The new CMS-FDA RAPID pathway could reduce the wait between FDA authorization and Medicare coverage for certain breakthrough devices from about a year or more to as little as two months.
A medical device can win FDA authorization and still wait months for Medicare coverage. The Centers for Medicare & Medicaid Services (CMS) and the FDA said their new RAPID pathway, short for Regulatory Alignment for Predictable and Immediate Device coverage, is meant to narrow that gap for certain FDA-designated breakthrough devices, potentially reducing the timeline from about a year or more to as little as two months.
FDA and Medicare make different decisions about the same device. FDA decides whether a device can be marketed, while CMS separately decides whether Medicare will cover it. RAPID is meant to connect those steps earlier by aligning evidence planning before authorization.
Abbott’s MitraClip offers a real-world example of that gap. The device received FDA approval in October 2013, while CMS’ national coverage determination, or NCD, took effect in August 2014. CMS later expanded coverage in January 2021 for MitraClip’s use in secondary mitral regurgitation.
A 2023 Stanford-led study suggested this kind of delay is not unusual. Looking at 64 novel devices and diagnostics that needed a new Medicare reimbursement path, the researchers found that only 28 reached at least nominal coverage during the study period, with a median time of 5.7 years. Just six reached a coverage milestone within two years, and only 18 did so within three years. The study also found that smaller manufacturers tended to face a harder path to coverage than larger ones.
CMS said RAPID would bring the agency into discussions with FDA and device makers earlier in development, with the aim of helping companies generate evidence that can support both FDA review and Medicare coverage decisions, particularly for Medicare beneficiaries.
The pathway is not open to all medical devices. RAPID is for certain breakthrough devices that address unmet medical needs among Medicare beneficiaries. It applies to certain Class II devices in FDA’s Total Product Life Cycle Advisory Program, or TAP, and to Class III devices whether or not they are in TAP.
FDA’s Breakthrough Devices Program applies to certain devices that may offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. That means RAPID is limited to devices that qualify for that designation, not all medical devices.
To qualify, a device must be studied in a clinical trial under an Investigational Device Exemption, or IDE, which is the FDA pathway that allows an investigational device to be tested before marketing. CMS said those studies must include Medicare beneficiaries and measure outcomes agreed on in advance by CMS and FDA.
Under RAPID, CMS said it will issue a proposed national coverage determination on the same day an eligible device receives FDA market authorization. An NCD is Medicare’s decision on whether a particular item or service is covered. That would begin the required 30-day public comment period. CMS’ NCD process generally takes 9 to 12 months. Under RAPID, the agency said eligible devices could receive Medicare coverage and payment as soon as two months after authorization.
Related: FDA Transitions to QMSR, Updating How Medical Device Inspections Are Conducted
The announcement also puts another CMS pathway on hold. CMS said it will pause the Transitional Coverage for Emerging Technologies, or TCET, pathway for new candidates while RAPID is rolled out. TCET was finalized in August 2024 to help certain breakthrough devices move through Medicare coverage review more quickly, with CMS saying at the time that it aimed to finalize an NCD within six months after FDA market authorization for accepted technologies.
What happens next is still procedural. CMS said a proposed notice outlining RAPID will soon be published in the Federal Register, followed by a 60-day public comment period. The agency said the new pathway is expected to take effect once the final notice is published.
Reuters reported that CMS expects around 40 devices to be initially eligible for the pathway.
For device makers, the change means Medicare coverage planning may begin much earlier in development. For Medicare patients and the clinicians treating them, RAPID could narrow a long-standing gap between FDA authorization and coverage.
How much faster the pathway works in practice will become clearer once CMS publishes the full notice.
FAQs
Does FDA authorization mean Medicare will pay for a device right away?
No. FDA authorization means the device can be marketed. Medicare coverage is a separate decision about whether the program will cover it.
What is a national coverage determination (NCD)?
A national coverage determination (NCD) is Medicare’s national decision on whether a particular item or service is covered. If the Centers for Medicare & Medicaid Services (CMS) issues one, it applies across the Medicare program.
What is the difference between a national and local coverage decision?
A national decision applies across Medicare. A local one is made by a regional contractor and may apply only in certain areas.
Why can coverage still take so long after FDA authorization?
Because authorization is only one step. A device may also need a coverage decision, a billing code and a payment path before access becomes straightforward in practice.
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