Report from the Alliance for CME Annual Conference

“Is your whole article going to consist of !@#*% (expletives deleted)?” quipped a CME provider as we waited in line for drinks at the Alliance for CME annual conference opening reception. Point well taken. Without doubt, the hottest topic at the conference was the Accreditation Council for CME's draft revision of the Standards for Commercial Support — now called the Standards to Ensure the Separation of Promotion from Education within the CME Activities of ACCME Accredited Providers. But while the draft sparked a lot of confusion and contention, attendees didn't get much clarification at the conference. So we decided the most helpful thing we could do for you was to pose the questions you raised at the conference to Murray Kopelow, MD, chief executive, ACCME, Chicago; and Norman Kahn Jr., MD, chair of the ACCME's task force on the Standards, and vice president, science and education, American Academy of Family Physicians, Leawood, Kan.

MM: A major concern expressed by Alliance participants is that the stipulation precluding doctors from teaching if they have a conflict of interest would mean, as one attendee said, that the vast majority of medical experts would be disqualified from being teachers.

Kahn: That's too extreme an interpretation. At one end of the spectrum is the physician who discloses that “I was recently trained by company X and I am paid by company X and they expect me to clear what I say with them.” That would be a conflict of interest. At the other end are people who have many long-standing speaker bureau relationships, speak primarily for CME, not for promotion, and speak about lots of different topics. They would probably not be perceived as having a conflict of interest. And then there is everybody in between.

Kopelow: If this is the admission by the commercial supporters and the CME community — that [the majority of] relationships are conflictual and that therefore [the new Standards] are going to exclude all these people — that's important. That's a huge issue for the CME community to discuss and reconcile.

MM: Providers are also concerned that the new Standards will make the process of recruiting speakers much more difficult as they will need to get disclosures before inviting teachers.

Kopelow: Yes, we are asking them to do more. That is absolutely correct. We're proposing that disclosure is no longer the single best tool to address conflicts of interest, and that CME providers and the teachers and authors are going to participate in the reconciliation of conflicts of interest. CME providers have to take some responsibility, from a professional and educational perspective. They're not meeting planners or logistics people.

[The new rules] remove the issue that people have talked about many, many times: “The teacher is about to walk in the room, and the learners are here, and we don't have the disclosure information yet.” We've got to put those days behind us. We have ARC [Accreditation Review Council] data that says up to 30 or 40 percent of our providers cannot demonstrate that disclosures are being made when they come up for reaccreditation. If 50 percent of providers have problems with speakers refusing to disclose and another 40 percent don't have disclosure information, you have to create a new system.

MM: Will the provider have responsibility for ensuring the disclosure is accurate?

Kopelow: We can't hold our providers responsible for non-truthfulness.

Kahn: If they find out a speaker has been duplicitous, then they have to decide whether they want to use that speaker ever again. That's not an ACCME issue, that's a provider issue.

MM: Another big area of confusion: What is the difference between vested interest and conflict of interest?

Kahn: If a person is an agent of a commercial firm and therefore is putting proprietary interests of that firm into CME, that is a conflict of interest.

Kopelow: An example: A cardiovascular surgeon is promoting a surgical treatment. The surgeon's recommendations meet our content validation requirements, or perhaps an even higher standard — the American Academy of Family Physicians evidence-based CME requirements. The surgeon has a vested interest. But let us say that same surgeon owned the company that made a surgical device, and the literature was not clear about whether that device was better than traditional open heart surgery — now that person may have a conflict of interest. That's because the surgeon's interest in getting doctors to use the device may be in conflict with patients' interests in receiving the safest, most cost-effective care. A provider could reconcile that by recusing the person as a speaker, or perhaps that surgeon will remain silent on devices and someone else will address the issues of devices.

MM: There is also concern about the impact on CME staff members. What if, for example, a CME staff member needs to recuse herself from planning an activity, but her supervisor expects her to be responsible for all activities?

Kahn: If somebody does have what they perceive to be a conflict, they should indeed recuse themselves, and it isn't appropriate to expect that person to be responsible.

Kopelow: If the daughter of the president of Merck is the CME planner, this is an issue. How is she going to reconcile that? How does she put herself at arm's length from Merck?

MM: What constitutes a conflict of interest for CME providers? For example, if a specialty society receives $1 million from a pharmaceutical company for its foundation, would that constitute a conflict of interest?

Kahn: The only time that would be a conflict is if the $1 million grant carried with it conditions that related to CME programming. If somebody said, “I'll sign a 20-year contract to buy four exhibits, but in return I expect you to do CME programming on topics of my interest every year,” that's a conditional grant. That's a violation under the Standards.

The American Medical Association Council on Ethical and Judicial Affairs has distinguished gifts to organizations from gifts to physicians. Gifts to organizations are given for visibility, for good will, whereas gifts to individual physicians are given to affect their prescribing habits.

MM: You've said that it's up to each provider to create their own definitions of conflict of interest. However, CME providers are worried that they will be penalized by the ACCME for doing something wrong if their own interpretation differs from yours.

Kopelow: The ACCME plans on identifying benchmarks to guide providers. If an organization is out of compliance with the Standards for Commercial Support because of conflict of interest, because its definition of a boundary and our definition is different, we'll be clear about the difference between our expectations and the provider's practices. They will be required to come into compliance. If they refuse, their accreditation will be subject to review and they could be put on probation, but it will be because they refuse to change — not because they did something wrong.

MM: Another concern is that the revised Standards will discourage commercial supporters from funding CME. In a survey of Pharmaceutical Alliance for CME (PACME) members, respondents predicted that while the PhRMA code and the Office of Inspector General's guidance for pharmaceutical manufacturers would lead to more money for CME, the revised Standards for Commercial Support might result in a reduction of CME funding.

Kahn: I'm speaking now as a provider. My experience is that companies are more concerned about being squeaky clean than they ever were before. So I would think the companies would welcome clearer Standards.

MM: Providers are concerned that the administrative responsibilities will be onerous. Your comment?

Kahn: In the old Standards, if somebody refused to disclose, you would just say they refused to disclose. Now, you can't do that. You have to get that disclosure. I don't consider that onerous. But is that more work? Absolutely, that's more work. But in order for learners to make informed decisions, there must be full disclosure.

MM: Some providers charge that the new Standards are simply a reaction to the recent media coverage.

Kopelow: Positive media is an important indicator of things, but it is not the ACCME's goal. This work on the Standards started in 2000, before the press was interested.

Kahn: If we're going to get media coverage, we'd like to have media coverage that works to our advantage, that says to the public through the media: Commercial support cannot and does not influence the CME process. Your physicians can make up their own minds about what they prescribe.

MM: Why was the terminology describing funders changed from “commercial supporter” to “contributor”?

Kopelow: [To clarify that] any contributed funds must be accounted for even if they don't come from an FDA-regulated firm. When the Centers for Disease Control or the American Heart Association gives money to develop CME, there are no commercial interests in that relationship that need disclosure [but the funds still need to be accounted for].

MM: There's concern about the relationship between traditional CME providers and medical education and communication companies. Currently, pharmaceutical companies often hire the communication company. Now, the provider will be selecting the firm.

Kahn: That's the way it was always supposed to be. It was always the provider's responsibility to select a communication company. It is absolutely the expectation that the pharmaceutical company not select the communication company.

Kopelow: Organizational type is not as important as the business model [of the company] and the education development process. The issue is: Who has control of the content and what is their commercial interest? When a non-accredited education company develops CME on behalf of a [drug or device] firm — following the content specifications of that firm — it is as if the drug firm developed the CME. The provider will have to show the ACCME that the content was designed free of the [drug firm's] control.

MM: What about the impact on pharmaceutical speakers' bureaus and their relationships with CME?

Kopelow: The [pharma firm] could say, “We will only provide commercial support to educational activities where none of our speakers are on the faculty, because we don't want to be perceived as creating a conflict of interest.” Or, “We will provide commercial support for this activity and our speakers can serve on the faculty, but the provider needs to do more about reconciling the conflict of interest.” These are all potential tactics or solutions.

MM: The new Standards remove the requirement for disclosure of unlabeled and unapproved uses. Will removing this requirement open accredited CME up to even more criticism?

Kopelow: If you make a clinical recommendation [in a CME activity], it needs to be supported by evidence. [See the ACCME's content validation policy.] That trumps whether it's off-label or not.

MM: Some people have said that we have enough regulations, we just need to enforce them. Why doesn't the ACCME, for example, send monitors to programs? Take more responsibility for proving compliance, rather than relying on providers' self-reporting?

Kopelow: It is important to distinguish between monitoring and enforcement. The ACCME has never discussed taking an enforcement role in the field in order to change providers' practices on site. We could get more involved with on-site data collection in a monitoring context, and we definitely plan to discuss an increased monitoring role for ACCME. We've piloted it already and we know it can produce important data.

Kahn: Why don't we send monitors to programs? Because that's over-regulation. Providers are saying they don't want to be responsible, that they want the ACCME to be responsible? I don't think they really mean that. They want to invite additional external regulation? I don't think they really mean that. They want to increase the expense of accreditation? I don't think they really mean that.

MM: There's concern about the differences between the PhRMA code and the new Standards.

Kopelow: The major difference is that the PhRMA code describes physician teachers as service providers to industry. The draft Standards say that becoming beholden to a firm could create a conflict between the interests of the teachers and the learners. Physicians have to get together and decide, from a professionalism point of view, the proper way to behave.

Next Stop — Speaker Honoraria

Speaker fees continue to escalate, yet none of the current CME, pharmaceutical industry, or government guidelines set parameters for faculty honoraria, other than saying that they should be “reasonable.” In addition, there continues to be ambiguity regarding the demarcation lines between promotional and educational speakers.

The PhRMA code, in the section “Speaker Training Meetings,” says that healthcare professionals can be offered reasonable compensation for the time spent in a pharma firm's speaker training program. That part of the code is a concern, says Norman Kahn Jr., MD, chair of the ACCME's task force on the Standards. “What that clearly shows is that the intent of a company in speaker training is that healthcare professionals be paid promotional speakers for the company.”

“Over the years, the market forces setting honoraria have become competitive forces between pharmaceutical firms — not competitive forces between CME providers,” says Murray Kopelow, MD, chief executive, Accreditation Council for CME, Chicago. “The new Standards of Commercial Support [challenge] that.” To address the issue of speaker honoraria for CME activities, the ACCME plans to bring together different CME organizations and commercial supporters over the next few months to decide what the ACCME's role should be in establishing honoraria guidelines.

First Amendment Violation?

Remember the Washington Legal Foundation, the organization that brought suit against the FDA, charging that its restrictions on promotion of off-label use violated the First Amendment? They have issued similar criticism about the new Standards. Here's an excerpt:

“The proposed Standards are a clear violation of First Amendment rights because of their content-based restrictions on truthful speech.…WLF believes there is no justification for suppressing speech unless there is good reason to believe that the speech is false. If a CME provider believes that doctors can better evaluate what they are being told by a speaker if the speaker discloses all potential sources of bias, then by all means the provider should require such disclosure. But WLF does not believe that there can be any justification for suppressing truthful speech altogether based solely on a fear of potential sources of bias.”

Raise Your Voice

Responses to the revised Standards for Commercial Support from the major CME organizations were not available at press time. However, we plan to run excerpts in the June issue. If you would like your comments to be considered for publication, please contact Tamar Hosansky at (978) 466-6358, or send her e-mail at thosansky@primediabusiness.com.