Life Science Compliance Update

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November 16, 2012

AMA CEJA: AMA House of Delegates Passes Clarification to Align with ACCME Standards for Commercial Support

HOD 2012 2
The American Medical Association (AMA), held it’s Interim Meeting, where the House of Delegates discussed, debated, and voted on several important recommendations.

Of importance to our readers and stakeholders in  continuing medical education (CME) community, the house also clarified the AMA’s ethical guidance on CME—the Council on Ethical and Judicial Affairs (CEJA) Report 1-A-11.  Specifically, CEJA recommended that Opinion E-9.011, which was last updated in 1996, be amended because “CME has evolved substantially, as have standards for the conduct of CME providers, such as those of the ACCME.”  In addition, CEJA pointed to its 1-A-11 Report, adopted in June 2011 and subsequently Opinion E-9.0115, as “developments” that led to updating E-9.011.  

The revisions to E-9.011 were made to ensure consistency among Opinions in the Code of Medical Ethics, to avoid unnecessary repetition of guidance set out in AMA policies and other standards for CME.  Revisions were developed in consultation with the Council on Medical Education.  The majority of the recommendations and changes made are consistent with the CEJA Report 1-A-11 from June 2011, and are also consistent with ACCME Standards for Commercial Support. 

The Guidelines for physician-attendees were edited for clarity, including replacing cross-references to E-8.061, “Gifts to Physicians from Industry,” with explicit guidance regarding subsidies for expenses of attending CME activities.  

Specifically, the modified position urges physicians to “decline any subsidy offered by a commercial entity other than the physician’s employer to compensate the physician for time spent or expenses of participating in a CME activity.” 

As a point of clarification this is already the practice for CME providers in certified CME.  While industry support of CME may allow physicians and health care providers to attend CME events for reduced registration costs—CME programs with commercial support are prohibited from using funds to fund a physician’s travel or expenses for a CME activity.  The Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support explicitly prohibit such activities, Specifically, Standard 3.12 states that: 

The [CME] provider may not use commercial support to pay for travel, lodging, honoraria, or personal expenses for non-teacher or non-author participants of a CME activity. The provider may use commercial support to pay for travel, lodging, honoraria, or personal expenses for bona fide employees and volunteers of the provider, joint sponsor or educational partner.  

In addition, Standard 3.9 states that “No other payment shall be given to the director of the activity, planning committee members, teachers or authors, joint sponsor, or any others involved with the supported activity.  Standard 3.10 states that “If teachers or authors are listed on the agenda as facilitating or conducting a presentation or session, but participate in the remainder of an educational event as a learner, their expenses can be reimbursed and honoraria can be paid for their teacher or author role only,”—thus their participation cannot be reimbursed.    

Industry trade codes, such as those by PhRMA and AdvaMed, as well as many professional medical associations, also have similar policies. 

Moreover, if a CME company who received support from a pharmaceutical company for an educational grant, paid for the travel or expenses to attend an activity, the federal government could view such payments as a “kickback” to the physician that induces him or her to prescribe the company’s drugs.   

What may be problematic about this newly adopted position is continuing education or training for medical devices.  As we have covered several times, the training of physicians on medical devices is highly technical and requires physicians to sometimes travel to a manufacturer to obtain the best form of education—often by the creator or innovator that invented the device.  If this newly adopted position does not provide flexibility for medical device training, the education of physicians may suffer due to the prohibitive costs that travel and lost patients may have.   

Other Recommendations  

Guidelines for faculty and sponsors were also updated to remove specific references to guidance from other entities (e.g., Accreditation Criteria, Standards for Commercial Support and related policies of the ACCME; Guidance on industry-supported educational activities from the FDA; and Code on Interactions with Healthcare Professionals of PhRMA). 

CEJA acknowledge that “Physicians should strive to further their medical education throughout their careers, to ensure that they serve patients to the best of their abilities and live up to professional standards of excellence.” 

Participating in formal CME activities is “critical to fulfilling this professional commitment to lifelong learning.”  As attendees of CME activities, physicians should: 

a)    Select activities that are of high quality and are appropriate for the physician’s educational needs.

b)    Choose activities that are carried out in keeping with ethical guidelines and applicable professional standards.

c)    Claim only the credit commensurate with the extent of participation in the CME activity.

d)    Decline any subsidy offered by a commercial entity other than the physician’s employer to compensate the physician for time spent or expenses of participating in a CME activity. 

Physicians should strive to further their medical education throughout their careers, for only by participating in CME can they continue to serve patients to the best of their abilities and live up to professional standards of excellence.  Fulfillment of mandatory state CME requirements does not necessarily fulfill the physician’s ethical obligation to maintain his or her medical expertise. 

Attendees 

Guidelines for physicians attending a CME conference or activity are as follows: 

(1)  The physician choosing among CME activities should assess their educational value and select only those activities which that are of high quality and appropriate for the physician’s educational needs.  When selecting formal CME activities, the physician should, at a minimum, choose only those activities that

(a)  are offered by sponsors accredited by the ACCME, the American Academy of Family Physicians (AAFP), or a state medical society;

(b)   contain information on subjects relevant to the physician’s needs;

(c)  are responsibly conducted by qualified faculty;

(d)  conform to Opinion 8.061, “Gifts to Physicians from Industry.”

(2)  The educational value of the CME conference or activity must be the primary consideration in the physician’s decision to attend or participate. Though amenities unrelated to the educational purpose of the activity may play a role in the physician’s decision to participate, this role should be secondary to the educational content of the conference.

(3)  Physicians should credit commensurate with only the actual time spent attending a CME activity or in studying a CME enduring material.

(4)  Attending promotional activities put on by industry or their designees is not unethical as long as the conference conforms to Opinion 8.061, “Gifts to Physicians from Industry,” and is clearly identified as promotional to all participants. 

Faculty. 

Guidelines for physicians serving as presenters, moderators, or other faculty at a CME conference are as follows: 

(1)  Physicians serving as presenters, moderators, or other faculty at a CME conference should ensure that

(a)  research findings and therapeutic recommendations are based on scientifically accurate, up-to-date information and are presented in a balanced, objective manner;

(b)  the content of their presentation is not modified or influenced by representatives of industry or other financial contributors, and they do not employ materials whose content is shaped by industry. Faculty may, however, use scientific data generated from industry-sponsored research, and they may also accept technical assistance from industry in preparing slides or other presentation materials, as long as this assistance is of only nominal monetary value and the company has no input in the actual content of the material.

(2)  When invited to present at non-CME activities that are primarily promotional, faculty should avoid participation unless the activity is clearly identified as promotional in its program announcements and other advertising.

(3)  All conflicts of interest or biases, such as a financial connection to a particular commercial firm or product, should be disclosed by faculty members to the activity’s sponsor and to the audience. Faculty may accept reasonable honoraria and reimbursement for expenses in accordance with Opinion 8.061, “Gifts to Physicians from Industry.” 

Sponsors 

Guidelines for physicians involved in the sponsorship of CME activities are as follows: 

(1)  Physicians involved in the sponsorship of CME activities should ensure that

(a)  the program is balanced, with faculty members presenting a broad range of scientifically supportable viewpoints related to the topic at hand;

(b)  representatives of industry or other financial contributors do not exert control over the choice of moderators, presenters, or other faculty, or modify the content of faculty presentations. Funding from industry or others may be accepted in accordance with Opinion 8.061, “Gifts to Physicians from Industry.”

(2)  Sponsors should not promote CME activities in a way that encourages attendees to violate the guidelines of the Council on Ethical and Judicial Affairs, including Opinion 8.061, “Gifts to Physicians from Industry,” or the principles established for the AMA’s Physician Recognition Award. CME activities should be developed and promoted consistent with guideline 2 for Attendees.

(3)  Any non-CME activity that is primarily promotional must be identified as such to faculty and participants, both in its advertising and at the conference itself.

(4)  The entity presenting the program should not profit unfairly or charge a fee which is excessive for the content and length of the program.

(5)  The program, content, duration, and ancillary activities should be consistent with the ideals of the AMA CME program.

 

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So how important is CME to the industry as a whole?

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