When a Medicare patient receives a diagnosis, she shouldn’t be told that the most effective FDA-approved treatment might be covered by Medicare — in six years. Yet this is the reality confronting patients nationwide, creating a bureaucratic barrier between seniors and lifesaving medical innovation.
This troubling delay between FDA approval and Medicare coverage represents a crisis hiding in plain sight. While breakthrough medical technologies reduce hospital stays by 38% and cut deaths from breast cancer by 43%, Medicare patients — who often need these innovations most urgently — wait nearly six years to access them after regulatory approval.
That’s why dozens of state life sciences associations from coast to coast recently joined together to urge the Centers for Medicare and Medicaid Services (CMS) to create a streamlined pathway for Medicare coverage of breakthrough medical technologies. We’re not asking for preferential treatment; we’re asking for common sense, putting patients first.
The current system shortchanges patients and stifles the innovation that makes America the global leader in medical technology. Our industry has significantly contributed to decreasing fatalities from heart disease and stroke by 49% and the enabling of earlier identification of diseases like Alzheimer’s and Parkinson’s. Existing programs like the Transitional Coverage of Emerging Technologies pathway fall short, lacking the scope and breadth of coverage needed to meaningfully increase access.
The solution is straightforward. Implementing a program mirroring key tenets of the original Medicare Coverage of Innovative Technology framework would provide coverage for FDA-authorized breakthrough technologies — including diagnostics that enable early detection and prevention — while establishing a clear road map for CMS to collect additional evidence for permanent coverage decisions. This approach respects both the FDA’s rigorous safety standards and Medicare’s need for evidence-based coverage.
Under the current process, Medicare patients are often the last to access breakthrough innovations. Private insurers frequently cover FDA-approved technologies years before Medicare acts, creating a situation where seniors and disabled Americans — who often have the greatest medical needs — are denied timely access to impactful medical technology.
This isn’t just a health care issue — it affects American competitiveness. When our Medicare system creates yearslong delays for breakthrough technologies, it signals to global investors and innovators that America may not be the best place to bring medical innovations to market. Countries with more streamlined approval-to-coverage pathways become increasingly attractive for companies developing the next generation of lifesaving devices and diagnostics.
As CEO of Utah’s life sciences trade association and chair of the national State Medical Technology Alliance (SMTA), I regularly witness this challenge’s real-world impact. Utah exemplifies what’s at stake. A 2021 report prepared by Macro Policy Advisors for AdvaMed, a national association of medical technology companies, found Utah ranked the eighth-largest medical technology center nationwide in revenue and ninth in jobs. Our $6 billion medical technology industry employs nearly 16,000 people earning an average of $66,455 annually, 25% above the state average.
Medical technology generates significant economic impact beyond direct employment. Each dollar of medtech revenue in Utah creates an additional 75 cents in state economic activity, while each medtech job supports 1.4 additional jobs across our economy. This multiplier effect extends to all 50 states, where America’s $149 billion medical technology industry supports nearly 400,000 high-paying jobs while driving economic growth and solving healthcare challenges. challenges.
The broad coalition supporting this reform — spanning patient advocacy groups, state trade associations and medical technology companies — demonstrates that this transcends typical industry advocacy. When organizations representing Alzheimer’s patients, cancer survivors and cardiac care advocates unite with business groups, it signals a genuine need requiring immediate attention.
CMS has an unprecedented opportunity to modernize Medicare coverage for medical innovation. The Trump administration has prioritized reducing regulatory obstacles and making America healthy again. This is an opportunity to deliver on both simultaneously by ensuring seniors have timely access to preventive technologies and breakthrough treatments.
Every day of delay means more Medicare patients are denied access to technologies that could extend their lives, reduce their suffering or improve their outcomes. They deserve better than bureaucratic inertia that prioritizes process over patients.
The question isn’t whether Medicare should cover breakthrough medical technologies — it’s how quickly we can make that coverage a reality. Six years is six years too long.