Innovation and advocacy in medical technology go hand-in-hand, and 2019 proved to be a year of extraordinary progress for AdvaMed and the medical technology industry. During the year, we achieved full and permanent repeal of the medical device tax. Capping AdvaMed’s decade-long campaign to get rid of this innovation-crushing tax, repeal was arguably the most significant win in the association’s history (see Advocacy In Action for details).
From repealing the device tax to achieving key Medicare payment reforms that will expand patient access to innovation, to launching The Story of Medtech patient engagement platform and the AdvaMed Advance inclusion and diversity initiative, working together we achieved critical results on behalf of industry and patients.
Fulfilling our mission to continue improving health care and improving lives, AdvaMed worked throughout the year with policymakers and other stakeholders in Washington and around the world to advance health policy solutions that yielded important benefits to AdvaMed members and the patients they serve. In brief, AdvaMed’s advocacy successes in 2019 included:
- Winning full and permanent repeal of the medical device excise tax, saving our industry nearly $2 billion annually.
- Addressing increased regulatory activity surrounding ethylene oxide sterilization while educating stakeholders on its importance, and bolstering our industry’s reputation for providing safe and effective health care solutions.
- Accomplishing key Medicare payment reforms, and improved coding processes, to support medtech innovation and speed patient access to breakthrough products and other life-changing new treatments and cures.
- Ensuring effective implementation of key provisions we supported as part of the FDA user fee agreement and the 21st Century Cures Act, as well as regulatory reforms in the FDA Reauthorization Act, to help accelerate patient access to innovation.
- Launching our MedTech Information Sharing and Analysis Organization, in line with our cybersecurity principles, to provide a safe space for the medtech industry to share cybersecurity information. We also achieved inclusion by FDA of key industry priorities in planned revised draft guidance on premarket cybersecurity.
- Exempting our industry from new burdensome and redundant state-level data privacy requirements in California and several other states, leading a national effort to address similar data privacy legislation in other states, and pushing back against inappropriate state-based “Right to Repair” legislation.
- Achieving key international objectives, such as improvements in regulatory processes in China and Brazil, prevention of centralized pricing across China, mitigation of reimbursement cuts in Japan, pro-innovation provisions in the U.S.-Mexico-Canada free trade agreement, and progress toward stopping price controls in India.
- Addressing ongoing global challenges, including issues surrounding implementation of new device and diagnostics regs in Europe, the trade war with China, and volume-based procurement in China’s provinces.
- Advancing new safe harbors to the U.S. anti-kickback statute to enable more expansive and patient-centric value-based payment arrangements, civil justice and litigation reform, implementation of a comprehensive refresh of AdvaMed’s U.S. Code of Ethics, and increased global harmonization of high-standard codes.
- Leading pro-innovation diagnostics regulatory reform efforts in concert with lab, patient and provider organizations, including through support of stakeholder processes on the Hill to refine bipartisan legislation poised for introduction in the House and Senate.
- Securing passage of bipartisan legislation (the LAB Act) through AdvaMedDx and in partnership with laboratories, aimed at ensuring more accurate Medicare reimbursement rates for diagnostics.
- Advocating through AdvaMed Accel for legislation and administrative rule-making that promotes investment in small firms, advancing initiatives that bring together a wider range of stakeholders in the innovation ecosystem – including academic institutions, and engaging the investment community directly for the benefit of small companies.
- Unveiling AdvaMed’s Center for Digital Health as a flagship advocacy platform to advance digital health policy, support and promote the contributions of our industry to data-driven health care, and assert our thought leadership on emerging issues such as data privacy.
- Creating AdvaMed’s biggest and best-ever annual conference in Boston in September. The MedTech Conference achieved double-digit percentage growth for the second year in a row, with over 3,300 attendees representing more than 1,400 companies and stakeholder groups from 39 countries.
- Rolling out our new patient engagement platform, The Story of Medtech, to provide a forum where our strongest advocates – patients – can share their stories of how they have benefited from the innovations your companies produce.
- Debuting our AdvaMed Advance initiative – at a special summit in September – to promote inclusion and diversity in the medtech industry, share best practices and collaborate on ways to make our industry the most diverse, inclusive and innovative in the world. This included creation of a framework to facilitate industry development of company-specific workplans and evaluate our progress. During the year, we also signed the CEO Action for Inclusion pledge to advance diversity and inclusion in medtech.