Healthcare Coalition Urges CMS to Accelerate Medicare Coverage for Breakthrough Medical Devices
Key Insights
A coalition of 67 healthcare and medical technology organizations has petitioned CMS Administrator Dr. Mehmet Oz to create a streamlined pathway for Medicare coverage of breakthrough medical devices and diagnostics.
The groups cite a study showing nearly six years pass between FDA authorization and Medicare coverage for new technologies requiring new reimbursement pathways.
The coalition proposes adopting a framework similar to the withdrawn Medicare Coverage of Innovative Technology (MCIT) program, which would provide automatic coverage for FDA-cleared breakthrough technologies.
A coalition of 67 healthcare and medical technology organizations has called on the Centers for Medicare & Medicaid Services (search) to establish a streamlined pathway that would accelerate Medicare patients' access to breakthrough medical devices and diagnostics. The groups, led by AdvaMed (search) and including patient advocacy organizations and state medtech associations, submitted a letter to CMS Administrator Dr. Mehmet Oz urging the agency to align more closely with the Food and Drug Administration (search) to reduce coverage delays.
Six-Year Coverage Gap Highlighted
The coalition cited a recent study revealing that nearly six years typically pass between FDA authorization of new technology and Medicare coverage for devices requiring new reimbursement pathways. "Patients should not be forced to wait the better part of a decade for access to safe and effective medical technology," the organizations wrote in their letter to Oz.
The groups emphasized the significant impact medical technology has had in recent decades, noting that advances have shortened hospital stays, reduced deaths from breast cancer (search) by 43%, and cut fatalities from heart disease (search) and stroke (search) by nearly half. They also highlighted how devices and diagnostics have enabled earlier detection of conditions such as Alzheimer's and Parkinson's disease (search).
Proposed MCIT-Style Framework
The coalition urged CMS to consider adopting a framework modeled after the Medicare Coverage of Innovative Technology (MCIT) program, which was introduced under a prior administration but later repealed in 2021. Such a policy would provide automatic coverage for FDA-cleared breakthrough technologies and establish a clear timeline for CMS to gather additional evidence needed for permanent coverage decisions.
AdvaMed (search) described their preferred approach as ensuring Medicare patients receive more timely access to FDA-authorized devices while providing "a clear, predictable roadmap for CMS to collect additional necessary evidence for making a permanent coverage decision."
Current Programs Deemed Inadequate
While acknowledging that CMS has existing programs such as the Transitional Coverage of Emerging Technologies initiative, the groups argued these efforts fall short of delivering consistent, timely access to innovations. The coalition expressed encouragement by Oz's "early focus on exploring options for a better pathway for recently approved medical devices," referencing his confirmation hearing comments that Medicare should cover newly approved medical devices more quickly.
Legislative Efforts Continue
The letter noted that legislative proposals such as the Ensuring Patient Access to Critical Breakthrough Products Act have sought to enshrine this approach in law. Legislators have attempted to incorporate aspects of the MCIT framework into U.S. law since 2021, including a bill introduced by a senator in May, though legislative progress has been limited.
The MCIT program remains contentious, with the Association of American Medical Colleges (search) having previously warned that the safety and effectiveness of breakthrough devices in the MCIT population may be unknown, contributing to the program's 2021 rescission.
"This administration has a significant opportunity to course correct and make meaningful progress on improving American health," the coalition wrote, urging Oz to "take bold action" to ensure Medicare beneficiaries are not left behind as new treatments become available.