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Legal Affairs — 2018

Innovation Advocate  

AdvaMed’s Legal team advocates for a predictable legal environment that values innovative health care solutions, enhances public health, ensures patient access to advanced medical technologies, and advances the highest global standards for ethical interactions between industry and health care professionals (HCPs). Working with over 1,500 in-house lawyers and compliance officers at member companies around the world, our team weighs in on important litigation impacting the medtech industry across the country, and engages government regulators, physician specialty societies and other stakeholders to provide leadership and expertise on key legal issues.  

Value-Based Care 

This year, AdvaMed’s Working Group on Advancing Value-Based Health Care submitted revised proposals for new Anti-Kickback Statute safe harbors to facilitate value-based pricing, warranties, and risk-sharing arrangements. AdvaMed met with HHS Office of Inspector General (OIG) officials to discuss our proposals and submitted related comments to key stakeholders on Capitol Hill, at CMS and OIG.  

Ethics & Compliance  

In 2018, AdvaMed’s legal team led a comprehensive refresh of AdvaMed’s Code of Ethics on Interactions with Health Care Professionals. Based in part on feedback from diverse stakeholder groups, the refresh aims to ensure the AdvaMed Code keeps pace with our dynamic and innovative industry, and the evolving compliance landscape. Headed by a working group of over 50 lawyers and compliance officers, the effort culminated in AdvaMed Board approval in December 2018. The revised code is expected to become effective Jan. 1, 2020. 

Outside the U.S., the association continued to lead global efforts to ensure medtech industry compliance with the highest ethical standards. In the Asia-Pacific region, AdvaMed worked with government and industry stakeholders to increase the number of industry associations with a code of ethics to 29 (up from 13 in 2012), and spearheaded development of a distributor tool kit to facilitate compliance efforts.   

AdvaMed also held its 11th annual Global Medtech Compliance Conference in May in Paris, in collaboration with MedTech Europe. During the event, the Global Medical Technology Alliance – representing 26 leading international and regional medtech associations including AdvaMed – announced adoption of globally harmonized ethical business principles applicable across their respective member associations. 

In Latin America, at the April Summit of the Americas in Lima, Peru, Secretary of Commerce Wilbur Ross praised the medtech sector’s leadership in business ethics, and expressed his support for the Inter-American Coalition for Business Ethics in the Medical Technology Sector – established by AdvaMed and its medtech industry partners in Latin America and already boasting 16 harmonized codes of ethics across the region.