The Case: Maggie Machiano, VP of product development at Regulators and Monitors, makes arrangements to exhibit RM’s products at state and national meetings and in skill-enhancing laboratories across the country. When the Gallbladder Problems Society comes to her to solicit support for an upcoming conference, Maggie sends GPS an exhibit agreement and payment to cover the fees delineated within the Exhibitor Prospectus, and stipulates the number and type of the equipment available for the educational sessions.
GPS’s CME director, Rebecca Navgater, PhD, is responsible for reviewing current policies and making recommendations for bringing noncompliance areas into compliance. Rebecca reviews all exhibit contracts and Letters of Agreement for educational grants, and also compares the estimated value of in-kind contributions and amounts of commercial support. After preparing a commercial support summary grid, she notices that RM uses a single document to cover both exhibits and in-kind contributions. Conscious that this could be an issue, she arranges a meeting with Dr. Mooreforus, GPS executive director.
Time to Separate
What documentation should Rebecca bring to the meeting with the executive director?
Parochka: She should bring the summary grid of commercial supporter educational grants and in-kind contributions and a recent copy of the Accreditation Council for CME Standards for Commercial Support highlighting the role of the Letter of Agreement. It is imperative that her explanation be backed by data, commonly accepted CME policies, and a copy of the AdvaMed Code.
Overstreet: She should also obtain copies of exhibit contracts and LOAs, as well as relevant industry codes of conduct that deal with exhibits and in-kind support.
Can exhibit agreements include the arrangements for in-kind contributions?
Parochka: GPS policies and procedures separating promotion and education must be in place to satisfy both Accreditation Council for CME and Food and Drug Administration regulations. Equipment and supplies that constitute in-kind contributions must be assigned an estimated dollar value, indicated in the CME activity budget and noted in a Letter of Agreement between the commercial interest and CME Provider.
Overstreet: You’re right, Jackie—in-kind support as defined by the ACCME is support for education and should be documented, monitored, and communicated separately from exhibit support. Rebecca should also ensure that learners are informed appropriately about in-kind support.
How should Rebecca handle a discussion with Maggie about exhibit and educational activity documentation?
Parochka: While it’s important to preserve relationships with commercial interests, no accredited provider wants to be found in noncompliance with ACCME policy. GPS needs two separate documents covering financial contributions from commercial interests. Rebecca could consider taking Maggie to lunch and explaining why she needs separate documentation for educational support and exhibit fees.
Overstreet: Rebecca could also prepare draft agreements and solicit Maggie’s input, which would protect both parties while meeting both of their needs.
How do you document the value of in-kind contributions?
Parochka: Although in-kind contributions are not explicitly mentioned in the AdvaMed Code, device manufacturers are asked to establish a “fair market value” using objective, verifiable criteria, and methods used by companies should be documented. Providers can ask donors for the “fair market value” of equipment provided for the educational sessions.
Overstreet: If the product cannot be reused, its fair market value is what it would cost the provider to purchase the product; reusable products may have a reduced market value. Whatever the value, providers should note it in the LOA, as well as in the activity budget.
Karen Overstreet, EdD, RPh, FACME, CCMEP, is executive director, Lippincott CME Institute, Wolters Kluwer Health Medical Research, Blue Bell, Pa. Reach her at Karen.Overstreet@wolterskluwer.com.
Jacqueline Parochka, EdD, FACME, is president and CEO, Excellence in Continuing Education Ltd., Gurnee,
Ill.; and partner, PTR Educational Consultants. Reach her at JacquelineParochka@comcast.net.
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