Earlier this month it was reported that two Oregon physicians entered into settlement agreements with the Oregon Department of Justice (DOJ) for failing to inform their patients of relationships with a medical device manufacturer. The civil action was brought by the Oregon DOJ under the Oregon Unlawful Trade Practices Act. The physicians were compensated by Biotronik, Inc. for participating in a program in which sales representatives were trained and certified to assist other physicians with programming and calibrating the company’s products. The amount of compensation received was not disclosed. Further, according to the article, the complaint states that each physician “had the potential to be paid each time he selected a Biotronik device for his patients rather than another manufacturer’s device.”
As part of the settlement, each physician agreed to pay a $25,000 fine to the state and to publish on their practice websites a hyperlink to the database of payments reported by pharmaceutical and medical device manufacturers that will be posted by the Centers for Medicare & Medicaid Services (CMS) in accordance with the federal Sunshine Act. According to news sources, Biotronik also is under investigation by the DOJ.
It is no secret that health care professionals are concerned about public perception and inaccurate reporting when manufacturers begin submitting information about health care professional payments and other transfers of value to CMS early next year. Because nearly every state has a consumer protection statute, health care professionals and manufacturers should be aware of this significant legal development.