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

For one, providers saw a new, formal firewall policy adopted by the board ofthe Accreditation Council for CME (ACCME) last month. But the council did notfully 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. “Asthe rubber meets the road on this, we’ll find out more.”

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

Murray Kopelow, MD, ACCME executive director, subsequently told MM&Mthat ACCME’s intent is to limit the definition of a commercial interest largelyto FDA-regulated companies (i.e., drug, device and biotech firms) and, forexample, to firms such as advertising agencies or those whose interests arealigned with them. As such, the term “marketing” in the new definition caninclude, but is not limited to, for-profit CME providers owned by or having a businessunit that does promotional work for commercial interests. Firms such as thesemay need to take additional steps to transition to an independent corporatestructure, possibly beyond the corporate firewalls many have erected.

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

While he offered somebasic criteria for the new corporate structures, Kopelow said providers cansubmit structures to ACCME going forward.

“It’s a service we offer in support of people who have to make seriousdecisions,” Kopelow said. “They can submit to us any time up untilthey present themselves for accreditation in Aug. 2009.”

Kopelow said publishers of journals or otherpublications do not automatically fall under the expanded definition of acommercial interest just because they sell advertising space. The company creatingor buying the advertising would be considered the commercial interest. However,a publishing company could be part of the definition, if its parent or sistercompany 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 regardingrequired corporate firewalls could affect some publishing companies who areaccredited CME providers or who have divisions or units that are accredited bythe ACCME,” said James Magrann, executive director, Lippincott CME Institute(LCMEI).

Owner Wolters Kluwer Health spun out LCMEI just last year in a move intendedto “strengthen the firewall between its accredited education services and othercompany 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 theirparent or sister companies fall under the new definition of commercial interestand the degree of required changes to their respective corporate structures, itwould be helpful for all providers if the ACCME would more clearly define theterm ‘market’ used in the new policy.”

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

“Now any accredited provider needs to know a heck of a lot about its jointsponsor 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 thetransparency of such partnerships in jeopardy. Until now, many commercialsupportershave required that any third partyinvolved in a CME activity also be included in the letter of agreement betweenthe grantor and accredited provider. With the new policy notformally 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 toshops like [universities] and it will be business as usual, except hidden underthe surface,” said the same source. “You’re pushing the whole thing undergroundto 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 anacknowledgement that all provider types struggle with conflicts of interest.The Coalition for Healthcare Communication, which had urged ACCME to apply thestructural requirements more evenly since April, released a fresh response tothe policy that is notable for its forcefulness.

“The ACCME seems to be creating two classes of CME providers; one classwhere the potential for financial conflicts of interest requires extraordinaryaction 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 accreditedproviders. But, noted Cearnal, “What is difficult to understand is the ideathat commercial support from drug and device companies is more likely to biasthe 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—institutionalconflict of interest—at a system level,” said a source. “Instead, it wasspecial rules for special people.”

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