During the 22nd Annual Conference of the National Task Force on CME Provider/Industry Collaboration, there was a presentation about the passage of the American Medical Association (AMA) Council on Ethical & Judicial Affairs (CEJA) Report 1-A-11, Financial Relationships with Industry in Continuing Medical Education, which addressed industry support of continuing medical education (CME).
We have written extensively on this issue. 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. It was passed, largely to honor the outgoing chairman of CEJA and with the support of the several large medical societies including the AAFP.
The presentation at the Taskforce, moderated by Norman Kahn, MD, of the Council of Medical Specialty Societies, included the Director of Ethics Policy and Secretary of CEJA. The discussion was entitled, “10 Myths about CEJA 1.” While the presentation attempted to address myths, it may have created some of their own.
First, AMA staff presentation and interpretation of CEJA 1-A-11, as discussed below, perhaps overreached in a number of areas. AMA staff has used their own “interpretation” and “judgment,” which sometimes are contrary to the explicit language contained in the CEJA report, to suggest things that are not written anywhere in the report. And even more troublesome, is that AMA staff plans to take their “interpretation” of CEJA 1-A-11 and have a number of Webinars in the following months, professing “What CME Providers Need to Know About CEJA Report.”
Second, and more importantly, AMA staff comments come prematurely. CEJA 1-A-11 has not been fully adopted yet. In fact, CEJA recently published an Opinion (1-I-11) regarding CEJA 1-A-11, which revealed a very important procedural clarification that some may not be aware of. As noted by CEJA:
Opinions of the Council on Ethical and Judicial Affairs will be placed on the Consent Calendar for informational reports, but may be withdrawn from the Consent Calendar on motion of any member of the House of Delegates and referred to a Reference Committee. The members of the House may discuss an Opinion fully in Reference Committee and on the floor of the House. After concluding its discussion, the House shall file the Opinion. The House may adopt a resolution requesting the Council on Ethical and Judicial Affairs to reconsider or withdraw the Opinion.
Accordingly, when the House of Delegates meets November 12-16, 2011 in New Orleans, there will be an opportunity for any member of the House of Delegates to make a motion to have the CEJA report sent to a reference Committee, and that Committee can then have the report reconsidered or withdrawn. As noted by the AMA website, the CEJA Opinion 1-I-11 is a “DRAFT resolution, subject to change.”
Consequently, AMA noted that, “final documents will be made available to the HOD on or before Friday, Oct. 21, at which time they will be numbered and assigned to reference committees. All resolutions submitted for consideration at the 2011 Interim Meeting are subject to review by the Resolution Committee which is responsible for reviewing resolutions to determine their compliance with the meeting’s focus on advocacy and legislative issues.”
Presentation and Discussion
The following are some of the key discussion points the AMA staff person presented at the taskforce.
Myth 1: “CEJA 1” prohibits all industry support for CME (slide 2)
AMA staff noted that the goal of CEJA 1 is for there to be “independence from industry support.” The slide noted that, industry support ethically is acceptable when:
- There is a demonstrated need
- The activity requires high-cost resources
- The decision to seek/accept funding is independent, prospective
- The decision-making process is transparent
We agree with the opening statement that it is a myth that CEJA 1-A-11 does not prohibit commercial support. But the follow up comments state the goal of CEJA is independence from industry support. Nowhere in CEJA 1-A-11 or in the 1-I-11 Opinion (which is identical), does it state that the goal of CEJA 1 is for there to be “independence from industry support.” The only thing even close to this suggestion is the following:
When possible, CME should be provided without such support or the participation of individuals who have financial interests in the educational subject matter. (1-I-11, line 26-27).
This language contains no suggestion that support for CME should be independent from industry. Instead, it only suggests the need for CME providers to evaluate when it is and is not possible to provide CME support. Accordingly, the CEJA report does not in any way stand for independence from industry support, but rather it confirms ACCME principles and other CME guidelines that call on CME providers to be transparent and document their need for and use of commercial support.
Myth 2: “CEJA 1” prohibits participation by anyone who has financial relationships with industry (slide 3-4)
AMA staff noted that the goal of CEJA is to have “no reliance on conflicted experts.” The slide explained that participation by conflicted expert is ethically acceptable when:
- Dissemination of device/technique/technology will benefit patients, public, professional community
- Activity meets a demonstrated need
- Participation is central to success of activity
- Individual is uniquely qualified
- Steps are taken to mitigate potential influence
- commensurate with financial interest at stake
- including disclosure – source, nature, magnitude of interest
- Decision-making process is transparent
We agree with the opening statement that it is a myth that CEJA 1 prohibits participation by anyone how has a financial interest. Yet, once again, this interpretation could be considered a stretch. Nowhere in the entire CEJA report does it say that experts who have financial interest or even potential conflicts, should be banned from CME. Instead, the report explicitly recognizes that:
In some circumstances, support from industry or participation by individuals who have financial interests in the subject matter may be needed to enable access to appropriate, high quality CME. (1-I-11, line 29-31).
Contrary to AMA staff’s explanation, the CEJA report recognizes undoubtedly that there will be instances where reliance on an expert with financial interests in the educational subject matter is necessary to enable access to appropriate, high quality CME. And the report supports the use of experts with financial interests by reassuring physician-learners that there is no need for concern about such reliance because CME providers will make “vigorous efforts … to maintain the independence and integrity of educational activities.” (1-I-11, line 31-32).
The CEJA report necessarily uses language to acknowledge that there will be “circumstances” when ACCME, CEJA and CME providers will recognize that reliance on support from industry or participation by individuals who have financial interests “may be needed.” To suggest that CEJA means a complete ban on such individuals or “no reliance” is therefore an incorrect interpretation.
It should also be noted that AMA staff perhaps overstated CEJA with respect to the new kind of reporting and disclosure that will be required if the report is adopted. As noted above, AMA staff asserted in their slide the steps that CME providers need to take to mitigate potential influence, which included disclosure of the “magnitude of interest.” AMA staff mentions “magnitude” twice in fact, on Slide 4 and 7. However, this is not what CEJA adopted.
Specifically, the CEJA report explicitly states that, only “individuals who have a substantial financial interest in the educational subject matter” are required to disclose the “magnitude of the individual’s specific financial interest.” (1-I-11, line 34-38).
Conclusion
Ultimately, the presentation by AMA staff produces concern. CME providers are worried that radical members of CEJA, including staff, will use the report to push their restrictive agenda on CME providers by painting a picture that the goals of the CEJA report are “independence from industry support” and “no reliance on conflicted experts,” rather than what was actually stated in the CEJA document.
In fact, if AMA staff believes that it is the goal of the CEJA report to “articulate broad ethical principles” (slide 8). However, nowhere in the entire CEJA report does it give CEJA the responsibility to articulate any such principles or guidance, let alone “broad” ones. However, this may be of no concern to CEJA staff, because they assert, as AMA staff did in their presentation, that implementing the report will be a matter of “judgment.”
It is evident from CEJA’s approach during this presentation, that their “judgment” is a stark contrast to what the CEJA report actually states and what the AMA House of Delegates voted to pass. The repeated statements that all faculty and CME providers will have to disclose the magnitude of financial support—when in fact the report states that disclosure of magnitude is for only those faculty with a “substantial financial interest”—is concerning, because it appears that CEJA staff may be using this kind of “education” as a backdoor to implement language that was in previous CEJA reports.
Had AMA Staff made this presentation at the House of Delegates meeting this past summer where CEJA 1 was adopted, with the goals of CEJA as independence from commercial support, no reliance on conflicted experts and reporting the magnitude of every relationship, it is doubtful that the House of Delegates would have passed this bill.
To avoid a floor battle over this report at next month’s AMA House of Delegates meeting in New Orleans, it is in CEJA’s and AMA’s best interest for their staff to remain true to the facts of the documents. Otherwise, they may be fighting the CEJA CME battle for many years to come.