WentzMiller & Associates, LLC

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has a breadth of experience in the CME / CPD world. He brings 16 years of experience at the American Medical Assn. (AMA) where he served as associate director of CME / CPD and director of Strategic CME Business Development. He has also served as professional education officer for the American Society of Gastrointestinal Endoscopy (ASGE). Mr. Paulos served a six-year term on the Board of the Alliance for Continuing Education in the Health Professions (ACEHP). He has been an Associate and then Senior Associate of WMGS since 2011.

The US agency responsible for administering the Sunshine Act has backtracked (see p. 241) on its special exemption for reporting of industry payments to accredited CME providers who in turn pay speakers. The Centers for Medicare and Medicaid Services (CMS) says the exemption is redundant with another Sunshine Act provision that "excludes indirect payments ... where the applicable manufacturer is 'unaware' of ... the identity of the covered recipient". So CMS argues that unless the manufacturer identifies the speakers to receive payments from a CME provider or pays the speaker directly, payments to the provider are excluded from reporting. Nonetheless, CME providers are gathering steam to oppose removing the exemption, fearing that the change would leave many murky areas for physicians and industry, which might use its removal as an excuse to further cut grants. Comments must be filed by September 2. France, the only country besides the US to have a Sunshine law, requires manufacturers to also disclose transfers of value to pharmacists, nurses, students and societies. Disclosures in France are retroactive to 2012, and data are available on a public website.

Accreditation systems in Canada also are evolving to accommodate new forms of learning, technology and practice. The College of Family Physicians of Canada (CFPC) has been awarding credits for over 50 years. The present system, Mainpro, was introduced in 1998. Its first evolution went from credits for CME (M1) to a higher level of credits for CPD (Mainpro C) that is based on self-assessed needs, evidence- based resources and self-reflection. The menu of activities accredited rapidly expanded from traditional topics covering medical knowledge to a broader range that included skills such as teaching, research and communication.

The US Sunshine Act broadly applies to both domestic and foreign drug and device manufacturers that operate in the US, reports a major Texas law firm. Therefore those companies "will need to prepare to collect and report data about their interactions with US physicians anywhere in the world." Even physicians who practice exclusively abroad will probably be included so long as they maintain US licenses. CME providers around the world will now be asked by commercial supporters to provide data on gifts, including meals, travel, speaking fees and the like, given to any US physicians attending their programs, if the companies themselves do not maintain full records. Pfizer has already informed its subsidiaries, who in turn are notifying providers. And companies that operate in the US cannot circumvent reporting by paying doctors indirectly through their foreign entities. All data must be reported back, say the lawyers.

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