“The public and political climate in the United States, particularly concerning the high cost of drugs in the Medicare program, has resulted in intense scrutiny of Accreditation Council of Continuing Medical Education (ACCME), as well as of many CME providers. This climate of fault-finding, blame and threat, couched as inquiry, has understandably stimulated organizations to react, and to sometimes over-correct in immediate response.“ Normand Kahn, MD
This sums up the situation that the ACCME has succumbed to in their recent calls for comments – the proposals to over correct as a response to intense scrutiny and fault-finding, blame and threat coached as inquiry.
As a background, in June and August the ACCME issued calls for comments on interaction between providers of CME and commercial supporters, the criteria for funding and the use of speakers and writers who have also spoken at promotional venues.
Several organizations have responded or in the process of responding to the ACCME.
One organization: The Council of Medical Specialty Societies, consisting of 32 specialty society members, representing more than 500,000 (2/3rds) of all physicians, issued two letters to the ACCME in response to their call for comment. The first letter CMSS response to the first call for comment, looks at the items from the June call for comment. Some key discussion points include:
On the items of communication between commercial supporters and CME providers:
“A commercial interest provides commercial support for a CME activity that is often (although not always) within the scope of that commercial interest's business objectives. This is only logical. Even non-commercial interests (organizations that fall outside the definition of a commercial interest as defined by the ACCME) generally support activities that further the mission or the objectives of the supporter. For example, the prestigious Gerber Foundation whose mission is "to enhance the quality of life of infants and young children in nutrition, care, and development" would most likely not support a CME program that addresses Alzheimer's dementia in the older patient.”
The CMSS member organizations invest significant resources, both human and capital, in addressing their missions to provide continuing professional development for their members.
To address these missions demands that the organization look beyond the member's dues/CME registration fees to other sources of revenue. Corporate support is one such revenue alternative.
Many, if not most, commercial interests have initiated a grant process that standardizes the application and levels the playing field for fair evaluation of requests. It appears reasonable for potential grantees to seek to understand the criteria for a grant request to comply with grant requirements. Such process communication between grantee and grantor is common practice with private philanthropies (such as the Robert Wood Johnson Foundation) and with the federal government (such as AHRQ), as well as with industry, and is considered standard operating procedure.
They acknowledge that: However, it would be inappropriate for an accredited provider to request, or for a commercial interest to communicate content preferences, such as preferred topics (see ACCME 1 above), in discussions prior to submitting a grant. Again, SCS 1 rightly places the burden of documentation and truth upon the CME provider to ensure independence from commercial interest bias or control. In this light, the proposed ACCME clarification would be consistent with current behaviors of commercial interests and CME providers, and of the intent of the ACCME Standards
for Commercial Support.
Call for Comment: The ACCME believes that due consideration be given to the
elimination of commercial support of continuing medical education activities:
The proposal is that the commercial support of continuing medical education end.
CMSS position:
The Council of Medical Specialty Societies does not support the proposal that commercial support of continuing medical education end.
Background:
CMSS fully supports the ACCME Standards for Commercial Support and enthusiastically champions the 2004 updates. These Standards require that CME providers, in this case medical specialty societies, clearly and completely separate educational content from commercial bias, which may be perceived as resulting from commercial support. CME providers may offer and physicians may claim CME credit for participating in certified CME activities.
They agree with the ACCME that all parties need to weigh in on this issue and suggested a commission (using perhaps the Conjoint Commission), to hold meetings around this issue.
On the proposed new Paradigm which would require all of a group of criteria to be met in order for an activity to be eligible for CME funding (which is almost impossible, epically for orphan diseases with little government documents on the issues).
CMSS position:
The Council of Medical Specialty Societies does not support the new paradigm in its current draft format, as described above, but rather recommends modifications to ensure the separation of bias from commercial support of CME, and further recommends a process for debate and discussion of the proposed new paradigm, so that it may ultimately come to be as universally accepted as are the ACCME Standards for Commercial Support.
CMSS does not believe that the proposed extreme solution to the problem of the perception of commercial bias in commercially supported CME, as outlined in the proposed "new paradigm", is appropriate or necessary, as it removes the responsibilities of CME providers, particularly specialty societies, from the design and implementation of CME which is free from commercial bias.
It is important to pause to recognize the practical realities of corporate support. In the absence of support for CME, currently approximately $1 billion annually, the likelihood that such support will find its way into Direct to Consumer Advertising, and more problematic, into promotional education, is strong. If the goal is to eliminate product bias from the education of physicians, it will be critical to avoid an unintended consequence of stimulating significantly increased product biased education through the mechanism of promotional education.
The Second Letter addressed information around the August Call for Comment
which proposes:
"Persons paid to create, or present, promotional materials on behalf of commercial interest cannot control the content of accredited continuing medical education on that same content."
CMSS position:
Persons paid to create or present promotional materials on behalf of commercial interests (who therefore disclose a conflict of interest) need not be excluded from accredited continuing medical education on the same subject if and only if their conflict of interest can be resolve.
They point out that CME providers have invested significant resources to resolve conflict of interest and propose the following alternatives:
Be considered for universal criteria for resolving disclosed conflict of interest.
- Peer review: members of the planning committee, or other authors/speakers without a conflict of interest, review the content an author/speaker plans to use in a CME program, after which the author/speaker may not change that content.
- Evidence-based presentation: the author/speaker is required to present an evidence-based CME program that conforms to nationally accepted standards of evidence-based CME (not just having the speaker say "this is an evidence-based presentation").
- Modify content: the author/speaker may present on pathophysiology, research data, and other content, but not make practice recommendations (these are made by another speaker, who discloses no such conflicts of interest).
- On-site monitoring: trained monitors (volunteer physician and staff) attend the presentation and determine if subtle or overt biased crept into the talk, with significant consequences.
These issues need a lot more consideration and real debate, the CMSS did an outstanding job in outlining the issues.
Over the course of the next days we will be publishing links to all responses to the ACCME’s call for comments as they become available.
From ACCME:
From CMSS: