CMS and FDA Introduce RAPID Program for Medicare Coverage of Breakthrough Medical Devices
For years, one of the most frustrating realities in medical device innovation has been the gap between getting a device approved by the Food and Drug Administration and actually getting it covered by Medicare. That gap, which has historically stretched to a year or more, is now the target of a significant new federal initiative.
On April 23, 2026, the Food and Drug Administration and the Centers for Medicare and Medicaid Services jointly announced the Regulatory Alignment for Predictable and Immediate Device program, known as RAPID. The goal is straightforward: compress the timeline between Food and Drug Administration authorization and Medicare national coverage from over a year down to as little as two months for certain breakthrough medical devices.
Breakthrough devices are a specific category of novel medical devices determined by the Food and Drug Administration to offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. To qualify for breakthrough device designation, a device must either represent a breakthrough technology, have no approved or cleared alternatives, offer significant advantages over existing options, or have its availability deemed in the best interest of patients.
Why the Gap Existed in the First Place
Under the previous system, the evidence a manufacturer needed to satisfy the Food and Drug Administration could be quite different from what Centers for Medicare and Medicaid Services required to make a coverage decision. That mismatch forced manufacturers into a sequential process: first clearing the Food and Drug Administration, then starting the Medicare coverage process from scratch. The result was delays of a year or more before a device could actually be reimbursed, which created significant uncertainty for manufacturers, investors, and the patients who needed access to these innovations.
How RAPID Changes Things
RAPID changes that dynamic by bringing both agencies into the process from the very beginning. Starting at the Investigational Device Exemption stage, meaning before pivotal clinical trials even begin, both the Food and Drug Administration and Centers for Medicare and Medicaid Services will jointly guide study design so that the evidence generated satisfies both agencies simultaneously. The result is that a proposed national coverage determination can be issued on the same day as Food and Drug Administration authorization, with a final determination targeted within 60 to 90 days.
Importantly, RAPID does not guarantee automatic Medicare coverage. Centers for Medicare and Medicaid Services retains full discretion and the process includes a 60-day public comment period. But for eligible devices, the path to coverage becomes significantly more predictable and compressed than anything the industry has seen before.
The capacity of the program is also worth noting. While the previous Transitional Coverage for Emerging Technologies pathway accepted only up to five breakthrough devices per year, RAPID is expected to cover approximately 40 to 60 currently qualifying devices, with more becoming eligible over time. Centers for Medicare and Medicaid Services has indicated it intends to pause accepting new candidates into the Transitional Coverage for Emerging Technologies pathway while RAPID is implemented.
A Look Back: Previous Government Efforts
RAPID is not the first attempt to close the gap between authorization and coverage. The federal government has tried several approaches over the years with varying degrees of success.
The Parallel Review program was introduced jointly by the Centers for Medicare and Medicaid Services and the Food and Drug Administration back in 2011, allowing simultaneous review of clinical data by both agencies. It was made permanent in 2016 but was capped at five candidates per year and saw very limited successful utilization overall.
In January 2021, the first Trump administration finalized the Medicare Coverage of Innovative Technology rule, which would have provided automatic national Medicare coverage for breakthrough devices for up to four years from Food and Drug Administration authorization. The Biden administration repealed that rule in November 2021 and replaced it with the Transitional Coverage for Emerging Technologies pathway in August 2024, which offered an expedited but still relatively limited route for up to five breakthrough devices annually. Industry criticism of that program centered on its limited capacity and the failure to coordinate with the Food and Drug Administration or manufacturers on trial design before coverage review began.
Bipartisan legislation, the Ensuring Patient Access to Critical Breakthrough Products Act, has also been introduced in Congress and would provide four years of automatic transitional Medicare coverage for breakthrough devices upon Food and Drug Administration authorization, though its momentum may slow if RAPID moves forward successfully.
RAPID vs. the Previous Transitional Coverage for Emerging Technologies Pathway
Here is a direct comparison of how RAPID differs from the framework it is replacing:
| Feature | Transitional Coverage for Emerging Technologies (Existing, Now Paused) | RAPID (New) |
| Eligible Devices | Up to 5 breakthrough devices per year | Approximately 40 to 60 currently qualifying devices |
| Centers for Medicare and Medicaid Services and Food and Drug Administration Coordination | Centers for Medicare and Medicaid Services did not participate in the pivotal trial design | Both agencies jointly guide pivotal study design from the Investigational Device Exemption stage |
| Coverage Timeline | Nomination typically 12 months before authorization; final determination within approximately six months after | Proposed determination issued same day as authorization; final within 60 to 90 days |
| Coverage Duration | Transitional and tied to evidence development plan | Permanent Medicare coverage from the date of the final determination |
| Evidence Standard | Two-step process with initial evidence preview and potential evidence development plan | Single premarket evidence process jointly agreed upon by both agencies from the outset |
| Coverage Mechanism | National coverage determination with coverage with evidence development; Centers for Medicare and Medicaid Services retained full discretion | National coverage determination issued concurrently with authorization; Centers for Medicare and Medicaid Services retains discretion on compressed timeline |
| Automatic Coverage | No | No |
The Complication: Proposed Repeal of Breakthrough Device Add-On Payments
There is a significant complication running alongside the RAPID announcement that device makers and investors need to watch closely.
On April 10, 2026, Centers for Medicare and Medicaid Services proposed repealing the alternative New Technology Add-On Payment pathway for breakthrough devices as part of the fiscal year 2027 Inpatient Prospective Payment System proposed rule. That pathway had previously allowed breakthrough devices to receive hospital add-on payments without having to demonstrate substantial clinical improvement over existing technologies. If finalized in fiscal year 2028, the repeal would apply to both inpatient and outpatient settings.
The practical tension here is real. RAPID determines whether Medicare will pay for a breakthrough device at all. The New Technology Add-On Payment pathway determines how much Medicare pays hospitals that actually use one. A device that gains faster coverage under RAPID but loses its add-on payment eligibility could end up nominally reimbursable but commercially underadopted because the economics for hospitals don't support using it. That is a scenario manufacturers and investors will need to model carefully as both proposals move through the rulemaking process.
Comments on the proposed New Technology Add-On Payment repeal are due by June 9, 2026.
Why This Matters
RAPID represents one of the most substantive federal efforts to date to align regulatory and coverage timelines for innovative medical devices. If it works as intended, manufacturers gain a far more predictable path from clinical development to commercial reimbursement. Because Medicare coverage decisions often inform what commercial payers decide to cover as well, faster Medicare access under RAPID could also accelerate broader market uptake for qualifying devices.
For investors, the compressed timeline between capital deployment and commercial inflection is potentially significant. The historical record of the Parallel Review program, however, serves as a reminder that structural alignment between agencies has not always been enough on its own to move devices through coverage at scale. How RAPID performs in actual execution will be the real test.
