CME Activity Guidelines

Activity: An educational event for physicians, which is based upon identified needs, has a purpose or objectives and is evaluated to ensure the needs were met.

Sponsor/Provider: The institution or organization that is accredited to present CME activities.

Conflict of Interest: When an individual has an opportunity to affect CME content about products or services of a commercial interest with which he/she has a financial relationship. The role and/or financial relationships of spouse/partner must also be considered.

Continuing Medical Education (CME): Continuing medical education consists of educational activities which serve to maintain, develop, or increase the knowledge, competence, 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.

Commercial Interest: Any entity producing, marketing, re-selling, or distributing health care goods or services, consumed by, or used on, patients.

Commercial Supporter: Institutions or organizations that provide financial or in-kind assistance to a CME program or for a CME activity.

Financial relationships: are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as employment, management position, independent contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels, board membership, and other activities from which remuneration is received, or expected. ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner.

Professional Practice Gap: The difference between actual and ideal performance and/or patient outcomes.

“In patient care, the quality gap is “the difference between present treatment success rates and those thought to be achievable using best practice guidelines.”¹

As CME content goes beyond issues of direct patient care, the ACCME is using professional practice gap to refer to a quality gap in areas that include but also can go beyond patient care (e.g., systems’ base practice, informatics, leadership and administration).

Relevant financial relationships: Any amount occurring within the past 12 months that create a conflict of interest.²

1. Closing the Quality Gap: A Critical Analysis of Quality Improvement Strategies. Fact Sheet. AHRQPublication No. 04-P014,March 2004. Agency for Healthcare Research and Quality, Rockville, MD.
2. The Accreditation Council for Continuing Medical Education. (January 2007). Education Tools and Resources. Tools to Support Implementation of the ACCME’s Updated Accreditation Criteria. Retrieved January 24, 2007 from

The purpose of Continuing Medical Education (CME) is to facilitate life-long learning among physicians so that their practices may reflect the best medical care for their patients. The goal of CME is to help physicians enhance their performance in practice. All involved in the CME enterprise – educators, meeting planners, faculty, authors, speakers, accredited providers, supporters, and the physician learners themselves – are responsible for fulfilling this goal.

The Jacobs School of Medicine and Biomedical Sciences CME Office ensures that any activity receiving AMA PRA Category 1 credit™ through the University meets standards established by the Accreditation Council for Continuing Medical Education (ACCME). “Essential areas” have been established by the ACCME to assure physicians and the public that Category 1 approved CME activities meet accepted standards of education. These guidelines outline accepted standards for continuing medical education activities and serve as a companion to the CME Proposed Activity Application Packet for activities seeking CME Certification.

As an accredited CME provider, the Jacobs School of Medicine and Biomedical Sciences CME Office must be involved in the initial planning stages of any activity for which Category 1 credit, through the Jacobs School of Medicine and Biomedical Sciences, is sought. This occurs before dates, speakers, and activity content have been confirmed. It must occur prior to the preparation and dissemination of any activity announcements.

1. A Jacobs School of Medicine and Biomedical Sciences faculty member, either full time or clinical, must be the Activity Director or significantly involved in the activity planning.
2. The appropriate Department Chair(s) of the Jacobs School of Medicine and Biomedical Sciences (or an affiliated teaching hospital) must be notified and willing to endorse the activity.

1. Return the completed application packet to the UB CME Office
2. All applications must be submitted at least six months in advance of the proposed activity date.
3. If applying for Certification Only, the application must be submitted with non-refundable Application Fee of $250. (If approved, this amount will be applied to the fixed certification fee.)
4. All forms MUST be completed in their entirety and all appropriate documentation attached for application to be reviewed. Incomplete or handwritten applications will be returned.
5. A minimum of 2 - 3 weeks will be needed to review this request.
6. CME Approval is required prior to confirming speakers.
7. Formal written approval by the CME Director is required prior to advertising event.

Approval is based upon your adherence to the CME Guidelines and Standards provided by this office.

Failure to follow these guidelines can result in this activity being denied Category 1 credit.

The CME Proposed Activity Application Packet has been designed to facilitate the development of an educational activity. When Category 1 credit is awarded by the Jacobs School of Medicine and Biomedical Sciences, the CME Office is required to document program development and implementation, and to ensure that the activity meets all nationally established accreditation standards.

The application packet contains the following:

1. Preliminary Data for proposed CME Activity provides initial information about the activity including location and contact information.
2. Needs Assessment determines and documents the need for a continuing medical education activity. Identifying the educational needs of your target audience will lead directly to the formulation of activity learning objectives, content, and instructional design.
3. Learning Objectives for Content Validation should clearly link needs to instructional content and desired learning outcomes. Outlining potential topics and speakers will assist in identifying outcomes for which this activity has been planned. The final version of these objectives/outcomes will be listed on the activity brochure.
4. Outcomes Measurement In order to determine the effectiveness of the activity, changes in learners’ competence, performance, and / or patient outcomes must be analyzed.
5. Budget/Financial Support Appropriate planning requires an understanding of funding and its sources.
6. Activity Director/Planning Committee Declaration must be completed for each person who is in a position to influence the content of the activity. This includes the Activity Director(s), Planning Committee Member(s), and CME Planner(s). The Activity Director’s Department Chair/Unit Chief must review, manage and resolve conflict of interest (if applicable) and approve prior to formal CME approval.

The Jacobs School of Medicine and Biomedical Sciences CME Office certifies various types of CME activities upon submission of an application packet for determination of AMA PRA Category 1 credit™.

1. Live Conference Activity – Live conferences (workshops, symposia, courses, etc) that are not offered on a regularly scheduled (weekly, bi-weekly, or monthly) basis.
       a. Certification Only – Application is made to CME Office for determination of AMA PRA Category 1 credit™ while the host department handles all coordination and logistics of the activity.
2. Additional guidelines and materials are required in the preparation of the following activities.
3. Enduring Material – Printed, recorded or computer-assisted instructional materials. This may include journals, CD-ROMS, and Internet based activities.
4. Regularly Scheduled Series (née RSC/Grand Rounds) – Department-based educational activities which occur on a weekly, bi-weekly or monthly basis.
5. Regional Activity Series – Educational activities that take place at regional hospitals. The CME Office provides limited assistance and identification of speakers based on need and interest.

The Jacobs School of Medicine and Biomedical Sciences is NOT an accredited provider for any other continuing education credit. However, completion of Family Medicine credit (AAFP) application is available upon request.

When beginning the process of designing professional development activities, the goals and overall purpose of the activity should be established prior to any other work. A GOAL is a statement of the intended general outcome of an instructional unit or program. A goal statement describes a more global learning outcome. This is different than a learning objective, which is a statement of one of several specific performances, the achievement of which contributes to the attainment of the goal. A single GOAL may have many specific subordinate learning objectives.

All continuing medical education certified for AMA PRA Category 1 credit is designed to change physician competence, performance in clinical practice, and / or improve patient health status. One or more of these goals must be identified in the general needs assessment section of the application. All planning and design of the CME activity will grow from the goal and purpose, including the methods of needs assessment, development of learning objectives, selection of content and instructional design, and methods of outcomes measurement.

The educational need for each activity must be substantiated. Identification and assessment of physician continuing education needs provide the basis for formulating learning objectives and planning the activity. The needs assessment data could result from a survey of potential learners, identified new skills, and/or QA/QI reports of clinical practice. The need must identify and address clinical or organizational professional practice gaps.

A written paragraph from the physician perspective in which you describe the need and method used to determine need for this activity is required. Your paragraph should be 4 – 5 sentences in which you very specifically answer the following questions:

• Who is the target audience for this activity? (e.g., Primary Care Providers, MD, DO, NP, PA, RN, etc.)
• Why is this activity being planned for this audience?
• What are the gaps in clinical or organizational practice you wish to address?

Indicate the methods used to determine educational need. Literature reviews, professional community needs and Evidence-Based Medicine Resources are just a few of the methods that may be used to support the educational need of an activity. Supporting documentation for the methods used must accompany the CME Application.

The method of delivering content to help learners and teachers transfer knowledge most effectively is essential to the success of your CME activity. Matching target audience needs and learning objectives to educational content can be achieved through selection of the most appropriate learning format: large group didactic lectures, workshops/small group discussions, hands-on training, case based scenarios, and panel discussions are just a sample of the formats that can be used for Live CME activities.

The Jacobs School of Medicine and Biomedical Sciences has adopted the Accreditation Council for Graduate Medical Education’s (ACGME) Core Competency model for physician competence. All activities certified for Category 1 credit must identify and integrate one or more of the six ACGME Core Competencies into the curriculum of the activity.

Objectives outline what participants should know or be able to do at the end of an educational activity. Stating objectives is essential to planning, implementing and evaluating desired outcomes of continuing medical education activities. Asking the question, “What is the intended result of the instruction in terms of the learner?” facilitates writing educational objectives. Objectives need to clearly link to the educational need, and should be attainable and measurable.

Objectives should be written AFTER educational need is assessed and the target audience is determined, but BEFORE teaching and evaluation methods are selected. There are three characteristics essential to ensuring clear statements of objectives.

First, an objective must describe the competency to be learned in performance terms. The choice of a verb is all-important here. Such frequently used terms as ‘know’, ‘understand’, ‘grasp’, and ‘appreciate’ do not meet this requirement. If the verb used in stating an objective identifies an observable student behavior, then the basis for a clear statement is established. The List of Verbs for Formulating Educational Objectives is provided for assistance.

Second, an objective should make clear how well a learner must perform to be judged adequate. This can be done with a statement indicating a degree of accuracy, a quantity or proportion of correct responses or the like.

Third, an objective should describe the conditions under which the learner will be expected to perform in the evaluation situation. What tools, references, or other aids will be provided or denied should be made clear.

Sometimes, one or even two of these elements will be easily implied by a simple statement. Other times, however, it may be necessary to clearly specify in detail each element of the objective. The following is an example of a completed learning objective:

The ACCME requires that activities / educational interventions be developed in the context of desirable physician attributes, such as the six ACGME Core Competencies:

Patient Care requires physicians to demonstrate their abilities in providing patient care that is compassionate, appropriate and effective for the treatment of health problems and the program of health.

Medical Knowledge requires physicians to demonstrate knowledge of established and evolving biomedical, clinical, epidemiological, and social-behavioral sciences, as well as the application of this knowledge to patient care.

Practice based learning and improvement requires the physician investigate and evaluate their care of patients, appraise and assimilate scientific evidence, and to continuously improve patient care based on constant self evaluation and life-long learning. Physicians are expected to develop skills and habits to be able to:

• Identify strengths, deficiencies, and limits in one's knowledge and expertise;
• Set learning and improvement goals;
• Identify and perform appropriate learning activities;
• Systematically analyze practice, using quality improvement methods, and implement changes with the goal of practice improvement;
• Incorporate formative evaluation feedback into daily practice;
• Locate, appraise, and assimilate evidence from scientific studies related to their patients' health problems;
• Use information technology to optimize learning; and
• Participate in the education of patients, families, students, residents and other health professionals, as documented by evaluations of a resident's teaching abilities by faculty and/or learners.

Systems-Based Practice requires physicians to demonstrate an awareness of and responsiveness to the larger context and system of health care, as well as the ability to call effectively on other resources in the system to provide optimal health care. Physicians are expected to:

• Work effectively in various health care delivery settings and systems relevant to their clinical specialty
• Coordinate patient care within the health care system relevant to their clinical specialty;
• Incorporate considerations of cost awareness and risk benefit analysis in patient care;
• Advocate for quality patient care and optimal patient care systems;
• Work in inter-professional teams to enhance patient safety and improve patient care  quality;
• Participate in identifying system errors and in implementing potential systems solutions.

Professionalism requires physicians to demonstrate a commitment to carrying out professional responsibilities and an adherence to ethical principles. Physicians are expected to demonstrate:

• Compassion, integrity, and respect for others;
• Responsiveness to patient needs that supersedes self-interest;
• Respect for patient privacy and autonomy;
• Accountability to patients, society and the profession;
• Sensitivity and responsiveness to a diverse patient population, including but not limited to diversity in gender, age, culture, race, religion, disabilities, and sexual orientation
• Larger context and system of health care, as well as the ability to call effectively on other resources in the system to provide optimal health care.

Interpersonal Skills and Communication requires the physician to develop skills that are effective in the exchange of information and collaboration with patients, their families, and health professionals. Physicians are expected to develop skills and habits to be able to:

• Communicate effectively with patients, families, and the public, as appropriate, across a broad range of socioeconomic and cultural backgrounds;
• Communicate effectively with physicians, other health professionals, and health-related agencies;
• Work effectively as a member or leader of a health care team or other professional group;
• Act in a consultative role to other physicians and health professionals, and health-related agencies;
• Work effectively as a member or leader of a health care team or other professional group;
• Act in a consultative role to other physicians and health professionals; and
• Maintain comprehensive, timely and legible medical records, if applicable.

Outcomes measurement is essential to the educational process. How will you know if your activity makes a difference or help change clinician behavior or patient health outcomes? Every activity receiving Category 1 credit must be evaluated. Outcomes-based evaluation or measurement looks at impacts/benefits/changes to your attendees (as as result of your educational activity) during and/or after their participation in your activity.

The following items must be components of any evaluation process.

1. Participants must be requested to evaluate activity presentations and content in terms of stated practice gaps (need) and learning objectives. All feedback, written and verbal, should be assessed to determine if objectives were met.
2. Participants must be requested to evaluate commercial bias in the delivery of educational content. Sample questions are available upon request.
3. If the activity seeks to change physician competence: participants must be requested to describe their learning process and their intent to change their behavior or practice in terms of knowledge, skills, and/or attitude; or change in knowledge must be objectively measured.

If the activity seeks to change physician performance: participants must be requested to describe or objectively measure the changes they have made to their practice or list reasons (barriers) to implementing change.

If the activity seeks to change patient health outcomes: patient health data must be measured objectively before and after the educational intervention.

In order to measure change, status must be measured or described both before and after the educational intervention has been issued. This can be accomplished through the use of various tools and formats. Samples of outcomes-based evaluation tools and formats are available from the CME upon request.

A typed, substantive summary of the evaluation responses and outcomes measures must be provided to the CME office. The summary, in combination with the organizing committee and activity director(s) own feedback, should be used to make recommendations for future programming.

The Jacobs School of Medicine and Biomedical Sciences is ultimately responsible for ensuring that all financial decisions affecting any activity it approves for Category 1 credit meet ACCME and AMA standards and requirements. The ACCME Standards for Commercial Support of Continuing Medical Education (SCS) and The AMA Ruling on Gifts to Physicians are available upon request from the CME or can be accessed at the ACCME site.

Accredited providers and physicians must both know and comply with the two AMA Council on Ethical and Judicial Affairs (CEJA) opinions that address the ethical obligations that underpin physician participation in CME, 8.061, “Gifts to physicians from industry” and 9.011, “Ethical issues in CME” (for the full text, go to the AMA site. Certain CME idioms have shifted since the CEJA opinions were approved in 1990 and 1993. So in the full text of the opinions, “sponsors” describes providers and “programs” refers to activities.

Prior to formal approval, the following items need to be prepared and forwarded to CME for review:

1. A draft operating budget to include: advertising costs; speaker honorarium and expenses; food and beverage and all other anticipated course expenses.
2. Proposed registration fee schedule: indicate charge for physicians and for non-physicians if there is a separate charge.
3. List other anticipated income: commercial support from pharmaceutical companies, grant support, institutional support, etc.

Send a revised, final copy of the Budget including an itemized breakdown of all income and expenses to the CME Office. A Final Budget Form will be provided with the credit claim form, disclosure summary, and evaluation prior to the conference.

The ACCME 2004 Standards for Commercial Support describe practices (independence, resolution of personal conflicts of interest, appropriate use of commercial support, appropriate management of associated commercial promotion, content and format without commercial bias, and disclosures relevant to potential commercial bias) appropriate for accredited providers to ensure that their CME activities are independent, free of commercial bias and beyond the control of persons or organizations with an economic interest in influencing the content of CME.

When commercial interests contribute funds and services for the development of CME activities, it is considered commercial support. Commercial support has the potential to introduce bias that threatens the integrity of the CME enterprise.

Any time a commercial interest provides support for an approved CME ACTIVITY it is necessary that a LETTER OF AGREEMENT be filled out. Forms may be obtained through the CME Office. Signatures are required from the Activity Director, a representative of the commercial interest and the CME Office.

1. All companies supporting an activity must be made known to those attending the activity.
2. Signed copies of all the Letters of Agreement need to be forwarded to the CME Office.
3. All commercial funds must be paid to the institution or organization (Jacobs School of Medicine and Biomedical Sciences or affiliated teaching hospitals) certifying the activity. Outside organizations may request the management of activity finances contingent upon CME approval.
4. Supporting companies may NOT pay speakers, other individuals or organizations directly for any course related expenses. This includes honorarium, travel, food or beverage, etc. All disbursements will be made in accordance with the University (or affiliated hospital) procedures.

The ACCME’s 2004 Updated Standards for Commercial Support requires the Activity Director and Planning Committee to declare ANY financial relationship or interest in relation to their involvement with the educational content of any proposed activity PRIOR to CME approval.

The Standards for Commercial Support also require that all speakers, authors (i.e., posters, abstracts) and everyone in a position to influence the content of the activity declare ANY financial interest or relationship in relation to their involvement with the educational content of any proposed activity PRIOR to confirmation of the final program.

The following guidelines have been established to ensure compliance with these national standards.

1. All Activity Directors and Planning Committee members must complete the Planner / Speaker Declaration Form and submit this form with the original application for CME credit. This form must be completed for each person who is in a position to influence the content of the activity Application. The role and/or financial relationships of spouse/partner must be considered and listed accordingly.
2. Any disclosure of financial relationships must be reviewed and resolved according to the CME Identification and Resolution of Conflict of Interest Policy. The Faculty Disclosure Review Survey must be completed for every individual that discloses any financial relationship(s) on the Planner/Speaker Declaration Survey.
3. Declarations from all Activity Directors, Planning Committee Members, Speakers, Authors, and any other persons in a position to influence the content of the activity MUST be disclosed to the learners PRIOR to the start of the activity. Disclosure information must be included in printed materials distributed at the CME activity. Samples are available for appropriate wording.
4. In very limited circumstances, verbal disclosure may be made through a moderator during the activity (e.g., a speaker substitution on the day of activity). Verbal disclosure must be documented and signed by the Activity Director. This documentation must be provided to the CME Office.
5. Copies of all Planner / Speaker Declaration Forms must be provided to the CME Office no later than four weeks prior to the activity date.

Activity announcements include all materials (such as brochures), in both print and electronic formats, that are designed to build awareness of the activity among the target physician audience. These should feature an activity’s educational content, with advertising for unrelated amenities playing a secondary role. Any announcement, if it references the maximum number of credits for which the provider has designated the activity, must clearly include the complete Accreditation and Certification statements (see below).

Publicity may not be printed or distributed until verbal or written confirmation is received from the Director of Continuing Medical Education, that the activity has been approved for credit. A Save the Date or preliminary announcement with no reference to CME may be released prior to formal activity approval. It is not permissible to state on any activity announcements that application has been made for Category 1 credit or that CME credit has been applied for or CME credit is pending. The final draft of all activity announcements must be reviewed and approved by the CME Office before printing.

A “save the date” announcement (such as a card mailer with limited space) may indicate that AMA PRA Category 1 credit will be provided without stating the exact amount, but only if the provider has already certified the activity. This announcement may read, “This activity has been approved for AMA PRA Category 1 Credit™.”

The following items are required as a part of all formal activity brochures or announcements in order to comply with accreditation standards.

1. Activity or Course description is a brief statement of what is to be taught, reflecting what the faculty intends to accomplish. Educational need(s) upon which the activity is based can be stated in the course description as well as the target audience for whom the activity is designed. This is most frequently done by listing physician practice specialty.
2. Educational Need for the CME activity. This can be included in the activity or course description.
3. Learning objectives must be clearly and prominently visible.
4. The following accreditation and certification statements must be used in all printed announcements. No substitutions are allowed. The number of credits must be incorporated into the certification statement provided below. Credit is calculated based on activity content and is equal to the amount of time participants spend receiving formal instruction. Breaks and meal times are not counted as part of the credit.

The Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo is accredited by the ACCME to provide continuing medical education for physicians.

The Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo designates this live activity for a maximum of 0.0 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo , as the accredited provider, must be prominently displayed as a SPONSOR on the front of the brochure or announcement, using the following logo format. Electronic versions in various formats are available.

An activity is jointly provided by two institutions or organizations when only one of the institutions is accredited. A commercial interest cannot take the role of the non-accredited partner in a joint sponsor relationship. The accreditation and certification statement and logo must be listed in all printed announcements. No substitutions are allowed.

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo 

The  Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo is accredited by the ACCME to provide continuing medical education for physicians.

The  Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo designates this live activity for a maximum of 0.0 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Handout materials for all certified Category 1 activities must include the following information.

1. Coordinating Department/Unit
2. Topic, Title, Date of Presentation
3. All speakers and activity director/planning committee: titles, affiliations AND declaration information
4. All commercial supporters and entities including educational grantors, exhibitors and in-kind support
5. Sponsorship logo, SCS, accreditation, and certification statements

Additional elements are required for Enduring Materials and RSS Conferences

There is an overwhelming response from CME attendees at activities covering a wide range of clinical topics requesting handouts from presenters. These materials could be copies of the speakers’ presentations and / or materials to supplement the presentation. Some examples include: a bibliography, abstract, journal article, evidence-based guidelines, etc. Activity Directors are encouraged to request handouts from speakers for inclusion in the Program Syllabus.

The University of Buffalo acknowledges and encourages the appropriate use (i.e., reproduction, distribution, performance and display) of copyrighted works and materials for teaching, scholarship and research purposes consistent with federal copyright law and the standards for fair use. For a thorough discussion of Copyright Clearance and Fair use, please see the University of Buffalo Web Page. If you plan to distribute copyrighted materials at this CME activity, you must first obtain permission to do so from the Copyright Clearance Center and then indicate in writing to the attendees that you have obtained this permission. The conference coordinator will be responsible for obtaining permission to copy course materials.

• Direct Credit – University at Buffalo
• One-time Live Activities: $150/100 participants
• Regularly Scheduled Series: Initial Fee is waived, $50 annual renewal fee
• Enduring Material: $1000/3 years
• Joint Providership Credit (Non-University at Buffalo Organization)
• One-time Live Activities: $300/100 participants
• Regularly Scheduled Series: Initial Fee $250, $50 annual renewal fee
• Enduring Material: $1000/3 years
• Fees and instructions for payment will be provided with formal written approval.