Lessons from ACCME's first reply on firewall policy

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Bruce Bellande, PhD, was pleased to learn this month that regulators accepted the cache of materials he sent them as adequate demonstration of corporate separation.

“The ACCME believes the accredited provider is separate from the commercial interest,” read the letter, referring to Bellande's firm, CME Enterprise, and a sister company that produces promotional programs, called Avant.

But as he pored over the Oct. 12 note from Murray Kopelow, MD, chief executive of the Accreditation Council for CME, his confidence began to wither.

“Is this considered a done deal, or is this an interim?” he wondered. “The ACCME believes that we're separate, but is that for a month, a year, until something else changes?”

CME Enterprise was the first provider to present its documents for vetting by the agency since an Aug. 24 policy update, after which ad agencies and publishers learned they may need to create a new holding company to own their educational partner or accredited provider. Kopelow invited providers to send corporate structures to him up until they reapply for accreditation in 2009. Last week the ACCME created a similar process for non-accredited providers.

Bellande said he hopes his experience with the agency may be helpful to others who may be wondering what to expect. He offered several cautions. First, he said there remains confusion around what is meant by “corporate structure.”

“In our case, I interpreted it to be an accurate, up-to-date…organizational chart of the corporate structure…of the accredited provider and an organizational chart of the services which [are] a common area for both independent companies.”

Also pertinent, he felt, was the firm's certified education independence policy, which governs relationships with any entity outside CME Enterprise. Additionally, he included a flow chart of how the provider identifies, discloses and resolves conflicts of interest, intra- and inter-corporate, plus the staff disclosure form.

Along with the documents sent in early September, the president of CME Enterprise sent a follow-up note to Kopelow asking whether what was sent would suffice to make a determination. Kopelow replied saying it was sufficient.

The response came in about a month stating that CME Enterprise and Avant were indeed sister companies, whose only tie was that they're both owned by the same company, Deborah Wood Associates.

However, Bellande was in the dark until then. “There was no assigned process within ACCME other than you send it…and it would be reviewed and you would receive a response. Beyond that, [there was] no delineation of how it would be done, by whom, when, etc.”

In retrospect Bellande said he feels fortunate that the reply was favorable. But his firm's corporate structure was relatively straightforward: one side promotional, one side accredited and a common link to the owner.

“There's a question I would have, as other organizations come forward, some of whom will be much more complicated than we are…with multifaceted enterprises built in, whether or not…there would be some reinterpretation of the process or further redefinition.”

For every firm impacted by ACCME's redefinition of a “commercial interest,” complying can be very expensive. In Bellande's case, he anticipated the firewall change—although he didn't know when it was coming—and months ago began the process of completely separating his offices from the two other companies. His firm moved into new quarters Sept. 10, with a separate staff, computer and phone system.

“This takes months of work,” he said. Other providers who feel they may need to take additional steps have ample time to do so before the 2009 cut-off. But the expense involved may prevent others from moving forward until they know more about the process.

“It's not defined well enough,” Bellande said. “The processes are not known and therefore that uncertainty is, ‘I will hold back and wait until there's more information or someone else moves forward and gives me some guidance on what to do or not.'”

As for Bellande, known to many as the former executive director of the Alliance for CME (ACME), he was still feeling hesitant. After all, the letter from Kopelow made no guarantee that ACCME wouldn't contact him in the future, asking for more proof and putting his accreditation status in jeopardy again.

“Do I feel secure that that's the end of this, with this interpretation?” he said. “No, I don't.”
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