The Alliance for Continuing Medical Education (Alliance), which represents more than 2,300 professionals who strive every day to improve patient care and outcomes through the design and delivery of unbiased, evidence-based education for health care professionals, recently submitted its comments in response to the American Medical Association Council (AMA) on Judicial and Ethical Affairs (CEJA) Report 1-A-11 on “Financial Relationships with Industry in Continuing Medical Education.”
For all certified continuing medical education (CME), Alliance members adhere to the Standards for Commercial Support promulgated by the Accreditation Council for Continuing Medical Education (ACCME), of which the AMA is a member organization
Alliance Response to CEJA 1-A-11
The Alliance strongly recommended that CEJA Report 1-A-11 be referred back to CEJA for additional consideration and modification because the report:
- Does not fully recognize the ACCME guidelines
- Is not supported by available, scholarly research and
- Would require that providers spend time and resources developing unnecessary processes.
The Alliance noted that CEJA extended its jurisdiction beyond the authority granted to it by offering opinion CME without fully recognizing that the appropriate accreditation guidelines are currently in place to govern these relationships, such as the ACCME updated Standards of Commercial Support, which are backed by serious consequences when violations are discovered.
In addition to accreditation standards, the Alliance also noted how the Food and Drug Administration (FDA), the Office of Inspector General (OIG), the National Institutes of Health (NIH), the United States Senate and countless regional and state agencies have investigated and issued guidance, opinion or ruling shaping these interactions. They also recognized how an increasing number of organizations, professional societies, member groups, academic centers and healthcare organizations have developed and issued their own codes of ethics and standards for interactions with industry, as well as mechanisms to monitor and identify challenges to those policies.
Accordingly, the Alliance asserted that sets of clearly defined national standards, federal, regional and state regulation, as well as local policy and monitoring already exist to manage potential influence of CME by industry. These, coupled with a troubling lack of evidence suggesting these mechanisms, as they have been in place since 2005, are ineffective, negate the need – regardless of authority – for CEJA to issue an opinion on the matter.
In addition, the Alliance noted that there is no evidence, which shows that learner confidence in the independence and integrity of CME is promoted because of no industry support or faculty relationships related to that CME. As a result, the Alliance recommended that CEJA eliminate its contention that CME should be provided without commercial support “when possible.”
The Alliance also recommended that CEJA eliminate the language requiring physicians who “organize, teach, or have other roles in CME” to disclose to physician learners what steps have been taken to mitigate potential influence of financial relationships because such a requirement would move the AMA into the role that has been established for the ACCME. The Alliance explained that this additional standard is not part of the current ACCME Standards for Commercial Support and that there is no current requirement that this mechanism be reported to the learners.
The Alliance also identified that CEJA’s report is unclear as to what group(s) would make a determination of need for industry funding of CME, on what criteria decisions would be made, and what system would be used to prospectively evaluate all educational activities for industry funding.
Consequently, they also recommended that instead of limiting education funding from industry, which would result in a further decrease of education activities, appropriate organizations that support the provider communities should seek new sources of incremental funding for physician education
Finally, the Alliance asserted that CEJA’s prohibition or limitation of expert physicians who work with industry would likely reduce the quality and effectiveness of physician education. Further, they noted how eliminating or reducing the role of physicians (with industry relationships) who excel in teaching other clinicians, and to eliminate or reduce the role of this group of educators could also negatively impact the quality and effectiveness of medical education.
Accordingly, the Alliance recognized that CEJA’s approach conflicts with the goal of advancing patient outcomes and population health by potentially limiting access to the best available scientific information delivered by those physicians who may possess the highest level of expertise. Moreover, they noted how CEJA’s recommendation would not permit physicians, who have spent much of their professional careers researching and understanding the diseases and infections that affect patients, to serve as faculty or content developers.
This could lead to the use of faculty and developers who may not be as knowledgeable about the array of therapeutic entities, emerging therapies, barriers to care, contraindications, risk management issues, and patient adherence challenges.
For these reasons, the Alliance recommended that 1-A-11 be referred back to CEJA.