposed Changes
Included in the proposed changes are new terminology, new requirements, more clarity around who can and cannot be accredited or control content of accredited continuing education activities, and an incorporation of policies into the Standards, instead of having separate documents.
Mr. Lemon applauded the ACCME and its Task Force for their efforts to incorporate the policies into the Standards, thus making the information more easily accessible.
One of the more general changes in the proposal is that the Standards will go from being known as the “ACCME Standards for Commercial Support” to the “ACCME Standards for Integrity and Independence in Accredited Continuing Education,” to better reflect the scope and extent of the Standards.
The proposed Standards include new terminology, such as “eligible entities,” which will refer to organizations that are eligible for accreditation and/or control of content in the ACCME system, and “ineligible entities,” which refers to organizations that are not eligible for accreditation nor control of content. Ineligible entities were formerly known as commercial interests. The purpose of this change is to clarify that eligibility for accreditation is not based on whether an organization is for-profit or nonprofit, but instead based on its primary mission and function. Updated lists of types of organizations in each of the two categories have also been included to provide additional clarity.
Additional new language includes “mitigate,” which replaces “resolve” with reference to actions taken related to handling conflicts of interest (no change in intent) and “Accredited Continuing Education,” which replaces “Continuing Medical Education” and serves to be inclusive of all health professions and differentiate from non-accredited education.
Eligible vs Ineligible Entities
Ms. Schultz indicated that the document describes the general types of organizations that are considered eligible entities. There is no major change of intent apparent here, as these types of organization are eligible for accreditation under the current system. whose primary mission and function are one of the following: (1) providing clinical services directly to patients; (2) the education of healthcare professionals; or (3) serving as fiduciary to patients, the public or population health. It also includes organizations that are not otherwise ineligible. ACCME also provided an expanded list of organizations that may be considered eligible entities that takes into account the changing nature of how and where patient care is provided, as well as the interaction of care with the digital space.
The proposed ACCME definition of an ineligible entity differs slightly from the current definition of a commercial interest:
Current definition: “A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. “[i]
Proposed definition: “Entities that are ineligible to be accredited in the ACCME System are organizations whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.”[ii]
Ms. Schultz noted the addition of the word “primary” (emphasis added on slide below) and the more general term “healthcare products,” rather than good or services. For the first time, the proposed Standards also provide a list of the specific types of organizations that are ineligible entities. As with the list of eligible entities, this list addresses the changing nature of what is considered an ineligible entity and reflects current and evolving changes in the commercial space.
Standard 1: Ensure Content is Valid
Standard 1 focuses on ensuring the content presented accredited continuing education is valid. Most of the requirements included in this Standard are not new but integrate previously issued ACCME policy and/or guidance documents. The specific references to controversial topics is based on guidance previously provided by ACCME that includes any topic that is not supported by generally acceptable level of evidence demonstrating efficacy in humans, such as the current state of cannabis/marijuana medicine and some forms of alternative/complementary medicine. Some have raised the concern that this provision may be seen to apply to content addressing off-label use. While this does not appear to be the intent, comments on this issue should probably be submitted for clarification.
For these controversial topics, the proposed Standards allow the content of an accredited activity to have discussion about the state of evidence related to these topics but must not advocate for the approaches or teach healthcare professionals how or when to use them. For example, ACCME has previously indicated that an eligible entity could hold a panel discussion on the evidence, but not get into dosing or for which patients something that is controversial can be used. This is the same approach that the AAFP adopted in 2019.
Standard 2: Prevent Marketing or Sales in Accredited Continuing Education
Standard 2.2 focuses on preventing marketing or sales from creeping into Accredited Continuing Education. There is a requirement in this section of the Standards that faculty members are not permitted to promote or sell products or services that serve their professional or financial interests during an accredited activity. This is a new requirement for ACCME, but not for those who have been involved in nursing continuing education. Some examples of that are authors promoting a book they wrote or content where faculty might be from a tertiary medical center and advocating for referral of patients to their center or practice.
Standard 2.3 indicates that accredited providers must also not share the names and contact information of learners with any ineligible entities or their agents without the explicit consent of the individual learners each time the data is to be shared. This consent must include the name of the ineligible entity receiving the learner information and describe how the entity intends to use the information. In this instance, it may be helpful for ACCME to better define what a learner is, as a broad definition could be seen to include all registrants at an activity, such as an annual scientific meeting. The webinar panelists saw this latter interpretation as being disruptive to the marketing of exhibit space.
Standard 3.1: Identify, Mitigate, and Disclose Relevant Financial Relationships with Ineligible Entities
In addition to replacing “resolve” with “mitigate,” Standard 3 requires providers to collect disclosure information from everyone in a position to control content about all of their financial relationships with ineligible entities for the prior 12 months. Historically, they only had to collect information about commercial interests related to the content of the CME/CE activity. The panelists commented that in academic practices focused on research, this listing may be pages long and not be sorted to indicate those with eligible and ineligible entities. Education on potential options for obtaining this information, such as yearly disclosure, would be welcome.
Standard 3.2: Ownership/Employee
The requirement that employees of ineligible entities cannot be planners or faculty is not new. The specific addition of “owners” is new, and the panelists recommend comments on defining what constitutes ownership. There are three exceptions to that general rule, and these are not new:
“(a) if the activity is not related to the business lines or products of the employer/company; (b) when the content of the 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 (c) if 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.”[i]
What is new is the rule and the exceptions are now being integrated into the Standards.
Standard 3.3: Identify Relevant Financial Relationships
The proposed Standards clarify that the accredited provider must sort through and identify financial relationships to determine the ones that are relevant to the content or activity. This process may require resources not currently available to all providers, such as web searching skills.
Standard 3.5: Disclosure
This Standard requires providers to include a statement that all relevant financial relationships have been mitigated. Learners must receive the information before engaging with the accredited education. This is new, but many providers already do this.
Standard 3 – Self Directed Learning
Standard 3 creates an exception for self-directed learning. In these circumstances, accredited providers do not need to identify, mitigate or disclose relevant financial relationships. This does not cover case-based regularly scheduled series (RSS) but is limited to point-of-care learning in which the learner is completely in charge of selecting the sources of information. If this is point-of-care learning where the provider recommends or maintains a compendium of resources, the accredited provider must confirm that the resources are not produced by ineligible entities. This may require engaging in the disclosure and conflict mitigation process.
Standard 4: Manage Commercial Support Appropriately
There are some relatively notable changes in the proposed Standard 4. Consistent with current Standards, the accredited provider must make all decisions regarding the receipt and disbursement of commercial support. However, the proposed Standards state that the accredited provider is responsible for dispersing the commercial support. The proposed changes also state that the commercial support used for honoraria or travel expenses of planners, faculty and others in control of content must be paid by the accredited provider and not by an ineligible entity or by a joint provider.
Requiring the accredited provider to directly pay for these expenses as opposed to allowing the accredited provider to give permission to a joint provider to pay these expenses has the potential to disrupt staffing, costs and faculty satisfaction with the timing of reimbursement. Mr. Lemon suggested that this may be an item worth sharing comments on about upholding the intent of what the ACCME is trying to protect here but offer suggestions in ways we can do that to maintain intent while allowing for administrative efficiency throughout the process.
Ms. Schultz noted that we also need to think of this as not just affecting providers and joint providers but may lead to rethinking in the supporter community and impact how budgets are prepared. Mr. Sullivan raised another concern: some of the universities have expressed that they are not set up for faculty payments and expenses. Additionally, universities may add a “dean’s tax,” depending on the situation, thereby increasing prices. Additionally, to set up a new vendor in some hospital systems could be time consuming, potentially difficult, and may involve Stark or Anti-kickback legal considerations. Commenters should propose other ways to achieve the intent and highlight specific ways in which the proposed requirement might result in unintended consequences.
Standard 5: Manage Ancillary Marketing around Accredited Continuing Education
Nothing new here and just puts things in one place as opposed to multiple places. Arrangements to allow ineligible entities to market or exhibit in association with accredited education must not: influence any decisions related to the planning, delivery, and evaluation of the education; interfere with the presentation of the education; or be a condition of the provision of financial or in-kind support from ineligible entities for the education.
The Standard also requires that the accredited provider ensure that learners can easily distinguish between accredited education and other activities, including non-accredited education and marketing. Ms. Schultz noted that one possible point that needs clarification is Standard 5.2, which notes that marketing, exhibits, and non-accredited education must not occur in the physical space immediately before or after an accredited education activity and must not be interleafed within the accredited education. Defining what is meant by “immediately” would be helpful, as would clarifying what is meant by the restriction on “interleafed” activities. Additionally, there is a requirement that learners 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. Clarification on what is meant by “click through” would also be beneficial to the community.
Webinar Questions and Answers
One question was what is the concern ACCME has about the current practice of joint providers paying honoraria and reimbursing expenses. Mr. Lemon attempted to answer, thinking that there may be concerns about ensuring that the accredited provider maintain responsibility for the process and looking to ensure those individuals do adequately get paid and/or reimbursed. In any comments submitted to the ACCME, it would be helpful to suggest how administering the faculty expenses can be done by a joint provider with the accredited provider maintaining control.
Another question asked whether a founder of a commercial interest can speak at an accredited CME event if the content of the presentation does not mention the company’s product. The panelists noted that the issue isn’t whether the product is mentioned but that the content of the activity cannot address the business lines of that owner’s company.
Focused on interleafing, there was a question about whether a non-accredited activity could be interleafed with an accredited activity and what it meant, such as would it impact an annual meeting that has both CME and non-CME sessions. Mr. Lemon noted that the intent is to protect the integrity of the room/space where the accredited activity is taking place and suggested that the intent behind the Standard is to ensure clear separation between the two and an adequate break should be between them. He thinks an interleafing, or “interspersing,” is an instance where sessions 1 and 2 are accredited, session 3 isn’t, and then session 4 is, without any breaks taking place before or after session 3.
Another question focused on the definition of interleaf, wondering if listing non-accredited activities on the agenda would satisfy that requirement. Mr. Lemon noted that there needs to be a clear separation between accredited and non-accredited activities. He also acknowledged, however, that the intent comes into play when, for example, the first half of the day included accredited activities followed by lunch and an afternoon of non-accredited activities. He cautioned providers to examine the overall intent of the activity.
One attendee asked whether home health agencies are considered eligible entities, and the answer was that, yes, they would be considered an eligible entity unless the entity is owned or controlled by an ineligible entity/commercial interest. That is currently ACCME’s position for any of those on the eligible list.
Another question touched on hospital-based providers and whether Standard 4 could result in CMS implications when it comes to their receipt of and disbursal of funds. Mr. Sullivan acknowledged that there are potential Antikickback Statute and Stark implications and is happy to address the question in more detail via email. He also noted that the CME Coalition’s forthcoming comprehensive guide on compliance with all of the laws, standards, and ethical/behavioral guidelines governing the healthcare CPD space will have more details on the issue.
Another question was focused on whether the new Standards change when providers are required to disclose relationships. Mr. Lemon noted that the proposed Standards seem to still require disclosure before the learners engages in the education.
A question on Standard 3.2 came in, asking whether industry scientists would not be able to present as faculty at any conference that is accredited. Ms. Schultz noted that if the activity is related to the content of the employer of the industry scientist, they could not present unless they fell into one of the exceptions. There are some associations with many industry members, and those industry members could talk about the regulatory process or basic science behind a new approach, but could not talk about clinical trial results.
Additional questions and answers are included in the replay of the webinar, link below.
It’s important to read the entire document of proposed changes, as you may see areas that concern you that were not mentioned in the webinar. The ACCME document also contains the current Standards for Commercial Support. Responses should be submitted using the link to the online survey included in the document. The format and questions included in the online response survey are provided in the document for ease of constructing cut and paste replies.
All comments on the proposed changes and suggestions for the roll out period are due to the ACCME no later than 5 pm CST on Feb. 21, 2020. Once the comment period closes, the ACCME Board of Directors will review the responses at its March meeting. After the Board makes modifications and adopts the revised Standards, the ACCME will release a transition plan for the CME community. In the meantime, the current Standards for Commercial Support remain in place, and providers should adhere to them.
 ACCME Definition of a Commercial Interest. https://www.accme.org/accreditation-rules/policies/definition-commercial-interest (accessed 1.27.2020)
 Call For Comment Information Package: Standards for Integrity and Independence in Accredited Continuing Education. Downloadable at https://www.accme.org/publications/calls-for-comment (accessed 1.27.2020