By Randall Rutta
As patient advocates, we’ve witnessed countless stories of hope deferred and lives put on hold while Medicare beneficiaries wait several years for access to breakthrough medical technologies that the FDA has already deemed safe and effective. This unacceptable delay between innovation and access must end. Innovation does not benefit patients without coverage.
Recent momentum in Congress gives reason for optimism. The National Health Council (NHC) and our patient-advocate members applaud the House Ways and Means Committee for passing the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343), a significant step toward eliminating the bureaucratic barriers separating Medicare patients from life-saving innovations.
The Urgency Behind the Numbers
The statistics paint a stark picture. Medical technology has transformed health care outcomes: reducing hospital stays by 38 percent, cutting breast cancer deaths by 43 percent, and decreasing heart disease and stroke fatalities by 49 percent. Yet for technologies requiring new reimbursement pathways, Medicare patients face an average six-year wait after FDA authorization before gaining coverage access.
Consider what this means for a 68-year-old diagnosed with early-stage Alzheimer’s disease. While an FDA-approved breakthrough diagnostic sits in regulatory limbo, precious months tick by – months that could have meant earlier intervention, better outcomes, and preserved quality of life for both patient and family.
Congressional Leadership Deserves Recognition
The NHC extends our gratitude to the congressional leaders driving this critical legislation forward. The House committee’s action on H.R. 5343, alongside the parallel Senate effort with S. 1717, demonstrates that breakthrough medical technology access transcends party lines. These bills would provide four years of coverage for FDA-designated breakthrough devices while creating a clear roadmap for permanent coverage decisions.
The Critical Need for Diagnostics Inclusion
While we celebrate this progress, we must emphasize one crucial gap: diagnostic tests. The current legislation excludes breakthrough diagnostics – including tests for early cancer detection, Alzheimer’s disease, and traumatic brain injury – that are equally transformative for patient care.
Diagnostics don’t just identify disease; they prevent costly hospitalizations, guide appropriate treatments, and enable early interventions that can dramatically alter patient trajectories. Any comprehensive breakthrough coverage program must include these critical tools, and we appreciate the Ways and Means committee’s willingness to work for their inclusion.
CMS Must Act Simultaneously
Congressional action, while essential, cannot be our only pathway forward. Earlier this year the NHC joined 67 stakeholder organizations in writing CMS Administrator Dr. Mehmet Oz, urging immediate administrative action to create a streamlined pathway for breakthrough technology access.
The existing Transitional Coverage of Emerging Technologies (TCET) program, while well-intentioned, falls short due to its voluntary nature and limited scope. Administrator Oz has the opportunity to implement a program providing predictable coverage for FDA-authorized breakthrough technologies.
We’re encouraged by the commitment shown by both Administrator Oz and FDA Commissioner Marty Makary to eliminate “repeat, duplicative approval processes.” This administration has positioned itself as committed to making Americans healthier. Here is a ready-made, concrete opportunity to deliver on that promise.
A Call to Action
Medicare beneficiaries deserve better than a system that forces them to wait years for access to technologies their government has already certified as safe and effective. They deserve a health care system that values innovation, prioritizes patient outcomes, and recognizes that breakthrough medical technology isn’t a luxury; it’s a lifeline.
The tools to fix this broken system exist. The political will is emerging. Now we need the courage to act decisively, because for millions of Medicare beneficiaries, the time for incremental change has long passed. The time for breakthrough coverage is now.
Randall Rutta is chief executive office of the National Health Council, a non-profit organization dedicated to providing a united voice for the 160 million people living with chronic diseases and disabilities and their family caregivers.