RAPID Pathway Accelerates Medicare Coverage for Breakthrough Devices

April 27, 2026

RAPID Response: CMS and FDA Team Up to Fast-Track Medicare Coverage for Breakthrough Devices

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On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) jointly announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new initiative designed to dramatically accelerate Medicare coverage for certain FDA-designated Class II and Class III Breakthrough Devices. A proposed procedural notice will be published in the Federal Register, followed by a 60-day public comment period, with the pathway becoming effective upon publication of the final notice. Below, we address the key questions this announcement raises for stakeholders.

What Is the RAPID Coverage Pathway?

The RAPID pathway is a new, coordinated process through which CMS and the FDA will work together — and with device innovators — earlier in the technology development lifecycle so that evidence generated for FDA premarket review can also support Medicare national coverage decisions. By aligning evidence expectations during the investigational stage rather than after market authorization, the pathway is intended to significantly reduce the historical gap between FDA clearance or approval and Medicare coverage. As described by CMS Deputy Administrator John Brooks, CMS will be able to provide coverage "within 60 to 90 days of FDA approval across the Medicare population for new devices that offer promising therapies".

Why Is This Pathway Being Introduced Now?

The medical device industry has long raised concerns about the delay between FDA authorization and Medicare reimbursement. AdvaMed, the leading medical device trade association, has noted that the median gap between FDA authorization and Medicare coverage for breakthrough technologies is nearly six years. This delay has been widely viewed as a barrier to patient access and a deterrent to investment in innovative medical technologies. CMS Administrator Dr. Mehmet Oz and FDA Commissioner Marty Makary have framed RAPID as a key initiative to address these delays, with the two agencies now "functioning as a single team".

Which Devices Are Eligible for the RAPID Pathway?

To qualify for the RAPID pathway, a device must meet the following criteria:

• The device must carry the FDA's Breakthrough Device designation.
• It must address unmet medical needs among Medicare beneficiaries.
• For Class II devices, the manufacturer must be participating in the FDA's Total Product Life Cycle Advisory Program (TAP); Class III devices are eligible regardless of TAP participation.
• The device must be the subject of an Investigational Device Exemption (IDE) study that enrolls Medicare beneficiaries and studies clinical health outcomes agreed upon by both the FDA and CMS. According to a senior CMS official, approximately 40 devices currently qualify for the RAPID pathway, with an additional 20 potentially eligible. This represents a significant expansion over the Transitional Coverage for Emerging Technologies (TCET) pathway, which was capped at approximately five candidates per year.

How Does the RAPID Pathway Work?

The pathway operates through two key mechanisms:

Early Alignment on Evidence. CMS will participate in the early and frequent engagement that currently occurs between the FDA and device manufacturers through the Breakthrough Devices Program. Specifically, as companies design their pivotal IDE studies with the FDA, CMS will coordinate to ensure those studies also collect the specific clinical evidence required for a Medicare coverage determination. Previously, manufacturers sometimes failed to generate the evidence CMS required for coverage, necessitating new, duplicative trials.

Synchronized Coverage Determinations. Under the RAPID pathway, CMS will issue a proposed National Coverage Determination (NCD) on the same day that an eligible device receives FDA market authorization. This triggers a statutorily required 30-day public comment period. This streamlined approach could enable predictable national Medicare coverage and payment as soon as two months after market authorization, compared with approximately one year or more under the current standard NCD process.

How Does RAPID Differ from the TCET Pathway?

The TCET pathway, finalized in August 2024, was also designed to expedite coverage for breakthrough devices, but it differed in several critical ways from the new RAPID pathway. Under TCET, CMS did not work with the FDA and manufacturers before trial design, which led to misalignment in data generation to support the Medicare coverage process. Additionally, TCET was capped at approximately five candidates per year, a limitation that drew criticism from industry groups such as AdvaMed. The RAPID pathway removes this cap and addresses the alignment issue by involving CMS at the IDE study design stage. CMS has announced that TCET will be paused for new candidates as the agency focuses on RAPID implementation. Importantly, devices approved through the RAPID pathway would receive permanent Medicare coverage.

What Is the Current Status and Timeline?

The RAPID pathway is not yet final. A proposed procedural notice will be published in the Federal Register in the coming days. The public will then have 60 days to provide comments on the procedural notice. CMS will respond to those public comments in a subsequent final notice, and the pathway will become effective upon publication of that final notice in the Federal Register.

Recommendations and Takeaways for Stakeholders

What Should Manufacturers Do Now?

The RAPID pathway represents a potentially transformative opportunity for device manufacturers, but early and proactive engagement will be essential. Manufacturers with devices that carry or are seeking FDA Breakthrough Device designation should immediately evaluate whether their products meet the RAPID eligibility criteria, including IDE study enrollment of Medicare beneficiaries and study of CMS-agreed clinical health outcomes. Companies should also consider participating in the FDA's TAP program, particularly for Class II devices, as TAP participation is a prerequisite for RAPID eligibility at that classification level.

Manufacturers should proactively engage both the FDA and CMS at the earliest stages of IDE study design to ensure that pivotal trial endpoints are aligned with both premarket review requirements and Medicare coverage expectations. As CMS Deputy Administrator John Brooks stated, the pathway is designed to "demystify the process by providing a clear signal to device manufacturers of exactly what targets they need to hit to get Medicare coverage". Manufacturers should take advantage of this signal.

Finally, manufacturers should closely monitor the upcoming Federal Register publication and consider submitting comments during the 60-day comment period to shape the final procedural notice.

What Should Providers Do to Prepare?

Providers — including hospitals, health systems, and clinicians — should prepare for the possibility of faster integration of breakthrough devices into clinical practice. With national Medicare coverage potentially arriving within two months of FDA authorization rather than a year or more, providers will need to plan for earlier adoption of new technologies, including workforce training, supply chain readiness, and clinical workflow adjustments.

Providers should also pay close attention to the NCD coverage criteria that CMS establishes under this pathway. CMS has historically used NCDs to set clinician and institutional requirements based on expert guidelines and clinical study results, including eligibility criteria, provider experience requirements, and facility standards. Providers should be prepared to meet these requirements promptly upon coverage finalization.

Providers should consider submitting comments during the RAPID rulemaking process and advocating for policies that ensure adequate reimbursement to support adoption of newly covered devices.

What Does This Mean for Patients and Patient Advocacy Groups?

The RAPID pathway has the potential to substantially reduce the time that Medicare beneficiaries wait to access breakthrough medical devices. For patients with life-threatening or irreversibly debilitating conditions who currently have no approved treatment options, this accelerated timeline — from approximately one year or more down to potentially two months — could be life-changing. The pathway also has the potential to reduce disparities in access, as national coverage determinations apply uniformly across the Medicare population, unlike local coverage decisions, which can vary by region. Patient advocacy organizations also should consider engaging in the upcoming 60-day public comment period to ensure that patient perspectives are reflected in the final procedural notice.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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Orrick, Herrington & Sutcliffe LLP
2026

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