Recently, the American Medical Association (AMA) Council on Ethical and Judicial Affairs (CEJA) held it’s two webinars to discuss Report E-9.0115 Financial Relationships with Industry in Continuing Medical Education. This past June, after four previous failed attempts, the AMA House of Delegates passed a significantly revised version of the report, with a bare majority on the first vote. The webinar included:
- Bette Crigger, PhD, Director of Ethics Policy and Secretary of the Council on Ethical & Judicial Affairs at the American Medical Association.
- Sharon P. Douglas, MD is Professor of Medicine and Associate Dean for VA Education at the University of Mississippi School of Medicine.
- Norman Kahn Jr., MD, is the Executive Vice President and CEO of the Council of Medical Specialty Societies.
Consequently, after an October CEJA presentation during the 22nd Annual Conference of the National Task Force on CME Provider/Industry Collaboration, the CME Coalition wrote a letter to Modena H. Wilson, MD, MPH and Sharon Douglas, MD, who is Chairwoman of CEJA, expressing the Coalitions concerns about the “10 myths about CEJA” presentation.
Specifically, the CME Coalition noted that the AMA presentation an interpretation of the CEJA Report was perceived by many in the audience as being inconsistent with its explicit language. For example, AMA staff stated that according to the Report, “independence from industry support” is a primary goal. However as the Coalition noted, “the Report’s actual language, however, contains no such suggestion that CME support by industry should be eliminated. In fact, the Report only indicates that CME providers must continue to evaluate when industry support is, or is not, appropriate.”
The Coalition also reminded CEJA that “The Report explicitly supports the use of such experts with financial interests by reassuring physician-learners that they can rely on these experts’ availability in the future because CME providers will make “vigorous efforts … to maintain the independence and integrity of educational activities.” (1-I-11, line 31-32). However, on this matter too, the presentation left many unanswered questions and perhaps implied a more restrictive position than the Report intended.”
As a result, the Coalition noted its concern that if “AMA representatives are permitted to offer interpretations of the CEJA Report that deviate from its actual provisions, the AMA will be committing a disservice to audience members who wish to understand its true position on this issue of considerable complexity and controversy.”
Based on the changed nature and tone of the CEJA webinars and the points of clarification AMA staff made during the call, it appears that CEJA clearly and adequately addressed many of the concerns the CME Coalition and other CME stakeholders expressed.
CEJA Webinar and CEJA Report 1
CEJA first explained the nature of CEJA reports or Opinions, which are used to “analyze ethical issues and develop ethical guidelines for physicians.” They explained that CEJA Opinions are used to propose guidelines, which are presented to the AMA HOD through the House’s reference committee process. Recommendations of reports adopted by the House are subsequently published as Opinions in the Code of Medical Ethics.
The CEJA 1 report was a product of a joint working group convened by CEJA and the Council on Medical Education. CEJA explained that it received extensive input from stakeholders to create its report including:
- Testimony in reference committee, along with written commentary including detailed recomendations from Association of Clinical Researchers and Educators, Council for Medical Specality Societies, Alliance for CME and many other stakeholders.
- Special in-person consultation with representatives from CME providers across the spectrum, as well as industry and public interest groups
CEJA also explained that the rationale behind CEJA 1 was three core principles
- Transparency
- Independence
- Accountability
CEJA defined transparency as “providing the information physicians need to make their own judgments about CME activities.” Specifically, they noted that transparency, according to the language of CEJA 1 includes:
- The source and nature of financial interests (b)(1), (b)(ii)
- Steps taken to mitigate potential influence (b)(iii)
- In situations that involve substantial financial interests, the magnitude of financial interests (c)(v)
Unlike the first presentation CEJA made during the 22nd Annual Conference of the National Task Force on CME Provider/Industry Collaboration, staff explicitly recognized that CEJA 1 only required magnitude when a situation involves substantial financial interests. Nevertheless, CEJA emphasized that in the interest of transparency, CME providers should disclose magnitude as well.
Another core principle CEJA noted was independence, which they defined as
- Ensuring that the profession sets educational goals and priorities, based on identified needs.” (c)(i)
- Giving preference to qualified faculty or content developers who don’t have financial interests in the educational subject matter (c)(iii); and
- Taking steps to minimize or mitigate potential influence (b)(iii), (c)(vii)
Accountability
- Transparent process for determining when industry support is needed (c)(ii)
- Transparent process for determining when participation by a “conflicted expert” is justifiable (c)(iv)
- Being able and willing to discuss how principles of transparency and independence have been applied in relation to specific CME activities
Case Study
Specialty Society A convenes a planning committee for its CME program. At the beginning of each committee meeting, committee members, all of whom are members of the society, are asked to disclose relationships with companies in the pharmaceutical and medical surgical device industries. Half of the committee members disclose varying relationships with one or more companies.
Question #1
Is it okay for half the members of planning committee to have relationships with industry?
Answer #1
Dr. Douglas and Criggers noted that it depends on the nature of the relationships. They noted that the CEJA report indicates that relationships that are indirectly related to the educational activity, modest, or distant in time, are less likely to affect the activity and are less likely to be perceived to affect the activity. Accordingly, they noted several issues to consider regarding financial interest and potential influence:
- How directly related to the educational activity is the given relationship/financial interest?
- What is the scope or nature of the relationship/financial interest?
- Is the relationship distant in time or ongoing?
Criggers and Douglas then noted that the CEJA opinion does not set specific thresholds or dollar amounts for financial interests, or what exact percentage of a planning committee is appropriate to have financial interests. Instead, they noted that CME planning committees that have a high proportion of members with financial interests, who, in general, have the potential to be conflicted, could be seen as not consistent with new CEJA opinion.
Instead, they asserted that it would be better if a planning committee had few or no members with relationships that might influence the program.
Nonetheless, they noted that in limited circumstances, which they did not define with any specificity, a society could be permitted to allow “conflicted” individuals to serve on a planning committee. In such a case, they explained that the society or CME provider must take steps to mitigate potential influence, and disclose the relationships.
The planning committee draws educational goals for the CME program from a needs assessment done by the society among its members and gap analyses of the society’s clinical registries. The committee determines that program goals are to increase knowledge of physicians in the society in the specific areas identified by the needs assessment and to close the performance gaps identified through the gap analysis. These combined goals are a priority for the society for the near future.
Question #2
Is process sufficient to determine needs, goals, and priorities?
Answer #2
CEJA for the most part deferred the answer to this question to the criteria under the AMA PRA Category 1 credit system and the related regulations, rules and requirements for CME to meet this category.
After developing the program, the planning committee seeks faculty who are knowledgeable experts in the requisite areas, have demonstrated pedagogical skills, and who are anticipated to be a “draw” for attendees. Each faculty member is required to disclose fully his or her relationships with pharma or device companies. Several proposed faculty members disclose relationships of varying types.
Question #3
Are these criteria for selecting faculty consistent with CEJA’s new policy?
Answer #3
CEJA first noted that its opinion does not set any criteria for faculty selection and that it is the responsibility of each individual CME provider. However, Criggers and Douglas noted that identifying faculty based on expertise, pedagogical skills, and reputation seemed reasonable. They also confirmed that requiring each potential and confirmed faculty member to fully disclose their financial relationships is consistent with the CEJA opinion.
The planning committee determines that based on the nature of the relationships disclosed, these individuals may serve as faculty members, under certain conditions.
Question #4
Is the need for faculty with relationships justifiable?
Answer #4
CEJA noted several issues to consider when determining faculty selection with potentially “conflicted experts”
- Is the individual’s participation central to the success of the educational activity?
- Does the activity meet a demonstrated need?
- What steps should be taken to mitigate the potential influence given the nature of the relationship at issue?
CEJA noted that if a society or CME provider determines that an individual faculty has a substantial interest, but otherwise meets the provider’s criteria to serve on the faculty, the CME provider must disclose the source, nature, and magnitude of the interest.
Consequently however, CEJA noted that its opinion made clear that for CME providers, preference should be given to faculty without financial interests in the subject matter related to the activity. They clarified again however that the less related the interest is to the educational activity, the more modest in scope and the more distant in time the interest is, the less likely the relationship will be problematic.
CEJA emphasized that the importance here is that the society or CME provider have a transparent process to make the decisions of whether to allow an individual with an interest to serve on the faculty.
Each faculty must disclose her relationship(s). In addition
- Some faculty are asked to organize their presentations using the evidence-based CME model preferred by the society, which includes disclosing to learners the source and level of evidence for practice recommendations made during the presentation
- Some faculty are asked to submit their presentations for advance peer review by two experts identified by the society (on the understanding that the presentation cannot be changed after peer review). The expert reviewers are also asked to disclose relationships; one discloses relationships with industry, the other discloses no relationships.
- Some faculty are asked to present only on pathophysiology and/or research findings of the condition covered in their presentation, without making any practice recommendations, because although the individual’s disclosed relationship(s) with industry enable him or her to make uniquely available contribution, the relationship(s) Is too close to be perceived as unbiased. The planning committee and staff intent to serve as on-site monitors of many, but not all presenters.
Question #5
Are the proposed strategies for mitigating potential influence sufficient?
CEJA noted that there were three mitigation strategies present in this part of the hypothetical
- Evidence based presentation
- Peer review of the presentation
- Although individuals with unique contributions were allowed to serve as faculty when they had relationships, they were not asked to make practice recommendations and instead, to just focus on research findings and objective science because their relationships were too close for potential conflicts.
CEJA explained that its opinion does not establish specific strategies of how to mitigate potential conflicts. They noted that the strategies used in the example above, such as a robust, evidence based model and proactive peer reviews, all seemed to be appropriate strategies.
With the program finalized, the society seeks funding from the pharmaceutical and medical-surgical device industry to help defray the cost of the program. This will allow the society to charge lower registration fees to attendees and thus enhance the society’s ability to achieve its priority goals.
Question #6
Is the rationale for commercial support sufficient?
Answer #6
CEJA noted several issues to consider regarding the rationale for industry support
- Does the activity meet a demonstrated need for the intended audience?
- Would declining industry support significantly undermine the capacity to provide high quality CME on this subject matter for the intended audience?
Dr. Douglas asserted that lowering registration fees and convenience of a program for attendees is not a rationale for commercial support consistent with CEJA’s new opinion. However, she recognized that industry support is sometimes needed to ensure high quality CME access, and noted two factors to consider:
- Whether the CME activity involves expensive tools, technology, equipment or a highly specialized environment, which would require the CME provider to impose fees that would be prohibitive, relative to other fees in that area.
- Whether the absence of commercial support would undermine the CME activity
QUESTIONS FROM PARTICIPANTS
It was first noted that the CEJA report only focuses on pharmaceutical and medical device companies, not other interests (i.e. insurance companies). They also noted that CEJA did not focus on relationships with book chapters or other more narrow relationships.
CEJA again emphasized that the report is an Ethical Opinion, meant to be a guideline, and to be applied accordingly.
CEJA was asked to define the term “when possible” as used in the CEJA Report—“When possible, CME should be provided without such support or the participation of individuals who have financial interests in the educational subject matter.”
CEJA explained that “when possible’ expressed an aspiration of the ethical opinion, which is to maximize the independence of CME from industry support. They asserted that the default presumption should be “no industry support, except special circumstances as defined in CEJA’s ethical guidance.”
When asked to define “magnitude” CEJA explained that it is the dollar amount of the interest involved. They noted that CEJA does not set thresholds for dollar amounts, but recommended that CME providers set up a range of dollar values (i.e. $1,000-$10,000) in which the interest falls.
With respect to planning committees and members, CEJA emphasized again that a CME providers planning committee needs to have goals and processes in place to ensure that priorities are being set and prospective needs assessments are being conducted if and when commercial support is sought. They again pointed to the criteria for the AMA PRA Category 1 credit system. In addition, CEJA emphasized that its opinion, once again, is ethical guidance, and that the details of implementation rest with CME providers individually, not with CEJA’s opinion.
CEJA clarified that the opinion requires that the nature (i.e. speaking, consulting) and source (i.e. name of company) of an identified interest be identified in all cases, and that the magnitude (i.e. specific dollar amount) only be identified when a faculty member has a substantial interest. However, they noted that the philosophy and three principles underlying the CEJA opinion would support uniform disclosure of magnitude.
CEJA noted that it is up to individual CME providers to determine whether all presentations, or only those with speakers who have disclosed interests, should be reviewed for bias.
CEJA noted that the use of commercial support at a hotel or resort is more appropriately discussed in CEJA’s 8.061 opinion about the nature of appropriate venue. The CEJA opinion does not specify an answer to resorts however, it was noted that CEJA will be revisiting this opinion soon. The essence of the 8.061 guidance is that
- Venue must be an appropriate learning environment; and
- The focus must be on educational content, not amenities in the educational venue
CEJA clarified that a financial interest that is “material” includes ownership interest in company that has interest in the educational subject matter of the CME activity the faculty is part of; royalties; ongoing compensation for consulting; participating in advisory body; speaker’s bureau. CEJA noted that there is no specific detail in the opinion about how long the relationship has to be terminated for that would allow the CME provider or faculty not to disclose. They noted to look at ACCME SCS for guidance.
CEJA explained that CME providers must disclose to learners the steps they used to mitigate potential conflicts. See (b) (iii). They again reiterated that the source and nature of commercial support should be made available to learners, and again, suggested that magnitude should in all cases in the “spirit of transparency.”
CEJA did not specifically define what a “substantial financial interest” is when asked. Instead, they pointed to the accompanying CEJA report, which outline examples, such as, ownership interest in company; financial interest in subject matter; royalties related to subject matter; ongoing compensation, consulting, etc. They also noted that having a fiduciary position within the funding company or being on the board of directors would also be a direct and substantial interest, requiring the disclosure of magnitude, as well as nature and source.
CEJA emphasized that the opinion does not have an absolute prohibition on faculty who have a potential financial conflict of interest in the subject matter. They noted that when considering faculty with financial interests and relationships to look at
- How directly related to the activity the relationship is
- The scope or nature of the relationship
- How distant or ongoing in time the relationship is
They again reiterated that the CME provider needs to have a transparent process in place if choosing to include an individual with financial interests, and needs to take robust steps taken to mitigate potential bias. They again noted that preference should be given to faculty without a conflict.
CEJA noted several criteria when, in their opinion, it would be ethically justifiable to accept commercial support
- Demonstrated need for audience
- Use of cadavers
- Very resource intensive CME
- Specially equipped center for training
- Particular subject matter
- Declining industry support would significantly undermine ability to provide high quality CME
- CEJA however declined to define “significantly undermine,” and instead stated that it is a matter of judgment and very context specific
- Vigorous efforts made to ensure integrity/objectivity
- Resource poor communities
CEJA noted that the goal of the opinion is to articulate core principles and guidelines and that the expectation is that the CME community will integrate these principles and guidelines into practice as quickly as possible. CEJA emphasized several times that its purpose, particularly in this opinion, is not to “police” CME providers.
They went on to quote a passage from Harvard Medical Schools conflict of interest policy to make the point that CEJA hopes CME providers will come to a shared understanding of the opinion and form a consensus around it.
CEJA noted that with respect to industry RFPs, if industry already has a plan for a program, and therefore, the CME provider would not be able to perform a prior needs assessment, goals or priorities, this kind of RFP would be problematic under CEJA’s opinion. They noted that there is nothing in the CEJA opinion to prohibit CME providers from responding to RFPs, but nevertheless emphasized the importance of gap analysis, needs assessment, and independence in the process of applying for such grants.
CEJA clarified that an honorarium paid to a faculty for the current program he is participating in does not need to be disclosed as a gift of financial interest, but that it could form the basis of a subsequent disclosure. They noted that previous conferences or engagements where a physician received honorarium is something that should be disclosed.
CEJA emphasized that individual faculty should disclose interests even when there is no commercial support. They noted that the CEJA opinion applies to any education in the spirit of education.
CEJA noted that CME faculty may use results of industry-sponsored research in their CME materials and the CEJA opinion does not specifically address use of industry data/research.
With respect to exhibits/exhibitors at CME events, CEJA noted that this topic was outside of the CEJA opinion, and not educational per se. The CEJA opinion only deals with CME. Finally, CEJA noted that to address conflicts of interest, CME providers must follow the mitigation strategies in the proposal, which include
- Creating firewalls
- Pulling support from multiple sources
- Allocating resources independently
- Asking faculty to suspend their relationship for a period of time or to forgo compensation.
CEJA mentioned the “blind trust model” of the Georgia State Medical Association.
Conclusion
For the great majority of the CEJA recommendations they are already included in the ACCME Standards of Commercial Support®. So much of what is recommended is already accomplished by current rules of practice of continuing medical education providers.
CEJA noted that there is no plan to include further guidance on the implementation of the opinion, but that they will be taking feedback. They again emphasized that CEJA is not policing CME, but rather issuing ethical guidance and their philosophy and that this is the ethical opinion of the AMA. CEJA emphasized the importance of independence of medical education, not independence from industry.
They closed by noting that the CEJA opinion is going through the post AMA meeting process, and will be added to database in full, but is not up on the web, and will let us know when it will be up.