On March 24th, 2022, the Advanced Medical Technology Association’s (AdvaMed) Board of Directors approved updates to the AdvaMed Code of Ethics (Code), which provides guidance to the healthcare industry on interactions between medical technology companies and healthcare professionals (HCPs). The revised Code goes into effect on June 1, 2022.
Of particular note to HCPs are the updates to guidance around company-hosted educational and training events. It is common in the industry for companies to provide education and training to the HCP community; however, these events can implicate the federal anti-kickback statute because they may involve the provision of free items (e.g., meals) to HCPs. The Code has long provided guidance to industry on best practices for structuring these arrangements. Under the updated Code, AdvaMed provides additional guidance related to the provision of alcohol at company-conducted events, as well as factors to consider when evaluating and selecting venues, including restaurants, for company-conducted events. Addressing the transition to a virtual world over the last two years, the Code provides guidance to companies on the provision of meals and refreshments during company-conducted meetings that are held virtually. The Code also cautions companies to consider whether there is a legitimate need to pay HCPs’ travel expenses for in-person events where the purpose can be accomplished through a virtual event.
Additionally, the updated Code provides guidance around value-based care and other innovative business models. In new FAQs, the Code clarifies that bonafide consulting arrangements between HCPs and companies includes arrangements involving the development, evaluation or implementation of value-based care. The Code further permits companies to provide HCPs with information related to the economically efficient use of medical technologies in the context of a value-based arrangement, provided that the company does not interfere with the HCP’s medical decision making or provide such information as an unlawful inducement. AdvaMed specifies a company’s provision of free services to an HCP in order to eliminate the HCP’s overhead expenses as an example of such unlawful inducement.
The updated Code provides additional resources to enable companies and HCPs to structure arrangements between them in a compliant manner.
Copyright © 2022 Robinson & Cole LLP. All rights reserved.National Law Review, Volume XII, Number 100