"The verb "resolve" could be the most challenging new requirement in the Standards," comment CME veterans Lewis A. Miller, MS, and Dennis K. Wentz, MD, in an e-mail statement. Their observation strikes at the core of the discussion surrounding the new revision of the Accreditation Council for CMEâ€™s Standards for Commercial Support.
Unlike the current Standards, the proposed version, if approved, will require CME providers to identify and resolve all conflicts of interest. AsChief Executive Murray Kopelow, MD, told The Wall Street Journal in an April 19 article, that addition may be "a small sentence, but itâ€™s pretty powerful." That rule, plus the other new requirements in the Standards, will mean significant changes in the way ACCME accredited providers operate, and will also affect their nonaccredited educational partners and commercial supporters as well, says Steven M. Passin, president, Steve Passin & Associates, Newtown, Pa.
To begin with, in order to identify conflicts of interest, CME providers, under Standard 2.1, will have to obtain disclosures from everyone who is in a position to control the content of an educational activity.
"Does "everyone" mean that the provider prepares a list of every individual on the planning committee, any speakers, authors, or consultants it uses, staff in the commercial supporterâ€™s office of medical education or marketing, etc., and provides each such person with a form certifying the extent of any relevant financial relationship with any commercial interest?" ask Wentz and Miller, who are cofounders of WentzMiller & Associates, Darien, Conn., and Beaver Creek, Colo.
"Everyone" does include teachers, planners, and managers from the CME providerâ€™s office, as well as educational partners, joint sponsors, and vendors, responds Kopelow. But "everyone" does not include people working for the commercial supporterâ€”as they are precluded from having control of the content by Standard 1.1, which says that CME activities must be developed free of the control of a commercial interest.
As for what must be disclosed, Standard 2.1 says that all relevant financial relationships with any commercial interest must be revealed to the provider. Relevant is defined as financial relationshipsâ€”in any amountâ€”that occurred within the past 12 months that create a conflict of interest.
Wentz and Miller question whether that timeframe should be extended. "Suppose an author or speaker on a program in 2004 received nothing in 2003, but received $100,000 or more in research money from a supporter in 2002â€”shouldnâ€™t this disclosure be required?" Thatâ€™s one of the many decisions CME providers will need to make as they implement the new Standards.
In another major change, anyone who refuses to disclose cannot have control of CME activities and will be disqualified from being a planning committee member, a teacher, or an author. Under the current Standards, a refusal to disclose does not preclude people from planning CME activities or teaching them. However, "The Accreditation Review Committee and the Council have always said that if the majority of [your teachers] are refusing to disclose, you are out of compliance," explains Kopelow. "What is new is that CME providers must make decisions and take actions on the basis of the conflict of interest information."
What Is Conflict of Interest?
But in order to make decisions about conflict of interest, providers will have to define exactly what it is. The ACCME is issuing its definition in a separate policy, which, according to Kopelow, will say: Any financial relationship with a commercial interest that is relevant to the content is a conflict of interest. "There are no de minimis requirements," he says. "Itâ€™s not that $1,000 is fine, but $5,000 is too much." The reason the definition will be in a separate policy, rather than incorporated into the new Standards, is because "if it needs more clarification, or we need to change or modify it, we can do it more nimbly if it is outside of the Standards."
Since the ACCME policy will not specify dollar amounts, CME providers will have to make those decisions themselves; draft new policies on disclosure that define what amounts of money constitute a conflict of interest and therefore could exclude a teacher, planner, or manager; and communicate those parameters with everyone required to disclose, says Passin.
To obtain all these disclosures and resolve any conflicts of interest, CME providers will now have to start the disclosure process much earlier on in the planning process. They will also need to revamp their disclosure forms so they apply to all the parties who now must fill them out, says Passin. Providers working with international teachers will need to take extra precautions, communicating deadlines way in advance, and making sure to explain the consequences of not reporting, he adds.
"Itâ€™s going to be awkward," says Passin. "I donâ€™t think it will be difficult to implement, but it will be difficult to figure out what to do with [the disclosures] when you get them back." He advises providers to develop procedures specifying who convenes to review disclosures, methods of documentation, and processes to qualify or disqualify teachers, planners, and managers.
We Need Examples!
Those procedures will involve more than a black-and-white decision about whether to qualify or disqualify somebody from participating in CME content development. Unlike the first draft revision of the Standards, issued in January 2003, this new draft does not require CME providers to automatically disqualify teachers or planners who have a conflict of interest. It is up to the providers to decide how to resolve those conflictsâ€”and many are asking for more specific guidance on what procedures will satisfy the ACCME.
"We are going to support [CME providers] with examples and explanations about the range [of acceptable methods]," says Kopelow. For instance, if a CME provider discovers that a speaker has a conflict of interest, the provider can choose a different speaker, or inform the speaker that he or she will not be allowed to make recommendations about specific drugs or treatments, but will just explain the physiology of the drugs.
But that last example doesnâ€™t sit well with Wentz and Miller. "We find it hard to believe that a provider can place restrictions on what the speaker or author can say because of relationships with a supporter; that might carry the taint of censorship," they counter.
"Itâ€™s not as if [providers] have to pick one of those choices," says Kopelow. "Those are just examples of process. What they have to do is have a mechanism, and the mechanism will be up to them."
Flexibility is a good thing, but it can have its drawbacks, says Karen Overstreet, EdD, RPh, president, Nexus Communications Inc., North Wales, Pa. "I appreciate the fact that they leave the policymaking up to the providers, but itâ€™s hard to develop a policy without a clear definition of what the policy is addressing." Without more specific guidance, she and other CME professionals express concern that some providers may try to get around the spirit of the new Standards. "Some providers may choose to ask physicians on their disclosure form: â€˜Do you have a conflict of interest, yes or no.â€™ Thatâ€™s a very easy, low-cost way to get at that conflict of interest question," she says. "Most physicians arenâ€™t going to check â€˜Yes, I have a conflict of interest.â€™People are going to be looking for ways to develop policies that are easy to operationalize, but Iâ€™m not sure that gets at the intent of [the new Standards]."
There will be providers who will only pay lip service to Standard 2.3, acknowledges Kopelow, but they will be out of compliance with Standard 5, which says that activities must be free of commercial bias. "If your activities are commercially biased, youâ€™re not resolving conflicts of interest. Look at it from an outcomes perspective," he says.
Creating Faculty Confusion
With CME providers creating their own parameters, there will probably to be a wide range of policies. "At the very least, itâ€™s likely to create a fair amount of confusion on the part of [physicians] who serve as faculty for several, if not dozens, of CME providers," predicts Jack Kues, PhD, assistant dean for CME, University of Cincinnati; and past president of the Society for Academic CME. "What is considered a conflict with one provider may not be considered a conflict with another provider, and how a faculty member has to behave will vary with different providers. Maybe the faculty memberâ€™s mental health isnâ€™t our top priority, but it certainly is likely to create some confusion."
CME activity participants, as well, will be dealing with different providersâ€™ definitions of conflicts of interest. Passin suggests that providers develop new formats for learner disclosures, and consider creating financial categories similar to the ones used by the federal government for candidates in office, and then use those categories when making disclosures to learners (e.g., up to $15,000, $15,000 to $30,000, $30,000 to $60,000, more than $60,000).
Time to Diversify
Itâ€™s not just faculty conflict of interest that must be resolved; CME providers must resolve their own conflicts. To protect themselves, CME providers should diversify their relationships with commercial supporters, recommends Passin, and not rely, for instance, on one pharma firm for 80 percent of their funding.
Good advice? It depends, says Kopelow. "The conflict exists when there is an incentive to act in a certain way in order to maintain or increase the value of a financial relationship. As you get closer and closer to one [company] youâ€™re more clearly the agent of that firm." On the other hand, he adds, "having many customers does not necessarily cause a disincentive."
Reining in Honoraria
The new Standards also address the controversial issue of faculty honoraria: Standard 3.7 states that CME providers must have written policies and procedures covering honoraria for planners, teachers, and authors. The previous Standards did not require written policies, but did say that honoraria should be reasonable.
This stricter guideline may have been included "because there has been some concern that honoraria are being set quietly by commercial supporters," says Kues. "Now, requiring the providers to have such policies may create conflicts between physicians on pharmaceutical speaker bureaus and the pharmaceutical companies. Putting thought into [an honoraria policy] is one thingâ€”enforcing it is going to be a tougher issue."
Regardless of how difficult it is, CME providers will need to enforce honoraria policies, as payment of exorbitant honoraria may indicate a conflict of interest, cautions Passin.
He thinks this policy will level the playing field for specialty societies, helping them gain control of honoraria paid to speakers presenting at satellite symposia. "At specialty society annual meetings, often satellite symposia pay higher honoraria to speakers than the specialty society does for its own part of the program. And that pulls the best faculty over to those satellite symposia. This will enable the specialty society to have more control. They could say: Your honoraria must fit within our policy."
Standard 3.10 also says that when people participate in a program both as teachers and learners, they should be reimbursed only for expenses related to their teaching role. "I think itâ€™s fabulous that providers are being supported in principle to pay for only those expenses related to the provision of educational services," says Jacqueline Parochka, EdD, president, Excellence in Continuing Education Ltd., Chicago. "There are faculty members who push the envelopeâ€”ask for first-class fares, registration fees to attend the annual conference, etc., and hold the accredited provider hostage with these demands. Now, the providers can turn to this Standard, and say, â€˜See, here it is in black and white.â€™"
ACCMEâ€™s Stamp of Approval
How will providers know if the systems they develop for identifying and resolving conflict of interest, and adhering to the other rules, will satisfy the ACCME? The ACCME will be providing education workshops and a Q&A on its Web site, Kopelow says. "Weâ€™re going to be patient and let [providers] implement and deploy. Just like we do now, we will ask them to show us their system. We want to see their data and mechanism for improvement. Thatâ€™s the model that works best for us and our providers because the mechanisms for implementing this are going to be as diverse as the provider types."
But some question whether the ACCMEâ€™s system of enforcement is strong enough.While the ACCME has had a complaints and inquiries process for many years, Frederic S. Wilson, category manager CME, Procter & Gamble Pharmaceuticals, Mason, Ohio, has been disappointed in that process, which, he says, appears to have no teeth. He would like to see a system that "alarms the ACCME into action regarding violations." Heâ€™d also like to see "appropriate penalties promptly levied to empower the CME enterprise to self-regulate."
Overstreet also has concerns about the monitoring process. "I think the version that the ACCME approved is a huge improvement over the previous draft version. But Iâ€™m still not convinced that we needed a change," says Overstreet. "I havenâ€™t seen any data that says that the current Standards arenâ€™t working. Certainly there are violations and there are outliers in the accreditation system. We need to enhance our monitoring processes and deal with those outliers, rather than make new guidelines that arenâ€™t going to be monitored any better than the previous ones. If theyâ€™re not going to remediate, if theyâ€™re not going to do something to help people who are not complying, changing the rules is not going to help at all."
As for implementing a stricter monitoring process, "Weâ€™re not going to send out the CME police to find people doing things wrong," Kopelow says. However, he adds that the ACCME may develop a more comprehensive process of activity review. In the past, the ACCME initiated a pilot program where physicians, both general practitioners and specialists, were trained in the Standards for Commercial Support, observed activities, and reported back. The ACCME may consider implementing such a program again.
Meanwhile, the ACCME will monitor the degree of compliance and non-compliance. "When people say to us, â€˜Your system is a failure. Thereâ€™s commercial bias,â€™ weâ€™ll be able to show them data and say, â€˜No, thatâ€™s not true," says Kopelow. "Regardless of provider type, 99 percent of the time, physician experts and the general physician public report that there is no bias."
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