AdvaMed’s Medical Innovation Agenda for the 119th Congress
In 2025 and 2026, the 119th Congress has a critical opportunity to advance policies aimed at enhancing patient access to vital medical tests, treatments, and technologies. These advancements are crucial for improving patient outcomes, according to the Medtech Association, AdvaMed®.
AdvaMed® has identified several top priorities for the current Congress, aiming to drive greater medical innovation, improve the patient and provider experience, and ultimately save and improve lives.
“I invite you to read our Medical Innovation Agenda for the 119th Congress through the eyes of patients. Would these bipartisan policies improve their quality of life, or extend their lives, or even save them? Our view at AdvaMed®, the Medtech Association, is that each and every one of them would. And we ask you not only to support them—but to actively promote them.” ––Scott Whitaker, President and CEO, AdvaMed®
AdvaMed® is collaborating with leaders and medtech champions from both parties in Congress to foster innovation and expand access to medical technologies.
Top Priorities for the 119th Congress
Scott Whitaker, President and CEO of AdvaMed®, emphasized the rapid pace of medical technology innovation, from AI-assisted diagnostics to wearable and implantable technologies. He underscored the importance of setting up doctors, nurses, and innovators for success. He also asked Congress to champion policies that streamline medical technology regulation, making it more efficient, transparent, and predictable.
“Let us ensure the government does not stand in the way of transforming patients’ lives.”
— Scott Whitaker, President and CEO, AdvaMed®
Modernizing CMS to Strengthen U.S. Leadership
One of the key areas of focus is modernizing the Centers for Medicare and Medicaid Services (CMS). Currently, the process for payment and reimbursement from CMS often lags behind the Food and Drug Administration (FDA) approval process. AdvaMed® advocates for updates to outdated laws and regulations to improve patient access and drive innovation in the medtech sector. A significant challenge is the median wait time of 5.7 years for a CMS decision on FDA-cleared technologies, a period known as the “valley of death”.
Expanding Patient Access to Breakthrough Technologies
AdvaMed® is urging Congress to expand patient access to breakthrough medical technologies. This includes expediting coverage determination processes and improving the availability of devices for patients through Medicare. The organization is advocating for policies to ensure that eligible medical technologies get timely coverage.
Ensuring Tax Policies Support Innovation
AdvaMed® also emphasizes the need to support the medical technology industry with suitable tax policies. Key among these measures is reinstating the ability to immediately expense research and development costs, which would incentivize investment, support small businesses, and promote further innovation. More than 80% of the medtech industry is made up of small businesses.
Harnessing the Power of AI
Artificial intelligence (AI) is transforming the medical field, and AdvaMed® is actively working with Congress to ensure that policies are in place to facilitate the safe and effective use of AI. They are advocating for updates to the Health Insurance Portability and Accountability Act (HIPAA) to allow for data sharing to aid in AI model training and development while preserving patient privacy. They are also urging Congress to develop a clear payment pathway for algorithm-based health care services and digital therapeutics.
Strengthening U.S. Leadership in the Global Market
The U.S. leads the global medtech market, and AdvaMed® is pushing for policies that maintain this dominance. They advocate for ensuring U.S.-made products’ global availability, addressing trade barriers, and securing commitments in trade agreements that support innovation. This includes securing exemptions and/or exclusions for medical technologies when tariffs are considered, securing continuity of patient access in the European Union, and addressing any possible trade barriers with Japan.
Securing American Medtech Supply Chain Resilience
AdvaMed® is working with the administration to avoid disruptions in the health care delivery system as a result of tariffs. Disruptions in the medtech supply chain can affect patient care and therefore, Congress should work to ensure sufficient quantities of key materials for the industry.
Strengthening the Regulatory Process
Congress should work with AdvaMed® to monitor the FDA’s success in meeting increased hiring targets for medical device reviews and ensure the streamlining of the review process. They also advocate for electronic labeling modernization, which will improve the availability and accessibility of information for both patients and healthcare professionals.
Ensuring Patient Access to Accurate Diagnostic Tests
AdvaMedDx® is working with Congress to ensure that patients can access accurate diagnostic tests. This includes establishing a technology certification pathway, updating point-of-care testing regulations, and reforming the CLIA waiver process. The organization is also working to reform the PAMA methodology and strengthen the nation’s public health infrastructure.
Boosting Next-Gen Medtech Innovation
To support the small businesses that drive innovation in the medtech sector, AdvaMed® is pushing for payment policies that increase the adoption of innovative technologies, as well as federal funding that supports research and development.
Scott Whitaker, President and CEO of AdvaMed®, provided his perspective on the future of the industry to the 119th Congress.
Scott Whitaker’s signature from the letter to Congress.
