With the May deadline for implementing the Accreditation Council for CME's updated Standards for Commercial Support breathing down their necks, participants at the 2005 Annual Conference of the Alliance for CME, held January 26 to 29, were hot to find some answers about how the rules will play out in their organizations. Attendees at Standards-related sessions found themselves packing into the meeting rooms at the San Francisco Marriott, even sitting on the floors and overflowing into hallways where they strained to hear how different organizations are handling some of the stickier areas of the new rules governing disclosure and conflict of interest.
Time to Tweak
At the Medical Specialty Society Provider Section session at the Alliance meeting, 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, which require CME providers to obtain disclosures from anyone controlling CME content, and resolve any conflicts of interest. You just need to codify, document, and perhaps tweak your current procedures — then build on what you already have. For example, the American College of Obstetricians and Gynecologists already reviews all disclosures; now they just need 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 protection built in through its policy of changing presidents — who select new committee members — every year. Disclosure is required after a new member is selected.
When the American Psychiatric Association 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 CME, with the Arlington, Va. — based association. Also, evaluations can ask participants if they perceived commercial bias. Their responses will help to validate that you have a conflict-of-interest resolution system in place — as long as participants found the content objective, that is. In addition to sending monitors to satellite programs (APA has integrated satellites into its main program and made them subject to the same policies), the association has sanctions. On the first bias violation, APA sends a letter warning that if the problem happens again, that person will be banned from presenting at APA for three years. On the second violation, APA follows through. “It's checks and balances along the way, from soup to nuts,” Debenham 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.”
What Else Needs to Be Disclosed
Once you have identified and tweaked current procedures, 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 Ophthal-mology now requires disclosure from everyone who could affect content, said William Hering, PhD, director of CME and Programs with the 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 scope of disclosure brought some gasps from the audience.) The AAO put its disclosure form online, where relevant CME stakeholders can pick from a drop-down menu the pharma/device companies with which they have relationships.
The disclosure statements stay online, which caused some discussion among the participants about privacy issues for nonpresenters. “We want to be sure that everyone who 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. It also has a peer-review committee for enduring materials. If, after a warning, someone doesn't disclose, they are barred from participation in that activity. The academy also uses a “Documentation Checklist for CME Activities” form similar to thesurveyors' form that must be completed before the activity can move forward.
To ensure bias doesn't creep into live activities, AAO notifies the chair,, and panelists that the first slide has to contain disclosure of any financial relationships, and it has monitors scouting the content at its annual meeting.
The Society of American Gastro-intestinal Endoscopic Surgeons also made some changes, including changing the software it uses for abstract submission, so disclosures have to be complete or the abstract 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 process, followed by one including disclosures. Atask force reviews the disclosures to see if they relate to the presentation's content.
Getting Buy-In from Committee Members
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. Among the suggestions made during a breakout session, were to insist that the first slide be on disclosure, to have the substitute fill out a disclosure form on site, or to do a verbal disclosure. But that only covers disclosure, not resolving any potential conflicts of interest.
Panelist David Baldwin, manager, accreditation services, ACCME, 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 approved ahead of time — so it's not OK to deviate from the prepared materials.
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 caused angst at the session. “Does this mean we can't have ads in our program book? They are 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.”
Ensuring the Integrity of Education
At a mini-plenary session focusing on the updated Standards, attendees heard the perspectives of providers from a medical education company, another specialty society, and a medical school.
To help ensure the integrity of education and drive compliance with the updated Standards, Thomson Healthcare established a CME compliance department, of which he is now vice president, said panelist Mark H. Schaffer, EdM, Thomson Professional Postgraduate Services, Secaucus, N.J. “I no longer report to anyone with fiduciary responsibility,” he said. He reports directly to the general counsel, Thomson Scientific & Healthcare.
As for other changes the organization needs to make, “Once I stopped hyperventilating, I realized that we are already doing most of what the updated Standards require — we just need to document it better,” he said. For instance, Thomson has a complex faculty selection and content development process. No one individual ever controls the content. Content is developed by an educational council of physicians, then is vetted by an editorial staff, and then is reviewed again by the educational council. While Schaffer said he used to become frustrated watching the physicians argue about content on the slides, he now views such arguments as a comfort — part of the process of ensuring that activities are balanced and unbiased.
Professionalism and Ethics
The timing of the updated Standards was good for heart-related organizations, said panelist Marcia J. Jackson, PhD, senior advisor, education, American College of Cardiology Foundation, Bethesda, Md. The ACC, the American Heart Association, and other heart-related organizations had convened a conference on professionalism and ethics in 2004 that examined issues related to education and relationships with commercial interests.
A task force at the conference began developing a disclosure policy and procedures that all the heart associations would agree to follow, providing consistency for members, explained Jackson. Although the updated Standards do not require it, the heart associations felt that disclosures should include the degree of financial relationship with a commercial interest. On the ACC's new disclosure forms, people will be asked whether their relationship is modest — $10,000 or less — or significant, defined as $10,000 or more, Jackson said. Also included in the new disclosure form is a statement that the person's contribution to the activity will be based on best available evidence.
To minimize the time involved in collecting disclosures, the ACC is aiming to create a Web-based disclosure database of all CME contributors that could be updated regularly. The ACC could then e-mail perspective faculty members the disclosure information that was on file in the database, and ask them to review it and update it if necessary. Jackson says the ACC hopes to partner with its sister societies in creating and using this database to streamline the process for faculty as well as for staff. “We are concerned that active presenters might have to fill out multiple disclosure forms, which would be annoying,” said Jackson. For the full conference report, visit www.acc.org/clinical/con sensus/ethics/index.pdf.
Guinea Pigs, Get Ready
The University of Alabama will be one of the first accredited providers to be surveyed after the new Standards go into effect, said panelist Linda Casebeer, PhD, associate director of the university's division of CME, in Birmingham, and associate director, Outcomes Inc. “We are one of the guinea pigs.” While UAB already asks faculty to use evidence-based content in their presentations, now on the UAB's new disclosure form, faculty will be asked to sign a statement saying that they will be clear about the type of evidence that supports their key teaching points — for instance, whether it's their professional opinion or comes from a guideline or a meta-analysis, said Casebeer, adding that most physicians already do that. “This is one of the best ways that we can ensure integrity, whatever their relationships are,” said Casebeer.
While Casebeer and other presenters said that their process for identifying and resolving conflicts of interest was very much a work in progress, Casebeer said it is important for providers to develop a policy in order to reassure staff. At UAB, “there was confusion and chaos because [staff members] thought that they had to review every piece of content.” Like other providers, UAB is using a peer-review and monitoring process to evaluate content. The monitoring process has been in place for about two months, she said. “It has settled a lot of the chaos. The worst part is for people not to know in what direction to move. Even if the policy will be revised or changed, it's important to develop it as a starting place.”
ACCME Pledges Help, Not Hassles
“You will get help from us — not aggravation and turmoil,” Murray Kopelow, MD, chief executive, Accreditation Council for CME, Chicago, promised during one of two ACCME-run mini-plenary sessions at the Alliance for CME annual conference. The ACCME has expended a great deal of effort in recent months to help providers understand what they need to do to comply with the updated Standards and to ease the pain of the transition. For instance, Kopelow said that providers from specialty societies, medical schools, and medical education and communication companies were invited to ACCME headquarters to discuss what they were doing already to prevent and detect bias, and what changes they might have to implement.
The ACCME received kudos for its initiative from a participant at the mini-plenary. Melinda Steele, MEd, CME director, Texas Tech University Health Sciences Center, Lubbock, Texas, was one of the providers who met with the ACCME. She said that her initial reaction to the updated Standards was that she would have to change everything she did, “but as the dialogue progressed, we realized we're already doing things to meet compliance. We would need to change the packaging and tweak policies and letters. I am pleased to say I'm now comfortable [with the updated Standards] and I want to plug the ACCME for being so receptive to these dialogues.”
In response to providers' requests, the ACCME released a tool kit (available at www.accme.org), which was distributed at the conference. Hoping to avoid a repeat of what happened at the AMA's CME Provider/Industry Collaboration conference this fall, where attendees were furious because the guidance materials accompanying the updated Standards seemed to be onerous requirements rather than recommendations, Kopelow emphasized that the ACCME's new tool kit provides examples and suggestions — not rigid rules — for compliance. In fact, he pointed out that on every page of the implementation tools section there is a disclaimer, stating that providers are not required or expected to use the information; the disclaimer also says that using the examples does not guarantee that providers will be found in compliance with the new Standards.
Kopelow also said that providers will be judged on their compliance with the updated Standards in increments. For instance, the first round of providers to fall under the new Standards, those up for reaccreditation in November 2006, will only have to document compliance with the new rules for the time period since they went into effect. “Even if you do it all wrong, all that will happen is you will be asked to do a progress report a year later that shows what you're doing to correct the problem,” he said. Providers won't be accountable for complying with the updated Standards for the full four-year reaccreditation period until 2010, and by that time they will have had ample opportunity to develop implementation strategies and to learn from their colleagues. “So you don't need to worry until 2010,” Kopelow concluded. “It's a lifetime away.”
Kopelow Takes Your Questions
When Murray Kopelow, MD, chief executive, Accreditation Council for CME, opened up his session at the Alliance for CME annual conference for questions, attendees rushed to the microphones with their specific concerns. Here are some of the audience members' burning questions, and Kopelow's replies.
QUESTION: Do the planning committee disclosures have to be disclosed to the learner?
ANSWER: Yes, if they control the content.
Q: If a person who controls content divests himself from the relationship, do you still have to disclose the conflict?
A: If the conflict is gone, it's resolved, but you still have to disclose it if it's within the 12-month period.
Q: Do faculty have to disclose all relationships, or just relevant ones?
A: In section 2.1 of the updated Standards, it states that “all relevant financial relationships with any commercial interest” must be disclosed to the provider. That means the relationship is present and relevant to the content.
Q: Can you give examples of safeguards for controlling commercial bias?
A: There are things you can do to prevent commercial bias, such as peer and content review to ensure the data's validity. Some people we have talked with who have highly motivated teachers who also are at high risk for bias, instruct them that they need to use evidence-based medicine when they get to areas with bias potential. Others have people on a panel to question the faculty member on that area. Also, when the difference in knowledge between the faculty and learners is greatest, the learners are less likely to perceive bias. Specialty societies for years have handled this by using monitors who are trained to look for bias.
Q: Some specialty societies could overdo disclosure to the point where it impacts the program. How much disclosure is too much?
A: I think the Alliance does a good job in their program book. It says that if there's nothing listed after a faculty name, the person has nothing to disclose. If a faculty member has nothing to disclose, we don't need to see that statement over and over again. But if 80 percent of your faculty have blank spaces below their names — which implies they have nothing to disclose — and we find out those areas are blank because they didn't turn in their disclosure forms, that's a different story.
Q: How should we deal with a course director who has a conflict of interest?
A: Take the scenario written about in The New York Times several years ago. Faculty for an activity about stents owned the company that made the stents, and they controlled the content. It's a clear case of conflict of interest. Someone else should be the chair. You also can use external evaluation and peer review to add a layer of decision-making if you have someone with a conflict who is that involved in the control of the content.
Q: What if the situation is not that obvious — he's a consultant to the pharma company, but is the best person to have for a particular activity. Is disclosing enough?
A: What the audience might perceive as just disclosure really could be much more — you made sure that the faculty picked are the best for the job, that the content is evidence-based, etc.
Q: Why all the articles criticizing CME when many of us are already doing a lot of what the updated Standards ask?
A: Because 30 percent of our accredited providers are not in compliance with disclosure. We have not yet measured content validation or the presence of bias.
Faculty that Serve as Faculty and Do Promotional Programs
One of the greatest challenges CME providers face is that they're often drawing faculty for certified activities from the same pool of speakers who are trained to do promotional programs for pharma companies. This problem will continue under the updated Standards, which do not prohibit faculty who serve on speakers bureaus from speaking at CME activities, as Murray Kopelow, MD, chief executive, Accreditation Council for CME, has clarified.
At a mini-plenary, Sue Ann Capizzi, MBA, assistant director, division of continuing physician professional development, and director, CME strategic business development, American Medical Association, Chicago, Ill., suggested asking speakers to make this statement: “It is my obligation to disclose to you (the audience) that I am on the speaker's bureau for [name of commercial interest(s)] and I have received training to provide promotional presentations for these companies. However, I acknowledge that today's activity is certified CME and thus cannot be promotional. Therefore, I have agreed that for this presentation, I will not be using materials or information prepared by commercial interests for promotional programs, and will give a balanced presentation using the best available evidence to support my conclusions and recommendations.”
“Am I dreaming?” asked Capizzi. (She added that this is her own idea and has not been reviewed by any organization.) Judging by the loud applause that accompanied her suggestion, there are many providers who will try to make her dream come true.