For the lesson profession, a familiar drill: shifting rules (Updated 9/26/07)

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A new policy that has profound effects on how medical education outfits do business has put some previously understood issues in play for industry.

For one, providers saw a new, formal firewall policy adopted by the board of the Accreditation Council for CME (ACCME) last month. But the council did not fully explain what the policy, with which providers have two years to comply, will look like.

“ACCME has a tendency to release policy and then make modifications to it,” said Don Young, managing director, Discovery Institute of Medical Education (DIME), an accredited provider owned by agency holding company Publicis. “As the rubber meets the road on this, we'll find out more.”

What is known at this point is that the ACCME now defines a “commercial interest” as any entity “producing, marketing, re-selling or distributing healthcare goods or services consumed by, or used on, patients.”

Murray Kopelow, MD, ACCME executive director, subsequently told MM&M that ACCME's intent is to limit the definition of a commercial interest largely to FDA-regulated companies (i.e., drug, device and biotech firms) and, for example, to firms such as advertising agencies or those whose interests are aligned with them. As such, the term “marketing” in the new definition can include, but is not limited to, for-profit CME providers owned by or having a business unit that does promotional work for commercial interests. Firms such as these may need to take additional steps to transition to an independent corporate structure, possibly beyond the corporate firewalls many have erected.

“I felt like we've been pretty extensive in our model in terms of what we put in place,” Young said. “At DIME, we are completely separated from any promotional business. We are set up as a stand-alone CME organization within the holding company, so we're basically a wholly owned subsidiary of Publicis.”

While he offered some basic criteria for the new corporate structures, Kopelow said providers can submit structures to ACCME going forward.

"It's a service we offer in support of people who have to make serious decisions," Kopelow said. "They can submit to us any time up until they present themselves for accreditation in Aug. 2009."

Kopelow said publishers of journals or other publications do not automatically fall under the expanded definition of a commercial interest just because they sell advertising space. The company creating or buying the advertising would be considered the commercial interest. However, a publishing company could be part of the definition, if its parent or sister company is engaged in an agency relationship that involves marketing, re-selling or distributing on behalf of a commercial interest.

“The new ACCME commercial interest policy and Dr. Kopelow's clarifications regarding required corporate firewalls could affect some publishing companies who are accredited CME providers or who have divisions or units that are accredited by the ACCME,” said James Magrann, executive director, Lippincott CME Institute (LCMEI).

Owner Wolters Kluwer Health spun out LCMEI just last year in a move intended to “strengthen the firewall between its accredited education services and other company products,” such as its journal publishing arm Lippincott Williams & Wilkins, the firm said in a 2006 statement.

Magrann added, “For publishing companies to better gauge whether their parent or sister companies fall under the new definition of commercial interest and the degree of required changes to their respective corporate structures, it would be helpful for all providers if the ACCME would more clearly define the term ‘market' used in the new policy.”

Another area made uncertain by the new policy was the matter of who can offer joint sponsorship, the logistic and implementation support that non-accredited medical education companies provide for many universities, hospitals and not-for-profits. Accredited providers were asking what due diligence they must do of their joint sponsor, as the latter may be defined under the new policy as a “commercial interest,” and ACCME-sanctioned providers cannot do business with commercial interests.

“Now any accredited provider needs to know a heck of a lot about its joint sponsor and who owns them,” said one source who wished to remain anonymous. “That's going to be a major headache.”

While it might not eliminate the practice, the rule may have put the transparency of such partnerships in jeopardy. Until now, many commercial supporters have required that any third party involved in a CME activity also be included in the letter of agreement between the grantor and accredited provider. With the new policy not formally recognizing joint sponsorship, it could push the practice underground, with accredited entities using meeting planners without disclosing them.

“What could end up happening is, under the current policy, work could go to shops like [universities] and it will be business as usual, except hidden under the surface,” said the same source. “You're pushing the whole thing underground to where the system can no longer hold anyone accountable.”

The new structural requirements are relevant to all accredited CME providers, if the new definition of “commercial interest” applies to them. Absent, though, was an acknowledgement that all provider types struggle with conflicts of interest. The Coalition for Healthcare Communication, which had urged ACCME to apply the structural requirements more evenly since April, released a fresh response to the policy that is notable for its forcefulness.

“The ACCME seems to be creating two classes of CME providers; one class where the potential for financial conflicts of interest requires extraordinary action and another where the same potential does not,” wrote Marty Cearnal, co-chair of the coalition's CME committee.

The ACCME has maintained that drug and device companies cannot be accredited providers. But, noted Cearnal, “What is difficult to understand is the idea that commercial support from drug and device companies is more likely to bias the CME activities produced by one group of accredited providers than another.”

Other provider types have some built-in conflicts that need to be managed, he said.

“There was an opportunity to address a systemic problem—institutional conflict of interest—at a system level,” said a source. “Instead, it was special rules for special people.”

Kopelow is scheduled to speak at next month's meeting of the AMA National Task Force on CME Provider/Industry Collaboration. Both the task force meeting, as well as the ACCME board's November gathering, could represent opportunities for further clarification on the new policy.

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