Here's a sneak peek of one piece of Medical Meetings' coverage of the Alliance meeting, to be published in the March/April issue:
Not surprisingly, the Medical Specialty Society Provider Section Meeting at the Alliance for CME Annual Conference, held January 26 to 29 in San Francisco, focused on how societies are coping with the updated Standards for Commercial Support. As Suzanne Ziemnik, Med, director, division of CME, American Academy of Pediatrics, Elk Grove Village, Ill., said at the session s start, "The reason the Alliance is having record-breaking attendance is due to both beautiful San Francisco and [David Baldwin, manager, accreditation services, with the Accreditation Council for CME, Chicago] and his colleagues at ACCME."
Baldwin began by walking participants through some of the changes to the updated Standards, including the controversial Element 2.3, which says, "The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners." He said, "While the responsibility to resolve in advance is new, the practice of resolving or managing conflict is not," he said.
Then representatives of several societies, including the American College of Obstetricians and Gynecologists, the American Psychiatric Association, and the American Academy of Ophthalmology, shared what they were doing to comply.
Don t Panic
The biggest message was, "don t panic." Several panelists emphasized that you probably already are doing most of what you need to do to be in compliance with the updated Standards. You just need to codify and document the procedures you already have in place--and perhaps tweak the system a bit then build on what you already have. For example, ACOG already reviews all disclosures; the only change needed to be in compliance with the new Standards is to do it earlier in the process, said Kathryn Bell, EdM, manager, Educational Programs, with the Washington, D.C.-based society. ACOG s committee selection process already has anti-bias built in through its policy of changing presidents who select new committee members every year, and regularly rotating members and. Disclosure is required after a new member is selected.
When APA reviewed its current procedures, it unearthed a board-member-disclosure process that, while in place for committee appointments, hadn t previously been used for this purpose. Now it will be, said Kathleen Debenham, director, Department of Continuing Medical Education, with the Arlington, Va.-based American Psychiatric Association. Also, evaluations that are already being used can help to validate that you have a conflict-of-interest-resolution system in place as long as participants answer that they didn t perceive bias in the content, that is. In addition to having monitors at satellite programs (APA is one of the few groups that has integrated satellites into its main program and made them subject to the same policies), the association also has sanctions in place. On the first bias violation, APA sends a letter warning that if it happens again, that person will be banned from presenting at APA for three years. On second violation, APA follows through on the threat. "It s checks and balances along the way, from soup to nuts," she said. "Do disclosure earlier, educate committee members, codify what s already on the books, and look at evaluations and outcomes to measure how well your system is working."
Building It Out
Once current procedures are identified and tweaked, panel members suggested that you ask what else might be needed. For example, ACOG now requires that the committee meetings be documented in writing. The organization also developed a new disclosure form that includes an agreement to abide by ACOG s code of ethics.
The American Academy of Ophthalmology now requires disclosure from everyone who could affect content, said William Hering, PhD, director of CME and Programs with San Francisco-based AAO. And they have to disclose not only any financial relationships they have, but also those of their business partners, employers, and families, including their spouse, domestic partner, parent, child and spouse of a child, and siblings and siblings spouses. (The breadth of the disclosure scope brought some gasps from the audience.) It put its disclosure form online, where committee members, faculty, and other relevant CME stakeholders can use a drop-down menu of likely companies. The disclosure statements stay online, which caused some discussion among the participants about privacy issues for non-presenters. "We want to be sure that everyone that needs to know, knows everything," said Hering. The question of who has to go public with disclosures, as opposed to disclosing just to the provider, was a hot, albeit unresolved, issue at one of the breakout sessions. AAO sends the disclosures to a committee of peers to review for relevance to an activity. AAO also has a committee of peer reviewers for enduring materials. If, after a warning, someone doesn t disclose, they are barred from participation in that activity. The academy also uses "Documentation Checklist for CME Activities" form similar to the ACCME surveyors form that must be completed before the activity can move forward.
To ensure bias doesn t creep into the content of live activities, AAO notifies the chair, faculty, and panelists that the first slide has to be about the disclosure of any financial relationships, and it has monitors scouting the content at its annual meeting.
The Society of American Gastrointestinal Endoscopic Surgeons also made some changes, including changing the software it uses for abstract submission so disclosures have to be complete or it won t be accepted for review, said Erin Schwarz, manager, Programs and Education, with the Los Angeles-based SAGES. The submissions then go through a blind selection, followed by one including disclosures. A volunteer task force reviews the disclosures to see if they relate to the presentation s content.
But don t stop with disclosure "The identification of relationships is important, but once it is determined that there are conflicts, we expect the provider to be proactive with this information to ensure that the educational content will be free of commercial bias," said Baldwin. He cited the panelists examples of establishing criteria for planning committees. Having peers review the content in advance might also be an option. Providers might present opposing views within a CME activity. However, it would be difficult to resolve conflicts by simply countering one person with a conflict with person with an alternative conflict. Baldwin said. "It would be better to have a cross-examination of the potentially biased content than to just offer differing viewpoints. Also, providers might choose to communicate to the faculty that you expect them to provide evidence-based content."
Still Under Construction
Questions remain, including sticky wickets like how to get buy-in from the committee members, who are already asked to do a lot, and now are being asked to do even more. Last-minute faculty substitutions also are an ongoing cause for concern. During a breakout session, some suggestions were to insist that the first slide be on disclosure, have the sub fill out a disclosure form on site, or do a verbal disclosure. But that only covers disclosure, not resolving any potential conflicts of interest.
Baldwin suggested that, if you have a pool of faculty you draw from regularly, you could educate them on the rules ahead of time. Another participant said that step-in speakers need to know the rules, too, and one of them is that the content is prescribed and approved ahead of time so it s not OK to deviate from the prepared materials of the faculty they re subbing for.
Element 4.2 of the updated Standards, which says that "Live (staffed exhibits, presentations) or enduring (printed or electronic advertisements) promotional activities must be kept separate from CME," also was causing some angst at the session. "Does this mean we can t have ads in our program book? That is a huge revenue source for us," said one participant. Baldwin indicated that if the program book just contains the logistics of the meeting, ads are allowable, but "Anything with educational content cannot have ads."
To comment on this post, click on "comments" below. To receive a weekly update, e-mail Sue. And if you have a challenge, or any advice for this specialty society person looking for ways to keep her CME committee happy with the new Standards disclosure requirements, please e-mail me or post a comment. Thanks!