IF THE RATIFICATION of the Accreditation Council for CME's new Standards for Commercial Support proceeds on schedule, you should be prepared to begin to implement your new conflict of interest (COI) process in October 2004 with the deadline for all steps in place by April 1, 2005. To meet this schedule, accredited providers should immediately start the following process with their leadership group:
Form a COITask Force, comprising physician representatives from your CME committee or advisory board, members of staff, and other members of the leadership team. Note that even members of the task force may be in a COI position, in which case they should recuse themselves from certain discussions.
If you work in a big institution, don't forget to inquire to see if a committee on disclosure/ethics already exists that might have developed some answers to issues you need to discuss. If a committee is already in place, try to dovetail your policies with the institution's.
Do an analysis of the new requirements and present them to the task force.
Don't expect easy answers. One of the intentions of the, I suspect, is to facilitate this important discussion in each accredited organization. This is not about an even playing field, but about complying with the new Standards and operating in the public interest.
Be prepared to develop clearly worded policies on the management of conflict of interest and instructor/author honoraria; criteria for adjudicating and resolving all COI dilemmas before each CME activity; methods for acquiring disclosure information from CME participants; and processes for documenting your mechanisms to identify and resolve COI.
Analyzing Conflict of Interest
The crux of the COI requirements in the Accreditation Council for CME's new Standards for Commercial Support is that the provider is now charged with interpreting and managing COI. What mechanism will the provider use to resolve all COI before the CME's delivery? We suggest analyzing three aspects of the COI:
- Follow the money
What is the size of the financial relationship and percent of review/income represented by this relationship?
- Examine content control
If the COI exists, to what degree does the individual or institution have the opportunity to control the content? If the threshold of COI is too high, to what degree should that opportunity be limited?
- Investigate incentives for influence
Has the supporter set a performance standard that rewards the individual or institution based on such things as activity enrollment, increased prescription rates, or other noneducational performance criteria? If so, these rewards act as an incentive for the individual or institution to bias content by increasing the value of the supporter's product or decreasing the value of a competitor's product or devices.
You will need to determine your options for dealing with real or perceived COI. Remember that there are more options than to qualify or disqualify an individual. For example, you can limit involvement in the critical synthesizer role during the planning process that sets the platform for the development of specific content. Additionally, you can use your internal or contracted content validation services to assure that content is unbiased, patient care recommendations are acceptable to the profession and your institution, and scientific studies used in the content are accurate and comply with U.S. research standards.
Steven M. Passin is president of the CME consulting firm, Steve Passin & Associates in Newtown, Pa. He has also served as deputy health secretary for California. Contact him at Passin@PassinAssociates.com.