ACTIVITY DETAILS
EDUCATIONAL NEEDS
DESIGNED TO CHANGE
APPROPRIATE FORMATS
COMPETENCIES
ANALYZES CHANGE
STANDARDS FOR INTEGRITY AND INDEPENDENCE IN ACCREDITED CONTINUING EDUCATION
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.
STANDARD 4: MANAGE COMMERCIAL SUPPORT APPROPRIATELY
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.
ACCREDITATION STATEMENT
Application Information
*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.
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.
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.