As issues surrounding content validity and fair balance remain in the spotlight, many accredited providers are seeking and receiving grants from multiple commercial interests to help minimize commercial bias in their continuing education activities. By receiving support from multiple grantors, the opportunity for a single grantor to control or influence the content of the certified activity is minimized. Organizations that may have relied in the past on a handful of grantors to fund all their CE activities can now find ways to reduce the potential bias toward one therapeutic agent and minimize the risk to the grantors. But multiple funding for CE activities comes with a number of pitfalls as well.
Letters of Disagreement
Case in point: An accredited provider identifies a need, submits grant requests to multiple commercial interests, and receives the grants. This process alone is arduous, and many great CE activities have withered and died on this vine. The accredited provider drafts a letter of agreement (LOA) and submits it to the grantors. Here comes the dreaded phone call, the one from Grantor A who doesn't want to sign the LOA because the company legal department won't approve it. Another grantor calls and says it can't sign an LOA with the name of a competitor on it and asks why the terms and conditions don't contain language its legal department always uses. The accredited provider checks the Accreditation Council for CME's updated Standards for Commercial Support, but they simply state there must be an LOA between the accredited provider and the commercial interest. They do not mandate whose LOA must be used or specify the terms and conditions.
Defuse Power Struggles
Over the years, accredited providers have worked diligently with their grantors to educate them about the regulatory guidelines and other guidances governing CE activities. Many of us have endured hours of discussions with legal departments whose interpretations of these guidelines range from very liberal to extremely conservative. With multi-funded activities, accredited providers find themselves revisiting similar questions with new grantors — and facing challenging new scenarios with familiar grantors. For instance, what should a provider do when each grantor wants its company name to appear first on the commercial support designation statement for a multi-funded activity? How should a provider respond to grantors who initially agreed to provide assistance in generating the target audience, but now cannot disseminate invitations because their legal departments feel it is againstguidelines? More so now than ever, accredited providers must become master negotiators and diplomats.
As an accredited provider, you can get grantors to sign LOAs by using a combination of your agreement and theirs. The goal should be compliance with minimal disagreement. Consider listing the names of your grantors in alphabetical order on commercial support statements to avoid awkward power struggles. During the planning process, outline in writing all the grantors' issues, such as supplemental recruitment assistance, and clarify the legal and regulatory questions that you or they may have. What's important is how we as accredited providers demonstrate compliance with the spirit of the regulatory guidelines while skillfully negotiating with our grantors andto provide flexibility and protection for all parties involved in certified CE activities.
Ann C. Lichti is the assistant director of CME for a New York — based medical education and communication company. She has worked in continuing education for three and a half years. She previously worked for a clinical research organization in northern New Jersey as a document/database manager. Reach her at email@example.com.
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