As demonstrated at the September meeting of the National Task Force on CME Provider/Industry Collaboration, pharmaceutical companies are coming under almost microscopic scrutiny for their activities supporting accredited CME — not only from the Accreditation Council for CME and the Food and Drug Administration, but now also from the Office of Inspector General of the Department of Health and Human Services.

OIG is looking for intent to defraud the Medicare and Medicaid programs in every act that might inappropriately influence prescribing, including payment to speakers, program content, and spending on attendees. Industry and providers are worried about the proposed tighter regulations coming from ACCME. And FDA is still hunting for evidence of an inappropriate mix of education and promotion. And, as pointed out at the Task Force conference, pharma tends to support product-related programs and ignore CME proposals in areas that may benefit care but aren't related to major drug categories.

How can the industry change its image to the regulators, the public, and physicians under these negative pressures? Here's an idea worth considering: Form a CME foundation supported by pharma, which will be controlled by an independent board, responding to grant proposals from accredited providers, regardless of product category. The rules for grant-making would be related to demonstrated need, a program designed to meet those needs, and an evaluation plan related to some measure of outcome — whether behavior change, performance, or patient health.

The industry could start by setting aside 15 percent of the roughly $720 million it spends on accredited CME (each company applying that percentage to its spending). This would provide an initial pool of $100 million of nondirected pharma support for accredited CME, to be renewed at a level of 10 percent of such spending for the following four years. This would be a voluntary and tax-deductible contribution on the part of each company, whose names would be prominently associated with the foundation as members of an advisory donor panel. The independent board would be instructed to distribute at least 75 percent of the assets annually, and to report to pharma, ACCME, and the CME community at large on the results of its activities.

Such a move would gain tremendous positive support for the industry, would benefit physicians and their patients, and could reduce the scrutiny by federal agencies — especially related to activities conducted by the foundation.




Lewis A. Miller is corporate editorial director, Dowden Health Media; chairman of Intermedica Inc.; and founder and director of the Global Alliance for Medical Education.

WHAT DO YOU THINK?

Will this idea work, or do you have another approach to share? Please contact MM Editor Tamar Hosansky at (978) 466-6358 or thosansky@primediabusiness.com.