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NAMEC and CME Industry Related News.


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  • 01 Jun 2011 4:33 PM | Deleted user

    From the pen of the president:

    As previously mentioned, I have been working with the ACCME, ACPE and a number of CME representative organizations to produce a press release related to the REMS initiative on Opiods. This press release demonstrates our support to this initiative and explains why each of the representing organizations considers this important to the CME enterprise as a whole. We have attached a copy of the release to this article and if you support the comments with, ask that you send it out through your usual press outlets confirming your support of this initiative. I will let you know of any further developments as they occur.

    To read the document, please click here.

    Chris Bolwell, President NAMEC

  • 28 Dec 2010 3:45 PM | Deleted user

    NAMEC COMMENTS TO THE OFFICE OF INSPECTOR GENERAL

    REGARDING

    A ROADMAP FOR NEW PHYSICIANS

    AVOIDING MEDICARE AND MEDICAID FRAUD AND ABUSE

    The National Association of Medical Education Companies (NAMEC) functions as a representative of, and advocate for, the medical education companies that employ thousands of continuing medical education (CME) professionals in the U.S. who provide CME activities that reach more than 150,000 physicians and other health care professionals annually. NAMEC’s mission is to promote best practices in CME to meet the goal of providing education that improves patient care.

    NAMEC applauds the Office of the Inspector General’s proactive approach to educating new physicians as they enter practice with the Roadmap for New Physicians Avoiding Medicare and Medicaid Fraud and Abuse publication. However, there are several errors and omissions about CME on page 26 of the PDF document that can cause these new physicians to have unnecessary reservations about participating in accredited CME.  CME programs are designed to address physician practice deficiencies (gaps) that are well documented in all clinical areas and to unnecessarily limit the perceived range of educational choices available could have serious ramifications on patient care and outcomes.

    NAMEC recommends that the following highlighted content be revised to more accurately and effectively direct new physicians to necessary quality education.

    1.  “It is important to distinguish between CME sessions that are educational in nature and sessions that constitute marketing by a drug or device manufacturer. Industry satellite programs that occur concurrently with a society meeting are generally promotional, even if the primary speaker is a physician who is well known in the field.”

    The above does not appropriately or clearly distinguish between certified CME activities, ie, those that are produced by organizations accredited to provide education for health care professionals, from those that are produced or provided by industry, ie, promotional. It is not accurate to state or imply that most satellite programs are promotional. Additionally, the juxtaposition of these two statements incorrectly suggests that the primary criterion a physician should use to distinguish between CME and promotion is whether the program is a satellite symposium.

     Many satellite symposia are certified CME programs that are supported by industry through independent educational grants, solicited and prepared under the strict and transparent requirements of accrediting organizations, rather than promotional activities. For example, the following organizations hold national congresses where all official satellite symposia must be accredited CME programs: 

    American Academyof Family Physicians, American Academyof Neurology, American Academyof Pediatrics, American College of Cardiology, American Society of Hematology, and American Society of Clinical Oncology.

    The most important aspect of determining that a program is educational rather than promotional is omitted from the section, that is, whether the program fulfills AMA PRA Category 1 requirements set by the Accreditation Council for Continuing Medical Education (ACCME) or similar designations from American Osteopathic Association (AOA), the American Academy of Family Practice (AAFP), the American Board of Medical Specialties, or a state medical society.

    For a CME program to be certified for AMA PRA Category 1 Credit ™, it must be sponsored by a CME provider that adheres to the ACCME Standards for Commercial SupportSM. These standards stipulate that commercial interests (such as drug and device manufacturers) have no control over identification of CME needs, determination of educational objectives, selection and presentation of content, or personnel involved in control of content. The Standards also require that all product-promotion material must be kept separate from CME activities, that presentations give a balanced view of all therapeutic options and that any relevant financial relationships of those in control of CME are disclosed. The AOA Guide for Commercial Supporters contains similar expectations of independence.

    The distinction between CME and promotion continues to be blurred in the Roadmap with the large highlighted statement:

    2.  “Note that although physicians may prescribe drugs for off-label uses, it is illegal under the Federal Food, Drug and Cosmetic Act for drug manufacturers to promote off-label uses of drugs”.

    Although accurate, the context of this statement in a section titled Continuing Medical Education, can lead the reader to erroneously conclude that any educational session, including certified CME, that addresses off-label use is violating the law. The FDA’s 1997 Guidance on Industry-Supported Scientific and Educational Activities specifically states that

    “discussions of unapproved uses, which can be an important component of scientific and educational activities, are not permissible in programs that are or can be (because the provider is not functionally independent) subject to substantive influence by companies that market products related to the discussion. Thus the agency has traditionally sought to avoid regulating activities that are produced independently from the influence of companies marketing the products.”  (emphasis added)

    Therefore, not only is it acceptable and legal for CME to discuss off-label uses, it is the only organized educational setting where a physician may learn about such uses and be assured that the content is balanced and independent. The same FDA guidance lists the following factors as considerations for evaluating activities and determining independence, which could be a useful addition to the Roadmap:

    ·         Control of content and selection of moderators and presenters

    ·         Disclosures

    ·         The focus of the program

    ·         Relationship between provider and supporting company

    ·         Provider involvement in sales and marketing

    ·         Provider’s demonstrated failure to meet standards

    ·         Multiple presentations

    ·         Audience selection

    ·         Dissemination

    ·         Ancillary promotional activities

    ·         Complaints

    Lastly, the final sentence of the section on serving as faculty for industry-sponsored CME, asks

    3. Does the sponsor prepare a slide deck and speaker notes, or am I free to set the content of the lecture?”

    This statement is confusing. Industry sponsors are responsible for all slide decks and speaker notes for their promotional activities. In contrast, in CME activities, it is the accredited provider and the faculty who are responsible for the content that is presented within their educational activities. Under accreditation requirements industry is prohibited from making any contribution to this content or engaging with faculty on content for the activity. An accredited CME provider, to develop a coherent educational program, must (according to the ACCME Essential Areas and Elements document):

    ·         Incorporate into CME activities the educational needs (knowledge, competence, or performance) that underlie the professional practice gaps of their own learners

    ·         Generate activities/educational interventions around content that matches the learners’ current or potential scope of professional activities

    ·         Choose educational formats for activities/interventions that are appropriate for the setting, objectives and desired results of the activity

    Additionally, the ACCME Policy on CME Content states that accredited providers are responsible for validating the clinical content of CME activities they provide.  Specifically, 1) all the recommendations involving clinical medicine in a CME activity must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients, and 2) all scientific research referred to, reported, or used in CME in support of or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection, and analysis.

    Consequently, it is the accredited CME provider, not the individual faculty, who is responsible for the overall design and conduct of an educational program. Providers apply principles of adult learning to develop unique and effective programs that go beyond mere recitation of knowledge and support enhanced competence and performance. Therefore, a framework of content and active exercises is often developed by the provider to ensure the program’s effectiveness. Faculty contribute their expertise in the subject matter within this framework. Thereafter, the provider must further assure that faculty-developed content is compatible with the learning objectives, the educational design being utilized, and the tenets of evidence-based medicine listed above to avoid introduction of personal biases of the faculty into the program.

    Concerns and controls addressing CME funding, quality, and independence from bias are legitimate.  However, all stakeholders, especially those representing the OIG, should be vigilant about the accuracy of stated regulations, evidence, and conclusions.  The Roadmap for Physicians, Avoiding Medicare and Medicaid Fraud and Abuse should appropriately recognize

    the legitimacy and vitally important role of CME in the continuous professional development of physicians and more clearly distinguish it from promotional activities.  As the elected officers and directors of NAMEC, we would be more than willing to participate in discussions about this process.

    Best Regards,

                                                                                                                                   

    Chris Bolwell, BSc                                                                                                                                           

    President                                                                                           

    Sandra T. Weaver, MS -- Immediate Past President         Marissa Seligman, PharmD – President-Elect

    Linda Coogle, MBA, CCMEP – Treasurer                                 Kurt Boyce – Secretary

    Lea Ann Hansen, PharmD, BCOP – Director                          Scott J. Hershman, MD, CCMEP - Director

    Matthew D. Horn, MD – Director                                               Carrie

    Pedersen Hudak, MA , CCMEP - Director

    Joseph Kim, MD, MPH – Director

  • 01 Dec 2010 4:32 PM | Deleted user
    The submissions open on Dec. 3rd for the 4th Best Practice Awards. Please visit the Awards link in the Members Only Section for more information, or email the NAMEC Headquarters at: info@namec-assn.org.

    Thank you!

    *Submissions are scheduled to close on Dec. 17th
  • 08 Oct 2010 2:11 PM | Deleted user

    The Pennsylvania Medical Society posts video on You Tube . . . Physicians discuss the benefits of new continuing medical education criteria.

    http://www.youtube.com/watch?v=j1i1hXGwzIc&feature=related

  • 08 Oct 2010 2:10 PM | Deleted user

    In politics it is rare for politicians running for the same off office to agree on anything. But this week a unique agreement arose between the three gubernatorial candidates in Massachusetts.

    As the negative consequences surfaced in Massachusetts on the Pharmaceutical and Medical Device Manufactures Code of Conduct i.e. “the gift ban” and built up over time, individuals in the commonwealth running for governor realized the significant  is approval of the gift ban and as a result, the State House News Service reported yesterday that whoever the next governor is, the gift ban may be gone.

    http://www.policymed.com/2010/10/massachusetts-gubernatorial-candidates-unanimously-support-repeal-of-the-gift-ban.html

  • 30 Jul 2010 1:22 PM | Deleted user

    NAMEC History 101
    Our Founding Fathers . . . and Mothers

    For more information, visit the Honorary Members page.

  • 30 Jul 2010 1:19 PM | Deleted user

    NAMEC BOARD OF DIRECTORS: Call for Nominations coming soon!

    NAMEC recognizes that an active Board of Directors is vital to the success of our organization. While we know that taking on a volunteer role is a tremendous investment in time, it is also a rewarding experience in the recognition of efforts and provides opportunities to build relationships within the CME Industry.

    In the next few weeks, NAMEC will be distributing a Call for Nominations. Elections will then be held in September and results will be announced at the NAMEC Educational Meeting that is held in conjunction with the 21st Annual Conference of the National Task Force on CME Provider/Industry Collaboration, to be held Oct.13-15, 2010 in Baltimore. The specific date and time of the NAMEC meeting will be announced in the near future.

  • 26 Jul 2010 1:21 PM | Deleted user

    NC-CME announces Extension of Certification program

    The National Commission for Certification of CME Professionals (NC-CME) is pleased to announce an Extension of Certification (EOC) program offered to Certified CME Professionals (CCMEPs) when their current certificates expire. 

    The EOC will serve to extend the initial 3-year certification to 5 years for candidates who fulfill the EOC eligibility requirements. Active CCMEPs may submit their EOC applications 3-6 months before the expiration date noted on their certificates. For example, the first Class of June 2008 will submit EOC applications between January 1 and March 31, 2011.Qualified candidates will receive updated certificates and will continue to be included in the National
    Registry of Certified CME Professionals, accessible online at www.NC-CME.org

    Each candidate’s EOC eligibility worksheet will be reviewed for evidence of his/her own personal continuing professional development that has taken place since the initial certification date. The EOC point requirement will be 12 points, compared with 15 points required for initial certification; the EOC registration fee will be $275, compared with the initial fee of $450.  Attendance at conferences and webinars, memberships in CME organizations, and volunteer work in the CME community are among the activities that may qualify toward the 12-point requirement. 

    Candidates for the 2-year extension will not be required to sit for an exam. When the extension period expires candidates for recertification will need to pass the exam that is being given at that time, which ensures that CCMEPs will be tested every 5 years to demonstrate that they have kept up-to-date with current CME rules and regulations. 

    Notices will be sent to each CCMEP 6 months before his/her certification expires. CCMEPs who allow their certification to expire, then wish to be reinstated, will be  required to pass the currently available 3-hour certification exam and will need to document 15 points of education/experience in the CME field within the past 3 years. 

    For full details regarding EOC and recertification, go to www.NC-CME.org

  • 21 Oct 2009 9:28 AM | Deleted user
    HTML clipboard

    FOR IMMEDIATE RELEASE

    CONTACT: Anna Trott

    Wednesday, October 21, 2009

    NAAMECC BUSINESS OFFICE PHONE: 205-824-7612

    NAAMECC ANNOUNCES ELECTION RESULTS FOR BOARD OF DIRECTORS

    October 14, 2008 --- The North American Association of Medical Education and Communication Companies (NAAMECC) today announced 2009 election results for its Board of Directors. The new officers and board members will take these positions at the October 2009 meeting of the American Medical Association’s Task Force on Industry/Provider Collaboration in Baltimore.

    The New NAAMECC Board Officers are:

    President: Sandra Weaver, MS
    Email: sandy.weaver@comcast.net

    President Elect: Chris Bolwell, BSc
    Email: c.bolwell@imedex.com

    Past President: Stephen M. Lewis, MA, CCMEP
    Email: slewis@globaleducationgroup.com

    Treasurer: Linda Coogle, MBA, CCMEP
    Email: lcoogle@clinicaloptions.com

    Newly elected NAAMECC Board Members are:

    Kurt Boyce
    Email: kurt.boyce@optumhealthed.com

    Lea Ann Hansen, PharmD
    Email: lhansen@educationalconcepts.net

    Joseph Kim, MD, MPH
    Email: jkim@medcommedia.com

    About NAAMECC:

    NAAMECC is the leading advocacy and education organization for medical education companies and their educational partners. NAAMECC provides member companies and the medical education professionals they employ with cutting-edge information and expert contacts to achieve success in CME.

    Naamecc Business Office ~ 3416 Primm Lane ~ Birmingham, AL 35216

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