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 in order 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.
- Continuing Medical Education (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.
Sections
Planning Activities
- Activity planning should be performed prior to submission of educational grant requests.
- Content of educational programs and selection of presenters, authors, and target audience will be determined by activity planners, the CME provider, and/or joint educational provider. Ineligible companies may not provide input on these elements. (SCS 1.1)
- The content or format of a CE activity or its related materials must promote improvements or quality in healthcare and not specific proprietary business interests. (SCS 5.1)
- Social events or meals associated with CE activities cannot compete with or take precedence over the educational events. (SCS 3.11)
- Educational materials that are part of a CE activity, such as slides, abstracts and handouts, should not contain advertising or 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. (SCS 4.3, 5.2)
Commercial Support
- An educational grant does not allow a company to display at a CE event. The CE activity planners should determine if separate exhibits/displays are appropriate for the activity. See the “Exhibits/Displays” section for more information.
- 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 manufacturers decline.
- Terms, conditions and purposes of commercial support must be documented in a written Letter of Agreement (LOA) between the ineligible company and the CME provider as well as any educational partner. The LOA must be signed by the ineligible company and the CME Provider prior to the date of the activity. (SCS 3.4, 3.5, 3.6)
- Support from ineligible companies must be disclosed to the learners prior to the beginning of the activity. This disclosure may not include the use of a corporate logo, trade name or a product-group message of the ineligible company. (SCS 6.3, 6.4, 6.5)
- If in-kind support is used, such as company medical equipment for demonstrations or A/V equipment, a signed LOA for in-kind support needs to be obtained and signed by both the company and a Washington University representative prior to the activity. The company providing this support should be acknowledged at the time of the course.
- Promotional material or product advertisement of any type is prohibited in the room where CE is taking place. (SCS 4.2)
- All decisions regarding the collection and disbursement of financial support will be made by CME and/or Joint Education provider. (SCS 3.1)
- 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 CE activity faculty or planning committee members. Any payments, including expenses or honoraria, will be made by the CME provider or joint provider. (SCS 3.8, 3.9)
- 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 CE 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. (SCS 3.12)
- If there are funds available to pay honoraria, the CME Honoraria Policy must be followed. (SCS 3.7)
- Any remaining unspent funds from a CE 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 CE activities. (SCS 4.1)
- Determination of exhibit space, levels, and exhibit fees should be made by each CE activity chair or committee.
- Exhibits, promotional material or product advertisement of any type is prohibited in the room where CE is taking place and in the obligatory path to the meeting room. (SCS 4.2)
- 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. (SCS 4.2)
- Employees of ineligible companies who attend CE events should 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 CE 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 CE 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.
- Technical representatives from ineligible companies may assist Washington University faculty in the lab setting and may also be available to troubleshoot equipment issues or to assist with A/V, camera work, etc.
Outside References
- ACCME Standards
- ACCME Commercial Promotion rules
- FPP Industry Policy - Available to WU only
- CMS Open Payments
Reviewed/revised July 2007, June 2010, September 2011, December 2013, October 2014, June 2016, November 2018, June 2022