POLICIES & PROCEDURES FOR JOINT SPONSORSHIP University of Mississippi Medical Center Continuing Health Professional Education This manual is designed to provide guidance for personnel of non-accredited organizations seeking AMA category 1 credit(s)TM for physicians through joint sponsorship with the University of Mississippi Medical Center, Continuing Health Professional Education. For additional information contact: Elizabeth Franklin, Director Continuing Health Professional Education University of Mississippi Medical Center 2500 North State Street Jackson, MS 39216-4505 Phone: 601-984-1300 Fax: 601-984-1309 Email: efranklin@umc.edu TABLE OF CONTENTS Section Page Number Purpose and Mission 2 What is a Joint Sponsorship? 3 ACCME Essential Areas and Policies 4 AMA PRA Category 1 Credit(s)TM 5 UMMC Joint Sponsorship Policies 6-10 UMMC Joint Sponsorship Procedures 11-13 Joint Sponsor Application Attachment 1 Planner Information Form Attachment 2 Activity Information Form with Sample Attachment 4/B Activity Faculty Information Form Attachment 5 Disclosure Form Attachment 7A Disclosure Monitor Critique Form Attachment 7B Sample Evaluation Form Attachment 8 Sample Registration Form Attachment 9 Sample Roster Attachment 10 Joint Sponsor Proposed Income and Expense Budget Attachment 11 Post Program Income and Expense Budget Attachment 12 UMMC Letter of Agreement Attachment 13 UMMC Commercial Commitment Form Attachment 14 Document List to Accompany Application Attachment 16 1 CME MISSION PURPOSE The mission of the University of Mississippi Medical Center Division of Continuing Health Professional Education is to provide life long learning experiences for practicing health care professionals in order to improve patient care in the State. Continuing Health Professional Education department supports the Medical Center’s efforts to enhance competence and performance in patient care, medical knowledge, practice-based learning and improvement, interpersonal and communication skills, professionalism, and systems-based practice. The overall goals of the Continuing Health Professional Education department continuing medical education program are to: Provide high quality, life long learning experiences for health care professions in a cost effective manner; present activities identified by needs by health care professions to maintain competence in their chosen area of health care practice; and present activities which will ultimately lead to improved patient care. TARGET AUDIENCE UMMC CME activities are provided for all healthcare disciplines including nurses, dentists, physicians and associated allied healthcare professionals at the local, state, regional and national level as applicable. Multidisciplinary activities are encouraged in order to provide well rounded educational experiences. TYPES OF ACTIVITIES UMMC offers conferences, workshops, lectures, discipline specific seminars, review courses, e-learning courses, departmental regularly scheduled series (i.e. grand rounds, tumor boards, and morbidity and mortality conferences) and other CME activities as indicated by assessment of need. UMMC jointly sponsors activities with non-profit health care non-accredited entities when proposed activities are consistent with the mission and goals of the CME program and meet the Essentials and Standards o the Accreditation Council for Continuing Medical Education (ACCME) and other accrediting bodies as appropriate. Educational design and methods for CME activities are selected based on identified needs, content and expected results of the activity. CONTENT Content is developed based on the identified needs of the physicians and changes in areas of skills, abilities, and performance. Surveys, collaboration with State specialty organizations (example: The Mississippi Pediatric Academy and the Mississippi Society of Nuclear Medicine), Mississippi State Department of Health and UMMC expert focus groups contribute towards identification of educational gaps. UMMC utilizes ACGME/ABMS core competencies as a basis for the content areas of our regularly scheduled series of activities. UMMC strives to respond to educational needs of the physicians which includes but is not limited to medical ethics, diagnosis, treatment and prevention of disease, patient safety, coding, HIPAA and other regulatory issues as they relate to the target audience. EXPECTED RESULTS UMMC is committed to a CME program that fulfills its mission of advancing physician competence and clinical performance by providing high quality, cost effective activities with expected results of changes in physician competence and performance. 2 WHAT IS A JOINT SPONSORSHIP? The mutual planning, implementation and evaluation of a CME activity between two entities – the accreditation provider (UMMC School of Medicine) and an unaccredited organization. An entity with a commercial interest cannot take the role of a nonaccredited partner. The accredited provider (UMMC) in a joint sponsorship relationship is responsible for ensuring that all requirements in the ACCME Essential Areas and Policies are met including the Standards for Commercial Support. The University Medical Center will jointly sponsor continuing education activities with non-accredited, non-profit entities when the proposed activities are consistent with the mission and goals of the University’s Continuing Education Program and meet the essentials and standards required by the accrediting body for which continuing education credit will be awarded. Continuing Health Professional Education (CHPE) at the University of Mississippi Medical Center (UMMC) is to participate in all areas related to planning and implementation of UMMC sponsored and jointly sponsored continuing education activities in order to effectively accomplish the institution’s continuing education mission. 3 ACCME ESSENTIAL AREAS AND POLICIES WHAT ARE THE ACCME ESSENTIAL AREAS AND POLICIES? The Accreditation Council for Continuing Medical Education (ACCME) is the official accrediting organization for Continuing Medical Education (CME). The Essential Areas and Policies are criteria that must be met in order to achieve accredited status for CME. Please see http://accme.org/ for details. The ACCME defines joint sponsorship as activity planning and presentation between an accredited provider and a non-accredited entity. The accredited provider shall accept responsibility that the ACCME accreditation policies and procedures are met when educational activities are planned and presented in joint sponsored activities. The accredited provider must be able to provide the ACCME with written documentation that demonstrates how each jointly sponsored CME activity was planned and implemented in compliance with the ACCME policies and procedures. All printed materials (brochures, certificates, meeting programs, etc.) for the activities jointly sponsored must include the following 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 University of Mississippi School of Medicine and (insert name of unaccredited provider). The University of Mississippi School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The UMMC CHPE will utilize specific written policies and operating procedures to effectively govern the planning and implementation of jointly sponsored activities. CHPE will also require that the unaccredited joint sponsor meet requirements that are mandated by the University of Mississippi Medical Center as well as requirements for other health professional agencies from which credit is requested, i.e. Mississippi Nurses Foundation for nursing credit. 4 AMA CATEGORY 1 CREDIT WHAT IS AMA PRA CATEGORY 1 CREDIT(S)TM? AMA PRA Category 1 Credit(s)TM is non academic credit that can be applied toward the American Medical Association Physician’s Recognition Award. This award indicates participation in CME and is a means of recognizing a physician’s professional commitment to his or her patients, the medical profession and to the public. An activity can be designated AMA PRA Category 1 Credit TM if it is sponsored or jointly sponsored by an institution or organization accredited to provide continuing medical education by the ACCME or by a state medical society, and if the activity meets or exceeds the following criteria: 1. It conforms to the AMA definition of continuing medical education as defined in the AMA Physician’s Recognition Award booklet: Continuing Medical Education consists of educational activities that serve to maintain, develop or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public or the profession. The content of CME is that body of knowledge and skills generally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine, and the provision of health care to the public. 2. It is based on perceived or demonstrated educational need. 3. It is designed to meet the continuing medical education needs of an individual physician or a specific group of physicians. 4. The educational objectives of the activity are stated. 5. The content is appropriate for the specified objectives. 6. The teaching/learning methodologies and techniques are suitable for the objectives and format of the activity. 7. Evaluation mechanisms are defined to assess the quality of the activity and its relevance to the stated needs and objectives. 8. There is documentation of physicians’ participation. 9. Commercial support of the activity conforms to the Standards for Commercial Support established by the ACCME. Visit http://accme.org/ for further information. 5 UMMC JOINT SPONSORSHIP POLICIES 1. ELIGIBILITY FOR JOINT SPONSORSHIP a. The UMMC CHPE will consider for joint sponsorship only those activities in which a physician faculty member of UMMC, with expertise in the subject(s) to be presented, has participated in the planning, and subsequent implementation and evaluation. Applying organization must submit a completed application and all required supplemental materials. See Attached Application b. Retroactive credit cannot be granted. All documentation for a CE activity must be completed, received and reviewed five months in advance of the activity date. Any deviation is at the discretion of the divisional director or associate director. c. UMMC CHPE will not consider for joint sponsorship activities developed with for-profit entities, with obvious self-promoting or entrepreneurial motives, or for activities presented outside the borders of the United States of America. 2. a. b. c. d. e. f. TOPICS NOT ACCEPTED FOR JOINT SPONSORSHIP Personal Financial Planning Teaching Free discussion periods Self study Marketing Character development. 3. INSTRUCTIONAL FORMATS NOT ACCEPTED BY UMMC FOR JOINT SPONSORSHIP a. Films b. Audio tapes c. Remote courses without a joint sponsor physician director in attendance d. Videocassettes e. Television programs f. Activities for AMA category 2 credit g. Home study courses Some of the above may be used as supplemental material to a presentation but may not be stand-alone. 6 4. EDUCATIONAL GAP OF KNOWLEDGE, NEEDS ASSESSMENT, PURPOSE AND OBJECTIVES a. Gap of Knowledge/Needs The UMMC CHPE requires that a CE activity be based on specific, identified educational void or gap of knowledge in order to be considered for joint sponsorship. These needs must be documented and submitted with the application for the activity. Needs should be linked to a specific desired result so that it is clear why the activity is being offered. This will assist in assessing the ultimate success of the activity. Many methods exist to identify and assess the educational needs of physicians. See Needs Assessment Data Resources b. Objectives and Purpose Statement (1) Once identified, the needs must be addressed by the content presented. A statement of purpose and content must be drafted. (2) Educational objectives should indicate what the attendees should know or be able to do after the presentation of each topic. The activity director is responsible for determining at least one educational objective per topic. Speaker(s) should be given objectives/purpose in order to prepare their presentation(s) accordingly. (3) When preparing objectives, the following should be considered: (a) Why is the program being given? (b) What will it accomplish and what do we want the audience to learn? (c) How will the subject be presented and will the method of instruction help the physician learn and integrate the information into better patient care? (4) Patient Care. All activities should be linked to improving patient care or improving medical knowledge that will result in the physician providing improved patient care. 5. UMMC FACULTY DIRECTOR All activities must have a UMMC faculty appointed physician in the area of expertise of the proposed content of the activity. The faculty director shall be responsible for supervising the development, implementation, and evaluation and content validation of the activity. 6. JOINT SPONSOR DIRECTOR All organizations seeking joint sponsorship must identify a physician director in the area of expertise of the proposed content. A staff person should also be appointed to assume the following duties: a. Complete all paperwork associated with joint sponsorship application and activity records within the required CHPE time frame. b. Obtain all documentation and necessary signatures. c. Provide sufficient copies of the materials to CHPE as determined by CHPE. d. Maintain an attendance roster in accordance with CHPE guidelines. e. Distribute evaluation instructions and link to attendees at the activity. Evaluations done on-line via Survey Monkey. 7 7. CHPE PROGRAM ADMINISTRATOR All activities will have an assigned CHPE program administrator who will be available to assist in the planning, implementation and evaluation of the activity. 8. PLANNING The CHPE program administrator will consult with the UMMC faculty director and the joint sponsorship director. Discussion of quality CME and compliance with ACCME Essential Areas and Policies and Standards for Commercial Support, will include: a. Identification of specific target audience. b. Documentation of specific educational gap of knowledge, needs assessment, desirable attributes and potential barriers to learning or implementation. c. Preparation of statement of purpose and the educational objectives based on needs. d. Discussion of specific topic(s) and speaker(s). e. Speaker qualifications. f. Method(s) of presentation. g. Evaluation method(s) of the activity. h. Validity of category 1 credit through joint sponsorship. i. Relationship between the source of financial support and all persons in control of the activity. j. Joint sponsorship application fees and other fees deemed applicable that are assessed by UMMC CHPE. k. Activity budget requirements. 9. DISCLAIMER Agreeing to jointly sponsor an activity does not indicate University of Mississippi School of Medicine endorsement or promotion of the activity. Approval indicates only that UMMC has agreed to jointly sponsor the educational aspects of the activity and to designate AMA Category 1 PRA credit(s) TM. 10. JOINT SPONSOR RECORDS In accordance with ACCME policy copies of all items used in planning, implementing and evaluating the activity should be retained by both the accredited and the unaccredited joint sponsor for seven years. 11. EXHIBITS When commercial exhibits are part of the overall activity, exhibits and commercial promotional materials shall not be displayed or distributed in the same room immediately before, during, or after the educational activity. UMMC does not endorse any commercial product. 12. PROMOTIONAL MATERIALS a. The activity may not be advertised for credit prior to receiving formal authorization from the UMMC CHPE office. Wording such as “credit pending” or “Category 1 credit applied for” cannot be used on promotional materials, brochures, etc. 8 The learning format listed in the Credit Designation Statement must be one of the following AMA approved learning formats: 1. Live activity. 2. Enduring material. 3. Journal-based CME activity. 4. Test-item writing activity. 5. Manuscript review activity. 6. PI CME activity. 7. Internet point-of-care activity. b. Once official approval is received, all promotional materials must include the following statement, exactly as shown below, with the name of the unaccredited joint sponsor, the number of credits (hours) granted, and designated learning format inserted as indicated: 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 University of Mississippi School of Medicine and (name of joint sponsor). The University of Mississippi School of Medicine is accredited by the ACCME to provide continuing medical education for physicians. The University of Mississippi School of Medicine designates this (insert learning format) or a maximum of (insert number of credits) AMA PRA Category 1 Credit(s) TM. . Physicians should only claim credit commensurate with the extent of their participation in the activity. The University of Mississippi School of Medicine strives to ensure that its jointly sponsored activities are independent, free of commercial bias and beyond the control of persons or organizations with an economic interest in influencing the content of the activity. All persons who are in a position to control the content of this activity are required to disclose all financial relationships, and the nature of those relationships, occurring within the past 12 months. Speakers are also required to verbally disclose to the audience, during their presentation, when they have an intent to discuss an unlabeled use of a product and/or a product that does not have the FDA’s approval for use in discussion. c. The University of Mississippi School of Medicine must be listed on the front of all promotional material in the same type and font as the name of the joint sponsor as follows: This education activity is jointly sponsored by the University of Mississippi School of Medicine and (insert joint sponsor name) . 9 The learning format listed in the Credit Designation Statement must be one of the following AMA approved learning formats: 1. 2. 3. 4. 5. 6. 7. Live activity Enduring material Journal-based CME activity Test-item writing activity Manuscript review activity PI CME activity Internet point-of-care activity d. In addition to the above promotional materials, including the brochure and any handout(s) must list: (1) Organizations providing commercial support. (2) Commercial relationships disclosures. (3) Statement of purpose and educational objectives. (4) Target audience. e. Supporting commercial organizations may be described as: “supporting organizations”; “grant supported by….”; “speakers name, supported by an education grant from….”; or “we wish to thank the following for their support….” (1) Supporting organizations are not “sponsors” and should not be listed as such. (2) If commercial support is provided at a late date, the supporting entity may be listed in a handout, an insert in the brochure or on the program distributed at the meeting. Verbal recognition of all supporters should be given at the activity. 8. CREDIT CERTIFICATE UMMC CHPE will distribute a standard certificate that is used for all AMA PRA Category 1 credits TM. The joint sponsor may not distribute their own certificate indicating AMA accreditation. The certificate will be provided to all attendees that have attended and evaluated the activity. Only those topics evaluated by the attendee will receive credit. 10 UMMC JOINT SPONSORSHIP PROCEDURES 1. APPLICATION A completed application should be submitted to UMMC CHPE: a. The application and all supporting materials must be received by the division at least 6 months prior to the planned brochure or promotional distribution date, or the activity date if there is no promotion of the activity. b. The application should be forwarded to UMMC CHPE office and must be complete. Some details may be submitted in the draft stage. The application will not be considered complete until application fee and all required supporting materials are received. See Attached Application 2. SUPPORTING DOCUMENTS a. Planner Information Form To be submitted with application. See Attachment 2 b. Activity Information Form To be submitted with application. See Attachment 4/B c. Activity Faculty Information Form To be submitted with application. See Attachment 5 d. Disclosure Forms – To be submitted with application if possible. All speakers, course directors, planners, moderators, content validation reviewers and others who are in a position to influence activity content must sign this form and disclose any affiliations they may have with supporting commercial organizations or commercial organizations whose products, research, or services may be addressed in their presentation(s) within the last 12 months. See Attachment 7A e. Documentation of Disclosure – Disclosure Monitor Critique Form - To be submitted following the activity. The commercial relationships revealed on the Disclosure Form must be communicated to the audience prior to the presentation and must be documented. Verbal disclosure is also required prior to the lecture at the activity. The relationships may be communicated on the brochure, posted at the sign-in desk, printed on the meeting program or used as an individual handout for registrants. Documentation that this occurred must be via a completed and signed UMMC monitor critique form for each person. This form may be completed and signed by the faculty course director, a member of the joint sponsor planning committee, a member of the audience or a staff member of the joint sponsor organization that is in the activity room at the time of disclosure. See Attachment 7B 11 f. Curriculum Vitae – To be submitted with the application. A current curriculum vitae must be submitted for each speaker, activity planner, moderator and other persons who have control of content of the activity. g. Needs Assessment Documentation – To be submitted with the application. Copies of needs assessment i.e. meeting minutes, survey results, statistical report, etc. See Needs Assessment Data Resources h. Commercial Support If the program is receiving support from a commercial entity, a Letter of Agreement for Commercial Support (LOA) must be completed, signed by the company representative, joint sponsor director, and subsequently by UMMC CHPE. If the commercial entity has no official LOA the attached UMMC form is to be used. See Attached Letter of Agreement i. Promotional Brochure and Materials All promotional materials must conform to the guidelines under Promotional Materials, Pages 5-6 of this document. j. Evaluation – See application Section 5. For evaluation of learner competence UMMC’s CHPE form may be used. If not being used, submit a copy of the evaluation to be used i.e. pre/post tests. If UMMC’s evaluation form is used, attendees will only receive credit for those topics that he/she attends and evaluates. All other forms of evaluation should include an explanation of the criteria for completion. See Attached Evaluation Sample k. Joint Sponsorship Fees – Initial fee to be submitted with application. The joint sponsorship fee of $600 should accompany the application. This fee is non-refundable. No application will be considered for approval until the fee and all applicable attachments are received by the UMMC CHPE office. Per person credit fee will be assessed following the conclusion of the activity: Fee for Each Additional Repeat Presentation of the Same Activity: $100 1-4 approved credit hours = $35 per attendee 4.25 -8 approved credit hours = $45 per attendee 8.25-16 approved credit hours = $55 per attendee 16.25 and above approved credit hours = $65 per attendee This fee should accompany the required attendance roster or completed registration forms. No certificate will be issued without this payment being received. The joint sponsor shall also be invoiced for any additional expenses incurred by UMMC CHPE. 3. APPLICATION REVIEW The UMMC CHPE office will review the application and materials to ensure that the activity adheres to the structure discussed with the joint sponsor and UMMC faculty course director and that all supporting documents are provided. Any questions or potential conflicts will be discussed with the UMMC Faculty Course Director and the joint sponsor director. 12 Joint sponsor may conduct the same activity in its entirety as many times as needed during this period. If the activity changes in content a new application must be submitted along with the application fee. If the activity speaker(s) change a new agenda, speaker curriculum vitae and speaker disclosure form must be submitted prior to the activity. Upon receipt of all materials and final review by UMMC CHPE an official letter will be sent to the organization indicating approval or denial of the activity for credit. 4. REQUIRED DOCUMENTED PROCEDURES AT THE ACTIVITY a. An attendance roster must be maintained. b. Faculty disclosure of commercial relationships must be documented. c. Evaluation forms must be distributed and completed by all attendees requiring a certificate of attendance or UMMC’s on-line evaluation. 5. REQUIRED DOCUMENTATION FOLLOWING THE ACTIVITY The joint sponsor must send the following items to UMMC CHPE no later than two weeks after the activity: a. A synopsis of the evaluation tool if UMMC Survey Monkey not used. b. Typed attendance roster or completed registration forms for all attendees requiring credit. Additionally provide the following: Total number of attendees Number of attendees not requiring credit through UMMC. Example: 12 nurses, 16 PTs, 8 PAs See Attached Roster and Registration Form Samples c. A copy of any and all handout materials distributed. d. A copy of the final meeting program. e. Copies of Disclosure Forms and Monitor Critique Forms. f. All final copies of LOA’s from commercial supporters. g. Copy of final income and expenses for the activity. h. All associated fees. 6. CHANGES If the activity must be changed, cancelled or postponed following submission of the official application, detailed changes and reasons should be outlined in a memorandum to the UMMC CHPE office. Changes will be reviewed and determination made of the continued eligibility of the activity for CME credit. If the change involved the addition of commercial support, completion of the Letter of Agreement from Commercial Support should be included with the request change. Note: Companies may provide their own LOA’s instead of UMMC’s. If changes involve the agenda and topics a new application may be required. 7. REFUNDS The application fee and individual participant fees are non-refundable. Policies & Procedures 4/13; 8/13 13