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November 14, 2011

CME Coalition Announces Code of Conduct

Code of Conduct
The CME Coalition announced the adoption of the CME Code of Conduct, a ten-point list designed to bring clarity to the rules governing continuing medical education.  By formally and publicly agreeing to these basic principals, the members of the CME Coalition intend to demonstrate their support for transparency, adherence to established guidelines regarding "conflicts of interest," and scientific rigor as the basis for its curricula. 

As we recently noted, the CME Coalition, is a  new Washington-based organization comprised of continuing medical education (CME providers), beneficiaries of CME (including both educational institutions and professional societies) and sponsors of CME (such as pharmaceutical manufacturers and device makers).  The mission of the CME Coalition is to: 

  1. Educate federal policy makers on issues related to the provision of CME,
  2. Monitor state policy initiatives that could adversely impact CME, and
  3. Advocate for sensible federal and state policies to advance its practice. The CME Coalition will fulfill this mission by developing, managing, and implementing a government affairs and public relations strategy to further the interests of CME on Capitol Hill, with the Administration and among the states. 

Also embedded in the Code is the call for CME to further "the appropriate advancement and adoption of innovative technologies, treatments and procedures through state-of-the-art educational programming" as well as a commitment on the part of CME providers and supporters "to educating the public as to the vital role of continuing medical education to our health care system." 

Chris Lamond, Executive Director of the CME Coalition stated, "With this Code of Conduct, both practitioners and supporters of CME are affirming the vital role that industry-supported CME plays in our health care system, while unequivocally stating their adherence to the sensible rules and regulations that exist to eliminate inappropriate bias." 

As noted by an article in Medical Meetings, “The idea behind the new Code, says the CME Coalition’s Senior Advisor Andrew Rosenberg, was not to break any new ground or impose any more stringent limitations than are already required by the various CME accrediting bodies.   Instead, he says, the code is designed to pull all the disparate regulations surrounding CME and, specifically pharmaceutical and medical device/CME faculty/provider relationships, into one “10 Commandments” type of document.” 

“The hope, he says, is that it will make clear to the CME community and, perhaps more to the point, those on Capitol Hill, the rigorous requirements that are already in place to deal with potential conflicts of interest that could arise when industry commercially supports healthcare provider education.” 

CME Coalition members are asked to formally and publicly agree to the 10 principles to demonstrate their support for transparency, adherence to established guidelines regarding conflicts of interest, and scientific rigor as the basis for their curricula. 

Rosenberg says that, once everyone realizes the stringency of the rules under which CME is conducted, they also should realize that “they shouldn’t be discouraging private sector support for CME—they should be encouraging it. We should all applaud companies that want to participate and experts who want to engage in CME, not stigmatize them or putting unreasonable limitations on their engagement.” 

“The broader goal of the CME Coalition isn’t to lobby for any specific piece of legislation or to oppose or support any specific member of Congress,” Rosenberg says. “It’s to educate policymakers on Capitol Hill about what CME is, the rules that are in place to govern its practice and guarantee its scientific integrity, and to tell the story of how CME is changing the face of medicine and maximizing the benefits of innovation for patients.” 

“It also supports private sector commercial support for CME as a vital source of funding, without which, he says, “You are never going to maximize the uptake of innovation, you’re never going to improve physician awareness and education, and ultimately you’re never going to improve patient outcomes.” 

CME Code of Conduct 

Member companies and institutions of the CME Coalition pledge to both support andprovide the highest standards of continuing education for healthcare professionals in the best interest of patients. In adhering to these standards, the members of the CME Coalition promise to live up to the commitments and proper practices manifest in the following CME Coalition Code of Conduct. 

  1. Decisions concerning CME activity design and content, and decisions related to the support of CME, will always be made in the best interests of improving patient care and addressing public health needs. 
  2. CME content will always be evidence-based and free of inappropriate influence.
  3. CME activities will be designed to maintain, develop or increase the knowledge, skill, and professional performance of a clinician in the provision of the highest quality services for patients, the public at-large and the medical profession.
  4. CME providers and supporters are committed to furthering the appropriate advancement and adoption of innovative technologies, treatments and procedures through state-of-the-art educational programming. 
  5. CME providers and supporters are committed to educating the public as to the vital role of continuing medical education to our health care system. 
  6. CME providers must be transparent in disclosing the financial supporters of their programs, as well as the financial interest of any faculty or provider before the learner engages in the CME activity. 
  7. All CME activities must fall within the medical education certification bodies and public regulatory guidelines and policies that are designed to ensure independent performance and behavior. 
  8. CME providers must manage and disclose financial interest, defined as “when a planner, speaker or author both has a current financial relationship with a commercial interest and the opportunity to affect content relevant to products or services of that commercial interest” as defined by the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support. 
  9. CME providers and supporters agree to abide by the conduct standards set by all appropriate accrediting bodies. 
  10. CME providers and supporters must agree to adhere to the compliance guidelines and codes of conduct governing the interactions of drug and  device manufacturers with healthcare professionals as promulgated by the U.S. Food and Drug Administration, the Department of Health and Human Services Office of the Inspector General, the Pharmaceutical Research and Manufacturers of America and the Advanced Medical Technology Association.

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Although Mr. Rosenberg states - “The broader goal of the CME Coalition isn’t to lobby for any specific piece of legislation or to oppose or support any specific member of Congress", a quick look at the press releases on their website tells a different story.

On November 11, 2011 the CME Coalition put out a news release that says - "Today, the CME Coalition endorsed S.1700, the Medical Device Regulatory Improvement Act, a bipartisan bill introduced jointly by Senators Amy Klobuchar (MN), Michael Bennet (CO) and Richard Burr (NC)." In addition, the website clearly states that they have sent an "endorsement letter" to Senator Klobuchar.

This bill referenced in the news release seeks to weaken Conflict of Interest disclosure requirements for experts contributing to FDA advisory committees. This issue would appear to have little to do with CME regulations. The Coalition then tries to make the case that similar disclosure requirements on subject matter experts are damaging CME content.

Not only is the Coalition lobbying and endorsing for a bill that has little to do with CME matters, it is working to weaken the disclosure requirements of FDA and CME contributors. Reducing disclosure requirements can hide the motivation of the contributors from the public and can lead to great harm.

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