In 2023, Congress has the opportunity to advance policies that will dramatically improve patient access to the life-changing and lifesaving medical tests, treatment, 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 experience – and ultimately save and improve lives.

Our top medtech priorities for the 118^th Congress 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.

“America’s medtech companies continue to lead the world in medical innovation, improving lives and patient outcomes through accurate diagnostic testing, and safe and effective treatments. As we look to the future, the medtech industry is ready to strengthen its critical leadership role in meeting the needs of patients—we are ready to roll up our sleeves and work with the 118th Congress on policies that will prioritize and improve the lives of every patient in America, every time they need access to care.” 

––Scott Whitaker, President and CEO, AdvaMed

Top Medtech Priorities for the 118th Congress to Help Usher in a New Era of Innovation on Behalf of All American Patients

To the 118^th Congress:

More than ever before, the critical role the medical technology industry plays in our health care system was on full display throughout the pandemic. Our industry was at the center of the global crisis, developing and distributing billions of Covid tests and every other critical medical technology necessary to treat patients suffering from Covid.

We at AdvaMed, the world’s leading trade organization representing medical technology and device manufacturers, are proud of the medtech community’s incredible effort to meet the demands of the pandemic. But the reality is, it is only a small part of the overall picture of medtech: Everything you see, for example, when you walk into a clinic or doctor’s office or operating room—literally everything but the people and the pharmaceuticals—is medtech and plays an indispensable role in your care.

Whether it is the nearly 50 million surgeries performed annually in the U.S. or the delivery of 4 million babies, advancements in medtech are driving better outcomes, longer and healthier lives, and lower costs. Innovative medical technology is a key driver in increased U.S. life expectancy, which is projected to increase by nearly six years by 2060.

As we enter the 118^th Congress, there is a great opportunity for both sides of the aisle to come together on broadly bipartisan initiatives that will greatly impact patients. Recent polls show health care is a top priority of both Democratic and Republican voters; they want to see their elected representatives work across the aisle to improve access to care and lower costs—two areas in which medtech can play an important role.

And there’s nowhere better for the 118^th Congress to start than right here:

We have identified nine top priorities—from the unique vantage point of the lifesaving medical technology industry—that would have an immediate and long-term impact on patient care. Taken as a whole, they would unleash a new era of life-changing innovation for patients.

From diagnostics to treatment to recovery, patients want to know they are being treated not just by the best doctors and nurses—but with the latest and best medical technologies as well. Working together to turn these policies into law will go a long way toward ensuring every patient feels precisely that way about their care, every time.

We look forward to working with you to pass these initiatives and send them to the President’s desk.

Scott Whitaker
President and CEO
AdvaMed

Improve 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, as well as foster greater innovation. Congress should:

• Pass bipartisan legislation similar to the Ensuring Patient Access to Critical Breakthrough Products Act, introduced last Congress by U.S. Rep. Suzan DelBene (D-Wash.) and the late Rep. Jackie Walorski (R-Ind.), which 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.
• Work with CMS on its Transitional Coverage of Emerging Technologies (TCET) proposed rule to establish a distinct, predictable alternative pathway to national Medicare coverage for emerging medical devices and diagnostics.

Strengthen U.S. Medtech Industry’s Global Leadership Position

The U.S. is the global leader in medtech. Patients worldwide deserve access to the lifesaving, life-enhancing medtech developed by the American industry. Congress should:

• 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, and health care supply chain prioritization and broaden patient access to medical devices, such as those undertaken by the United States-India Trade Policy Forum and the Indo-Pacific Economic Framework.

Secure American Medtech Supply Chain Resilience

The pandemic highlighted the increasing interconnectedness of the global supply chain and the resulting vulnerability to our health care system of significant disruptions. Protecting and prioritizing health care supply chains, both at home and across the globe, are essential to ensuring the timely delivery of patient care. Congress should:

• Work with the Administration to ensure the federal government obtains and maintains sufficient quantities of the key medical technology inputs, including semiconductors, plastics, and medical grade packaging, needed for patient care.
• Continue to press for the prioritization of medical applications in semiconductor chip supply manufacturing and procurement incentives, including mature chips, at the federal and state levels.
• Work with AdvaMed and the Administration to help increase supply chain support through industrial base expansion and enhanced trade with reliable partners.
• Bolster trade agreements to include commitments on medtech supply chain resilience and health care prioritization.

Ensure Patient Access to Accurate Diagnostic Tests

Medtech companies will continue to deliver patients the diagnostic testing products they need and expect. In order to achieve this critical goal, Congress should:

• Enact the bipartisan Verifying Accurate Leading-edge IVCT Development Act (VALID) Act.
• Work with AdvaMed’s coalition of laboratory stakeholders to ensure appropriate Medicare reimbursement rates for diagnostic tests. The flawed implementation of the Protecting Access to Medicare Act (PAMA) created an unsustainable payment system, necessitating congressional action.
• Re-authorize the Pandemic and All Hazards Preparedness Act (PAHPA), and advocate for the inclusion of lessons learned from the response to COVID-19 to prepare for future pandemics and other health emergencies.

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 and net operating losses.
• Ensure that policies coming out of the Federal Trade Commission regarding non-compete agreements do not place small companies at a competitive disadvantage.

Strengthen Regulatory Process to Ensure 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.

Close the Care Gap for Underserved Communities

The gaps in care and outcomes between those served in our best facilities and those in underrepresented and vulnerable populations are unacceptable. Diversity in medical device clinical trials will help close the gaps. Congress should:

• Pass legislation to accommodate payment for alternative providers (nurses, nurse practitioners, primary care providers) who can support clinical research through use of alternative trial design or alternative data collection methods that are supported, including digital and telehealth technologies.
• Work with AdvaMed to enhance diversity in trials, support legislation to modernize human subject reimbursement and compensation regulations and create safe harbors for financial assistance for human subjects and investigators vis a vis the federal Anti-Kickback Statute.

Protect Sterilization Processes in Order to Protect Public Health

Federal regulations must protect the health care system’s ability to continue serving patients with sterile medical equipment. Congress should:

• Ensure EPA regulations allow the medtech industry to meet growing demand for sterile medical devices in health care settings nationwide, preserving a stable domestic function, complying with and exceeding all local, state, and federal laws on ethylene oxide emissions using sophisticated technology.
• Reiterate to federal, state, and local regulators that patients and communities come first in every aspect of medical technology, including the sterilization of the medical devices necessary for every aspect of health care, from screening to the operating room to post-operative care.

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 should:

• Reinstate the immediate expensing of research and development costs. The Tax Cuts and Jobs Act of 2017 changed expensing timelines to be amortized over a number of years. This change provides a disincentive for investment and makes U.S. businesses less competitive.

Learn more about AdvaMed’s policy work.