Every day in cardiac catheterization laboratories across America, interventional cardiologists witness both the promise and the limitations of modern cardiovascular medicine. We see patients arrive with chest pain or difficulty walking, and through minimally invasive procedures, often completed the same day, we restore blood flow that saves hearts and limbs. We also see patients who arrive too late, when disease has progressed beyond what even our most advanced technologies can reverse. 

As the nation's leading professional society dedicated to interventional cardiology, the Society for Cardiovascular Angiography and Interventions (SCAI) represents more than 5,000 physicians across 75 countries who are on the front lines of cardiovascular care. Our members perform over 900,000 percutaneous coronary interventions annually and treat countless patients with peripheral vascular disease. This expertise provides us with unique insight into both the remarkable capabilities of modern medical technology and the policy barriers that prevent too many patients from benefiting from these advances. 

This American Heart Month offers an opportunity to shine a light on two critical gaps in our healthcare system. First, approximately 400 Americans lose a limb to peripheral artery disease (PAD) every single day, and most of these amputations are preventable with early screening and intervention. Second, Medicare beneficiaries wait an average of six years after FDA authorization before gaining access to breakthrough medical technologies that could transform their care. These aren't abstract policy failures; they represent patients whose lives could have been fundamentally different with timelier intervention. 

Fortunately, two bipartisan bills currently under consideration in Congress offer solutions that would fundamentally improve cardiovascular care for millions of Americans: the Amputation Reduction and Compassion (ARC) Act (H.R. 307) and the Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343/S. 1717). Together, these measures represent a significant effort to modernize Medicare coverage while addressing critical health disparities that our members confront in their practices daily.   

Confronting the Silent Epidemic of Peripheral Artery Disease 

Peripheral artery disease affects 10–20 million Americans, yet 70% of the public remains unaware of this condition. PAD occurs when narrowed arteries reduce blood flow to the limbs, increasing the risk of heart attack, stroke, amputation, and death. 

The ARC Act addresses this crisis head-on by requiring Medicare and Medicaid to cover PAD screening tests—including ankle-brachial index testing and arterial duplex scans—for at-risk beneficiaries without cost-sharing. The legislation also establishes a national PAD awareness program through the Department of Health and Human Services. 

This legislation is essential because early detection saves lives and limbs. Advanced medical technologies, including drug-coated balloons, specialized stents, and atherectomy devices, enable interventional cardiologists to perform minimally invasive revascularization procedures that restore blood flow and prevent amputations. However, these interventions are only effective if PAD is diagnosed before reaching critical stages.   

Accelerating Access to Life-Saving Innovations 

While the ARC Act focuses on early detection, the Ensuring Patient Access to Critical Breakthrough Products Act tackles the downstream challenge of accessing innovative treatments. Currently, FDA-designated breakthrough devices, which by definition address life-threatening or irreversibly debilitating conditions, face bureaucratic delays that prevent Medicare coverage for years after approval. 

This legislation would provide four years of temporary Medicare coverage for breakthrough medical devices and diagnostic tests, creating a bridge period during which manufacturers can generate evidence for permanent coverage decisions. Importantly, the bill maintains critical safeguards, allowing CMS to suspend coverage immediately if evidence demonstrates harm or lack of clinical benefit.   

The Medtech Partnership in Cardiovascular Care 

Both legislative initiatives underscore the indispensable role of medical technology innovation in modern cardiovascular care. The sophisticated devices used to diagnose and treat PAD represent decades of research, development, and clinical refinement by the medtech industry. From next-generation imaging systems that enable precise diagnosis to advanced endovascular tools that allow minimally invasive treatment, these technologies have transformed what's possible for patients. 

Consider the evolution of PAD treatment: patients who once faced surgical bypass procedures with extended recovery times can now benefit from same-day endovascular interventions using cutting-edge devices. Drug-eluting stents, advanced atherectomy systems, and specialized balloons enable interventional cardiologists to restore blood flow with remarkable precision and safety. 

However, innovation without access provides no benefit. Medicare patients deserve timely coverage of the breakthrough technologies their government has certified as safe and effective. The current system where seniors wait years for access to devices that could prevent disability or death, represents a policy failure that these bills would correct.   

A Call to Action This American Heart Month 

As the leading professional society dedicated to interventional cardiology, SCAI urges Congress to pass both the ARC Act and the Ensuring Patient Access to Critical Breakthrough Products Act. These complementary measures would create a continuum of care: from early screening that catches disease before it becomes critical, to rapid access to innovative treatments that can preserve function and save lives. 

The statistics are stark: more than half of major amputees die within five years, and the total annual economic burden of PAD exceeds $233 billion. We have the screening protocols, the medical technologies, and the clinical expertise to dramatically reduce these numbers. What we need now is the policy framework to ensure all Americans can benefit. 

This American Heart Month, let's commit to policies that match the pace of medical innovation with the urgency of patient need. Patients deserve nothing less. 
 

Media Contact:

Gavin Stern 
[email protected], 202-644-8561 

About the Society for Cardiovascular Angiography & Interventions (SCAI) 

The Society for Cardiovascular Angiography & Interventions, established in 1978, stands as the primary nonprofit medical society dedicated to representing invasive and interventional cardiology. SCAI's mission is to guide the global interventional cardiovascular community by fostering education, advocacy, research, and upholding standards for quality patient care. For more than 40 years, SCAI has exemplified professional excellence and innovation worldwide, cultivating a reputable community of over 5,000 members committed to advancing medical science and providing life-saving care for individuals, both adults and children, affected by cardiovascular disease.  For more information, visit www.scai.org.