The increasing difficulty of obtaining commercial support in the new regulatory environment, the explosive growth in MECCs, and other CME provider dilemmas were on the agenda at a session led by Wanda Johnson, CMP, senior director, meetings and education with The Endocrine Society, at the Professional Convention Management Association Annual Meeting in January.
One impact of the new OIG guidance and PhRMA code on CME providers is that the systems pharma companies are developing for evaluating educational grant proposals are getting more complicated. Johnson cited the example of one commercial supporter that held a meeting for associations wanting to receive educational grants from that company. "They have a checklist they use to make sure requests meet all the ACCME, OIG, PhRMA, and AMA rules. Then they take your results and compare them against all the other requests they receive," she said. "Then you have to sign their Letter of Intent, which has been drafted by lawyers and so is legally binding. We used to have a two-page Letter of Agreement. Now they’re 15, 16 pages."
She mentioned one pharma company that sent a monstrous commercial support Excel spreadsheet template for her office to fill out. "It was incredibly complicated and took a long time to complete," she said. "There’s not only more time built in to the approval side, but it will also take more time on your side trying to fill out the forms."
(Share Your Experiences: How have the new regulations affected the commercial support process? MM’s March/April cover story will focus on this topic and we’d like to hear your views. Contact Executive Editor Sue Pelletier at spelletier@primediabusiness.com or call her at (978) 448-0377.)
Johnson then tip-toed into more hot topics, such as the potential impact of the recent explosive growth in medical education and communication companies on other types of CME providers. (Both MECCs and traditional CME providers were in the audience, and she was careful not to disparage either.) Johnson, who says she both partners with MECCs and competes with them for commercial support, believes "the main question is: Who do they work for? They may work for the commercial supporter in doing their ad campaigns, product launches, and many other activities outside of CME. The appearance of commercial influence is everything. You have to know if they’re trying to package a pharma company’s message in a way that appears nonbiased."
She recommended developing and disseminating written procedures for MECCs to avoid any potential for bias or conflicts of interest. For example, put it down in writing that the MECC can’t include unpublished, non-peer-reviewed slides containing internal company data in any slides it puts together for a speaker. She also recommended distributing Accreditation Council for CME rules and your organization’s internal policies to everyone involved, including MECCs. Despite some difficulties, Johnson said, "I believe the competition opens up new opportunities for partnership and balance. My vague answer to MECCs and the future is to keep your mind and your options open."
When it comes to complying with the PhRMA Code rules, Johnson acknowledged that providers can be put in an awkward position. "The dilemma is that CME providers have to try to stay within the rules, even though PhRMA doesn’t govern providers. What do you do if a doctor brings his wife to the dinner? Not let her in?" The biggest impact of the code in terms of meetings—that it limits what exhibitors can give away on the show floor—also gives providers some headaches. As one attendee asked, "What do we do when exhibitors come to us for our rules on how they have to comply with the PhRMA Code at our exhibition? We have nothing to do with it, but they keep looking to us for guidance." Johnson’s answer: "Be very careful. I’d just point them to the code and let them know that’s what they need to comply with. You don’t want to impose those rules yourself, especially since the OIG Guidance can involve punitive damages."
Among the resources she provided to participants:
ACCME Alliance for CME
North American Association of Medical Education and Communication Companies
Medical Meetings magazine