The Accreditation Council for CME has expanded the definition of commercial interest — a decision that could preclude some medical education and communication companies from maintaining their status as accredited CME providers.
Previously, commercial interests were defined as companies that produce healthcare products or services, usually meaning pharmaceutical/biomedical companies. The new definition casts a wider net, also including companies that market healthcare products. The purpose of the policy is to further ensure the separation of promotion from education, according to the.
While a few MECCs that are accredited providers are independent, many have parent or sister companies involved infor the pharmaceutical industry. If, under the new policy, a MECC is redefined as a commercial interest, it will no longer be eligible for accreditation. The new policy allows a provider to have a sister company that is a commercial interest, as long as there are adequate corporate firewalls; however, a provider cannot be owned by a commercial interest. To maintain their accreditation, these MECCs will need to alter their corporate structure.
The change has caused much concern among MECCs. We asked Murray Kopelow, MD, ACCME chief executive, to address these issues for our readers.
: As I understand it, this policy will affect the majority of MECCs. There is some feeling that the ACCME is trying to put MECCs out of business with this policy, yet the ACCME's announcement states that the intention is not to stop medical education companies from being accredited providers. Your comments?
Kopelow: ACCME does not intend for this rule to exclude medical education and communication companies. ACCME expects that if an accredited provider is controlled by an ACCME-defined commercial interest, then the owners of the two will set up the two companies as two separate and independent companies. MECCs convinced us in their feedback that they can create firewalls between sister companies but not between a parent and another company. MECCs are valued providers and important agents for ensuring the continued independence of accredited CME.
MM: According to an e-mail you sent to CME consultant Steve Passin, it's acceptable for the parent company to own both a commercial interest and an accredited provider.
Kopelow: Yes, we believe that firewalls can be set up in that circumstance, [for instance, if] the parent company is a holding company, not the advertising agency. There are holding companies and investors that are buying companies in order to make a profit, but they are not doing promotional work. ACCME had to draw a line somewhere, and we believe that structure can preserve independence.
MM: How does the ACCME define marketing?
Kopelow: The Web provides several definitions that fit. For example, “Marketing is the process of planning and executing the conception, pricing, promotion, and distribution of…,” or “The planning and implementation of a strategy for the sale and distribution….”
MM: Publishing/education companies create advertisements, identify key opinion leaders, support advisory board meetings, and create and plan publications. Do these activities constitute marketing under the ACCME's new policy?
Kopelow: They are not CME activities. It would be reasonable to say that if the activities are part of a strategy for the sale and distribution of heathcare goods and services, they are marketing. The provider and the producer of the product will know if the activity is part of a marketing strategy.
MM: Some say these activities support marketing efforts but that they are not marketing activities in and of themselves.
Kopelow: Yes, there are going to be fine lines to identify and make decisions about as every organization profiting from the distribution, promotion, or sale of healthcare goods or services consumed by, or used on, patients is not a commercial interest.
MM: Is the ACCME going to issue guidelines for what it considers an adequate corporate firewall?
Kopelow: The features of an independent corporate structure include 1) not owned or controlled by a commercial interest; 2) separate management; 3) employer of record is not a commercial interest; 4) separate governance where the majority cannot represent a commercial interest; and 5) the entity receives funds from a commercial interest only as commercial support.
MM: The ACCME says it will work individually with accredited providers that might be affected as they transition to an independent corporate structure. In what way?
Kopelow: We ask that providers communicate directly with ACCME as they evaluate the corporate structure in which they operate. If providers intend to change their structure, we invite them to provide their proposed solution to ACCME prior to taking any definitive action. ACCME would like to review the providers' plans before they are implemented.
MM: Some MECCs are concerned about the ACCME treating providers unequally.
Kopelow: Thanks for sharing that. We'll guard against it. We believe we're providing enhanced service rather than diminished service. We've never treated anybody specially or differently. Transparency will be important. We would attempt to post and share every decision that we make that is different than the other ones.
Closing LOA Loopholes
Along with the redefinition of commercial interest, the ACCME issued several other new policies, one of them concerning letters of agreement between accredited providers and commercial supporters. This states that providers will be found noncompliant with the Standards for Commercial Support if they enter into written agreements for grants that stipulate how they plan to fulfill ACCME requirements. We asked Kopelow to clarify this policy.
MM: Can a supporter specify in an RFP that it will fund education on a specific topic within a specified time frame at a certain amount of funding?
MM: Can supporters respond to providers' requests forrecommendations?
Kopelow: No. This practice must stop. If a provider uses a faculty member who has been recommended by a commercial interest then the commercial interest is, in fact, controlling the content of the CME. CME needs to establish independent mechanisms for determining who is speaking or writing the CME content. We can't tell industry not to make a suggestion — but it's certainly wrong to act on a suggestion because it is for certain that the message [delivered in the activity] is going to be a message that the commercial supporter wants delivered. This [stance] was reflected in our response to the Senate Committee on Finance when we said, “The ACCME recognizes that CME can receive financial support from industry without receiving any advice or guidance, either nuanced or direct, on the content of the activity or on who should deliver that content.”
MM: Does this policy preclude commercial supporters from, for example, reviewing content for medical accuracy?
Kopelow: This is not addressed by the current policies. The system is vulnerable when providers allow and act upon the feedback. But we recognize that the reviews are a form of cooperation with commercial supporters who [also are vulnerable]. If the content is blatantly false, the risk to the commercial interest is high. The ACCME has to help the provider manage the feedback. If the pharmaceutical company or device manufacturer says, “This content is misrepresenting our product to a level where we're going to be fined or go to jail,” they need some recourse. But if the commercial supporter specifies what data to present, then they are controlling the content. We've got to work on this area. It's very complicated.
We will continue to cover the ramifications of ACCME's new policies. To share your views, contact Editor Tamar Hosansky at (978) 466-6358; or send e-mail to firstname.lastname@example.org.
For previous coverage, check out “Proposed Rules Threaten MECCs,” June 2007, online at meetingsnet.com.
COMPLIANCE TOOLS PTR Educational Consultants LLC, has produced a toolkit to help CME providers comply with the Accreditation Council for CME's updated accreditation criteria. Visit www.ptreducationalconsultants.com.
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