In a development that surprised many CME professionals, the Accreditation Council for CME issued an FAQ document prohibiting providers from asking commercial supporters to suggest topics or speakers for educational activities, or to review content for accuracy. The document, released October 12, less than a week before the 18th Annual Conference of the National Task Force on CME Provider/Industry Collaboration, provoked heated discussion during sessions and breaks at the meeting.
First, Do No Harm?
While the Standards for Commercial Support make it clear that providers are not required to act on commercial-supporter suggestions regarding educational content, providers sometimes ask grantors to review an activity for medical accuracy. Now, thehas made it clear that such interaction is verboten. While the ACCME's goal is to protect CME's independence, some CME professionals think that the prohibition could jeopardize patient safety.
During one session, participants analyzed a case example involving content review in light of the new ACCME document. What if a grantor has new, unpublished information regarding product safety or efficacy? If the provider is not allowed access to that information, the end result could be that patients might be harmed, said one attendee.
Others pointed out that there are gray areas. Whether a provider should act on a commercial supporter's input might depend on whether the new data makes the company's drug look less or more effective, said one participant. If it makes the product look less effective, perhaps the provider could include the new information. On the other hand, when commercial supporters want to share unpublished studies with a provider, it raises a red flag, said a speaker. “It makes you wonder what other unpublished studies [they are not disclosing].”
During a breakout session on the grants process, participants asked the panelists from pharmaceutical companies their companies' responses to the FAQ. Most said their companies were taking a conservative approach, holding off on any CME speaker suggestions or accuracy reviews until their attorneys had time to analyze the situation. As for their opinions about the FAQ, one speaker said, “I'm having a yin-yang moment. If we want better patient care, isn't it better to ferret out information, and expose the bad and the good?”
A participant, also from a major pharmaceutical company, added, “We need public debate on this. We need to act in the best interests of patient care and the public health. Let's not throw the baby out with the bath water.”
In the bigger picture, some CME professionals expressed concern that the ACCME is cutting off positive collaboration between commercial supporters and providers. During a hot-topics session led by Murray Kopelow, MD, ACCME chief executive, a participant from a major pharmaceutical company voiced her perspective. Pharma companies, she said, not only have expertise in science, but understand how to design education so that it effectively addresses healthcare barriers — an expertise they want to share with CME providers. But in the current environment, she said, “we're feeling like there is no way to have dialogue, to exchange that information that could reduce healthcare gaps.” She urged Kopelow to communicate directly to pharma, not just through accredited providers. Her comment was greeted with audience applause.
“Talk to me,” Kopelow said, adding that he would be glad to have conversations with individuals from the pharma industry, and that he had recently met with Pfizer's CEO.
“I'll be calling you as soon as I get back,” she responded.
We followed up with Kopelow for clarification on the key issues that created confusion and concern during the conference. He reiterated that commercial supporters can still issue RFPs specifying topic areas, but added that providers and commercial supporters should pay close attention to the ACCME's new policy regarding letters of agreement. This policy says providers will be found noncompliant with the Standards for Commercial Support if they allow grantors to specify in the LOA how the provider will fulfill ACCME requirements.
MM: Regarding No. 6 and No. 7 in the list of FAQ released in October, providers are concerned that if they cannot ask commercial supporters to review content, there may be inaccuracies, or pharmaceutical companies may have new safety and efficacy data they would not be able to include, which could adversely affect patient care. What are your thoughts?
Kopelow: Content validity in CME is critically important. But it is not industry's responsibility to ensure the content validity of CME. It is industry's role to ensure the content validity of advertising and promotion. Yes, it is up to the providers to ensure that content is valid — perhaps through their review by independent teachers or authors or other content experts. It is absolutely essential that this validation not be performed by a commercial interest. If CME providers do not have access to content expertise, they must not turn to commercial supporters. They must seek that expertise from healthcare professionals who are content experts.
It is up to the speakers and authors of the CME [activities] to decide what data and information is included in CME. It is up to industry to put the data in the public domain — to make it available to teachers and authors. It is not part of the commercial supporters' role to collaborate on the content of CME.
If CME providers partner or collaborate with commercial interests in the development or refinement of the content of continuing medical education, the CME is not independent.
MM: There was also concern expressed about the decision-making process concerning No. 6 and No. 7. What was the approval process? Were these new policies approved by the board of directors and member organizations? If not, why not?
Kopelow: This is not new policy. The new FAQ provided by ACCME is in direct and explicit support of ACCME policy, first announced in September 2004 when ACCME [released] the updated Standards for Commercial Support. Since then, the ACCME has been saying: “Accredited providers must not allow commercial interests to directly (SCS 1.1) or indirectly (SCS 3.2) control the content of CME.” We have been enforcing this in the accreditation review process. [If providers select speakers based on commercial-supporter suggestions or] change CME content after review by industry [they're] allowing commercial interests to control the content of CME.
MM: You say this is not new policy. However, this is the confusion among CME providers: Standard 3 says a provider cannot be required by a commercial interest to accept advice, etc. It does not say a provider cannot ask for advice or review.
Kopelow: Thank you for pointing out a source of confusion. Our statement [included in the ACCME response to the Senate Committee on Finance] that “the ACCME believes that CME can receive commercial support from industry without receiving any advice or guidance, either nuanced or direct, on the content of the activity or on who should deliver that content” is the basis for the Q&A.
MM: Is there any recourse for commercial supporters concerned about accuracy of data presented in CME activities ?
Kopelow: ACCME is about to enter into a period of conversation and dialogue with providers and commercial supporters regarding the implementation of the five themes that emerged in July and were included in the ACCME's response to the Senate Committee on Finance. As we said in the response, during this dialogue “ …the future role of industry in CME, including that of a funder, will be evaluated in the context of independence.”
ACCME will reach out directly to individual firms that make FDA regulated products to listen to their views and perspectives. We expect this to start after the November board meetings.
MECC Firewall Gets Thumbs Up from ACCME
Accredited provider CME Enterprise, Carmel, Ind., is the first company to receive Accreditation Council for CME approval for its restructuring, under the ACCME's new redefinition of commercial interest. Announced in August, the new definition means that accredited providers that have parent or sister companies involved in marketing must reorganize their corporate structures in order to completely separate promotion from education. Otherwise, they risk being redefined as commercial interests, ineligible for accreditation.
Under the new structure, CME Enterprise and its nonaccredited sister company, Avant Healthcare Marketing Inc., are owned by Deborah B. Wood. Deborah Wood Associates, a third entity under the owner, handles finance and human resources. CME Enterprise president Bruce Bellande, PhD, says the company began planning the separation in June, anticipating ACCME's new policy. “We looked at separate [office space], how to create different servers, e-mail, the whole shebang,” he says. They also created a stringent policy regarding the independence of certified education. The restructuring, says Bellande involved “plenty of time and plenty of money.”
When submitting the restructuring to the ACCME for approval, Bellande didn't include any complicated legal documents. Rather, he sent a simple organizational chart, illustrating the company structure, and the detailed CE independence policy, which included CME Enterprise's process for managing and resolving conflicts of interest. One month later, on October 12, he received a letter from Murray Kopelow, MD, ACCME chief executive, approving the reorganization. In the letter, Kopelow also answered Bellande's questions, clarifying that it's acceptable to have consolidated payroll, health insurance, and 401(k) plans across the companies. However, it is not OK for the parent company to handle budgeting and grant reconciliation for CME Enterprise because those functions are part of the “planning and conduct of CME activities,” Kopelow wrote.
Although happy with the decision, Bellande acknowledges the process was stressful. “My concern from the get-go in being the guinea pig was I didn't know what to expect. I just had a gut feeling that [our restructuring] was right,” he says. Bellande compliments the ACCME's “fair and timely process.” If his company had not received approval, he wonders if there would have been an appeals procedure.
Some providers question whether the August 2009 deadline for companies to restructure will satisfy the Senate Finance Committee, which has expressed concerns about the long time it takes the ACCME to address violations. The deadline “may be too long,” responds Kopelow. “We chose this time because we know that CMEare signed and commitments are made in the one- to two-year time frame. If there is reason to consider shortening it, we could do so.”