In a medical-education ruling expected to have broad consequences, regulators said they will consider advertising agencies and journal publishers as commercial entities, requiring those that own CME units to spin them off as separate companies, and providing an extra layer of independence to firewalls that may already exist between them.
Med ed and communication companies (MECCs) could be hard hit by the policy, having to shoulder burdensome costs and deal with tax and legal issues.
“Many, many MECCs would fall into the category covered by this policy,” said Karen Overstreet, president, North American Association of Medical Education and Communication Companies. “We would have to set up new companies. This is going to be an expensive and time-consuming endeavor that perhaps isn't necessary.”
The rule was created when the Accreditation Council for CME (ACCME) amended a definition in its bylaws for what constitutes a “commercial interest,” a term that previously included only FDA-regulated entities.
By slapping the label on ad agencies and publishers, too, the ACCME sent for-profit med ed firms scrambling to determine whether they need to undergo a whole new round of restructuring. The rule is expected to impact the CME divisions of ad firms that are linked into large holding companies, as well as some publishers, depending on the company's corporate structure and the types of services that that company provides.
Many firms feel they are working in a gray area. Murray Kopelow, MD, ACCME chief
executive, elaborated on the policy in an e-mail to MM&M.
“ACCME does not intend for this rule to exclude medical education and communication companies (MECCs) from being accredited providers,” he wrote. “ACCME expects that if the ‘ad agency or publishing company' is an ACCME-defined commercial interest, its owners will set up the two ‘companies' as two separate and independent companies.”
In April, during a comment stage, advocacy groups like the Coalition for Healthcare Communication exerted a major push for the ACCME to explain its intent, specifically whether the term “marketing” as used in the ACCME's new definition extends beyond drug, device and biotech companies to other organizations. Kopelow's response appears to settle the debate.
“We have some clarity,” said John Kamp, JD, PhD, executive director of the coalition. “‘Commercial interest' is more than just an FDA-regulated entity.” It includes for-profit CME providers owned by or having a promotional or publishing arm.
Kopelow said MECCs, agencies and publishers would have to create a new holding company—under separate management and governance and receiving funds from commercial interests only as commercial support—to own their educational partner or accredited provider.
Kopelow said he wants providers to submit restructuring plans in writing before they're implemented. The rule is scheduled to take effect August 2008.
Overstreet theorized that ACCME's policy shift seems like “an overreaction to what's going on in the regulatory environment” and she wants to see “evidence that what we are currently doing is not working.” The timing of the rule lends credence to her point.
“It's not going to be impossible, but it will be difficult and costly for many companies,” said Kamp.