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NAMEC Letter to the Office of Inspector General

28 Dec 2010 3:45 PM | Anonymous

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


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