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2019 Legal Affairs

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

In 2019, AdvaMed advocacy led to HHS and CMS proposed rules to advance value-based health care. HHS’s proposed rule would add new safe harbors to the federal Anti-Kickback Statute (AKS), and modernize existing safe harbors, to give health care providers and manufacturers added flexibility to improve the quality of care for patients. The move represents a crucial step towards a more patient-centered, value-based health care system that will help achieve better clinical outcomes, lower costs, and an improved patient experience.

Civil Justice & Litigation Reform

During the year, AdvaMed elevated civil justice and litigation reform as a priority issue. Our recently formed Defense Academy Working Group focused on bringing transparency to the issues of misleading ads and third-party litigation funding, and we worked to support passage of bills in Tennessee and Texas aimed at regulating such ads disguised as medical alerts.

Ethics & Compliance

AdvaMed’s legal team led efforts to implement a comprehensive refresh of AdvaMed’s U.S. Code of Ethics on Interactions with Health Care Professionals, effective Jan. 1, 2020. Based in part on feedback from diverse stakeholder groups and approved by the AdvaMed Board, 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 included creation of an introductory video, training materials, and other tools and resources to aid awareness, member education and certification to the updated code.

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 31 – up from 13 in 2012 – and led a focus on innovative ways governments can incentivize enterprises to adhere to high-standard ethical business practices. As a result of AdvaMed efforts in recent years, harmonized codes of ethics have now also been adopted across every country in Latin America.