MSV Accredited CME Activity Form

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ACTIVITY DETAILS

Activity Title(Required)

Activity Type(Required)

Live Course – In Person

Live Course – Virtual

Live Course – Hybrid (Simultaneous In-person and Virtual)

Regularly Scheduled Series

Enduring Material

Other

Activity Date (or the date range of a multi-day activity):(Required)

Activity Hours:(Required)

(This should approximate the total number of hours the learners will be engaged in the activity. For example, if your RSS meets for an hour once a month, you will request 12 credits for the year.)

EDUCATIONAL NEEDS

In two or three short paragraphs, please describe the professional practice gap(s) of your learners that this activity will address, and how you identified those gaps.(Required)

Check the educational needs that apply:(Required)

Knowledge (knowing something)

Competence (knowing how to do something)

Performance (doing something in a different way)

State the educational needs that are the cause(s) of the professional practice gap(s). Tell us why the practice gap exists:(Required)

DESIGNED TO CHANGE

Briefly explain how your activity is going to change your learners’ competence, performance, or their patients’ outcomes. Tell how this activity will go beyond communicating new knowledge, and how it’s designed to change your learners’ actions. This might be written as learning objectives.(Required)

APPROPRIATE FORMATS

Provide details regarding the educational format(s) of this activity (such as lecture followed by Q&A, panel discussion, or hands-on simulation), and explain why the educational format is appropriate for the target audience, setting, objectives, and desired results of this activity.(Required)

COMPETENCIES

Select the desirable physician attribute(s) this activity will address. Use the checklist below, or you may enter other competencies recognized by your organization.(Required)

Other Desirable Physician Attributes:

ANALYZES CHANGE

Describe how you will obtain data or information about changes in your learners’ competence or performance or patient outcomes because of their participation in this activity. If you plan to use a post-activity survey to measure learners’ intent to change, include the questions you will ask regarding changes in competence or performance. (The questions must require that the learners reflect on specific changes they will make. It is not adequate to simply ask if the learners intend to change.) (If you will be using other change data such as quality improvement data or patient outcomes from a hospital database or an EMR, please describe.)(Required)

STANDARDS FOR INTEGRITY AND INDEPENDENCE IN ACCREDITED CONTINUING EDUCATION

STANDARD 1: ENSURE CONTENT IS VALID

We are responsible for ensuring that education is fair and balanced and that any clinical content presented supports safe, effective patient care.

1. All recommendations for patient care in accredited continuing education must be based on current science, evidence, and clinical reasoning, while giving a fair and balanced view of diagnostic and therapeutic options.

2. All scientific research referred to, reported, or used in accredited education in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection, analysis, and interpretation.

3. Although accredited continuing education is an appropriate place to discuss, debate, and explore new and evolving topics, these areas need to be clearly identified as such within the program and individual presentations. It is our responsibility to facilitate engagement with these topics without advocating for, or promoting, practices that are not, or are not yet adequately based on current science, evidence, and clinical reasoning.

4. We cannot advocate for unscientific approaches to diagnosis or treatment, and we cannot promote recommendations, treatment, or healthcare practices that have risks or dangers that outweigh the benefits or are known to be ineffective in the treatment of patients.

Please attest that this activity will meet all four expectations of Standard 1.(Required)

Check box to attest.

Attach the required documentation based on the activity type.

If the activity is a Live Course, Performance/Quality Improvement, or Other/Blended Learning activity: Attach documentation of the activity’s topics or content that includes the nature and scope of the CME activity (such as a content outline, agenda, brochure, program book, or announcement).

If the activity is a Regularly Scheduled Series (RSS) activity: Attach a listing of the dates, faculty,location, and topics for each session that you know so far. (At the end of the series, you’ll berequired to submit the full listing of session dates, faculty, and topics.)

If the activity is an Enduring Material (online or print) CME activity:
-If the activity is a printed Enduring Material, attach the full set of materials.
-If the activity is an online Enduring Material, attach instructions so that MSV CME staffcan access the CME activity. Provide us with a URL or direct link and genericusername(s) (e.g., “MSVCMEStaff” and a working password if needed), allowingaccess to the activity for the duration of the activity’s approval term.

Upload Documentation

Drop files here or

Max. file size: 50 MB.

STANDARD 2: PREVENT COMMERCIAL BIAS AND MARKETING

Accredited continuing education must be free of commercial bias and marketing.

1. All decisions related to the planning, faculty selection, delivery, and evaluation of accredited education must be made without any influence or involvement from the owners ande mployees of an ineligible company.

2. The activity must be free of marketing or sales of products or services. Faculty must not actively promote or sell products or services that serve their professional or financial interests during accredited education.

3. The names or contact information of learners cannot be shared with any ineligible company*without the learner’s explicit permission (opt-in or opt-out).

Please attest that this activity meets the expectations of all three elements of Standard 2.(Required)

Check box to attest.

STANDARD 3: IDENTIFY, MITIGATE, AND DISCLOSE RELEVANT FINANCIAL RELATIONSHIPS

Will this activity meet one of the exceptions listed below?

1. Accredited education that is non-clinical. Examples include such topics as basic science, leadership or communication skills training, research methods, or patient safety methodology.

2. Accredited education where the learner group is in control of content, such as a spontaneous case conversation among peers. (Activities such as Tumor Boards or Morbidity/Mortality Conferences, where the learners discuss cases that are brought to the session, are more properly considered Regularly Scheduled Series and do not qualify under this exception.)

3. Accredited self-directed education where the learner controls their educational goals and reports on changes that resulted, such as learning from teaching, remediation, or a personal development plan. When accredited providers serve as a source of information for the self-directed learner, they should direct learners only to resources and methods for learning that are not controlled by ineligible companies.

Does this activity meet any one of the exceptions for Standard 3?(Required)

Yes, this activity meets one of the exceptions for Standard 3.

No, it does not.

If Yes, describe how the activity meets the exception (and skip to Standard 4):

If No, to mitigate commercial bias in accredited CME, we are required to:

1. identify all financial relationships between ineligible companies and everyone in control of content.

2. determine whether each relationship is relevant to the activity and that person’s role.

3. mitigate all relevant financial relationships; and,

4. disclose all relevant financial relationships to learners before the activity.

Please list everyone who has any degree of control over the content of the CME activity in any way, including planners, faculty, moderators, panel members, reviewers, and staff. Also specify their role in the activity. (If you need additional rows, please contact the MSV CME office.)

Name of Person with Influence Over Activity Content

Email address

Role (e.g., Planner, Faculty, Reviewer, Staff, etc.)

Identification of Relevant Financial Relationships (RFRs): Each of these people must complete the disclosure form that asks about financial relationships* with ineligible companies*. The form must be signed (digital is OK) and dated and returned to MSV CME no later than two weeks prior to the activity.

The MSV CME staff will review the completed forms, and the CME staff will determine whether any relationships are relevant to the activity’s content. Note that any person who is an employee* or owner* of an ineligible company is prohibited from having a role in an accredited CME activity.

Mitigation of RFRs: Any person with a relevant financial relationship will need to have the relationship mitigated, to reduce or remove any bias from their role. The CME Staff will offer several mitigation strategies, including (for planners) recusal from planning decisions and removal from the planning committee, and (for faculty) use of generic rather than trade names in the presentation, avoiding use of corporate names and logos, review of slides or other materials by CME staff in advance of the presentation, and others. The mitigation strategy should be discussed with the person with the RFR and their agreement with the mitigation strategy should be documented.

Note: all faculty with a relevant financial relationship will be required to submit their slides and all other materials to the CME office at least one week prior to the start of the activity.

Disclosure of RFRs and their Mitigation to Learners: All RFRs must be disclosed to learners prior to the activity. Disclosure should include the name of the person, the nature of the relationship, and the name (only) of the ineligible company.

Disclosure to learners can be done by including a statement in the program materials, by including the information in a slide at the beginning of the activity, by having the speaker state their relationship, or a combination of these methods.

The absence of RFRs must also be disclosed for those without them.

Last, there must be a statement that all RFRs were mitigated.

Here is some sample text: “Dr. Jane Smith serves a consultant for Company X. Dr. John Jones is on the speaker bureau for Company Y. Dr. Ann Williams has received research support from Company Z. No other planners or faculty have disclosed relevant financial relationships. All financial relationships have been mitigated.”

To summarize, the documentation that is needed by the MSV CME office is:

1. A complete list of everyone who has or will have any influence of the content of the activity(listed in the table above).

2. A completed disclosure form from everyone on the list.

3. Documentation that everyone who has a relevant financial relationship has agreed tomitigation, and what that mitigation strategy is.

4. Documentation of the disclosure to learners including:
a. all RFRs (individuals’ names, relationships, companies’ names) to learners,
b. the absence of an RFR for everyone else (they don’t need to be named), and
c. that all RFRs were mitigated.

MSV can provide joint accreditation only to select activities that will receive commercial support* from ineligible companies*, or that have exhibits, advertising, or ancillary activities*. You must contact the MSV CME office to discuss your activity prior to submitting your application, as we may or may not be able to accredit your activity. If your activity with commercial support is approved, you will need to work closely with MSV CME staff throughout the planning and execution processes. The compliance rules around commercial support and advertisements/exhibits are detailed and somewhat complicated. Plan to be in regular contact with the MSV CME office as you work through this aspect of your activity, and we will partner with you to ensure compliance.

STANDARD 4: MANAGE COMMERCIAL SUPPORT APPROPRIATELY

Will you receive Commercial Support* for this activity, either money or in-kind support, from an ineligible company*?

Yes

MANDATORY: If commercial support (monetary or in-kind) is to be received, there must be an executed agreement (e.g., a contract or LOA) that specifies certain necessary expectations and is signed and dated by both sides prior to the start of the activity. These agreements and their signatures may be a hard copy or in digital form. All agreements must be received by the MSV CME office at least five working days prior to the activity, no exceptions. If you need a template to use for a commercial support agreement, please contact the MSV CME office.

If Yes, complete the table below. List the name(s) of the ineligible companies* that will be commercial supporter(s) of this activity and the dollar value of any monetary commercial support and/or non-monetary (in-kind) support. In-kind support should be given a dollar amount based on an estimated fair-market value.

Name of Commercial Supporter

Type of Commercial Support (Monetary or Non-Monetary [In-Kind])

Amount of Monetary Support (in US dollars)

If there are more than eight ineligible commercial supporters, please contact MSV’s CME office.

STANDARD 5: MANAGEMENT OF EXHIBITS, ADVERTISEMENTS, AND ANCILLARY ACTIVITIES

Will your activity include any of the following:

• Opportunities for ineligible companies to market or exhibit to learners, such as banners, posters, exhibit booths, sponsored refreshment breaks, sponsored charging stations, advertisements in a brochure or flyer, branded lanyards or name badges or keychains or pens, etc.
• Nonaccredited sessions (such as product demonstrations, panel discussions, or other presentations) that are developed by or with influence from an ineligible company* or with planners or faculty with unmitigated financial relationships?

Standard 5 Y/N

Yes

If you checked Yes, make note of the following restrictions to ensure that the accredited education is separate from marketing by ineligible companies—including advertising, sales, exhibits, and promotion—and from nonaccredited education offered in conjunction with this activity:

• No advertising or marketing can be allowed in the area where the CME sessions are held, at least 30 minutes before or after.

• No advertising or marketing can be allowed to be with or part of any educational materials, including handouts, slides, abstracts, learner evaluations, and disclosure information regarding planner/speaker financial relationships. Note: Materials that include only logistical information such as save-the-date messaging, program agendas, schedules, speaker lists, and room locations are NOT considered to be “educational material”, therefore advertisements are allowed in brochures that contain this information.

• Within 10 business days after your activity, you will be required to submit documentation of your activity separated from marketing. You may be required to submit all materials associated with the activity in which advertising or marketing for or on behalf of ineligible companies was permitted and/or evidence to demonstrate that the accredited education was separated in space and/or time from nonaccredited ancillary activities.

Please work with the MSV CME office in advance and throughout your process so that we can ensure full compliance with ACCME standards.

* GLOSSARY

Commercial Support: any financial or in-kind support from ineligible companies intended to defray the cost of producing an accredited activity. Commercial support is money that is given as a grant, without any return value other than recognition. This includes money with any label such as “educational grant” or “financial support” or “sponsorship”. It also includes in-kind support, such as the loaning of equipment for a demonstration or the time/effort of a medical device trainer. In-kind support should be assessed at a fair market value. Commercial support does not include fees for advertising, exhibits, or for ancillary activities sponsored by ineligible companies. There are strict but straightforward rules governing the management of Commercial Support, found in the ACCME’s Standard 4.

Exhibits, Advertising, and Ancillary Activities: any arrangement that allows an ineligible company to market or exhibit as part of an accredited CME activity. This category includes all financial support from ineligible companies where they receive something for their contribution. Examples include such things as a booth in an exhibit hall, a conference program with advertisements, banners or signs with corporate branding, sponsored events, lanyards or meeting badges with logos or branding, marketing materials distributed to participants, presentations organized by an ineligible company such as product demonstrations or “scientific symposia”, and branded meeting features like registration desks or charging stations. We are required to clearly separate accredited education from marketing. The rules for exhibits and advertising are found in the ACCME’s Standard 5.

Ineligible Company: any company that makes, markets, sells, re-sells, or distributes products used on or by patients. For-profit or non-profit status is immaterial. Direct providers of healthcare services (e.g., hospitals, health systems, physician practices) are not ineligible companies. For a full list of examples and exclusions to the definition, see page 4 of the ACCME’s Standards for Integrity and Independence.

ACCREDITATION STATEMENT

All communications about the activity (announcements, flyers, programs, etc.) should include the following statement:

For MSV internal activities: The Medical Society of Virginia is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

For jointly provided activities that MSV is accrediting: 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 Medical Society of Virginia and [name of your organization]. The Medical Society of Virginia is accredited by the ACCME to provide continuing medical education for physicians.

IMPORTANT NOTE: Until you have received notice that your activity has been approved by MSV CME Staff, you may NOT communicate that CME credit will be given for your activity, and you may not use the accreditation statement. Use of phrases such as “CME applied for” or “CME approval pending” are also prohibited and are not to be used in your communications.

Application Information

Name of individual completing this application:(Required)

First Last

Email:(Required)

Phone:(Required)

Organization and Department:(Required)

*GLOSSARY of CME TERMS
Activity Types Eligible for Accreditation:

Live Course: an activity with one or multiple sessions, held for a target audience over one or more consecutive days. Examples include a one- or several-hour activity on a topic delivered on one afternoon; a multi-hour activity with several speakers, delivered over a weekend; an “annual meeting” with multiple speakers addressing the same audience over several days.

Regularly Scheduled Series: a series of sessions with different content held over time (but not on consecutive days), all for the same general target audience. Examples include a grand rounds series held over a year; a “tumor board” conference held every two weeks; an “infection morbidity conference” held monthly.

Enduring Materials: an educational activity that is available unchanged over a period of time that allows learners to access it at their convenience. Examples include online learning modules that are available to a group’s members; recorded sessions from an annual meeting that are available online after the activity has ended; printed study books with learning tutorials and question forms that are available for free or for purchase.

There are other, less common, types of activities that are eligible for credit that are described on pages 4-5 of the AMA PRA booklet.

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Commercial Support: any financial or in-kind support from ineligible companies intended to defray the cost of producing an accredited activity. This includes money in any form or with any label such as “educational grant” or “financial support” or “sponsorship”. It also includes in-kind support, such as the loaning of equipment for a demonstration or the time/effort of a trainer or mock patient. In-kind support should be assessed at a fair market value. Commercial support does not include fees for advertising or for exhibits.

Employee of an Ineligible Company: anyone who is employed directly by an ineligible company, including those with part-time status. Such people receive an IRS W9 form at the end of the tax year. Consultants are not considered employees, although it is a financial relationship; these people receive IRS 1099-NEC forms at the end of the tax year.

Financial Relationship: any financial relationship between an ineligible company and someone who controls content of a CME activity. There is no dollar minimum, and all relationships in the prior 24 months must be reported by those individuals, even if they have ended. Examples include such things as being on a company’s advisory board, being part of a speaker’s bureau, or consulting on marketing strategy; research support is also a financial relationship, even when the money is given to the person’s department or institution and not directly to the individual.

Owner of an Ineligible Company: anyone with an ownership interest in an ineligible company, including those with stock in a privately held company (i.e., one that is not traded on an open stock exchange). Holding stock in a company whose stock trades on an open stock exchange is not considered ownership. Also, holding shares of mutual funds that include stock in ineligible companies is not considered ownership.