AdvaMed’s Medical Innovation Agenda for the 119th Congress
In 2025 and 2026, the 119th Congress has a critical opportunity to advance policies that will significantly improve patient access to life-saving medical tests, treatments, and technologies. According to the Advanced Medical Technology Association (AdvaMed), successful legislation would dramatically improve patient outcomes.
AdvaMed is committed to advocating for solutions that enhance the patient and provider experience to ultimately save and improve lives. The organization’s top priorities for this new congressional session, working with the new administration, highlight opportunities to address the most pressing issues facing patients and the medical technology industry today. AdvaMed will collaborate with leaders and medtech champions from both parties in Congress to foster greater medical innovation and expand access to medical technologies.
“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
Key Priorities:
Modernizing CMS for Medtech Innovation
The current process for payment and reimbursement through the Centers for Medicare and Medicaid Services (CMS) is often slower and less predictable than the Food and Drug Administration’s (FDA) review process. This leads to extended wait times for patients to access new technologies.
The median wait time for a Medicare coverage decision on an FDA-cleared medical technology is 5.7 years.
AdvaMed suggests the following:
- Reintroduce and pass bills from the last Congress such as: The National Coverage Determination Transparency Act, The Supporting Innovation for Seniors Act, The Timely Access to Coverage Decisions Act, and The Patient Access to Innovative New Technologies Act of 2024.
Expanding Access to Breakthrough Technologies
AdvaMed is seeking to expand patient access to breakthrough medtech innovations by improving the Medicare coverage pathway through CMS. This would help maintain the U.S.’s position as a leader in innovation.
- Congress should pass the Ensuring Patient Access to Critical Breakthrough Products Act.
Ensuring Tax Policies Support Innovation
Tax policy has the power to encourage the research and development critical to medical innovation. Congress should:
- Reinstate the immediate expensing of research and development costs, because the current tax code change provides a disincentive for investment and harms small businesses, which make up more than 80% of the medtech industry.
Harnessing AI to Improve Outcomes
Artificial intelligence is already playing a hugely important role in modern health care. AdvaMed is promoting:
- Evaluate the need to update the Health Insurance Portability and Accountability Act (HIPAA) for the AI era.
- Develop guidelines around patient notice and authorization for data used to develop AI.
- Address the impact of budget neutrality constraints on coverage and adoption of AI technologies.
- Develop a formalized payment pathway for algorithm-based health care services (ABHS).
- Pass legislation to facilitate the adoption and reimbursement of digital therapeutics.
Strengthening U.S. Global Leadership
The U.S. currently represents 40 percent of the global medtech market. To maintain and increase this position, AdvaMed is asking Congress to:
- Work with AdvaMed on tariff exemptions for medical technologies.
- Address implementation issues with EU regulations.
- Ensure stable medical device policies with Japan.
- Secure commitments for medtech global access in trade agreements.
Securing American Medtech Supply Chain Resilience
To protect healthcare supply chains, Congress should:
- Work with AdvaMed and the administration to avoid supply chain disruptions due to tariffs.
- Ensure the medtech industry has access to sufficient quantities of key medical technology inputs.
- Bolster trade agreements to include commitments on medtech supply chain resilience.
Strengthening the Regulatory Process
To ensure the latest medical technologies reach patients, Congress should:
- Work with AdvaMed to monitor FDA progress in meeting hiring targets.
- Ensure additional resources support streamlining the review process.
Ensuring FDA Keeps Pace
Medtech innovation is occurring at a rapid pace. Congress can ensure improvements through:
- Supporting electronic labeling.
Ensuring Access to Accurate Diagnostic Tests
The IVD (in vitro diagnostics) industry is a cornerstone of modern health care.
- Congress should enact legislation to authorize the FDA to implement a technology certification pathway for IVDs, modernize point-of-care and at-home testing regulations, and reform the CLIA waiver process.
Boosting Innovation via American Start-Ups
With a majority of American medtech companies being small businesses, Congress should:
- Pass payment policies that promote adoption of innovative technologies
- Continue to preserve tax policies that encourage investment in small medtech companies.
AdvaMed is encouraging Congress to create a supportive environment for innovation to improve the quality of life for patients.
