Breakthrough medical devices represent some of the most significant innovations in modern healthcare. Designed to treat life-threatening or debilitating conditions, these technologies often receive expedited authorization from the U.S. Food and Drug Administration (FDA). As of June 2025, more than 1,100 devices have been granted breakthrough designation, with 160 authorized for use. Despite this momentum, FDA approval alone does not guarantee that patients—particularly those on Medicare—can access these innovations.
Recently, industry stakeholders have renewed calls for the Centers for Medicare and Medicaid Services (CMS) to establish a faster, more predictable coverage pathway for breakthrough devices. Their efforts highlight the growing tension between innovation, regulation, and patient access.
The Coverage Gap
While FDA clearance ensures that a product is safe and effective for its intended use, reimbursement decisions fall under CMS. Without CMS coverage, many patients—especially those covered by Medicare—face significant barriers to accessing breakthrough technologies.
The Medicare Coverage of Innovative Technology (MCIT) rule, developed during the Trump administration, was intended to bridge this gap. MCIT would have automatically provided Medicare coverage for FDA-authorized breakthrough devices for up to four years, giving manufacturers time to gather additional clinical data. However, in 2021, the Biden administration rescinded the rule, citing concerns about paying for products without sufficient evidence of long-term effectiveness.
The Transitional Coverage Compromise
In place of MCIT, CMS introduced the Transitional Coverage for Emerging Technologies (TCET) pathway. TCET allows for limited, expedited coverage but caps participation at five devices per year and relies heavily on existing processes such as national coverage determinations and coverage with evidence development.
Critics argue that TCET is too restrictive, voluntary, and unpredictable, ultimately slowing access to breakthrough devices for Medicare beneficiaries. For manufacturers, the uncertainty creates challenges in planning commercialization strategies and securing investor confidence.
Stakeholder Pressure Mounts
On August 21, 2025, AdvaMed, a leading trade association for medical device manufacturers, joined with 66 other organizations in sending a letter to CMS. The groups urged the agency to revisit its approach and consider a pathway more closely aligned with the original MCIT framework.
“We urge CMS to create a timely, streamlined pathway for Medicare patients to access breakthrough medical technology,” the letter stated. The stakeholders stressed that aligning FDA authorization with Medicare coverage would reduce regulatory delays and bring life-saving innovations to patients more quickly.
Legislative efforts are also underway. Senator Todd Young (R-IN) has reintroduced the Ensuring Patient Access to Critical Breakthrough Products Act, which seeks to revive MCIT and provide clearer, more predictable rules for coverage.
Balancing Speed and Safety
The debate underscores a fundamental policy question: how can regulators balance the need for rapid patient access with the responsibility to ensure that taxpayer dollars fund only clinically effective products?
FDA approval confirms safety and efficacy, but long-term data may still be lacking at the time of market entry. CMS’s caution reflects its role as steward of Medicare funds, yet the current approach risks delaying access to transformative care. Stakeholders argue that a middle ground—where coverage is granted but closely monitored with evidence requirements—could satisfy both innovation and oversight priorities.
Conclusion
The story of breakthrough devices illustrates a broader truth: regulatory approval is just the first step in delivering innovation to patients. Without timely reimbursement decisions, even the most groundbreaking technologies may struggle to reach those who need them most.
At EMMA International, we help life science companies navigate these complexities—supporting regulatory submissions, reimbursement strategies, and market entry planning. As the policy landscape continues to evolve, our expertise ensures that innovators are prepared not just to achieve FDA approval, but to bring their products to patients in a way that is strategic, compliant, and sustainable.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more.
References
Al-Faruque, F. (2025, August 21). Groups pressure CMS to speed coverage of breakthrough devices after FDA authorization. Regulatory Affairs Professionals Society.
