On March 18, the Advanced Medical Technology Association (AdvaMed) announced revisions to its Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code or Code), last revised January 1, 2020. The new version of the AdvaMed Code will go into effect on June 1, 2022. AdvaMed's revisions are intended to provide useful and practical guidance to companies as they consider new ethical questions. The 2022 version of the AdvaMed Code (2022 Code) provides guidance on innovative business models, addresses recent value-based safe harbor modernizations, and offers further guidance on hosting company-conducted trainings and educational programs.

AdvaMed's announcement follows an update to the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Health Care Professionals, which covered many of the same topics.

AdvaMed's key updates to the 2022 Code include:

• Data-Driven Devices and Solutions: In its introduction, the 2022 Code now acknowledges data-driven devices and solutions. These include data-driven devices to enable data collection, aggregation, and analysis; clinical solutions to improve health outcomes; and business solutions to improve efficiency.

• Certification: Previously, the AdvaMed Code "strongly encouraged" companies adopting the Code to submit an annual certification, stating that the company adopted the Code and implemented an effective compliance program. The 2022 Code removes the suggestion that the certification occur annually, and it encourages (what appears to be) a one-time certification.

• Virtual Interactions: For the first time, the 2022 Code defines "virtual" interactions in its glossary as interactions "that involve[] attendees participating in a virtual environment that is generally enabled by digital technology rather than meeting in a physical location." The updated 2022 Code now includes a reference to virtual settings as options for various interactions throughout.

• Value-Based Care: The 2022 Code adds "value-based care" to its glossary, and defines it as "a health care delivery model in which contributors to care are paid based on individual patient health outcomes, population health outcomes, increasing access to healthcare for underserved populations, managing costs, and/or improving efficiency." These "may include payor-driven reimbursement arrangements for providers, arrangements between providers, and arrangements between providers and manufacturers or other participants in the health care system." The 2022 Code also adds assisting in the "development, evaluation, or implementation of an arrangement to advance value-based care" as an example of a bona fide consulting service and as a topic on which companies may train health care professionals.

• Consulting Arrangement Documentation: The 2022 Code adds "documentation" to the list of safeguards for engaging consultants. It now provides that companies "should maintain appropriate documentation which may include documentation regarding the process for determining legitimate need, fair market value compensation, and other relevant factors."

• Alcohol at Live Company Programs and Meetings: The 2022 Code provides new guidance as to best practices when hosting company-conducted training and educational programs or business meetings. With respect to alcohol, specifically, it states that decisions to provide refreshments, including alcohol, must comply with Section VII of the Code, which continues to require that the meal and refreshments must be modest and provided for an appropriate purpose, in an appropriate setting, and to appropriate participants. The 2022 Code further suggests that companies also consider implementing controls around the provision of alcohol, including for example, per-person drink limits, per-drink spend limits, limitations on the type of alcohol permitted, or disallowing alcohol at certain events. It also suggests that companies review AdvaMed's periodic benchmarking on best practices related to modest meals and refreshments.

• Educational Grants and Commercial Sponsorships: The 2022 Code updates the 2021 Code's FAQs on educational grants and commercial sponsorships, with a framework for how companies should assess requests for these activities. It now explains that companies may give varying weight to different factors in assessing whether to support a third-party program. For example, for a program in a resort location, the company "may want to consider other factors about the program to determine if, on the whole, the program is appropriate" — such as a robust agenda, whether there are recreational activities associated with the program, and whether the venue maintains adequate conference facilities.

• Virtual Meals and Refreshments: The 2022 Code provides that modest meals or refreshments may be provided in accordance with Section VII of the Code during meetings held virtually. Companies may create a process to control ordering and delivery, track attendance, and prohibit home delivery.

• Reimbursement and Health Economics Information to Negotiate Value-Based Contracts: The 2022 Code explains that companies may provide accurate and objective information relating to the economically efficient use of its medical technologies, including in the context of value- and outcomes-based contracting, but may not interfere with a health care professional's independent clinical decision-making or provide the information as an inducement.