Ineligible Company Policy for Washington University School of Medicine Continuing Education

Purpose

Educational activities at Washington University School of Medicine in St. Louis (WUSM) have benefited from the support of the health sciences industry. At the same time, these relationships have the potential to create conflicts of interest. All accredited Continuing Education (CE) activities will be planned and implemented in compliance with the Accreditation Council for Continuing Medical Education (ACCME) Standards for Integrity and Independence in Accredited Continuing Education to minimize such potential conflicts and ensure that education content is unbiased and independent of outside influence.

Definitions

Ineligible Company - any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. This does not include providers of clinical services directly to patients, government organizations, or non-healthcare related companies.
Commercial Support - an educational grant or in-kind support from an ineligible company.
Employee of Ineligible Company- any person who is employed by a for-profit organization that produces, markets, re-sells, or distributes healthcare goods or services consumed by or used on patients. This includes all individuals whose employer is an ineligible company regardless of their profession, position within the company, patient care responsibilities, or secondary employment at a non-commercial entity.
CME Provider - Washington University School of Medicine in St. Louis.
Joint Education Provider - Non-accredited organization that jointly plans and presents a CE activity with an accredited provider (WUSM).

These definitions are consistent with those of the ACCME.

Planning Activities

Activity planning should be performed prior to submission of educational grant requests.
Content, selection of presenters, authors, and target audience, delivery, and evaluation of accredited education activities will be determined by activity planners, the CME provider, and/or joint educational provider without influence or involvement from the owners or employees of an ineligible company. (S2.1)
The name and nature of all financial relationships with ineligible companies within the prior 24 months must be disclosed for all planners, faculty, and others in control of educational content. Identify and mitigate all relevant (educational content is related to the business lines or products of the ineligible company) financial relationships and take steps to prevent those with relevant financial relationships from inserting commercial bias into content. Individuals cannot determine the relevance of their relationship to the education. (S3.1a-b, S3, S4)
All relevant financial relationships and absence of relationships (nothing to disclose) must be made known to the learners prior to the educational activity and contain the names of all individuals with or without financial relationships, only the names (no logos) and nature of the relationship of the ineligible companies, along with the statement, “All relevant financial relationships have been mitigated” (S3.5a-d).
Relevant financial relationships do not need to be identified, mitigated or disclosed for accredited education if the education is non-clinical (leadership/communication skills training), the learner group is in control of the content (spontaneous case conversations among peers), or is self-directed education (learning from teaching, remediation or personal development). Learning sources should not be controlled by ineligible companies (S3.5.1-3).
Exclude owners or employees of ineligible companies from participating in any role of the CE activity unless one of the following conditions are met (S3.2a-c):
1. The content of the activity is not related to the business lines or products of their employer/company
2. The content of the accredited activity is limited to basic science research, such as preclinical research and drug discovery, or the methodologies of research, and they do not make care recommendations.
3. Participation is limited to technician to teach the safe and proper use of medical devices, and do not recommend whether or when a devise is used.
The content or format of a CE activity or its related materials must be valid, fair, and balanced based on current science, evidence, and clinical reasoning that supports safe, effective patient care. (S1.1-4)
Educational materials for a CE activity, such as slides, abstracts, and handouts, must be free from marketing or sales of products or services, and should not contain ineligible company logos. Generic drug/device names should be used; brand names should only be included if needed for clarification. If brand names are included, they should be included for products from all companies discussed. (S2.2)
Contact information of CE activity learners must not be shared with any ineligible company representatives without individual explicit consent. (S2.3)
Ineligible companies may not provide access to, or distribute accredited education to learners (S5.3).

Commercial Support

An educational grant does not allow a company to market or exhibit at an accredited CE activity. The CE activity planners should determine if separate exhibits/displays are appropriate for the activity. See the “Exhibits/Displays” section for more information. (S5.1.c)
It is preferable to request funding from multiple sources for an activity. An ineligible company may be the sole supporter in a case where they are the only manufacturer of a product or where other ineligible companies have declined.
Terms, conditions, and purposes of monetary and In-Kind (i.e., medical equipment, disposable supplies, AV equipment) commercial support must be documented in a written Letter of Agreement (LOA) between the ineligible company and WUSM CME office as well as any educational partner. The LOA must be signed by the ineligible company and the CME Provider prior to the start of the CE activity. (S4.2)
Support (monetary and in-kind) from ineligible companies must be disclosed to the learners prior to the beginning of the CE activity. This disclosure must not include ineligible corporate or product logos, trade names or product-group messages (S4.4)
Marketing, exhibits and non-accredited education developed by or with the influence of an ineligible company or planners/faculty with unmitigable financial relationships must not occur in the educational space within 30 minutes before or after accredited education. Accredited and non-accredited education must be clearly labeled and communicated as such to the learners. (S5.2a)
Learners must not be presented with marketing while engaged in a print, online, or digital accredited educational activity, nor will they need to click through, watch, listen to, or be presented with product promotion or product specific advertisement while engaging in the accredited activity (S5.2b).
Educational material that are part of accredited education (such as slides, abstracts, handouts, evaluation mechanisms, or disclosure information) must not contain any marketing produced by or for an ineligible company, including corporate logos, trade names, or product group messages. (S5.2c)
Information distributed about accredited education that does not include educational content, such as schedules and logistical information, may include marketing by and for and ineligible company (S5.2d).
Social events or meals associated with CE activities cannot compete with or take precedence over the educational events.
All decisions regarding the collection and disbursement of financial support will be made by CME and/or Joint Education provider and must be recorded for accounting purposes. (S4.1 (a-d), S4.3)
Funds from educational grants are to be processed through the CME department or Joint Education Provider.
No payment will be made from commercial supporters directly to CME activity faculty or planning committee members or pay directly for any expense related to the education or the learners. Any payments, including expenses or honoraria, will be made by the CME provider or joint provider. (S4.1a)
At the discretion of the course chairperson, registration fees and travel expenses for healthcare providers who are in training may be paid from commercial support, provided that selection of recipients is done by the course chair, university representative or Joint Education provider.
The CME provider may not use commercial support to pay for travel, lodging, or personal expenses for non-teacher or non-author participants of a CME activity. The provider may use commercial support to pay for travel, lodging, or personal expenses for bona fide employees and volunteers of the provider, joint provider, or educational partner. (S4.1a-d)
If there are funds available to pay honoraria, commercial support may be used in accordance with the CME Policy for Honoraria (S4.1b).
Commercial support cannot be used to pay for travel, lodging, honoraria, or personal expenses for individual learners or groups of learners in accredited education, but commercial support can be used to defray or eliminate the cost of the education for all learners. (S4.1c-d).
Any remaining unspent funds from a CME activity (after supporter reconciliations are complete) should be designated for future educational activities.

Note – Due to CMS Guidelines, be sure to read any LOA from an Ineligible Company closely for any stipulations.

Exhibits/Displays

Exhibit fees or advertisements are independent of commercial support and cannot influence planning or interfere with the presentations, nor can they be a condition of the provision of commercial support for CME activities.
Determination of exhibit space, levels, and exhibit fees should be made by each CME activity chair or committee.
Exhibits from ineligible companies must not influence any decisions related to the planning, delivery, or evaluation of the education, must not interfere with the education, nor be a condition of the provisions of financial or in-kind support granted for the education (5.1a-c).
An Exhibitor Agreement must be signed by all exhibitors prior to the course.

Employees of Ineligible Companies

Employees of ineligible companies may not engage in any sales or promotional activities while in the space of the educational activity. This is typically the room in which the education is occurring.
Employees of ineligible companies who attend CME events must wear University-provided name badges with company name clearly indicated. Company name badges should not be worn. Corporate logos or trade names displayed on clothing should be covered.
Employees of ineligible companies should not attend CME activities, such as rounds, where protected health information (PHI) may be presented (HIPAA guidelines), as they are not included in the Washington University / Barnes-Jewish Hospital “umbrella” of patient care team member providers.
Employees of ineligible companies may attend CME activities at the discretion of the activity chair for the direct purpose of the employee’s own education when HIPAA guidelines permit. When attending in this capacity, they may not engage in sales or marketing activities. For those employees of ineligible companies who wish to attend, we suggest registration fees be set, at the minimum, to cover the full actual cost of attendance.

References

Reviewed/revised July 2007, June 2010, September 2011, December 2013, October 2014, June 2016, November 2018, June 2022