Is a newsletter created by an ad agency on behalf of a pharmaceutical client that is an applicable manufacturer, consisting of a few journal abstracts on the disease state and information on patient adherence, a reportable payment or other transfer of value? If so, what “nature of payment” category should the newsletter be reported in? Additionally, can the ad agency as a third party collect and maintain the physician information that is required for reporting?
Yes, a newsletter consisting of a few journal abstracts provided to physician covered recipients from an applicable manufacturer (directly or indirectly) is considered a reportable payment or other transfer of value for purposes of Open Payments if the newsletter is valued at $10 or more or the aggregate amount of payments or transfers of value provided to a covered recipient exceeds $100 in a calendar year. Applicable manufacturers must select the “nature of payment” category that they believe most accurately describes a payment or other transfer of value. (42 C.F.R. § 403.904(e)(2)) Therefore, applicable manufacturers must select the “nature of payment” category that best describes the provision of the newsletter to a covered recipient. The “nature of payment” category applicable to newsletters created by advertising or marketing agencies is “gift,” depending on the circumstances of the transfer of value. Third parties, such as an ad agency, can maintain the information collected that is required for reporting by applicable manufacturers.Key words: Open Payments, Sunshine Act