Accreditation

Overview of Credit System
Application
Educational Planning and Content Development
Conflict of Interest
Joint Sponsorship
Commercial Support
Exhibits and Vendors


Overview of Credit System

Q: What is the ACCME?
A: The UC San Diego School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to sponsor (designate credit) continuing medical education (CME) for physicians. UC San Diego CME is tasked with ensuring that all CME activities are in compliance with the ACCME Essential Areas, Elements, Criteria, Policies and Standards for Commercial Support (SCS) as well as other regulations and laws as they relate to the provision of CME.

Q: What kind of credit are you offering to physicians?
A: We certify activities for AMA PRA Category 1 Credit™. The American Medical Association’s (AMA) Physician’s Recognition Program has been in effect for more than 40 years. AMA PRA credit is recognized and accepted by hospital credentialing bodies, state medical licensure boards and medical specialty certifying boards, as well as other organizations. Within the United States, the AMA only authorizes organizations that are accredited by the ACCME or by a state medical society recognized by the ACCME, referred to as “accredited CME pro­viders,” to designate and award AMA PRA Category 1 Credit™ to physicians.

Q: What is the definition of CME?
A: The AMA and the Council on Medical Education have defined continuing medical education as follows: CME consists of educational activities which 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 the 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.

Q: What types of activities can be certified for credit?
A: Non-promotional learning activities certified for credit prior to the activity that are in alignment with the definition of CME as described above.

Note: accredited CME providers may certify nonclinical subjects (e.g. office management, patient-physician communications, faculty development) for AMA PRA Category 1 Credit™ as long as they are appropriate to a physician audience and benefit the profession, patient care or public health.

CME activities may describe or explain complementary and alter­native health care practices. As with any CME activity, these need to include discussion of the existing level of scientific evidence that supports such practices.

Q: What kinds of activities are ineligible for AMA PRA Category 1 Credit™?
A: Education that advocates specific alternative therapies or teaches how to perform associ­ated procedures, without scientific evidence or general acceptance among the profession that supports their efficacy and safety, cannot be certified for AMA PRA Category 1 Credit™.

CME credit may not be claimed for learning which is incidental to the regular professional activities or practice of a physician, such as learning that occurs from:

  • Clinical experience
  • Charity or mission work
  • Mentoring
  • Surveying
  • Serving on a committee, council, task force, board, house of delegates or other professional workgroup
  • Passing examinations that are not integrated with a certified activity

Q: Who can claim AMA PRA Category 1 Credit™?
A: Physicians eligible to receive AMA PRA Category 1 Credit™ are individuals who have completed an MD, DO or equivalent medical degree from another country, or who have obtained a Fifth Pathway certificate.

Application

Q: Will you please give a definition for each type of activity listed on the application?
A: Live Activity: A live activity is an activity that occurs at a specific time. Participation may be in person or remotely as is the case of teleconferences or live Internet webinars. These may be offered through a variety of delivery mechanisms; examples include, but are not limited to, national, regional or local conferences, workshops, seminars, simulation workshops, structured learning activities presented during a committee meeting and live Internet webinars.

Regularly Scheduled Series (RSS):This is a live activity that is planned to have 1) a series with multiple sessions that 2) occur on an ongoing basis (offered weekly, monthly, or quarterly) and 3) are primarily planned by and presented to the UC San Diego’s School of Medicine professional staff. Examples of activities that are planned and presented as a regularly scheduled conference are Grand Rounds, Case Conferences, Tumor Boards and M&M Conferences.

Enduring Activity: Home study activities are CME materials that endure over time. These activities are typically delivered via monograph, DVD, CD-ROM and the Internet.

Journal-based CME: A journal-based CME activity is an activity in which an article, within a peer-reviewed, professional journal, is certified for AMA PRA Category 1 Credit™ prior to publication of the journal.

Performance Improvement (PI) CME: PI CME is a certified CME activity in which an accredited CME provider structures a long-term three-stage process by which a physician or group of physicians learn about spe­cific performance measures, assess their practice using the selected performance measures, implement interventions to improve performance related to these measures over a useful interval of time and then reassess their practice using the same performance measures. A PI CME activity may address any facet (structure, process or outcome) of a physician’s practice with direct implications for patient care.Click here for more information about this type of activity or contact our office.

Internet Point-of-Care Learning (PoC): An Internet PoC learning activity is a certified CME activ­ity structured by an accredited CME provider in which a physician engages in self-directed, online learning on topics relevant to their clinical practice. Learning for this activity includes a reflective process in which a physician must docu­ment their clinical question, the sources consulted and the application to practice.

For more information about any of the above types of activities, please refer to the AMA PRA booklet or contact Alison Ireton.

Q: How do I fill out the accreditation application?
A: The application is available on-line and consists of five pages that may be saved one page at a time. You may return at a later date to edit the application and add information. Please make sure you save the application as you go along to ensure sure you do not lose any information. Note that our office will not receive a copy of the application until you press the final submit button.

Q: What information do I need in order to complete the application? Is a sample application available?
A: Yes, sample applications are available. The Program Planning Document will also facilitate the collection of pertinent information needed for the application.

Q: When is the application due?
A: A minimum of 60 days prior to the activity.

Q: How does the review and approval process of applications work?
A: Once the accreditation application is submitted, it is vetted for accuracy and completeness by the Accreditation Manager, Director and Associate Dean. When this process is concluded, the application, on a per activity basis, is sent electronically to our CME Advisory Committee for review. We require a quorum of the advisory committee for preliminary CME approval. If your activity is granted preliminary approval you will receive a formal approval letter that outlines the requirments for the proper execution of your activity.

Q: What if my program is not finalized when I apply for credit; what do I do about the faculty disclosures?
A: All persons involved in the planning of the CME activity (including course directors, planners, speakers,
and committee members) must complete the UC San Diego conflict of interest (COI) disclosure form. Disclosures are due from course directors, planners and committee members before the application can be reviewed and credit can be awarded. Disclosures from speakers may be submitted at a later date (but no later than 4 weeks prior to the start of the activity) as the program and faculty are confirmed. If you envision any problems meeting this deadline, please contact our office.

Educational Planning and Content Development

Q: What do you mean by gap analysis?
A: In alignment with the ACCME criteria, CME activities sponsored by the UC San Diego School of Medicine must address educational needs defined by at least one professional practice gap. A practice gap is defined as the difference between current and optimal practice.

This gap can be expressed as the difference between “What Is” and “What Should Be”:

“What Is” - The healthcare professional's current knowledge, competence and performance skills (current patient care)

"What Should Be” - Established standards and criteria that must be achieved to promote the highest quality clinical performance and optimal patient outcomes (optimal/ideal patient care).

Q: What is a needs assessment?
A: An effective needs assessment will identify why the professional practice gap(s) exist and whether they are based on a lack of knowledge or competence, or due to sub-optimal physician behavior (did the physician do something wrong or fail to do something?).

Part of the needs assessment is also to summarize the data used to identify the gaps listed above and indicate the sources used. Note that at least two different sources must be used, such as patient care indicators; quality assurance data; scientific evidence from the literature; opinion from clinical or scientific experts; information from the general public, the media and/or other environmental sources; observed data from local or national databases; and/or surveys from past participants or prospective learners. Whenever possible, quality improvement data should be included as a component of the needs assessment.

Q: How do I write learning objectives that are measurable?
A: Visualize the learning objectives for this activity as “stepping stones” that enable you and your faculty to take the learner from the identified need to the desired result. In addition, learning objectives must be measurable and written from the perspective of what you expect the learner to do in the practice setting with the information you are teaching. As such, objectives should contain action verbs and criteria that help activity planners evaluate whether the gap(s) was/were closed (e.g., whether the activity helped increase competence, improve physician behavior and/or improve patient outcomes). Verbs that are commonly used but should be avoided include: know, learn, understand and appreciate. A list of effective verbs can be found here.

Q: What do you mean by expected outcome of the activity?
A: All CME activities should strive to increase competence, improve physician behavior and/or patient outcomes. Thus, the major reason for planning your CME activity should be to close the gap(s) you have identified. Note that while increased knowledge is an acceptable need for the activity, it is not considered by the current accreditation system to be a sufficient outcome. At a minimum, the goal of the activity should be improved competence.

Conflict of Interest

Q: What is considered a conflict of interest (COI)?
A: Conflict of interest is created when individuals in a position to control the content of CME, or their spouses/partners, have a relevant personal financial relationship with a commercial interest that produces, markets, re-sells, or distributes health care goods or services consumed by, or used on patients.

This may include 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 and clinical trials), consulting, speaking and teaching, membership on advisory committees or review panels, board membership and other activities for which remuneration is received or expected.

Q: What is a relevant financial relationship?
A: A relevant financial relationship is defined as any amount of financial gain occurring within the last 12 months that benefits the individual and therefore, may bias their opinions and teachings. Financial relationships of spouses and partners are included in this requirement.

Q: How can conflicts of interest be resolved?
A: Conflicts of interest may be resolved by 1) altering the financial relationship with the commercial interest, 2) altering the individual’s control over CME content about the products or services of the commercial interest and/or 3) validating the activity content through independent peer review. All persons in a position to control the content of CME must attest to content objectivity.

Q: What is the resolution process for conflicts of interest?
A: Disclosure is the first step in a process for UC San Diego CME to determine if the financial relationship is relevant to the content of the certified CME activity and the role and responsibility of the disclosing individual. When the content, role or responsibility is relevant, the second step is for the CME provider to resolve all conflicts of interest prior to the certified educational activity being delivered to learners. This process requires interventions by UC San Diego CME to resolve the COI or disqualify the conflicted party from participation. Anyone in a position to control certified CME content who fails or refuses to disclose is disqualified from further involvement in the current certified CME activity. Finally, learners must be informed of relevant financial relationships prior to the beginning of the certified educational activity.

Q: Do you have a conflict of interest policy?
A: Yes. Click here to view the policy.

Q: Who has to submit a disclosure?
A: All persons in a position to influence or control content (course directors, planners, presenters including moderators, medical writers, peer reviewers and staff) must complete a disclosure form disclosing any relevant financial relationships or they will be disqualified from being a part of the activity. A disclosure is required even if the individual has nothing to disclose; in this case, they will simply note that they have no disclosures.

Q: How do I submit my disclosure information?
A: Please use our online disclosure database to submit your disclosure information.

Q: How do I access the online UC San Diego CME disclosure system?
A: Click here or type http://cme.ucsd.edu/facultydisclosure in to your browser. To enter a new disclosure, use the Complete New Form section. To update a disclosure, enter the site through the Update Existing Form section. Disclosure information provided should be relevant to the topic discussed.  Also, disclosures must be updated every 12 months OR if disclosure information has changed, whichever is sooner. Planners/administrators can access completed disclosures for saving or printing by entering their email address and password in the Planners/Administrators section. For password help/retrieval, or for any further information, please contact Kirsten Allen.

Q: When are disclosures due to your office?
A: Disclosures for the course directors, planners and planning committee members are due along with the accreditation application. All other disclosures are due to UC San Diego CME a minimum of 4 weeks prior to the start of the activity. This timeline is required in order for us to review and to resolve all conflicts of interest prior to the start of the activity.

Q: What is peer review and when is it required?
A: A peer review of the educational content is required in the following instances:

  1. All enduring activities (print, internet, CD/DVD, audio, etc.)
  2. Any activity, live or enduring, that is supported by only one commercial supporter.
  3. Instances of high risk (for example, faculty with ties to industry that the CME staff and/or director deem to be of elevated risk for potential commercial bias) as determined by UC San Diego.

If activity content requires peer review, the final presentation or enduring materials must be reviewed in advance of the activity (and production of syllabus or course materials, if applicable), by a faculty member, preferably in the appropriate specialty area, who does not have a financial relationship with the commercial interest(s) of the accredited CME activity. Our office makes the determination if peer review is required and, if so, will notify you with further guidelines.

Q: Do I have to list all the disclosure information in the syllabus materials?
A: Yes, you have to include this information in the hand-out materials to ensure that the audience is aware of all potential conflicts of interest. It is important that they have this information when engaging in the activity so they can determine if there is any commercial bias influencing the presentation(s).Please use our template when preparing your disclosure summary. All CME activities are evaluated for the presence of commercial bias.

Joint Sponsorship

Q: Do you offer joint sponsorship opportunities?
A: Yes. However, all entities interested in joint sponsorship are vetted by the CME office for eligibility and are required to submit a Joint Sponsorship Questionnaire/Agreement in order for us to determine eligibility in agreement with the ACCME policy on joint sponsorship. Also, note that UC San Diego generally does not participate in any joint sponsorship, regardless of the entity’s organizational structure, unless the lead faculty member has a UC San Diego affiliation.

Q: Does the ACCME have special rules regarding Joint Sponsorships?
A: Yes, click here for more information.

Q: Our company is a commercial interest as defined by the ACCME, can we still be a joint sponsor?
A: No, a commercial interest is not eligible for joint sponsorship.

Q: What is the difference between directly sponsored and jointly sponsored?
A: A directly sponsored activity is one that is planned, implemented and evaluated by UC San Diego CME as the accredited provider. These are courses that are presented by UC San Diego, with no formal involvement from outside organizations. The majority of activities accredited by UC San Diego fall under this category.

In contrast, a jointly sponsored activity is one that is planned, implemented and evaluated by the UC San Diego CME and another non-accredited entity.

Commercial Support

Q: What is considered commercial vs. non-commercial support of CME activities?
A: Commercial support is any funding, direct or in-kind, that is given to a course from a commercial interest. The ACCME’s definition of a commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients (i.e. pharmaceutical companies and medical device manufacturers).

Non-commercial support is funding from any organization, foundation, or individual who does not produce, market, re-sell, or distribute health care goods or services consumed be, or used on, patients (i.e. NIH, non-profit foundations, etc.).

Both commercial and non-commercial support can be given in two ways: direct and in-kind.

Direct: A financial donation in the form of an educational grant; monetary donation.

In-Kind: The use of donated equipment, supplies, space, specimen, or services. For durable equipment, this includes the use of equipment that is to be returned after the completion of the course.

Q: Where can I find the ACCME Standards for Commercial Support?
A: Click here to download.

Q: What is a Letter of Agreement (LOA) and who signs them?
A: A letter of agreement is required for all educational grants and must be completed and signed by both the accredited provider (UC San Diego) and the commercial interest providing the commercial support prior to the start of the activity. Third parties and/or joint sponsors may also sign the written agreement but may not sign it instead of the accredited provider. Note: all LOAs, once fully executed, must be returned to UC San Diego CME.

Q: Do we have to use UC San Diego’s Letter of Agreement, or can we use the agreement provided by the grantor?
A: Either is acceptable. If using an agreement provided by the grantor then the written agreement must be in compliance with the following:

  • Be between the accredited provider (UC San Diego) and the commercial supporter. This means that both the accredited provider and commercial supporter must be listed in the written agreement as the parties entering into the agreement for commercial support
  • Itemizes how the provider (UC San Diego) will use the commercial support in the development and presentation of the CME activity
  • Includes the name of the joint sponsor or third party that would be receiving and disbursing the funds (if applicable)
  • Specifies the organizational name of the commercial interest(s) that supplied the funds
  • Specifies what funds or in-kind services will be given by the commercial supporter to support the provider’s activity
  • Be signed by both the accredited provider (UC San Diego) and the commercial interest providing the commercial support. Third parties and/or joint sponsors may also sign the written agreement but may not sign it instead of the accredited provider
  • Be signed by all parties prior to the activity taking place

Q: Are electronic LOAs acceptable?
A: Yes, electronic signatures are acceptable as evidence that written agreements are signed.

Q: Can a commercial supporter require in the written agreement that unexpended funds be returned to the commercial supporter?
A: Yes.

Q: Can a commercial supporter ask for an accounting of how their commercial support has been spent?
A: Yes. It is appropriate for an accounting of how the commercial support will be spent to be included in the written agreement between the provider and the commercial supporter. Most commercial supporters require reconciliation of funds post event.

Q: What is the difference between a supporter and a sponsor?
A: The sponsor of any UC San Diego accredited CME activity is always UC San Diego. Activities may be jointly sponsored by UC San Diego and other institutions, providing they meet requirements for Joint Sponsorship.

Note: Commercial interests can never be sponsors of a CME activity and use of the word “sponsor” to refer to a commercial interest who provided direct or in-kind donations to an activity is not in compliance with ACCME standards. An appropriate term for any commercial interest, non-commercial interest, individual, foundation, etc. who has given a direct or in-kind donation to an activity is “supporter.”

Q: A company has given all the funding necessary to pay for a course. Since they are the only financial supporter of this activity, can I list them as the sponsor?
A: No. UC San Diego is always the sponsor of an accredited CME activity. Funders cannot be listed a sponsors, but may be referred to as supporters.

Q: A company gave us commercial support for an activity. Can we offer them complimentary exhibit space as a benefit of their grant support?
A: No. A company may not be given a complimentary booth, table or any other space to display their products or promote their company as a result of giving an educational grant. Grant support for CME activities must be used to cover the expenses associated with the educational activity. No benefits can be offered along with such support.

Q: What is the proper way to acknowledge commercial supporters in the hand-out materials?
A: Acknowledgement of commercial support should simply list the company name and may not include any product-specific advertising. “We acknowledge support from the following companies” is one way of doing this. An example can be found here..

Q: Do I have to acknowledge my commercial supporters in the hand-out materials?
A: Yes, in the interest of transparency and in order to be in compliance with the ACCME Standards for Commercial Support, you must acknowledge all commercial support to the audience.

Q: Can a company give both direct and in-kind support to a course?
A: Yes, they may give an educational grant for a flat, specified amount as well as donate equipment or other supplies (for example, for a laboratory-based course). The Letter of Agreement (LOA) must clearly specify both kinds of support. Separate LOAs for direct and in-kind support may be submitted, or both types may be included on the same agreement.

Exhibits and Vendors

Q: Are exhibitors allowed at CME activities?
A: Exhibits are permitted at accredited UC San Diego activities; however there are strict policies which must be adhered to in order to maintain compliance with ACCME and UC San Diego regulations.

Exhibitor/vendors must abide by the ACCME Standards for Commercial Support and the UC Health Care Vendor Relations Policy. Any actions that are not in accordance with the above stated policies may result in the removal of the exhibit company and its representatives from the conference site, in which case no refund of exhibit fees will be allowed.

We recommend that you use our Exhibitor Agreement Form when making arrangements with companies renting exhibit space at UC San Diego CME activities.

Q: Where can I place the exhibitors?
A: Exhibitors may not share the same space as the accredited activity. This means that exhibit tables may be set up in another room, but not in the conference room itself, even if the activity is not in session. Any/all promotion or discussion of products and/or services must be done in the designated exhibit space (at the booth or in the designated exhibit hall); it may never be done formally or informally in the actual educational space. Examples of educational space include lecture halls, break-out rooms and laboratories.

Q: Company Z would like to do a presentation in one of the break-out rooms during the lunch break. They would be willing to pay a fee to do this. Is this allowed?
A: No. Commercial entities, whether providing a grant or purchasing exhibit space, may not do any promotion in any space used for education, regardless of whether or not they pay a fee. If a space is used for any part of the accredited activity, even if the activity is not in session, it may not be utilized for promotion.

Q: Company X would like to pay for lunch on one of the conference days. Is this permitted?
A: No. If a commercial supporter would like to give funds to support a course, they may give an educational grant. These grant funds are to be used in the manner in which the providers (conference coordinators) decide. A company may not pay directly for any part of a course (food, audiovisual expenses, room rental, etc). This applies to functions for participants, staff and/or faculty. For example, companies may not pay directly for a faculty dinner that is organized for the faculty of the course.

Q: What is the University of California vendor policy?
A: On July 1, 2008, the University of California implemented a vendor policy, “Policy on Health Care Vendor Relations” which provides system wide standards aimed at eliminating the potential of industry influence on health care providers’ decision making. This move is in keeping with approaches implemented at other Academic Medical Centers across the country.

Policy Highlights:

  • Prohibits gifts from vendors made directly to individuals;
    • Examples of gifts include: free lunches, drug samples and/or promotional products;
    • The policy permits vendors to donate money to the “Regents of UC” to support the University’s mission of education, patient care and research. There is also an exception for sample donations for use in the University-sanctioned free clinics;
  • Prohibits uninvited health care vendor sales calls;
  • Prohibits on-site use of any branded promotional products;
  • Enhances patient confidentiality provisions;
  • Requires that vendor paid preceptorships be conducted as either University courses or as continuing education courses.