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
• Privacy Policy
• Co-Sponsorship Policy
• Joint Sponsorship Policy
• Policy on Unapproved or “Off-label” Uses
• Policy Regarding Validation of Clinical Content
• Regularly Scheduled Conference Policy
• Policy for Internet Activities
• Enduring Materials Policy
• Honoraria Policy
• Reimbursement of Travel-Related Expenses Policy
• Policy Concerning Commercial Support of CME Activities and Procedures for Internal Compliance
• Step-by-Step Management of Disclosure of Financial Relationship and Conflict of Interest for a CME Activity

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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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 Conference Policy

January 2007 Revision

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

To assure that RSCs 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 RSC 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 or credit for participants awarded 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 RSC must be a full-time active staff member of the Case School of Medicine or on the Medical Staff of University Hospitals Health System or another Case 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. Needs, Learning Objectives and Educational Design: The planning committee develops a Statement of Need based on an assessment of the audience’s educational needs and defines global Learning Objectives to meet the need. The committee designs the educational structure most appropriate to affect knowledge transfer 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 RSC is received by the RSC Coordinator not later than 30 days following completion of the session. Required documentation for each session will be identified in the RSC’s submission checklist. All documentation for a session must be submitted at one time. All submissions including sign-in sheets are final upon receipt.

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.

9. Disclosure of Financial Relationship: 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 Case/UHHS 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. In RSCs where annual disclosures are involved, repeated verbal disclosure is not necessary.

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 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 RSC 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 RSC 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 on demand for a nominal fee by written request to the CME Registrar.

16. Graphic Identity and Publicity: Case Western Reserve University, University Hospitals Health System 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.

17. Annual RSC 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.

18. Guest Faculty Funded Through Other Accredited CME Providers:  For all RSCs where The Case School of Medicine CME Program is the accredited sponsor, the CME Program will take full responsibility for every session of an RSC during its annual term of sponsorship.   Instances may occur where guest faculty appearances for an individual session of an RSC 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 RSC.  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 Case CME Program for CME activities distributed over the Internet is the same as for live or other self-study activities. The UHHS 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 pharmaceutical or medical device manufacturer’s product website.

2. No links from the Case or any Case-contracted website to pharmaceutical or medical device manufacturer’s website are permitted.

3. Advertising of any type including, but not limited to, banner ads, subliminal ads and pop-up window ads, is prohibited within the educational content of CME activities on the Internet.

4. The Privacy and Confidentiality policies of the Case CME Program apply to all CME activities including Internet CME. The Privacy Policy of the Case Website, case.edu and the UHHS Website, uhhs.com, 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 Case and UHHS 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)

6. 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

7. 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.

8. 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.

9. Role of Commercial Interests: Accredited providers may not enlist the assistance of commercial interests to provide or distribute enduring materials to learners.

10. 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.

11. Evaluation by Learners: An evaluation methodology approved by the CME Program must be used for each unit of the enduring material.

12. 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.

13. 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 that he/she will offer to prospective faculty members. While there is no definitive scale for honoraria, the majority of local meetings sponsored by the Case School of Medicine and the clinical departments of University Hospitals Health System and presented by faculty do not offer an honorarium. Where an honorarium is offered, an honorarium of $500.00 to $750.00 for local presenters inclusive of travel expense is suggested. Honoraria for guest faculty is negotiable with $1,000.00 to $1,500.00 plus travel expenses a typical arrangement. Arrangements for honoraria must be confirmed in writing. In accordance with University policy and for tax reporting purposes, payment of honoraria to an individual must be made to that individual's home address.

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Reimbursement of Travel-Related Expenses Policy

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 expenses of $25.00 and greater. All requests for reimbursement are subject to audit.

• 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.
• Automobile Mileage: Reimbursed at $0.405/mile or the prevailing rate established by Case, whichever is higher. Travel must be itemized and mileage recorded.
• Taxi/Airport Limo Service: Reimbursed with 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 is 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, please indicate your portion of the expense only.

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Policy Concerning Commercial Support of CME Activities
and Procedures for Internal Compliance

March 2007 Revision

To ensure independence in development and implementation of CME activities from the control by commercial interests, the Case 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 Case 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 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 and Agreement form]
• The Case 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 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 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 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 CME Program must meet the following expectations:

(1) Education: The Case CME Program must provide the Activity Director, planning committee and faculty with documentation of Case’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.  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 and Agreement 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 Conflict of Interest: Activity Directors and their Department Chairs (or Program Directors) are initially responsible for resolving conflicts of interest identified during the disclosure process.  (See Step-by-Step Process for details.)  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:

• Disclosure of relevant financial relationships to the activity participants (required).
• Assurance that the presenter will rely on best available and highest quality scientific evidence, particularly with respect to therapeutic recommendations (required).
• Review of any slides or hand-out materials.
• Alter control over content of the content planner or presenter/author.
• Disqualification of the individual from presenting.  Select a presenter without the same or equivalent conflict.

(5) Stratification of Risk: All activities will be stratified by risk of commercial bias into the following categories:

Low: Activities developed and implemented within the Case School of Medicine and its teaching affiliates that are planned solely by Case faculty, take place in Case or affiliate facilities, have largely Case or affiliate participants and do not involve commercial support. [Examples include most Regularly Scheduled Conferences (“RSCs”) and conferences held internally at Case or affiliates. CME Program interventions to manage risk include learning opportunities for faculty, sponsorship agreements signed by both the Activity Director and his/her Department Chair, review of activity documentation including evaluations reporting bias and, for RSCs, monitoring as specified by the RSC Policy.]

Medium: Activities developed and implemented within the Case School of Medicine or its teaching affiliates that are planned solely by Case faculty, take place in Case, affiliates’ or local community facilities, are open to all participants and may involve commercial support. [Examples include local, directly sponsored meetings and RSCs with greater than occasional commercial support.  CME Program interventions to manage risk include all of the above plus monitoring of every live activity.]

High: Activities sponsored and/or implemented by the Case School of Medicine or its teaching affiliates that are planned in partnership or joint sponsorship with external organizations, take place anywhere, may be in print or be distributed over the Internet, are open to all participants and may involve commercial support, particularly support of a single commercial entity.  [Examples include joint sponsorships, national/international activities, Internet activities, and the active role of a medical education company or commercial supporter.  CME Program interventions to manage risk include all of the above plus a mandatory CME Program role on planning committee and peer review of content by the CME Advisory Committee (if requested by the Activity Director or CME Program planning committee member).]

(6) Evaluation and Monitoring: It is essential that activity participants actively participate in the monitoring process.  All activities should have participant evaluations submitted to the Case 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 commercial bias was perceived by more than 5% of the participants will be reviewed by the CME Program and the Activity Director.  Individual instances below the 5% threshold but remarkable for any reason will be addressed on a case-by-case basis.  Appropriate action to address the instance of bias as well as prevent further bias will be taken.

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

Purpose: Outline the process of implementing the Case CME Program Commercial Support Policy, specifically the disclosure of financial relationship by anyone in a position to control the content of a CME activity and resolution of any conflicts of interest (COI) that may be disclosed.  Make clear the responsibilities of the Activity Director, his/her Departmental Chair and the CME Advisory Committee for resolving COI.  Ensure that the Activity Director and the individual or institutional entity managing COI understand that they must attest to completing this process on each disclosure.

(1) Activity Conceptualization—Process Begins: A CME activity is conceptualized and a prospective Activity Director (AD) appointed with approval from the Dept. Chair.  Sufficient time should be available prior to commencement of the activity to complete the following steps.

(2) Activity Director Disclosure: The AD contacts the CME Program before planning begins.  NB: An activity that has already been developed, e.g. topics or speakers selected, cannot be in compliance with this model.  A CME Program staff member briefs the AD on the Commercial Support Policy, and requests disclosure of financial relationship (disclosure form) from the AD.  Dept. Chair reviews the disclosure, resolves COI as necessary and signs off on the disclosure.

(3) Review of AD Disclosure by CME: CME Program staff review the fully authorized disclosure on receipt.  The staff will have risk stratified the activity with respect to the Commercial Support Policy based on initial information about the activity.  In this light, the disclosure is analyzed by the staff.  With respect to resolution of any COI issue, staff may request peer review of the disclosure and COI management by a CME Advisory Committee Member.

(4a) AD Disclosure Approved—Initiate Planning Committee Disclosure: If the AD’s disclosure is determined to have demonstrated only resolvable COI or no COI was reported, the AD is asked to proceed with the planning process, develop a committee and request disclosure from every prospective committee member.  The CME staff member should participate on the planning committee to provide guidance and support for the disclosure and management of COI process.

(4b) AD Disclosure Not Approved: If the AD’s disclosure of conflicts of interest is determined to be unmanageable, staff along with the CME Medical Director contacts the AD and the Dept. Chair to discuss alternatives to developing the activity, for example changing the activity content or the Activity Director.  When changes are made, the process resumes at step (2) above.

(5) AD and Department Chair Review Planning Committee Disclosures: The AD reviews the disclosures with the Dept. Chair.  They jointly decide if any prospective planning committee member should not participate or in some way limit their participation.  A list of accepted planning committee members and their disclosures is then submitted to the CME staff.

(6) Selecting Activity Faculty and Review of Faculty Disclosures: The AD and his/her planning committee plan the activity.  When activity faculty members are identified, disclosures are requested.  The AD reviews the disclosures with the Dept. Chair.  They jointly decide if any prospective faculty committee member should not participate or have their participation specifically limited to resolve COI.  (An example of a specific limitation would be to excuse a faculty member from addressing an issue like therapeutic recommendations related to an identified COI.)  A list of accepted activity faculty members and their disclosures is then submitted to the CME staff.

(7) CME Committee Peer Review Option: In steps 5 and 6, if the CME staff has a question concerning the manageability of any COI which was acceptable to the AD and the Dept. Chair, that question may be referred to the CME Advisory Committee for peer review.  This peer review—when necessary--will be the final authority over whether or not a conflict of interest is manageable within the scope of the activity.

(8) Submission of Sponsorship Agreement: When the planning committee selection is complete and management of COI is approved by CME, the sponsorship agreement may be submitted for approval.  Faculty selection and the related disclosure/COI management process can take place before or after the agreement is submitted.

(9) Disclosure to Participants: In the context of the activity, the AD 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.