The Institute for Continuing Medical Education 
Policy No: GEN 74.0

Statement of Policy
The New York Eye & Ear Infirmary is committed to the highest educational standards of continuing medical education in the fields of Ophthalmology, Otolaryngology and Plastic Surgery through compliance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education.
 
Objective
In keeping with the New York Eye & Ear Infirmary’s mission to provide the highest quality, most technologically advanced and consistent multidisciplinary care in an error-free environment where the safety, dignity and comfort of each patient are paramount, the Institute for Continuing Medical Education (ICME) was established with the mission of improving the quality of patient care through the ongoing education of its physicians through the presentation of educational activities that enhance the theoretical and practical knowledge, as well as the skills of healthcare professionals.  CME activities are sponsored in the disciplines of Ophthalmology, Otolaryngology, Plastic Surgery and Managed Care and presented in a variety of formats, including formal symposia, lectures, seminars, hands-on laboratory workshops, printed monographs, journal CME activities and CD-ROM.

Procedure
The primary target audience for educational activities conducted by the ICME is ophthalmologists, otolaryngologists and plastic surgeons, but additional target audiences include primary care physicians, ophthalmic technicians, nurse practitioners, practice management staff and other healthcare professionals.

The scope of the ICME’s mission is to provide opportunities to continuously expand knowledge and clinical skills and to alleviate any deficiencies in the knowledge base and/or the quality of care rendered by the professional physician, to gauge the effectiveness of programs and to plan for future courses that continue to meet the needs of the professionals involved through the use of evaluations at the conclusion of courses and at a follow-up time, to assist practicing physicians in maintaining competence in their chosen fields by strengthening the habits, learning processes, critical inquiry, and balanced judgments that are the earmark of the truly professional and committed physician.

CME activities will typically include presenters drawn from the New York Eye and Ear Infirmary medical staff who are chosen on the basis of their leadership and professional knowledge in their specialized fields.  In addition, CME activities initiated by our staff also include other physicians or professionals who are nationally or internationally recognized leaders in their fields.  For live educational activities, great emphasis will be put on audio-visual presentations to aid and facilitate all participants in recognizing the symptomatology and treatment of diseases.

All CME activities are developed around stated needs derived from various needs assessment tools, such as previous activity evaluations, formal requests from physicians, new treatments, techniques or technologies, research findings, Quality/Utilization Review data, literature searches, informal discussions among staff physicians and area of interest surveys.

CME Staff
The ICME consists of a Director, an Administrative Assistant and a CME Advisory Committee. The Director is responsible for the overall administration of the department and its educational activities and ensuring compliance with the Essentials and Elements established by the Accreditation Council for Continuing Medical Education (ACCME).  The Administrative Assistant provides clerical support to the ICME Director.  The CME Advisory Committee consists of administrators and physicians representing a variety of disciplines. The CME Advisory Committee includes the President of the Infirmary, the Director of the Glaucoma Service, the Assistant Director of Pediatric Ophthalmology, the Director of Pathology, the Chairman of Otolaryngology, the Chairman of Plastic Surgery, the Residency Director of Ophthalmology, the Assistant Director of the Glaucoma Service, the Medical Director of the Infirmary and the ICME Director.  It is the CME Advisory Committee’s responsibility to ensure that all educational activities accredited by the ICME meet the quality academic standards established by the New York Eye and Ear Infirmary and fall within the guidelines defined by the ACCME.

Institutional Support
The President and Board of Directors of the New York Eye & Ear Infirmary are committed to allocating the resources necessary for the successful operation of the ICME.  The President and Board of Directors are committed to providing a salary and benefits for the ICME Director, as well as an annual operating budget, office space, equipment, supplies, and intra-institutional support from other Infirmary Departments, such as Ophthalmology, Otolaryngology, Plastic Surgery, Information Systems, Finance and Administration, et al

Confidentiality Policy
It is the intention of the New York Eye & Ear Infirmary Institute for Continuing Medical Education (ICME) 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 ICME program function that involves confidential information. Such confidential information includes physician mailing address, Social Security number and record of credit hours earned. Accordingly, all such confidential information will be retained in a secure electronic data base and filing system, never displayed where it may be observed or recorded and be released individually only upon receipt of written authorization from the party requesting their own information.

Privacy Policy
It is the policy of the New York Eye & Ear Infirmary Institute for Continuing Medical Education (ICME) 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). PHI should not be included in CME presentations unless specific authorization has been obtained from the patient in a manner consistent with 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 as 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).

Accreditation Statement
All continuing medical education activities directly sponsored by the New York Eye & Ear Infirmary must contain the following accreditation statement:

The New York Eye & Ear Infirmary is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Credit Designation
All continuing medical education activities directly or jointly-sponsored by the New York Eye & Ear Infirmary must contain the following credit designation statement:

The New York Eye & Ear Infirmary designates this educational activity for a maximum of [number of credits] AMA PRA Category 1Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Joint Sponsorship Policy
The ICME engages in joint sponsorship relationships with non-accredited institutions, companies and professional organizations with the understanding that the ICME takes full responsibility for monitoring content, funds and the joint sponsor’s adherence to ACCME Essential Elements and Policies.  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 New York Eye & Ear Infirmary, 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 and increase recognition of our teaching hospitals and clinical capabilities locally and worldwide.

It is the responsibility of the New York Eye & Ear Infirmary ICME 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 New York Eye & Ear Infirmary CME program. Materials submitted that demonstrate compliance may be from either New York Eye & Ear Infirmary’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 New York Eye & Ear Infirmary or a member of the Medical Staff of a teaching affiliate and must be actively involved in the planning and implementation of the educational activity to be sponsored from beginning to completion.

2.   Mission: The content, design and use of the educational activity must fit the ICME’s stated mission.

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 New York Eye & Ear Infirmary ICME.

4.   Accredited Sponsorship: The request for sponsorship of the activity must be submitted by the Activity Director or designated representative at least two 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 ICME 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 ICME and other costs as may be determined upon review of the course budget.

6.   Compliance with Activity Planning Process: It is preferable for the ICME 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 New York Eye & Ear Infirmary ICME.

7.   Representation at Live Events: If a live educational activity is involved, the New York Eye & Ear Infirmary ICME must ensure program quality, adherence to commercial support requirements and appropriate registration procedures. An ICME 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: The New York Eye & Ear Infirmary, 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 ICME prior to publication or listing.

9.   Management of Funds and Accountability: At the discretion of the New York Eye & Ear Infirmary ICME, the non-accredited provider may administer funds related to the management of the conference, but must document in detail and provide to the ICME an accounting of 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 following accreditation statement:

This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the New York Eye & Ear Infirmary and (name of non-accredited provider). The New York Eye & Ear Infirmary is accredited by the ACCME to provide continuing medical education for physicians.

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 New York Eye & Ear Infirmary ICME. The non-accredited sponsor and the third party educational provider (when applicable) must review the New York Eye & Ear Infirmary ICME joint sponsorship policy and sign the ICME Joint Sponsorship Agreement.

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 AMA PRA 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 New York Eye & Ear Infirmary Institute for Continuing Medical Education (ICME) is a co-sponsor of an activity with one or more accredited CME providers and is not the lead sponsor, the ICME 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 New York Eye & Ear Infirmary or any of its clinical departments.

Policy on Investigational Products or “Off-label” Uses
Presenters or discussants in CME activities sponsored by the New York Eye & Ear Infirmary ICME are obligated to disclose to the audience that a product is still investigational when an unlabeled use of a commercial product or an investigational use not yet approved for any purpose by the FDA is discussed or presented during an educational activity. Presenters/contributors are required to sign a statement on the Faculty Disclosure and Attestation Form acknowledging that obligation.

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 New York Eye and Ear Infirmary ICME requires faculty to demonstrate the scientific validity of recommendations involving the clinical care of patients.  The ACCME requires that “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.  The ACCME requires that “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.

Regularly Scheduled Conference Policy
Recurring live meetings, or “regularly scheduled conferences” (RSCs), are activities such as grand rounds, vitreous retina service conferences and tumor boards that are comprised of a number of “sessions” held weekly, bi-weekly or monthly during the course of a year. RSCs are sponsored by the New York Eye & Ear Infirmary ICME in order to provide diverse educational opportunities to staff physicians, support faculty/physician performance improvement, and enhance patient outcomes. Specific cases are presented and reviewed from initial diagnostic assessment to appropriate work-up, enabling the learner to recognize various ophthalmologic or otolaryngological symptoms and conditions and develop a therapeutic regimen.  The learner is afforded a better understanding of how to review, diagnose and treat specific ophthalmologic or otolaryngological conditions and/or diseases and will be able to apply this knowledge in his/her medical practice.

To ensure 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 ICME 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 ICME 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 New York Eye & Ear Infirmary.

3.   Planning Committee: The Activity is guided by a planning committee representing both the prospective audience as well as 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 New York Eye & Ear Infirmary ICME.

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 ICME as presented in the sponsorship agreement.

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 ICME not later than 60 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: Commercial support Letters of Agreement compliant with the Standards of Commercial Support are in place and filed with the ICME whenever funds are contributed in support of the activity or a session.

9.   Disclosure of Financial Relationship: Review of documentation of disclosure by the New York Eye & Ear Infirmary ICME will take place retrospectively on submission of all session documentation. 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 completes the Faculty Disclosure and Attestation form and that the presenter or moderator verbally offers disclosure prior to the start of his/her presentation. When verbal disclosure is given to attendees, it must be documented in writing that disclosure was indeed made and the type of relationships that were disclosed to the audience. This written documentation must be signed and dated by the Department Chair, Moderator or some other witness to the disclosure and submitted with other required RSC documentation to the ICME. In RSCs where annual disclosures are involved, repeated verbal disclosure is not necessary.

10. Evaluation Plan: The RSC planning committee will offer a systematic Evaluation Plan for the Activity. On a periodic basis the Activity leaders and participants will 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 ICME.

11. Monitoring: The RSC activity will be monitored by the ICME for compliance with this RSC Policy and the Activity Evaluation Plan. The ICME will support performance improvement initiatives to assure compliance. Monitoring will involve session attendance by a CME Advisory Committee member 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 ICME 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 ICME.

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. CME credit for individual participants cannot be earned while an Activity is under suspension. Subject to review by the CME Advisory Committee, sponsorship of an activity not in compliance at a level acceptable to the ICME will not be renewed.

14. Attendance Transcripts: The ICME will provide learners with current, accurate data on their participation in the Activity in the form of CME certificates. Attendance data will be maintained for six years. Individual transcripts may be obtained on demand by written request to the ICME Director.

15. Graphic Identity and Publicity: The New York Eye & Ear Infirmary must be properly identified on all promotional materials for continuing medical education activities. The format for all promotional materials must be reviewed and approved by the ICME prior to publication or listing.

Policy for Internet Activities
Compliance with the ACCME Essential Areas and Elements, the Standards for Commercial Support and the policies of the New York Eye & Ear Infirmary ICME for CME activities distributed over the Internet is the same as for live or other self-study activities. The NYEE Intranet is considered 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 New York Eye & Ear Infirmary or any New York Eye & Ear Infirmary-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 New York Eye & Ear Infirmary ICME apply to all CME activities including Internet CME. The Privacy Policy of the New York Eye & Ear Infirmary Website, www.nyee.edu, 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 New York Eye & Ear Infirmary website.

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 produced for distribution by other methods including, but not limited to, e-mail or compact digital disk.

Enduring Materials Policy
The New York Eye & Ear Infirmary ICME 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 hospital 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 New York Eye & Ear Infirmary ICME, 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 New York Eye & Ear Infirmary or, in the case of jointly sponsored educational activities, a recognized and accepted expert in the area being taught.

2.   Mission: The content, design and use of the educational activity fit the Mission of the ICME.

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 New York Eye & Ear Infirmary ICME.

4.   Sponsorship Fees: The provider of the enduring material agrees to pay a sponsorship fee as designated by the ICME 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 Advisory Committee. 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 Advisory Committee in a draft stage
• Approval: Approved by the CME Advisory Committee and CME Director 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 Advisory Committee in a draft stage
• Pre-release: Reviewed and evaluated by Activity Director, CME Director and at least one member of the CME Advisory Committee
• Approval: Approved by the ICME 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 expiration date.

8.   Compliance with Commercial Support Policy: To comply with the ACCME’s Standards for Commercial Support and the Commercial Support Policy of the New York Eye & Ear Infirmary ICME:

• 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: The New York Eye & Ear Infirmary 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 ICME prior to publication.

11. Evaluation by Learners: An evaluation methodology approved by the ICME must be used for all enduring materials.

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. The New York Eye & Ear Infirmary ICME chooses 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 Produced from Live Activities: The New York Eye & Ear Infirmary ICME considers the provider to have created two separate activities – one live activity and one enduring material activity. Both activities must comply with all New York Eye & Ear Infirmary ICME requirements, and the enduring material activity must comply additionally with all of the New York Eye & Ear Infirmary ICME policies that relate specifically to enduring materials.

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 New York Eye & Ear Infirmary and presented by faculty do not offer an honorarium. Where an honorarium is offered, an honorarium of $250.00 to $750.00 for local presenters inclusive of travel expense is suggested. Honorarium payments for guest faculty are negotiable, with $500.00 to $1,500.00 plus travel expenses being a typical arrangement. Arrangements for honoraria must be confirmed in writing. In accordance with New York Eye & Ear Infirmary policy and for tax reporting purposes, payment of honoraria to an individual must be made to that individual's home address.

Reimbursement of Travel-Related Expenses Policy
If an expense you need to incur is not included below, or if you have any question about any expenses which you wish to have reimbursed, call the ICME Director 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 $0.445/mile or the prevailing rate established by the New York Eye & Ear Infirmary, whichever is higher. Travel must be itemized and mileage recorded.
• Taxi/Airport Limo Service: Original receipts are necessary for reimbursement.
• 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, please indicate your portion of the expense only.

Policy Concerning Commercial Support of CME Activities
and Procedures for Internal Compliance
To ensure independence in development and implementation of CME activities from the control by commercial interests, the New York Eye & Ear Infirmary ICME complies with the Standards for Commercial Support of the Accreditation Council for Continuing Medical Education as approved and adopted September 28, 2004. The New York Eye & Ear Infirmary ICME 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. The New York Eye & Ear Infirmary acknowledges the valuable contributions by the pharmaceutical and medical device industry in support of this commitment.

Policy
All Activity Directors, planners involved in decisions about activity educational content, and activity faculty 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 New York Eye & Ear Infirmary ICME 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.
• The source and type of evidence must be provided to activity participants.
• 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 to activity participants:

• Everyone who is in a position to control or influence the content of an educational activity must disclose in writing all relevant financial relationships 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. A Faculty Disclosure and Attestation form is provided to activity planning committee members and teachers to facilitate this process.
• 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 relationship exists, 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 and the importance of disclosing financial relationships that may create a conflict of interest is made available by the ICME to all Activity Directors, content planners and faculty through its Faculty Disclosure and Attestation Policy and Form.
• Everyone 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. (Faculty Disclosure and Attestation Form)
• The New York Eye & Ear Infirmary ICME will assure the disclosure in writing to participants of each activity the financial relationships of all individuals involved in the development and presentation of content.
• The New York Eye & Ear Infirmary ICME will assess all activities for the potential for commercial bias and potential conflicts will be addressed with the Activity Director by the ICME Director and CME Advisory Committee.
• CME Activity Teachers/Contributors and Directors will be required by the ICME to attest in writing that his/her contribution to the educational content of the activity will be free of commercial bias and/or control by commercial interests.
• All activities sponsored by the New York Eye & Ear Infirmary ICME are subject to monitoring to ensure compliance with this policy, participant evaluation and peer-review to determine whether there is potential commercial bias.

Procedures
All activities sponsored or jointly sponsored by The New York Eye & Ear Infirmary ICME must meet the following expectations:

1) Education: The ICME must provide the Activity Director, planning committee and faculty with documentation of The New York Eye & Ear Infirmary Commercial Support Policy and any required additional information to aid in understanding the Policy and its implications.

2) Commercial Support: All commercial support, both monetary and in-kind, must be paid to the New York Eye & Ear Infirmary or, upon agreement, to the educational partner acting as a joint sponsor of an educational activity and be subject to direct financial oversight by either organization. Documentation must include:

• A Commercial Support Agreement signed by the New York Eye & Ear Infirmary ICME, the CME Activity Director, the joint sponsor (if applicable) and the commercial interest providing support.
• All financial contributions must be documented with a photocopy of the check.
• All in-kind contributions must be documented with a written description of the in-kind contribution, how its value was assessed or the manner in which it was paid.

3) Agreement and Disclosure: All individuals involved in the development and implementation of educational activities must agree in writing to the following principles through completion of the Faculty Disclosure and Attestation Form:

• 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.
• Adhere to current HIPAA regulations.
• Any individual may be disqualified from planning or implementing an activity if a conflict of interest that may contribute to commercial bias is determined to exist.
• Individuals who refuse to agree in writing to the points listed above will be removed from the educational activity.

4) Managing Conflict of Interest: Activity Directors and their Department Chairs (or Program Directors) are initially responsible for managing conflicts of interest identified during the disclosure process. The 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 managed in many ways, including:

• Assurance that the presenter will rely on best available and highest quality scientific evidence, particularly with respect to therapeutic recommendations.
• Limitations on what the presenter may discuss, for example addressing pathophysiology and patient evaluation, but not therapeutics.
• Disqualify the individual from presenting. Select a presenter without the same or equivalent conflict.

5) Evaluation and Monitoring: All activities must have participant evaluations submitted to the New York Eye & Ear Infirmary ICME that include the following questions enabling participants to actively participate in the monitoring process:

• Was commercial bias of content perceived? If ‘YES’, specifics.
• Was content presented in an objective and balanced way?
• Was the content based on evidence?

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

Management of Disclosure of Financial Relationships
and Conflicts of Interest for a CME Activity
Purpose: Outline the process of implementing the New York Eye & Ear Infirmary Commercial Support Policy, particularly the disclosure of financial relationship by anyone in a position to control the content of a CME activity and the identification and management of conflicts of interest that are disclosed. Make clear the responsibilities of the Activity Director, his/her Departmental Chair, the ICME Director and the CME Advisory Committee for managing identified conflicts of interest. The Activity Director and his/her Departmental Chair or Director will attest to completing this process at the time that they authorize the sponsorship agreement.

1) The Activity Process Begins: A CME activity is suggested based on educational needs and a prospective Activity Director (AD) is appointed with approval from the Dept. Chair or at the recommendation of an educational partner (joint sponsorship). The date of the activity should be at least 60 days or more away due to practical considerations involved in determining potential conflicts of interest, assessing educational viability and granting approval for AMA PRA Category I Credit by the CME Advisory Committee.

2) Faculty and Planning Committee Disclosures: The AD contacts the ICME at the commencement of the planning process. The ICME briefs the AD on CME fundamentals, reviews our Commercial Support Policy, provides the CME sponsorship/joint sponsorship agreement, CME Activity Accreditation Application, and   Faculty Disclosure and Attestation form which serve as educational resources on CME for the AD. The Activity Director is asked to provide his/her own disclosure of financial relationships and to secure disclosure from other potential activity teachers/contributors., Commercial Letter of Agreement form and activity evaluation template

3) Review of Disclosures by CME: On receipt of the disclosures, the ICME Director reviews the disclosure along with the material provided about the activity on the CME Activity Accreditation Application form. If the application material is complete it is forwarded to the CME Advisory Committee for review. The CME Advisory Committee reviews the disclosures for each activity. Their role is to determine if a conflict of interest is outside   the bounds of the ACCME Standards for Commercial Support. They jointly decide if any prospective planning committee member should not participate, that is, if any prospective member has disclosed a conflict that would indicate commercial bias. Any questions or concerns voiced by members of the CME Advisory Committee are transmitted to the AD, who must work with the CME Director and members of the CME Advisory Committee to resolve any potential conflicts or issues.

4) Faculty Disclosures Approved—Planning Process Continues: If it is determined that the AD and projected faculty disclosures demonstrate only manageable conflicts of interest or no conflict of interest was reported, the AD is directed to proceed with the planning process.  Faculty or planning committee members with manageable conflicts of interest are required to attest to the fact that these relationships/affiliations will not bias or otherwise influence their involvement in the educational activity, that practice recommendations given relevant to the companies with whom they have relationships/affiliations will be supported by the best available evidence or, absent evidence, will be consistent with generally accepted medical practice, and that all reasonable clinical alternatives will be discussed when making practice recommendations.  The AD is advised that if any new faculty or planning members, i.e. anyone who has any control over the content of the activity, are added to the activity the AD must request disclosure from them.

5) AD or Faculty Disclosure Not Approved: If any of the disclosures of conflicts of interest are determined to be unacceptable, the CME Director or a member of the CME Advisory Committee contacts the AD and the Department Chair to discuss alternatives to developing the activity, for example changing the content or the AD. When changes are made, the process resumes from the appropriate point above.

6) CME Advisory Committee Review: When all conflicts of interest have been addressed the CME Advisory Committee reviews the CME Activity Accreditation Application and renders a decision on whether or not AMA PRA Category I Credits will be granted to the Activity, and if so, how many credits will be assigned to the Activity.

7) Disclosure to Participants: In the context of the Activity, the AD and CME Director will assure that disclosure is made to participants in writing prior to commencement of the activity and verbally, as well, at the beginning of the Activity when the Activity is live or recorded.