This bill establishes a four-year transitional Medicare coverage period for FDA-designated breakthrough medical devices to ensure prompt patient access while final coverage determinations are made.
Todd Young
Senator
IN
This Act establishes a fast-track process to ensure Medicare coverage for medical devices officially designated as "breakthrough devices" by the FDA. Once designated, these devices receive a four-year transitional coverage period under Medicare Parts A and B. The legislation also mandates timely final coverage decisions and provides funding for the administrative oversight required by this new system.
Medicare Fast-Tracks Coverage for Breakthrough Devices: Four-Year Access Guaranteed for New Tech
The Ensuring Patient Access to Critical Breakthrough Products Act of 2025 is designed to solve a major frustration point in healthcare: the lag between when a new, life-changing medical device gets FDA approval and when Medicare actually agrees to pay for it. This bill essentially creates an express lane for the most innovative medical technology.
The Breakthrough Express Lane
Here’s the deal: If a device receives an official “breakthrough device” designation from the FDA—meaning it offers a significant advantage over existing options—Medicare must start covering it immediately under Parts A and B. This mandatory coverage kicks off a four-year “transitional coverage period.” Think of this as a guaranteed four-year window where Medicare patients get access to the new tech without the usual bureaucratic delay.
For patients and doctors, this is huge. It means if a new, cutting-edge pacemaker or a novel diagnostic tool comes out, Medicare beneficiaries—our parents, neighbors, and older colleagues—won't have to wait years for the Centers for Medicare & Medicaid Services (CMS) to finish its standard coverage review process. Instead, access is nearly immediate, tied directly to the FDA's initial designation. This provision lives in Section 2, ensuring prompt coverage of breakthrough devices.
The Catch: When Coverage Can Stop
While this four-year coverage is mandatory, it isn't unconditional. The bill includes two specific off-ramps where coverage can be terminated early. First, if the device is used outside of its FDA-approved instructions, Medicare doesn't have to pay. That’s standard operating procedure, but it’s worth noting. Second, and more importantly, the Secretary of Health and Human Services (HHS) can pull the plug if they decide, based on clinical data, that the risk of harm is greater than the potential benefits for Medicare patients (Sec. 2).
This second condition grants the Secretary significant power. While it protects patients from potentially dangerous tech, it also means coverage could disappear if new data emerges that raises safety concerns. For manufacturers, this adds a layer of uncertainty: they get four years of guaranteed coverage, but only if the data holds up under the Secretary's scrutiny.
Putting Manufacturers on the Clock
The bill also tightens the screws on the administrative process. Manufacturers whose devices get FDA clearance after this law takes effect can apply to the Secretary for the breakthrough designation. The Secretary then has a hard deadline: six months to make a decision. If the application is denied, the Secretary must clearly explain why and point out which criteria weren't met. This six-month window (Sec. 2) is crucial for manufacturers planning their market rollout, providing much-needed predictability.
Furthermore, the law ensures that the four-year transition period is used effectively. If a manufacturer asks for a final National Coverage Determination (NCD) at least nine to twelve months before the four years are up, the Secretary must issue that final, long-term decision before the transitional coverage expires. This prevents the device from falling into a coverage black hole after its temporary access window closes.
The Price Tag for the Fast Lane
To manage this new workload—reviewing applications, monitoring data, and issuing timely NCDs—the bill appropriates an extra $10 million annually to the CMS Program Management Account from fiscal years 2026 through 2031 (Sec. 2). This funding acknowledges that fast-tracking coverage requires more administrative resources, ensuring CMS has the budget to stick to those tight six-month and four-year deadlines. For taxpayers, this is the cost of ensuring rapid access to innovation.
Ultimately, this bill is a major win for patient access, cutting through the red tape that often delays the adoption of cutting-edge medical tools. It balances speed with safety by granting immediate access while maintaining the Secretary's authority to halt coverage if serious risks emerge, all while forcing the government to keep pace with innovation through strict deadlines and dedicated funding.