Mount Carmel's CME Program is committed to providing high quality educational activities to the members of its medical staff. The Division of CME acknowledges the valuable contributions made by industry and recognizes the benefits of partnering with industry to facilitate the transmission of evidence-based advances in medicine. All CME activities will be planned and implemented in accordance with the recommendations of the American Medical Association (AMA), Food and Drug Administration (FDA), and the Essential Areas and Policies of the Ohio State Medical Association (OSMA).
This policy provides for the solicitation of commercial support for CME activities. Mount Carmel physicians and designated Medical Education representatives shall solicit commercial support to assist with the cost of CME activities. Commercial support will be solicited from multiple companies who manufacture similar products relating to the CME topic. Commercial support from a single company will only be received in cases where that company is the sole manufacturer of a product or where other manufacturers decline participation. Commercial support will be sought and administered in accordance with the Standards for Commercial Support (SCS), other related policies of the Division of CME, and the following procedures:
Independence: All decisions in the planning and implementation of a CME activity must be made by physician planners or designees appointed by Mount Carmel and without the control of commercial interests. These include:
- identification of needs
- determination of educational objectives
- selection of presentation and content
- selection of faculty, planning committee members, and organizations that will be in a position to control the content of the activity
- selection of educational methods
- evaluation of the activity
Planners must verify that these decisions were made without the control of commercial interests by completing and signing a Planning Committee Disclosure Form.
A commercial interest will not be permitted to take the role of a non-accredited partner in a jointly sponsored relationship. (SCS 1.2)
Resolution of Personal Conflicts of Interest: Everyone who is in a position to control the content of an educational activity must disclose all relevant financial relationships (any amount occurring within the past 12 months that creates a conflict of interest) with any commercial interest. (SCS 2.1) Individuals who refuse to disclose or who do not submit disclosure in advance for review by a designated monitor will be disqualified from controlling the development, management, presentation, or evaluation of the CME activity. (SCS 2.2)
If a conflict of interest exists, the conflict will be resolved prior to the educational activity being delivered to the learner. Individuals who have a conflict of interest may be asked to 1) limit the content of their lecture to a report without recommendations 2) refocus the lecture, or 3) they may be disqualified from presenting. (SCS 2.3)
Appropriate Use and Documentation of Commercial Support: Mount Carmel-designated associates must make all decisions regarding planning and development of educational activities, including content validity, disposition, and appropriate disbursement of commercial support. Mount Carmel-designated associate(s) must follow the process outlined in the Policy for Honoraria and Policy for Disbursement of Commercial Support (distributed at the initial planning meeting). (SCS 3.1 and 3.2) All commercial support associated with a CME activity must be given with full knowledge of Mount Carmel-designated associate(s). (SCS 3.3)
Letter of Agreement: A Letter of Agreement (available on CME Forms Link) must be signed by both commercial supporter and provider stating the terms, conditions, and purposes of the commercial support, even if the support is given directly to Mount Carmel's educational partner or joint sponsor. (SCS 3.6, 3.7)
Appropriate Management of Associated Commercial Promotion: Mount Carmel may provide opportunities for commercial exhibits and advertising at its discretion and within the following provisions:
- Mount Carmel's CME Office staff or physician planners will arrange commercial exhibit placement and will not allow placement to be a condition of the provision of commercial support. (SCS 4.1)
- Activity content will not be influenced by commercial interests.
- Mount Carmel will not permit promotional activities (exhibits or presentations) to occur in the same space or place as the educational activity. (SCS 4.2)
- Mount Carmel will not permit product-promotion materials or product-specific advertisements to be placed in or during CME activities nor in or on educational materials such as slides, handouts, etc. (SCS 4.2). This does not apply to information distributed about the non-CME elements of a CME activity that are not directly related to the transfer of education to the learner. (SCS 4.2, 4.3, 4.4)
- Direct payment of a CME expense by a commercial source is prohibited. Commercial support in the form of an educational grant must be made payable to Mount Carmel Health System. (SCS 3.8)
- Mount Carmel will not permit a commercial interest to serve as the agent providing a CME activity to learners, e.g. distribution of self-study CME activities or arranging for electronic access to CME activities.
Attendance at CME Activities: Representatives of commercial companies may attend CME activities as passive learners and guests without charge. This includes companies not represented by monetary support as well as those companies that support the activity via educational grants.
Content and Format Validation Without Commercial Bias: Faculty members must agree to submit an outline of their lecture for peer review prior to their presentation. All presentations will be reviewed for balance and objectivity.
Faculty members must verify (with signature) that the content or format of a CME activity or its related materials will:
- promote improvements or quality in healthcare. (SCS 5.1)
- give a balanced view of therapeutic options; if trade names are used, trade names from several companies should be used when possible. (SCS 5.2)
- verify (with signature) that they agree to provide references of evidence accepted within the profession of medicine as adequate justification for indications and contraindications in the care of patients. (ACCME Policy 2002-B-0-9)
- be within the definition of CME and must not be known to a) have risks or dangers that outweigh the benefits or b) be ineffective in the treatment of patients. (ACCME Policy 1982-B-03)
Disclosures Relevant to Potential Commercial Bias: Mount Carmel requires everyone in a position to control the CME content to complete a Full Disclosure Form (available on CME Forms Link) indicating any relevant financial relationships (or lack thereof) including the name of the individual with the relationship, the name of the commercial interest(s), and the nature of the relationship the person has with each commercial interest. (SCS 6.1, 6.2) Disclosure information must be submitted in ample time for review by a designated monitor.
The source of all support from commercial interests must be disclosed to learners prior to the beginning of the educational activity and must include in-kind contributions. Disclosure may not contain the use of trade names or product-group messages. (SCS 6.3, 6.4, 6.5)
If a faculty member does not provide disclosure information prior to the deadline for printed materials, that information will be disclosed verbally at the live activity prior to the faculty member's presentation. A designee must verify in writing that verbal disclosure was made. (SCS 6.5)
Faculty members must:
- verify (with signature) that they agree to provide references of evidence accepted within the profession of medicine that support clinical recommendations for the improvement of quality in healthcare.
- agree to provide a balanced and objective view of all therapeutic options.
- submit an outline of their lecture prior to the educational activity for peer review.