AdvaMed’s Medical Innovation Agenda for the 119th Congress

In 2025 and 2026, the 119th Congress has the opportunity to advance policies that will dramatically improve patient access to the life-changing and lifesaving medical tests, treatments, and technologies that are so critical to improving patient outcomes. As long as there are patients in need, AdvaMed will continue advocating for solutions that will improve the patient and provider experience – and ultimately save and improve lives.

Our top medtech priorities for this new Congress, working together with the new administration, highlight opportunities to address the most important issues facing patients and the medical technology industry today. With these priorities as a guide, AdvaMed will collaborate with leaders and medtech champions from both parties in both houses of Congress to foster greater medical innovation and expand access to medical technologies.

Dear Members of the 119^th Congress,

In 2022, I said we were in the golden age of medical technology innovation. That is truer today than it was then. What’s more, we have the opportunity to work together to ensure that when history looks back on this era, people will call it the platinum age of medical technology innovation.

That is how quickly our industry is moving: From AI, which is already helping doctors to make more accurate cancer diagnoses, to wearable and implantable technologies that communicate in real time with doctors. From literal tattoos that monitor and transmit vital data to a patient’s care team, to robotic surgeries administered from thousands of miles away.

The definition of medical technology is clear: It is everything you encounter in the doctor’s office, the operating room, and even the minute clinic and telehealth. Medtech, without question, is the backbone of our health care system.

And the innovations on the horizon, through the medical technology industry, are hard to fathom. It is impossible to predict what health care will look like in five years, let alone 10 or 20.

From a policy perspective, how can we best set up our doctors, nurses, and medical technology innovators for success? How can we ensure patients live longer, healthier, and happier lives? What can you do as a champion for patients and medical innovation as a member of Congress, working with us as the Medtech Association?

What follows is a list of specific policies you can support, but the broader principle is simple: Support policies that will make the regulation of medical technology more efficient, more transparent, and more predictable, so that U.S. medtech innovators – the best in the world – remain on the leading edge of medical discovery. And as a champion for patients in Congress, you can ensure that the process for payment and reimbursement through CMS is every bit as efficient, clear, and predictable as the review process is at FDA. That is all our industry asks: Let us ensure the government does not stand in the way of transforming patients’ lives.

Your mother, your best friend, your grandfather, your children, and you – we are all patients, to one degree or another, at some point in our lives. Each of us relies on the medical technologies, devices, diagnostic tools, and imaging machines that take our vitals, that diagnose diseases, and that treat or cure them.

Patients deserve a regulatory process that unleashes and incentivizes the discovery and development of the medical technologies and treatments that help patients to see again, walk again, breathe easier, and live longer.

I invite you to read our Medical Innovation Agenda for the 119^th 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.

We look forward to working directly with you on this patient-focused agenda for the 119^th Congress.

Scott Whitaker
President and CEO
AdvaMed, the Medtech Association

Support the modernization of CMS to strengthen the U.S. position as the global leader in medtech innovation
FDA is known around the world for medical device safety and efficacy regulation, while the Centers for Medicare and Medicaid Services (CMS) does not enjoy the same reputation. Once a device is cleared by the FDA, the CMS process governing payment and reimbursement for that device does not match the efficiency, clarity, and predictability of the FDA’s. Outdated laws and regulations, misaligned policies for new technologies, insufficient performance metrics for key policy processes, and insufficient technical expertise slow down beneficiary access to many technologies. The median wait time for a CMS decision on an FDA-cleared medical technology is 5.7 years, and this is known as the “valley of death.” That is because more than 80 percent of the medtech industry consists of small businesses that too often cannot afford the years-long wait for a CMS decision and thus must close their doors. Too many promising, FDA-cleared medical technologies never get into patients’ and doctors’ hands because the process at CMS simply takes too long. Congress can address this by reintroducing and passing versions of these bills from the last Congress:

• H.R. 5389, the National Coverage Determination Transparency Act, requiring the Secretary of HHS to take action on national coverage determination (NCD) applications within 30 days of submission.
• H.R. 5388, the Supporting Innovation for Seniors Act, which would require Medicare Advantage plans to cover the same technologies covered by traditional Medicare.
• H.R. 5392, the Timely Access to Coverage Decisions Act, which would create a timeline for contractors reviewing local coverage determinations.
• H.R. 7939, the Patient Access to Innovative New Technologies Act of 2024, which would provide conditional approval for breakthrough devices to receive new technology add-on payment (NTAP) the first quarter of the year in which the device received FDA approval, clearance, or authorization.

Expand patient access to breakthrough medical technologies
Improving the Medicare coverage pathway through the Centers for Medicare and Medicaid Services (CMS) of breakthrough medtech innovations will benefit patients suffering from a lack of medical alternatives. Just as importantly, ensuring greater transparency and predictability in this process will spur greater innovation, helping to maintain the U.S.’s position as the leader in medtech innovation. While the Transitional Coverage of Emerging Technologies (TCET) rule implemented by CMS in 2024 is a step in the right direction, far more can and should be done to expand access to Medicare beneficiaries. Congress should:

• Pass bipartisan legislation similar to the Ensuring Patient Access to Critical Breakthrough Products Act, introduced last Congress by U.S. Reps. Brad Wenstrup (OH-02) and Suzan DelBene (WA-01) and in the Senate by U.S. Sens. Todd Young (R-IN) and Alex Padilla (D-CA). The legislation would guarantee Medicare beneficiaries access to cutting-edge, breakthrough medical innovation by expediting the coverage determination process and improving the availability of breakthrough devices for patients.

Ensure tax law keeps pace with medtech innovation
The right tax policy will help encourage the research and development that is so critical to medical innovation on behalf of patients in need. Congress’ opportunity to reauthorize the Tax Cuts and Jobs Act (TCJA) of 2017 gives us the opportunity to ensure tax policy helps, and does not hinder, those who are discovering the next treatments and cures patients depend on. Congress should:

• Reinstate the immediate expensing of research and development costs. The TCJA changed expensing timelines to be amortized over a number of years. This change provides a disincentive for investment, makes U.S. businesses less competitive and is particularly hard on small businesses and startups. More than 80 percent of the medtech industry is considered small businesses.

Harness the power of AI to improve outcomes and increase patient access to innovative medtech
As Congress grapples with the role of artificial intelligence on our roads, in our classrooms, and alongside us in the workplace, there is one realm in which the careful, thoughtful development of artificial intelligence and machine learning is improving and saving lives today – and it’s only getting started. Artificial intelligence is already playing a critically important role in our health care.

Leading this evolution in health care is the medtech industry that is driving the development and deployment of new AI applications that are safe and effective, improving both the patient and clinician health care experience.

We must take care in policymaking. Too much regulation, or inconsistent regulatory oversight, will stall the development of innovative medtech. Too little policy support, and lack of reimbursement for safe, proven technology, and patients will not have access to the benefits AI-enabled devices can provide.

In order to harness the technology’s immense power to support clinical workflows and augment the expertise of clinicians while improving the diagnosis and treatment of countless patients, AdvaMed recommends the following policy improvements.

• Evaluate the need to update HIPAA for the AI era. Ensure that HIPAA standards allow for the sharing of the datasets needed to train, test, validate, and re-train AI models while preserving patient privacy. The current HIPAA de-identification methods (authorization, safe harbor, and expert determination) stifle the high-volume data usage and sharing that can optimize the development of safe and accurate AI models.
• Develop appropriate guidelines around patient notice and authorization for the data used to develop AI. More data will allow for the creation of better, more accurate AI models. Patient notice and authorization should be at the center of additional data accessibility. New frameworks for health data regulation should consider any data limitations presented by HIPAA and other privacy laws.
• Legislation to address the impact of budget neutrality constraints on coverage and adoption of AI technologies. Generally, Medicare’s payment systems are required to maintain budget neutrality while developing new payment and coverage policies. These requirements and others like it have a significant impact on Medicare’s ability to expand coverage for and support the adoption of new technologies, including AI technologies, because the funding for these expansions comes at the cost of other services under the same payment system. We urge Congress to consider legislative solutions to address the impact of budget neutrality constraints on the coverage and adoption of AI technologies.
• Develop a formalized payment pathway for algorithm-based health care services (ABHS) to ensure future innovation and to provide Medicare beneficiaries access to this subset of FDA- authorized AI technologies for Medicare beneficiaries. A subset of AI technologies, ABHS are clinical analytical services delivered by FDA-authorized devices to a health care practitioner, using AI or other similarly designed software to produce clinical outputs for the diagnosis or treatment of a patient’s condition. ABHS provides quantitative and qualitative analyses, including new, additional clinical outputs that detect, analyze, or interpret data to improve the screening, detection, diagnosis, and treatment of disease. These technologies are rapidly developing and becoming increasingly integral to delivering optimal patient care. We urge Congress to pass legislation establishing a stable reimbursement pathway for FDA-cleared ABHS.
• Pass legislation to facilitate the adoption and reimbursement of digital therapeutics. Digital therapeutics are evidence-based, standalone or combination software products intended for management, maintenance, prevention, or treatment of a disease, disorder, or condition acting directly as a medical intervention or guiding the delivery of a medical intervention. These FDA- regulated medical devices can expand and extend access to critical health services. CMS recently extended coverage to a subset of digital therapeutics, defined by the agency as Digital Mental Health Treatment devices, but broader coverage and reimbursement policies are necessary to bring the full scope of these innovative therapies to the patients who need them most.

Strengthen the U.S. medtech industry’s global leadership position
The U.S. is the global leader in medtech, representing 40 percent of the global market. Two-thirds of the medtech used in the U.S. is made in the U.S., and our exports averaged approximately $72 billion between 2022 and 2024. Patients worldwide deserve access to the lifesaving, life-enhancing medtech developed by the American industry. To maintain U.S. strength in medical technology innovation and promote access to U.S.-made products around the world, Congress should:

• As tariffs are contemplated by the administration, work with AdvaMed to ensure exemptions and/or exclusions for medical technologies, given the critical nature of our products to the U.S. hospital supply chain and patients in need, and work with the administration to secure an efficient and effective exclusion process.
• Continue to ensure a level-playing field and better patient access to U.S. medical technologies in China, one of the fastest-growing medtech markets in the world.
• Continue to ensure continuity of patient access to medical technologies in the European Union by addressing serious implementation issues with the EU’s Medical Device and In-Vitro Diagnostic regulations.
• Work with AdvaMed to express to Japan the importance of maintaining stable, consistent medical device policies for the benefit of Japanese patients.
• In trade agreements, secure commitments that underpin medtech global access, such as best regulatory practices, regulatory harmonization, policies that reward innovation, and health care supply chain prioritization and broaden patient access to medical devices, such as those undertaken by the United States-India trade negotiations and the review of the United States-Mexico-Canada agreement.

Secure American medtech supply chain resilience
The medtech supply chain is increasingly complex and global. Natural disasters, geopolitical conflicts such as shipping attacks in the Red Sea, port strikes, and other factors beyond medtech manufacturers’ control can disrupt the supply chain and affect patient care. To protect and prioritize health care supply chains and ensure the timely delivery of patient care, Congress should:

• Work with AdvaMed and the administration to avoid disruptions in the health care delivery system as a result of tariffs that may create choke points across the medtech supply chain.
• Work with the administration to ensure that the medtech industry has access to sufficient quantities of the key medical technology inputs, including vital raw materials, parts, and electrical components necessary for patient care.
• Work with AdvaMed and the administration to help increase supply chain support through industrial base expansion, enhanced trade with reliable partners, and strategic use of the Defense Production Act.
• Bolster trade agreements to include commitments on medtech supply chain resilience and health care prioritization.

Specifically, Congress should pass bipartisan, bicameral legislation similar to the Medical Supply Chain Resiliency Act introduced last Congress by U.S. Sens. Tom Carper (D-Delaware) and Thom Tillis (R-N.C.) and Reps. Michelle Steel (R-Calif.) and Brad Schneider (D-Ill.) and the Promoting Resilient Supply Chains Act from Reps. Larry Bucshon, M.D., (R-Ind.) and Lisa Blunt Rochester (D-Del.). These bills would ensure that medical supply chains are strong, sustainable, and safe, allowing the industry to continuing treating patients across the globe.

Strengthen the regulatory process to ensure the latest medical technologies reach every patient
MDUFA V was a historic agreement, bringing greater predictability, consistency, and accountability to the entire device review process. Congress should:

• Work with AdvaMed to monitor FDA success in meeting increased hiring targets for medical device reviews.
• Ensure that additional resources support streamlining the review process such that improved performance targets are met for regulatory decisions on product submissions.
• Monitor FDA success in implementing provisions of the Consolidated Appropriations Act of 2023 including: predetermined change control plans, certificates to foreign governments, data transparency, and CLIA waiver provisions.

Ensure FDA keeps pace with the speed of medtech innovation
Medtech innovation is occurring at a more rapid pace than ever – and that pace will only pick up going forward. Patients depend on a predictable, transparent, and efficient review process for the medical technologies, devices, and diagnostic tests upon which they depend for their health and well-being. FDA has improved dramatically over the years, particularly as a result of the latest user-fee agreement, but Congress can ensure additional improvements through:

• Electronic labeling. Current law recognizes that device labeling, including additional accompanying information, such as instructions for use, may be provided electronically for a wide range of devices – including all prescription devices for use in health care facilities or by health care professionals, as well as other in vitro diagnostic devices for use by health care professionals or in blood establishments.

A bipartisan group of U.S. House of Representatives members introduced the Medical Device Electronic Labeling Act (H.R. 1539) in the 119th Congress. AdvaMed welcomes this legislation. Congress last addressed device electronic labeling in 2004. Since that time, reliance on online information has expanded astronomically. Consumers and patients, as well as health care professionals, increasingly turn to electronic sources for information about products. A growing number of popular consumer products are distributed without hard copy instructions.

Patients, physicians, caregivers, and manufacturers may all benefit from the broader application of electronic labeling for medical devices. Benefits to device users may include increased availability, utility, interactivity, and accessibility to the instructions for use.

During a Public Health Emergency, FDA may need to use its authority to quickly permit, under enforcement discretion or emergency use authorization, modifications to labeling, indications for use or functionalities of a medical device or diagnostic. Similarly, during a Public Health Emergency, the FDA may allow the expiration date of certain technologies to be extended. Rather than waiting for the manufacturer to physically print and distribute new labels or instructions for use to implement the change, electronic labeling would allow for real time updating of this information. This would help facilitate the availability of these expanded uses and labeling to patients and providers and to ensure they have accurate and up-to-date information.

Electronic labeling also is consistent with the FDA’s desire to keep pace with digital health innovation and encourage electronic communications in important functions.

The Food, Drug, and Cosmetic Act should provide for electronic labeling, including instructions for use, regardless of the setting of use or the intended user.

• Third-party lab testing. Manufacturers are responsible for the safety and effectiveness of their devices, including when using third-party medical device testing labs. In February 2024, the FDA noted concern that some third-party test labs overseas appeared to be generating test data that was unreliable. Testing from labs identified to be concerning will not be accepted by the FDA. We call on Congress to give FDA the authority necessary to publish a list of labs tested by third parties with a history of falsified data.
• Greater transparency and consistency in the de novo process. The de novo pathway is a classification process that uses a risk-based methodology for low- to moderate-risk devices for the approval of new and novel devices to be sold in the market. The current user fee agreement requires that 90 percent of de novo requests be decided within 150 days. The FDA is meeting this decision timeline, but half of the decisions are negative. We call on Congress to pass legislation requiring greater transparency from FDA on the rationale for its decision-making on de novo technologies.
• Recalls: A recall occurs when a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. In most cases, the manufacturer voluntarily recalls a device and notifies the FDA. The FDA will then post information about the action in the Medical Device Recall Database. Some members of Congress believe more needs to be done to communicate recalls with patients and in a timelier fashion and have proposed legislation that would institute a new, faster communication process. GAO is also looking at the current recall system and will be issuing a report with its findings.

Ensure patient access to accurate diagnostic tests
The in vitro diagnostics (IVD) industry, represented by AdvaMedDx, is a cornerstone of modern health care. Diagnostic tests are critical for personalized medicine and public health, as they inform patient care, guide treatment decisions, and improve health outcomes. Congress has a pivotal opportunity to empower patients and providers with critical diagnostic tools and to foster an environment that accelerates innovation. To achieve these goals, we urge Congress to pass legislation addressing regulatory, reimbursement, and public health-related policies.

A modern regulatory framework is essential to keep pace with scientific advancements and to ensure timely access to innovative diagnostics. A clear and predictable regulatory landscape encourages the development of new and improved diagnostic tests. Congress should enact legislation with the following key elements:

• Technology Certification Pathway: Authorize the FDA to implement a technology certification pathway for IVDs. This pathway would streamline the process for test developers to bring new or updated tests to patients and providers while ensuring reliability and accuracy. Under this program, eligible developers could be certified to develop multiple tests using a specific technology without the need for an individual premarket review of each test. This approach would make more tests accessible without the delays associated with individual FDA premarket submissions.
• Modernization of Point-of-Care and At-Home Testing Regulations: Point-of-care (POC) diagnostics are vital to the future of health care. With the increasing need for timely POC diagnostics – addressing issues from emerging infectious diseases to antibiotic resistance – and the benefits of broader access, these technologies are essential for providing timely care to patients. We urge Congress to modernize the FDA’s point-of-care testing regulations to accommodate advances in at-home and near-patient testing. Updating these regulations will ensure broader access to timely diagnostics, improve patient outcomes, and increase access by facilitating quicker diagnosis and treatment.
• Reforming the CLIA Waiver Process: CLIA-waived tests (e.g., tests performed in most physician offices and health clinics) play a vital role in supporting public health and advancing patient access by enabling diagnostic testing in a wide range of health care settings, including those serving underserved communities. We urge Congress to enact legislation to simplify and streamline the current process of obtaining a CLIA waiver. By reforming the CLIA waiver process, more diagnostic tests can be utilized in these settings, increasing patient access to essential health care services and improving public health outcomes.

Appropriate reimbursement policies are crucial for sustaining innovation in diagnostics and ensuring patients can access the tests they need. We urge Congress to enact legislation that would:

• Reform PAMA: Legislation is needed to address flaws in the Protecting Access to Medicare Act (PAMA) laboratory payment methodology. If left uncorrected, this defective approach will lead to reimbursement cuts that threaten access to both routine and advanced diagnostic testing, stifle innovation, and could force laboratories to close. By fixing the PAMA methodology, Congress can ensure that patients have access to the latest testing technology and innovations.
• Coverage of FDA-Approved Breakthrough Technologies: Enactment of legislation like the Ensuring Patient Access to Critical Breakthrough Products Act is needed to ensure Medicare coverage and payment for medical devices and diagnostic tests authorized under the FDA Breakthrough Devices Program. Currently, Medicare beneficiaries face significant delays in accessing lifesaving and life-improving diagnostic tests approved by the FDA under its Breakthrough Devices Program. Additionally, Congress should establish Medicare coverage for breakthrough technologies without an established Medicare benefit category, such as digital technologies that are otherwise not covered by Medicare.

Strengthening the nation’s public health infrastructure is vital for responding to emerging health threats. We urge Congress to:

• Reauthorize and Expand the Pandemic and All-Hazards Preparedness Act (PAHPA): We support the reauthorization and expansion of PAHPA, including provisions such as the Diagnostic Testing Preparedness Plan Act, to ensure a well-prepared and coordinated national response to public health emergencies. This includes prioritizing funding for the development and deployment of diagnostics during crises. By enacting PAHPA, Congress can strengthen the nation’s ability to respond swiftly and effectively to pandemics and other health threats.
• Ensure Continued Support for Public/Private Partnership Models to Expedite Test Development: In 2020, the National Institutes of Health launched the Rapid Acceleration of Diagnostics (RADx) Initiative to speed the development, commercialization, and implementation of technologies for testing. The RADx program works with IVD manufacturers, as well as multiple federal agencies, to accelerate the development and approval processes for critical diagnostics. RADx created highly successful public-private partnerships that facilitated the availability of diagnostics tests for infectious diseases, such as Mpox, COVID, and Flu A/B.
• Enact Antimicrobial Resistance (AMR) Legislation: Congress should enact legislation like the PASTEUR Act to incentivize the development of diagnostics and treatments for resistant infections, promoting the sustainable use of antibiotics. Addressing AMR is crucial for maintaining the effectiveness of existing antibiotics and ensuring new treatments are available to combat resistant pathogens.
• Permanently Fund the CDC’s Wastewater Surveillance Program: Congress should provide permanent funding for the CDC’s wastewater surveillance program, which offers early detection of pathogens by analyzing their viral presence in sewage. This program serves as an early indicator of community infection trends, regardless of health care access or testing availability, and is a critical tool for monitoring public health threats.

Boost next-gen medtech innovation through america’s start-ups
With more than 80 percent of American medtech companies considered small businesses, they are a key driver of the innovation that improves and saves patients’ lives. Ensuring their ability to bring their safe and effective medical devices to market is critical to improving patient outcomes. Congress should:

• Pass payment policies that promote adoption of innovative technologies, including TCET and other payment reforms.
• Work with AdvaMed to monitor FDA progress and rollout of the TAP Pilot to ensure compliance with MDUFA V requirements.
• Protect federal funding of research and development through programs like SBIR/STTR.
• Continue to preserve tax policies that encourage investment in small medtech companies such as provisions for qualified small business stock, research and development expensing, and net operating losses.

Learn more about AdvaMed’s policy work.