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    ACCME To Implement Stricter Regulation And Oversight of CME Activities While It Mulls Eliminating or Restructuring Commercial Support

    July 25, 2008

    The Accreditation Council for Continuing Medical Education (ACCME) recently announced several initiatives to tighten its oversight of accredited continuing medical education (CME) providers. A complete description of the ACCME initiatives may be viewed by clicking here.

    First, the ACCME has begun to ask CME providers to correct identified problems more quickly. In the past, the ACCME gave noncompliant providers months to make changes and well over a year to provide verification of compliance. Now the ACCME is working closely with noncompliant CME providers to ensure improvement plans are developed within weeks and documentation verifying improvement submitted within months of an adverse finding. The ACCME also has started to place more accredited CME providers – especially those that have been found out of compliance with the ACCME Standards for Commercial SupportSM  – on probation.  As a result, the probation rate has soared from about one percent to about 10 percent of providers seeking reaccreditation. 

    Second, the ACCME has reaffirmed its position that CME must be absolutely independent of commercial interests despite the receipt of commercial support from industry. The ACCME Board of Directors has adopted a policy statement declaring that “CME providers can receive commercial support from industry. CME providers cannot receive guidance, either nuanced or direct, on the content of the activity or on who should deliver that content.” The goal is to eliminate communications about topics, content and speakers between commercial supporters, teachers, authors, planners, or staff of accredited provider. To effectuate this policy, the ACCME is asking for comments on two standards designed to ensure the independence of CME activities.

    • Accredited providers would be prohibited from receiving communications from commercial interests announcing or prescribing any specific content that would be a preferred, or sought-after, topic for commercially supported CME (e.g., therapeutic area, product-line, patho-physiology).

    • Accredited providers would be prohibited from receiving communications from commercial interests regarding their internal criteria for providing commercial support.         

    Comments on these proposals may be submitted electronically through August 11, 2008 at this Web site.

    Third, the ACCME has established two new committees to enhance its focus on monitoring and surveillance of the CME system. The first committee will be responsible for screening “high risk” CME firms through the ACCME complaints and inquiries process.  Accredited providers who receive a large percentage of commercial support, whose CME content may need further validation, or who offer only jointly sponsored activities with nonaccredited organizations will be subjected to greater scrutiny.  The ACCME estimates that approximately 90 accredited providers fall into this “high risk” segment.  They will be asked to provide additional information about their compliance practices. The second committee will oversee the establishment of a database of CME activities and participants. Initially, all accredited providers will be required to transmit to the ACCME information on the provider’s CME activities. Next, the ACCME will expand the database with information from ACCME “monitors” who will attend CME activities. Finally, self-assessment data from accredited providers regarding commercial bias and content validity of their CME programs will be added to the database. Drawing from the database, the ACCME will publish conclusions about provider compliance on www.accme.org.

    The ACCME also is interested in initiating a national dialogue about eliminating or radically restructuring commercial support of CME. To frame the debate, ACCME has proposed three possible approaches, which include continuing with the status quo, completely eliminating commercial support, or adopting what ACCME is calling the “new paradigm” for commercial support. Under the new paradigm, industry could continue to support specific CME programs or provide funds to an industrywide pool to be distributed to various CME activities, but only if all of the following conditions are met:

    • The CME is based upon educational needs that are identified and verified by organizations, such as US Government agencies, that do not receive commercial support and are free of financial relationships with industry;

    • The CME addresses a professional practice gap of a particular group of learners that is corroborated by bona fide performance measurements, such as the National Quality Forum, of the learners’ own practice(s);

    • The CME content is from a continuing education curriculum specified by a bona fide organization or entity, such as the American Medical Association, Agency for Healthcare Research and Quality, American Board of Medical Specialties, and Federation of State Medical Boards; and

    • The CME is verified as free of commercial bias.

    Comments on eliminating or restructuring commercial support for CME may be submitted electronically through August 11, 2008 here.

    If you are interested in learning more about ACCME’s recent initiatives or filing comments on its proposals, please contact:

    Larri A. Short
    short.larri@arentfox.com
    202.775.5786

    Amy M. Swift
    swift.amy@arentfox.com
    202.857.6338

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