ACCME firewall letter sent, but not sealedBruce Bellande, PhD, was pleased to learn that regulators accepted the materials he sent them as adequate proof 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, he began to wonder, “Is this considered a done deal, or is this an interim? 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. Non-accredited providers can do the same.
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,” he said.
Also pertinent, he felt, was the firm's certified education independence policy, which governs relationships with any entity outside CME Enterprise; a flow chart of how the provider identifies, discloses and resolves conflicts of interest; plus the staff disclosure form.
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.
However, Bellande said he 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.”
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,” he said.
For every firm impacted by ACCME's redefinition of a “commercial interest,” complying can be very expensive. Bellande's firm moved into new quarters Sept. 10, with a separate staff, computer and phone system—a process that took months of planning.
Others who feel they may need to take additional steps may hesitate due to the expense involved.
The process is not defined well enough, Bellande said, “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.'”
Bellande was still feeling hesitant. 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.”