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CME Program Policies

To view the CME Program's policies and procedures scroll down or click the links below to go directly to a specific policy or procedure.

Confidentiality Policy

It is the intent of the Case Western Reserve University CME Program to maintain the confidentiality of any physician or healthcare provider information obtained or utilized by the CME Program in the course of registration for CME activities, participation as faculty, preparation and release of transcripts of activities for which credit has been earned, or any other CME Program function that involves confidential information. Such confidential information includes physician mailing address, Social Security number (used as a unique identifier) and record of credit hours earned. Accordingly, all such confidential information will (1) be retained in a secure electronic data base and filing system, (2) never displayed where it may be observed or recorded and (3) be released individually only upon receipt of written authorization from the party requesting their own information.

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Privacy Policy

It is the policy of the Case Western Reserve University CME Program to maintain the privacy of patients’ Protected Health Information (PHI) and to abide by all state and federal privacy laws (including the Health Insurance Portability and Accountability Act of 1996 (HIPAA)). Of specific concern to CME providers are situations where PHI might appear in a presenter’s written educational materials or audio/visual materials. For example, information attributable to a specific patient might be included in a written case study or verbal discussion of a case or might appear in a visual presentation such an x-ray or similar diagnostic image or test where patient identifiers have not been removed. Accordingly, PHI may not be present in any aspect of an educational presentation without a patient’s written authorization (and such authorization must be HIPAA compliant after April 14, 2003). Prior to presenting a presenter must represent and warrant that he/she has HIPAA-compliant authorization for any PHI in the presentation or presentation materials or that he/she acquired such protected health information from a source that (a) obtained a HIPAA-compliant authorization which authorizes Presenter's use of PHI during the presentation; or (b) was not under a legal obligation to maintain the patient's confidentiality.

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Co-Sponsorship Policy

Co-Sponsorship occurs when one or more accredited providers of continuing medical education agree to sponsor an educational activity to be designated for category 1 credit. In such arrangements, one sponsor must take the lead and accept full responsibility for the activity just as if it were the sole sponsor.

Where the Case Western Reserve University CME Program is a co-sponsor of an activity with one or more accredited CME providers and is not the lead sponsor, the CME Program requires that it must review and approve in writing before publication any print or other promotional, informational or instructional materials that include the name(s) or logo(s) of Case Western Reserve University or University Hospitals Health System or any of its clinical departments or wholly-owned subsidiaries.

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Joint Sponsorship Policy

ACCME accredited providers that plan and present one or more activities in partnership with a non-ACCME accredited partner engage in “joint sponsorship”. A commercial interest, defined as any proprietary entity producing health care goods or services, with the exception of non-profit or government organizations and non-health care related companies, cannot take the role of non-accredited partner in a joint sponsorship relationship.

The Case Western Reserve University CME Program, an ACCME accredited provider, will jointly sponsor CME for physicians locally, nationally or internationally in order to improve the health of patients and benefit all physicians through diverse educational opportunities, develop institutional relationships, increase recognition of our teaching hospitals and clinical capabilities locally and worldwide.

It is the responsibility of the Case CME Program to be able to demonstrate through written documentation compliance with the ACCME’s Essential Areas and Elements and Standards for Commercial Support of the ACCME and the policies of the Case CME Program. Materials submitted that demonstrate compliance may be from either Case’s files or those of the non-accredited provider.

To jointly sponsor and assure that each such sponsored activity is planned and implemented in compliance with all relevant policies and procedures, the following terms and conditions must be understood and agreed upon:

  1. Activity Director: The Activity Director must be a faculty member of the Case School of Medicine or a member of the Medical Staff of a teaching affiliate and must be actively involved in the planning and implementation of the program to be sponsored from beginning to completion.
  2. Mission: The content, design and use of the educational activity fit the Mission of the CME Program.
  3. Compliance with Applicable Policies: The non-accredited educational provider agrees to comply with the Essential Areas and Elements and Standards for Commercial Support of the ACCME and the policies of the Case CME Program.
  4. Accredited Sponsorship: The request for sponsorship of the activity must be submitted by the Activity Director or designated representative at least six months prior to the date of the activity (except in the case of regularly scheduled series sponsored locally.) The provider of the enduring material agrees to pay a sponsorship fee as designated by the CME Program and other costs as may be determined upon review of the Activity budget.
  5. Sponsorship Fees: The non-accredited sponsor agrees to pay a sponsorship fee as designated by the CME Program and other costs as may be determined upon review of the course budget.
  6. Compliance with Activity Planning Process: It is preferable for the CME Program to be directly involved in the development of the educational activity from the initial planning stage forward. Where this is not the case, the non-accredited sponsor must provide in advance acceptable documentation that program planning is in full compliance with the ACCME’s Essential Areas and Elements and Standards for Commercial Support and the policies of the Case CME Program.
  7. Representation at Live Events: If a live activity is involved, the Case CME Program must assure program quality, adherence to commercial support requirements and appropriate registration procedures. A CME Program staff member or designated representative must attend at least the primary registration day of the conference at the expense of the activity including all travel-related expenses. In some cases, the staff member or representative may be required to attend and monitor the entire duration of the activity.
  8. Marketing and Publicity: Case School of Medicine, its affiliated teaching partners and any third party educational provider must be properly identified on all publicity materials. All publicity materials must be reviewed and approved by the CME Program prior to publication or listing.
  9. Management of Funds and Accountability: At the discretion of the CME Program, the non-accredited provider may administer funds related to the management of the conference, but must document in detail and provide to the Case CME Program all expenditures and sources of funds.
  10. Joint Sponsorship Accreditation Statement: The accredited provider must inform the learner of the joint sponsorship relationship through the use of the appropriate accreditation statement. All printed materials for jointly sponsored activities must carry the appropriate accreditation statement.

Partnership with a joint sponsor will only be considered if the above conditions are agreed to by the non-accredited provider and any third party educational provider prior to review by the Case CME Program. The non-accredited sponsor and the third party educational provider (when applicable) must review this policy and sign the following statement:

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Policy on Unapproved or “Off-label” Uses

Presenters or discussants in CME activities sponsored by Case Western Reserve University are obligated to inform the audience if and when they discuss or reference the use of therapeutic agents or other commercial products that are not FDA approved or such discussion or reference is contrary to their labeling. Presenters are required to sign a statement on the Disclosure Form acknowledging that obligation.

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Policy Regarding Validation of Clinical Content

In support of physicians’ effort to make informed decisions, improve performance and assure their continuing ability to meet the high expectations related to maintenance of competence, licensure, board certification and hospital credentialing requirements, The Case Western Reserve University CME Program requires faculty to demonstrate the scientific validity of recommendations involving the clinical care of patients.

“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.” Adopted by the ACCME July 2002

Assurance of content validity relies on the scientific integrity of data from which conclusions are drawn and patient recommendations crafted.

“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.” Adopted by the ACCME July 2002

In order to demonstrate the validity of patient care recommendations in their written materials (syllabus or slides as printed handout) faculty are required to:

  1. Provide at least one clinical recommendation and up to a suggested maximum of three clinical recommendations per credit hour;
  2. Document clinical recommendations with references citing appropriate scientific evidence;
  3. Choose evidence that is the most rigorous, for example, meta-analyses, random control trials, cohort studies, case-control studies, multiple time series or expert consensus statements;
  4. Identify and list evidence supporting the recommendation immediately after the recommendation, for example, indented below the recommendation or boxed with it so that the relationship of the evidence to the recommendation is unmistakable; and
  5. Although not required, improve the usefulness of the references and the handout by annotating each reference and listing a Website where the full text may be easily accessed. “Annotating” a reference means including the title of the article or some textual description of its content and why it is relevant.

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Regularly Scheduled Series Policy

May 2009 Revision

Recurring live meetings, or “Regularly Scheduled Series” (RSSs), are activities such as grand rounds and tumor conferences that are comprised of a number of “sessions” held weekly, bi-weekly, monthly or quarterly during the course of a year.  RSS’s will be sponsored by the Case Western Reserve University CME Program in order to provide diverse educational opportunities throughout the CWRU School of Medicine and its affiliated teaching hospitals, sustain faculty/physician performance improvement, and support clinical integration of University Hospitals and its affiliated healthcare providers at their points of service.

To assure that RSSs are planned and implemented in accordance with the ACCME Essential Areas and Elements, including the Standards for Commercial Support (Revised 2004), the Activity Director of the RSS must agree to the terms and conditions of the following policy prior to commitment by the CME Program to sponsor or renew sponsorship of the Activity:

1. Sponsorship Agreement: The sponsorship agreement for the activity must be submitted by the Activity Director or designated representative to the CME Program at an interval sufficient for full evaluation prior to the first session. No sessions may be held unless a signed and fully executed sponsorship agreement is in place for both initial activity sponsorship and activity renewals.

2. Eligibility: The Activity Director of an RSS must be a full-time active staff member of the CWRU School of Medicine or on the Medical Staff of University Hospitals or another CWRU teaching affiliate.

3. Planning Committee: The Activity is guided by a planning committee representing both the prospective audience and the faculty providing the education. The Activity Director and all members of the planning committee must disclose financial relationships as required by the Standards for Commercial Support.

4. CME Program Mission: The content and design of the activity fit the Mission of the CME Program.

5. Professional Practice Gaps and Needs, Learning Objectives and Educational Design: The planning committee develops a Statement of Need based on their learner’s Professional Practice Gaps and assessment of the audience’s educational needs.  From this information, global Learning Objectives are identified. The committee designs the educational structure most appropriate to affect knowledge, performance, competence and change behavior as intended.

6. Compliance: The Activity Director agrees to comply with all Essential Areas and Elements, and the Standards for Commercial Support, in accordance with the policies and procedures established by the CME Program as presented in the Activity Director’s Guide.

7. Submission of Documentation: It is the Activity Director’s responsibility to assure that required documentation from each session of the RSS is received by the RSS Coordinator not later than 30 days following completion of the session. Required documentation for each session will be identified in the RSS’s submission checklist. All documentation for a session must be submitted at one time.

8. Commercial Support: Whenever funds are contributed in support of the activity or a session of the activity, commercial support agreements (typically referred to as “letters of agreement”) compliant with the Standards for Commercial Support must be appropriately authorized and provided to the CME Program along with copies of checks for the related grants, and a final reconciliation of how the funds were used.

9. Disclosure of Financial Relationship and Resolution of Conflict of Interest: Activity Directors must obtain disclosure of financial relationships from activity planners and faculty and resolve any real or apparent conflicts of interest as discussed in the CME Program’s Commercial Support Policy.  Review of documentation of disclosure and conflict of interest resolution by the CME Program will take place retrospectively on submission on a session by session basis.  Action may be taken thereafter as necessary if concern is raised about the management of any instance of perceived or actual conflict of interest. Activity Directors must assure that every presenter’s disclosure is available to attendees in writing and that the presenter verbally discloses at the beginning of his/her presentation.

10. Evaluation Plan: The activity planning committee will offer a systematic Evaluation Plan for the Activity. On a periodic basis the Activity leaders and participants will self-evaluate whether or not the Activity meets the stated professional practice gaps, needs and global learning objectives and what improvements, if any, are necessary. An annual evaluation is a minimum requirement. The Evaluation Plan must be accepted by the CME Program.

11. Monitoring: The Activity will be monitored by the CME Program for compliance with this RSS Policy and the Activity Evaluation Plan. The CME Program will support performance improvement initiatives to assure compliance when called for. Monitoring will involve session attendance by a CME Program staff or CME Advisory Committee member at least once annually. Deficiencies in compliance will be documented and brought to the attention of the Activity Director within 30 days of the date the deficiency is noted.

12. Improvement Plan: A plan for improvement will be developed, documented in writing to the CME Program and implemented by the Activity Director. This plan will be reviewed at the time of sponsorship renewal of the Activity or sooner if designated by the CME Program.

13. Suspension of an Activity: Failure to bring the Activity into compliance is cause for suspension of the Activity until such time as the elements for full compliance are demonstrated to be in place. Sponsorship for activities which cannot cure such defaults may be cancelled under CME Program policy.  CME credit for individual participants cannot be earned while an Activity is under suspension.  Sponsorship of an activity not in compliance at a level acceptable to the CME Program will not be renewed subject to review by the CME Advisory Committee.

14. Fees: The provider of the RSS agrees to pay an annual sponsorship fee as designated by the CME Program.

15. Attendance Transcripts: The CME Program will provide learners with current, accurate data on their participation in the Activity in the form of a transcript. Attendance data will be maintained for six years. Individual transcripts may be obtained through our website at http://casemed.case.edu/cme/.  This service is complimentary. 

16. Graphic Identity and Publicity: Case Western Reserve University, University Hospitals and other affiliated teaching hospitals must be properly identified on all publicity materials. The format for all publicity materials must be reviewed and approved by the CME Program prior to publication or listing.

  • Annual RSS Program Evaluation:  The CME Program will review its performance and the performance of its sponsored activities annually and report its findings for review and evaluation by the CME Advisory Committee.
  • Guest Faculty Funded Through Other Accredited CME Providers:  For all RSSs where The Case Western Reserve University School of Medicine CME Program is the accredited sponsor, the CME Program will take full responsibility for every session of an RSS during its annual term of sponsorship.   Instances may occur where guest faculty appearances for an individual session of an RSS are offered through an outside accredited CME provider such as a medical education company or medical school.  In such instances, the outside accredited CME provider may not become the primary sponsor the individual session.  The outside accredited provider may elect to (1) provide commercial support alone subject to the ACCME Standards for Commercial Support and the Commercial Support Policy of the CME Program, (2) provide commercial support as in (1) above and co-sponsor with the CME Program or (3) offer the guest faculty appearance in a venue outside the RSS.  In the case of co-sponsorship, a co-sponsorship agreement clearly delineating all responsibilities and all documentation such as financial disclosure completed to the satisfaction of the CME Program are required. A co-sponsorship fee of $750 will be assessed to the outside accredited CME provider.

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Policy for Internet Activities

Compliance with the ACCME Essential Areas and Elements, the Standards for Commercial Support and the policies of the CWRU CME Program for CME activities distributed over the Internet is the same as for live or other self-study activities. The University Hospitals Intranet including the Physician Portal is consider part of the Internet.  In addition, the following provisions also apply:

  1. No activities may be hosted by, or otherwise appear on, a website owned or controlled by a commercial interest.
  2. With clear notification that the learner is leaving the educational website, links to a pharmaceutical and device manufacturers’ product websites are permitted before or after the educational content of a CME activity, but shall not be embedded in the educational content of a CME activity.
  3. Advertising of any type is prohibited within the educational content of CME activities on the Internet including, but not limited to, banner ads, subliminal ads, and pop-up window ads. For computer based CME activities, advertisements and promotional materials may not be visible on the screen at the same time as the CME content and not interleafed between computer windows or screens of the CME content.
  4. The Privacy and Confidentiality policies of the CWRU CME Program apply to all CME activities including Internet CME.  The Privacy Policy of the CWRU Website, cwru.edu and the University Hospitals Website, uhhospitals.org, concerning information collection practices, “cookies” and other personal and aggregate data collection is detailed on the Website and applies to all visitors to the site including those visitors accessing the CME web pages.  CME activities must be in compliance with the privacy policies of the CWRU and University Hospitals websites.
  5. Technical requirements such as the hardware and software necessary to participate in the CME activity must be indicated at the start of the activity.
  6. As part of the activity, a mechanism must be in place for the learner to contact the provider if there are questions about the activity.
  7. Documentation that the provider owns the copyright for, has received permission for the use of, or is otherwise permitted to use copyrighted materials with an Internet CME activity must be provided before an activity may be posted to the Web or distributed electronically or in any similar way.
  8. The foregoing policy statements apply not only to live or self-study activities intended for distribution over the Internet, but also to activities created for the Internet that may be digitally recorded and re-purposed for distribution by other methods including, but not limited to, e-mail or compact digital disk.

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Enduring Materials Policy

The Case Western Reserve University CME Program will sponsor enduring materials for physicians locally, nationally or internationally in order to benefit all physicians through diverse educational opportunities, develop institutional relationships, and increase recognition of our teaching hospitals and clinical capabilities locally and worldwide.

The ACCME defines an enduring material as “a non-live CME activity that ‘endures’ over time. It is most typically a videotape, monograph, or CD ROM. Enduring materials can also be delivered via the Internet. The learning experience by the physician can take place at any time in any place, rather than only at one time, and one place, like a live CME activity.”

To ensure that each unit of a CME enduring material is planned and implemented in accordance with Essential Areas and Elements and Standards for Commercial Support of the ACCME and the policies of the Case CME Program, the following terms and conditions must be understood by the provider of the education and its Activity Director and agreed upon:

  1. Activity Director: The Activity Director must be a faculty member of the Case School of Medicine or a member of the Medical Staff of a teaching affiliate.
  2. Mission: The content, design and use of the educational activity fit the Mission of the CME Program.
  3. Compliance: The Activity Director agrees to comply with the Essential Areas and Elements and the ACCME’s Standards for Commercial Support in accordance with the policies and procedures established by the Case CME Program.
  4. Sponsorship Fees: The provider of the enduring material agrees to pay a sponsorship fee as designated by the CME Program and other costs as may be determined upon review of the Activity budget.
  5. Appropriate Media: The medium, or combination of media, chosen by the provider must be consistent in content and educational design with the stated learning objectives and be approved in the planning phase by the CME Program. The overall length of recorded materials and estimated study time must be specified on each unit of the CME Activity.
    • Draft: Reviewed by the CME Program in a draft stage
    • Pre-release: Field (or ‘beta’) tested with prospective learners and evaluated
    • Approval: Approved by the CME Program prior to release
    • Principal faculty and their credentials
    • Medium or combination of media used
    • Method of physician participation in the learning process
    • Estimated time to complete the educational activity (same as number of designated credit hours)
    • Dates of original release and most recent review or update
    • Expiration date (date after which enduring material is no longer certified for credit)
  1. Three Step Approval Process: Each unit of the enduring material (educational content, media and packaging) must be reviewed and approved through the following process:
    • Draft: Reviewed by the CME Program in a draft stage
    • Pre-release: Field (or ‘beta’) tested with prospective learners and evaluated
    • Approval: Approved by the CME Program prior to release
  1. Scheduled Review and Re-release: Providers must review each enduring material at least once every year or more frequently if indicated by new scientific developments. An enduring material cannot be certified for credit for more than two years without review on the part of the provider to ensure that the content is still up-to-date and accurate. That review date must be included on the enduring material, along with the original release date and a termination date.
  2. Compliance with Commercial Support Policy: To comply with the ACCME’s Standards for Commercial Support and the Commercial Support Policy of the Case CME Program:
    • There must be no product specific advertising in enduring materials
    • Acknowledgement of commercial support is required and must be placed only at the beginning of an enduring material
    • Acknowledgement may state the name, mission, and areas of clinical involvement of the commercial interests, and may include corporate logos and slogans, if they are not product promotional in nature
    • No brand names or product-group messages may be used in the acknowledgement, even if they are not related to the topic of the enduring material.
  1. Role of Commercial Interests: Accredited providers may not enlist the assistance of commercial interests to provide or distribute enduring materials to learners.
  2. Marketing and Publicity: Case Western Reserve University School of Medicine and its teaching affiliates must be properly identified on all marketing and publicity materials and each unit of the enduring material. All marketing and publicity materials and the enduring material must be reviewed and approved by the CME Program prior to publication.
  3. Evaluation by Learners: An evaluation methodology approved by the CME Program must be used for each unit of the enduring material.
  4. Verification of Learner Participation: A methodology for verifying physician participation must be agreed upon prior to release of the first unit of the enduring material. Providers often choose to include a post-test in their enduring material activities as a way to continue the education process and meet this requirement.
  5. Enduring Materials Re-purposed from Live Activities: The Case CME Program considers the provider to have created two separate activities – one live activity and one enduring material activity. Both activities must comply with all Case requirements, and the enduring material activity must comply additionally with all Case policies that relate specifically to enduring materials.

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Honoraria Policy

It is the Activity Director's prerogative to set an honorarium for activity planners, faculty and authors that he/she will offer to prospective faculty members.  While there is no definitive scale for honoraria, the majority of local meetings sponsored by Case Western Reserve University clinical departments and presented by faculty do not offer an honorarium.  Where an honorarium is offered, the CME Committee has suggested an honorarium of $500.00 to $750.00 for local presenters and local activities inclusive of travel expense.  Honoraria for guest faculty are negotiable with $1,000.00 to $1,500.00 plus travel expenses a typical arrangement.  NB: Any individual honorarium over $1,500 for local activities or $3,000 for regional, national or international activity is subject to review and possible revision by the CME Committee and should be presented to the CME Committee before it is offered.

Arrangements for honoraria must be confirmed in writing.  In accordance with University policy, for tax reporting purposes payment of honoraria to an individual must be made to that individual's home address.  With regard to commercial support of honoraria, the CME Program observes the ACCME's Standards for Commercial Support (Appendix A).

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Reimbursement of Travel-Related Expenses Policy

Reimbursement of an individual involved in a CME activity sponsored by the Case CME Program will be reimbursed according to the following schedule.  If an expense you wish to incur is not included below, or if you have any question about an expenses which you wish to have reimbursed, call the CME Program for clarification prior to incurring that expense.

Reimbursement must be itemized and requested in writing with original receipts for all expenses listed on the Statement of Travel Expense form with the exception of mileage.

  • Air Fare:  The cost of coach airfare will be reimbursed.  Submit actual ticket receipts and the original invoice indicating payment.  First-class airfare will be reimbursed at the coach rate only.  A receipt is also needed for any additional baggage charge.
  • Automobile Mileage:  Reimbursed at $0.55/mile or the current adjusted rate.
  • Car Rental:  Reimbursed with a receipt confirming the dates of rental.  Gasoline is also reimbursable with a receipt.
  • Hotel: Cost of standard room and reasonable telephone charges will be reimbursed with an itemized receipt.  Charges for fitness, spa, in-room movies, golf or other recreation are not reimbursable.
  • Meals:  Food service is often available at most activities.  Other reasonable meal expenses are reimbursable.  Reasonable meal expenses are defined as: Breakfast, $15.00 or less; Lunch, $25.00 or less; and Dinner, $35.00 or less.  When dining with other individuals, request only your portion of the expense.
  • Parking & Toll Charges:  Reimbursed with receipt.
  • Taxi/Airport Limo Service:  Reimbursed with receipt.

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Commercial Support Policy and Procedures for Internal Compliance

April 2009 Revision

To ensure independence in development and implementation of CME activities from the control by commercial interests, the Case Western Reserve University CME Program complies with the Standards for Commercial Support of the Accreditation Council for Continuing Medical Education as approved and adopted September 28, 2004.  The CME Program is committed to being an uncompromised provider of educational activities, life-long learning curricula and performance improvement strategies for practicing physicians through the dissemination and adoption of learning content based on the most recent, high quality scientific evidence.  

Policy

All Activity Directors, planners and activity faculty involved in decisions about activity educational content must recognize and agree in writing to abide by the following policy provisions and procedures:

(1) Requirements for activity content:

  • The educational content and related materials of all activities sponsored by the Case Western Reserve University CME Program must be independent of the control or influence of commercial interests in planning and implementation.

  • Content and related materials must promote improvements or quality in healthcare.

  • Content must provide a balanced view of therapeutic options.

  • Content must be based on the most recent, high quality scientific evidence.

  • Activity participants must be provided with the source and type of evidence.

  • Content that is not established medical practice must be so identified.

  • Discussion of unlabeled or investigational uses of a commercial product must be identified as such.

(2) Requirements for disclosure of relevant financial relationships:

  • Anyone who is in a position to control or influence the content of an educational activity must disclose in writing all relevant financial relationships (paid speaker, consultant, research grant holder, etc.) and positions (e.g. employee, shareholder, director, etc.)  A “relevant financial relationship” is any financial relationship in any amount occurring within the past 12 months or known to be forthcoming in the next 12 months that relates to the content or commercial supporter(s) of the activity that creates a conflict of interest or the appearance of a conflict of interest.  Relationships of the person involved in the CME activity are considered to include those financial relationships of a spouse or partner of the person involved in the CME activity.

  • Any individual who refuses to disclose relevant financial relationships will be disqualified from participating in the development, planning, implementation, provision or evaluation of CME activities.

  • All relevant financial relationships must be disclosed in a written format (print, slide, Web page) to participants prior to the presentation of content of the activity, including name of the individual, name of the commercial interest and the relationship between the two.  If no relationships exist, this must be disclosed in the same manner.

  • All sources of commercial support, both monetary and in-kind, must be disclosed to participants prior to the presentation of the content of the activity.

(3) Prevention strategies and monitoring to safeguard against commercial bias:

  • Education concerning this Policy and its related Procedures will be made available by the CME Program to all Activity Directors, content planners and faculty.

  • Anyone who is a position to control or influence the content of an educational activity must agree in writing to adhere to this policy and the ACCME’s Standards for Commercial Support.  [Disclosure of Commercial Relationship Form]

  • The Case Western Reserve University CME Program will ensure the disclosure in writing to participants of each activity the financial relationships of all individuals involved in the development and presentation of content.

  • The Case Western Reserve University CME Program will assess all activities for the potential for commercial bias and stratify the risk for bias in order to focus scrutiny on activities identified as having the greatest risk.

  • The CME Activity Director and his/her Department Chair in the Case Western Reserve University School of Medicine or other institutional program director will be required by the CME Program to attest in writing that they have reviewed the activity planning process and educational content and found both free of control by commercial interests or bias.  [Sponsorship Agreement]

  • All activities sponsored by the Case Western Reserve University CME Program are subject to monitoring to ensure compliance with this policy, participant evaluation and peer-review to determine whether or not commercial bias is in evidence.

Procedures

All activities sponsored by the Case Western Reserve University CME Program must meet the following expectations:

(1) Education: The Case Western Reserve University CME Program must provide the Activity Director, planning committee and faculty with documentation of CWRU’s Commercial Support Policy and complementary education to aid in understanding the Policy and its implications.

(2) Commercial Support: All commercial support, both monetary and in-kind, must be paid or contributed to Case Western Reserve University, one of its teaching affiliates or an entity subject to direct financial oversight by Case Western Reserve University.  Documentation must include:

  • A Commercial Support Agreement between the provider and the commercial interest providing support.

  • All financial contributions must be documented with a photocopy of the check and evidence of deposit.

  • All in-kind contributions must be documented with a Commercial Support Agreement.

(3) Disclosure and Agreement: All individuals involved in the development and implementation of educational activities must agree in writing (Disclosure of Commercial Relationship Form) to the following principles:

  • Disclose any financial relationship related to (a) the activity’s content, or (b) the activity’s commercial supporters.

  • Deliver balanced and evidence-based content.

  • Offer the source and type of evidence (i.e. animal study, meta-analysis, RCT, etc.)

  • Identify any discussion of unlabeled or investigational uses of a commercial product as such.

(4) Resolving Conflicts of Interest: The Activity Director and CME Medical Director are  responsible for resolving conflicts of interest identified during the disclosure process by prospectively reviewing the content (slides) and completing the Resolution of Conflict of Interest Form using one of the following  Mechanisms for the Resolution or Management of Conflict of Interest with Commercial Entities. Conflicts must be resolved to assure that every reasonable effort is made to prevent or eliminate any commercial bias.  The CME Advisory Committee in a peer review capacity has final oversight and discretion with respect to the resolution of any conflict.  Conflicts of interest may be resolved in many ways, including:

A. Alter the financial relationship. Individuals may change their relationship with commercial interests (e.g., discontinue contracted services).  This way no duty, loyalty, or incentive remains to introduce commercial bias into the CME content.  However, disclosure that such a relationship had existed within the preceding 12 months must still be made to the audience.

B. Alter control over content.  An individual’s control of content can be altered in several ways to remove the opportunity to affect content related to the products and services of a commercial interest. These may include:

  • Disqualify the speaker, author or planner and select a replacement.  If a COI cannot be resolved, the speaker, planner or author must be disqualified. If a speaker, planner or author refuses to disclose they will automatically be disqualified from participating in the CE activity. Failure to return a disclosure form will be considered to be a refusal to disclose.

  • Choose someone else to control that portion of the content. If a proposed presenter, author, or planner has a conflict of interest related to the content, someone else who does not have a relationship to the commercial interests related to the content may present or plan this part of the content.

  • Change the focus of the CME activity so that the content is not about products or services of the commercial interest that is the basis of the COI.

  • Change the assigned content so that it is no longer about products or services of the commercial interest. For example an individual with a conflict of interest regarding products for treatment of a condition could address the pathophysiology or diagnosis of the condition rather than the therapeutics.

  • Limit the content to a report without recommendations.  If an individual has been funded by a commercial company to perform research, the individual’s presentation may be limited to the data and results of the research. Someone else can be assigned to address broader implications and recommendations.

  • Limit the sources for recommendations. Rather than having a person with a conflict of interest present personal recommendations or personally select the evidence to be presented, limit the role of the person to reporting recommendations based on formal structured reviews of the literature with the inclusion and exclusion criteria stated (evidence-based).

C. Independent Content Validation.  Conflict of interest may be resolved if the presentation is peer reviewed and;

  • All the recommendations involving clinical medicine are based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients or

  • All scientific research referred to, reported, or used in CME in support or justification of patient care recommendations conforms to generally accepted standards of experimental design, data collection and analysis.

D. Review and Resolution.  Identified conflicts of interest may be reviewed by the Activity Director, Director of CME,  Medical Director of CME, Chairman of the CME Committee and/or identified experts(s) in the field as appropriate.  (Reviewers will also be asked to disclose their relevant financial relationships as a precaution against any COI they may have.)  Additional information on a presentation may be collected for review.  If a COI can not be resolved through the mechanisms described above, AMA Category 1 credit will not be approved or will be withdrawn.      

  • Oversight

All financial relationships will be disclosed to CME activity participants. Activities will be evaluated by participants and peer reviewers to determine if the content was free of bias and met acceptable scientific standards.

 (5) Evaluation and Monitoring: It is essential that participants actively participate in the monitoring process.  All activities must have participant evaluations submitted to the Case Western Reserve University CME Program that address the following concerns:

  • Was commercial bias of content perceived?  If ‘YES’, specifics. (Required question.)

  • Was content presented in an objective and balanced way?

  • Was the content based on evidence?

  • Was the source of evidence identified?

  • Was the type of evidence identified?

All activity evaluation summaries that indicate that commercial bias was perceived by more than 5% of the participants will be reviewed by the CME Program and the Activity Director.  Appropriate action to address the instance of bias as well as prevent further bias will be taken.

  (6) Procedures:

  • All commercial support must be in the form of a grant from the commercial interest.  (Exhibit fees—which are not treated like commercial support—may also be obtained.)

  • All grants must be payable to Case Western Reserve University, the accredited CME provider.

  • All grants must include a letter of agreement (LOA) stating conditions under which the grant is made.

  • Letters of agreement from commercial interests should be forwarded to the CWRU CME Program immediately upon receipt for review by the CWRU Office of Counsel for legal acceptability. Authorization can be made only by the Vice Dean, School of Medicine, and a University Vice President or his delegate. Direct LOAs to Amy Friedman (amy.friedman@case.edu) or Joan Farmer (joan.farmer@uhhospitals.org). Or fax to Amy or Joan’s attention at 216-844-8133.

  • If the CWRU CME Program’s letter of agreement is used instead of an LOA provided by a commercial interest, review by CWRU Office of Counsel is unnecessary but authorization can be made only by the CME Director and a University Vice President or his delegate.  Direct LOAs to Amy Friedman (amy.friedman@case.edu) or Joan Farmer (joan.farmer@uhhospitals.org). Or fax to Amy or Joan’s attention at 216-844-8133.

  • When grants are received by the department providing the education, documentation for the CME Program must include (a) a fully executed letter of agreement (signed by a representative of the commercial supporter and the SOM; (b) a photocopy of the grant check; (c) evidence of deposit (deposit slip, journal entry, etc); and (d) itemized reconciliation of how the funds were spent (honoraria, travel-reimbursement, catering, etc.)  Item (d) may be part of your income and expense summary.

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Step-by-Step Management of Disclosure of Financial Relationship and Conflict of Interest for a CME Activity

The Case Western Reserve University School of Medicine Continuing Medical Education Program (CWRU SOM CME) requires that all CME certified activities be developed free from the control of a commercial interest and be balanced, objective, and scientifically rigorous.

Definition of Conflict of Interest (COI)

A conflict of interest exists when individuals in a position to control the content of a CME activity have a relevant personal financial relationship with a commercial interest that benefits the individual and may ultimately bias the content being presented.  The following factors serve as part of the foundation for potential COI:

  • A financial relationship (in any amount) with a commercial interest occurring within the past 12 months and

  • The opportunity to affect the content of CME about the products or services of that commercial interest.

When the individual’s interests are aligned with those of a commercial interest the interests of the provider are in ‘conflict’ with the interests of the public. The interests of the people controlling CME must always be aligned with what is in the best interests of the public. 

The Role of CWRU SOM CME

CWRU SOM CME, as the designated Accreditation Council for Continuing Medical Education (ACCME) entity, is responsible for creating a mechanism to identify, manage and resolve all conflicts of interests for all individuals involved in the planning and implementation of an ACCME certified activity. CWRU SOM CME incorporates the following strategies as part of the overall planning process of CME activities:

  • Identify financial relationship that may constitute a potential conflict of interest for all individuals involved in the planning and implementation of the proposed CME activity (planning committee members, faculty presenters, authors, etc.).

  • Disqualify any individual who fails to provide disclosure from participation in the planning and/or implementation of the proposed CME activity.

  • Implement educational planning and design strategies that work to ensure that content is balanced, scientifically rigorous, and evidenced-based and reflects the current standards of care and/or future directions of medicine and healthcare.

  • Monitor and manage CME activities in accordance with the current standards, regulations and guidelines outlined by the constituencies involved in the delivery of continuing medical education, research and patient care.

  • Document the processes for needs assessment, gap analysis, content validation, and educational design that provide for fair and balanced discussion of the desired topics.

  • Monitor the execution of CME activities to validate the presence/absence of commercial bias and the consistent application of the standards of quality education for physicians and other healthcare professionals.

Procedures for Identifying, Managing, and Resolving Conflicts of Interest

All individuals in a position to control the content of a CME activity (planning committee members, speakers, authors, etc) are required to complete the CWRU SOM CME Disclosure of Commercial Relationship Form in which they disclose their financial relationships. CWRU SOM CME implements primary and secondary COI resolution methods for all CME-certified activities; the primary resolution method is implemented for all individuals in a position to control the content of a CME activity.  The secondary resolution methods are implemented for all individuals who have identified financial relationships with commercial interests through the primary resolution method.

Primary COI Resolution Method for All Activity Types: 

Completion of the CWRU SOM CME Disclosure of Commercial Relationship Form as described above.  In addition, learners will have the opportunity to identify any perceived commercial bias through the course evaluation.

Secondary COI Resolution Method Options by Activity Type:

All Activities:

  • The Activity Director(s) prospectively review the content (slides) and completes a Resolution of Conflict of Interest Form stating the action taken to resolve the COI.

  • The Disclosure of Commercial Relationship Form, completed Resolution of Conflict of Interest Form and content (slides) will be forwarded to the CME staff.

  • The CME Medical Director reviews the above materials and either signs off or content will be revised as needed according to the results of the review.

Timing of the Identification, Management, and Resolution of Conflicts of Interest

Activity Director(s) and Planning Committee Member(s):

  • Completion of the CWRU SOM CME Disclosure of Commercial Relationship Form before submission of the CME application.  Application will not be reviewed until disclosure is completed.
  • Financial relationship(s) is reviewed by CME staff:
    • If a COI is not identified:
  • No action will be taken and planning process can continue.
    • If a COI is identified:
  • Activity Director will complete the Resolution of Conflict of Interest Form Planning Committee.
  • CME staff will determine how topics and faculty were determined and obtain evidence that the topics represent a balanced, EBM approach.

Faculty/Speaker/Author:

  • Completion of the CWRU SOM CME Disclosure of Commercial Relationship Form no less than 14 days prior to the date of the presentation.
  • Financial relationship(s) is reviewed by CME staff:
    • If a COI is not identified:
  • No action will be taken and the individual can proceed with developing content.
    • If a COI is identified:
  • Activity Director(s) prospectively review(s) the content (slides) and completes a Resolution of Conflict of Interest Form stating the action taken to resolve the COI.
  • The Disclosure of Commercial Relationship Form, completed Resolution of Conflict of Interest Form and content (slides) will be forwarded to the CME staff.
  • The CME Medical Director reviews the above materials and either signs off or content will be revised as needed according to the results of the review.
  

Situations where Conflict of Interest cannot be effectively resolved  

While CWRU SOM CME strives to be flexible, accessible and helpful in the development and implementation of CME certified activities, there are some situations where adequate resolution of COI may not be feasible. In these situations, CME certification will not be provided.  Examples of these situations include:

  • Requests for CME certification of the content after the majority of the planning for the CME activity has occurred with faculty and/or content selections already determined;

  • Short planning timeframes that don’t permit adequate planning and implementation of required ACCME and CWRU SOM CME policies and procedures;

  • Inappropriate processes in educational planning and/or financial management that are not consistent with ACCME and/or CWRU SOM CME policies and processes.

Disclosure to Participants

In the context of the activity, the Activity Director will assure that disclosure is made to participants in writing prior to commencement of the activity and also verbally during the course of the activity where the activity is live.  Any specific limitations on participation of any faculty member should also be noted on their faculty listing for the activity.

 

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