On March 18, 2022, the Advanced Medical Technology Association (AdvaMed) – the world’s largest trade organization representing medical technology manufacturers – announced revisions to its Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code). The effective date of the revised AdvaMed Code is June 1, 2022.

The AdvaMed Code was updated to address arrangements to advance value-based care, consistent with the recent Anti-Kickback Statute (AKS) value-based safe harbor rules, as well as the U.S. Department of Health & Human Services, Office of Inspector General’s (OIG) November 2020 Special Fraud Alert on Speaker Programs. AdvaMed issued a revised Code, FAQs, and a standalone guidance document.

Key updates in the AdvaMed Code include guidance with respect to:

  • Providing alcohol at Company-conducted programs and meetings;
  • Virtual meetings and programs;
  • Interactions and arrangements with HCPs relating to value-based care (e.g., results-based, outcomes-based, or performance-based arrangements); and
  • Leveraging data and technology to provide innovative solutions and cost-effective care.

AdvaMed’s newest guidance follows shortly behind an August 2021 announcement by the Pharmaceutical Research and Manufacturers of America (PhRMA) – which represents the nation’s leading biopharmaceutical research companies – that it updated its Code on Interactions with Health Care Professionals, to address many of the same topics. The updated PhRMA Code took effect January 1, 2022.

Medical technology companies would be well-served to review the revised AdvaMed Code and guidance and consider adjustments to their current compliance operations in light of the updates.

Reed Smith is honored to serve as outside counsel to AdvaMed and we are pleased and available to provide additional information on and assistance with implementing the revised AdvaMed Code. Please reach out to the authors of this post or the Reed Smith attorneys with whom you regularly work for more information or guidance on these changes.