CMS and FDA Propose RAPID Medicare Coverage Pathway for Breakthrough Devices

Key Takeaways

• The Centers for Medicare & Medicaid Services (CMS) and US Food and Drug Administration (FDA) have proposed the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway that would coordinate evidence requirements earlier in device development, potentially accelerating Medicare coverage for eligible FDA-designated Breakthrough Devices.
• CMS aims to issue final national coverage determinations about 60 days after FDA authorization for eligible Class II devices and 90 days for Class III devices.
• Clinicians may see earlier Medicare access to qualifying technologies, although higher-risk devices with evidence gaps may require additional data collection through coverage with evidence development.

CMS and the FDA are advancing a new pathway intended to shorten the time between FDA authorization of certain breakthrough medical devices and national Medicare coverage.¹

RAPID coverage pathway would bring CMS into the device development process earlier, allowing the agencies and manufacturers to align on clinical evidence before FDA market authorization. For qualifying devices, CMS plans to issue a proposed National Coverage Determination (NCD) on the same day the device receives FDA authorization.¹

CMS states that national Medicare coverage could begin approximately 60 days after FDA authorization for eligible Class II devices and approximately 90 days after authorization for Class III devices.¹ The approach is designed to address a longstanding challenge in medical device coverage: Evidence sufficient for FDA authorization does not necessarily address the separate evidence CMS needs to determine whether a technology is reasonable and necessary for Medicare beneficiaries.^1,2

For payers, manufacturers, providers, and Medicare stakeholders, RAPID represents an effort to make the transition from regulatory authorization to coverage more predictable while maintaining a distinct Medicare evidence review process.

What is the RAPID Medicare Coverage Pathway?

RAPID is a proposed CMS-FDA pathway for certain devices that have received FDA Breakthrough Device designation.¹

Rather than waiting until after FDA authorization for manufacturers to begin addressing Medicare coverage requirements, CMS would participate earlier in discussions surrounding the device's clinical evidence. The agencies would work with manufacturers during the premarket phase to identify clinical outcomes relevant both to FDA review and to Medicare beneficiaries.^1,3

The goal is to allow evidence generated through an Investigational Device Exemption (IDE) study to support both regulatory review and the subsequent Medicare coverage determination when appropriate.¹

This coordination does not mean FDA authorization would automatically result in Medicare coverage. FDA assesses whether a device satisfies applicable requirements for marketing authorization, while CMS separately evaluates whether the device meets Medicare coverage standards. RAPID is intended to better align the evidence needed for those 2 processes rather than combine them.²

Which Breakthrough Devices Could Qualify for RAPID?

Eligibility for RAPID would be limited. According to CMS, eligible technologies would include certain presumptive Class II FDA-designated Breakthrough Devices participating in the FDA's Total Product Life Cycle Advisory Program (TAP) and planning to pursue a De Novo request, as well as Class III Breakthrough Devices planning to submit a premarket approval application. Class III devices would not be required to participate in TAP.¹

Devices would also need to be early enough in development for CMS and FDA to participate before an IDE study begins. The study must enroll Medicare beneficiaries and evaluate clinical outcomes that FDA and CMS agree are relevant to their respective reviews.¹

Additional CMS eligibility requirements include that a device

• is not already subject to a controlling Medicare NCD;
• can fall within a Medicare benefit category based on available information;
• is separately payable and capable of being billed to Medicare if approved; and
• is not otherwise excluded from Medicare coverage by law or regulation.¹

In vitro diagnostic products, including diagnostic laboratory tests, would not be accepted into RAPID. CMS indicated that Medicare administrative contractors should continue to make many coverage determinations for these products through existing processes.¹

How could RAPID Accelerate Medicare Coverage?

Timing is one of the central features of the proposed pathway.

Once an eligible device completes its IDE study and receives FDA market authorization, CMS intends to post both its NCD tracking sheet and a proposed NCD on the same day. A 30-day public comment period would follow.

CMS' stated goal is to issue a final NCD approximately 60 days after FDA authorization for Class II devices and 90 days for Class III devices.¹

That could represent a substantial reduction in the period between FDA authorization and a national Medicare coverage decision. Reporting and analysis of the proposal noted that the existing process may take a year or longer in some circumstances, while RAPID could potentially make national Medicare coverage available within months.^3,4

The model also differs from automatic or immediate coverage. Manufacturers would still need to generate evidence that supports Medicare's coverage requirements, and CMS would retain its NCD process and public comment period.^1,2

What Role Will Coverage With Evidence Development Play?

Not every RAPID device would necessarily enter Medicare coverage under the same conditions.

CMS said the clinical outcomes demonstrated during the IDE study and the device's relative risk would influence whether additional evidence development is necessary. Lower-risk devices may be more likely to have sufficient evidence at authorization to satisfy Medicare's reasonable-and-necessary standard, while higher-risk devices may have evidence gaps requiring coverage with evidence development (CED).

When CMS anticipates that CED may be necessary, the agency intends to work with FDA and manufacturers before authorization to align Medicare evidence requirements with FDA-required post-approval studies when possible.¹

CMS also emphasized that CED arrangements under RAPID would not be intended to continue indefinitely. They would be used to generate additional evidence needed to inform a longer-term Medicare coverage determination.¹

How Does RAPID Relate to TCET and Existing Medicare Coverage Pathways?

RAPID is the latest federal effort to address the gap between FDA authorization and Medicare coverage of emerging medical technologies.

CMS previously established the Transitional Coverage for Emerging Technologies (TCET) pathway, which provides another route for certain FDA-designated breakthrough devices. CMS plans to pause consideration of new TCET candidates while it focuses on RAPID.³

RAPID also builds on concepts used in the existing FDA-CMS Parallel Review program, under which manufacturers can engage both agencies during development.⁴

The new pathway, however, would establish more specific eligibility and study requirements while offering a clearer timeline for the Medicare NCD process. Analysis from Ropes & Gray noted that RAPID also appears to contemplate a greater degree of CMS-FDA coordination than Parallel Review.⁴

What is Changing With NTAP for Breakthrough Devices?

RAPID is focused on Medicare coverage, but a separate CMS proposal could also change how some breakthrough technologies are paid for in the inpatient hospital setting.

In its proposed fiscal year 2027 inpatient prospective payment system rule, CMS proposed eliminating the alternative pathway that allows certain FDA-designated Breakthrough Devices to qualify for new technology add-on payments (NTAP) without separately demonstrating substantial clinical improvement.

If finalized, beginning with fiscal year 2028 NTAP applications, breakthrough devices would need to meet the traditional NTAP requirements, including criteria related to newness, cost, and substantial clinical improvement.⁴

The 2 policies therefore address different parts of market access. RAPID could make the path toward national Medicare coverage more predictable, while elimination of the NTAP alternative pathway could increase the evidence required for certain technologies to receive additional Medicare payment.⁴

For managed care and market access stakeholders, that distinction will be important when evaluating the potential effect of the policy changes.

What Could RAPID Mean for Payers and Managed Care Stakeholders?

Although RAPID is a Medicare coverage initiative, earlier alignment between CMS, FDA, and manufacturers could have broader implications for evidence generation and technology assessment.

Potential considerations include the following:

• Earlier availability of clinical evidence focused specifically on Medicare populations
• Greater predictability surrounding national Medicare coverage timelines
• More explicit use of clinical outcomes relevant to coverage decisions during pivotal study design
• Potential CED requirements for higher-risk technologies with remaining evidence gaps
• A changing relationship between regulatory authorization, Medicare coverage, and Medicare payment for breakthrough devices.^1,3,4

For manufacturers, engaging CMS before pivotal evidence generation could reduce the risk of reaching FDA authorization only to discover that additional studies are needed to satisfy Medicare coverage requirements.³

For payers and other health technology evaluators, the process may also make evidence expectations and federal coverage timelines clearer, although RAPID would not eliminate the need for independent assessments of clinical evidence, utilization, and value.

What Happens Next for the RAPID Coverage Pathway?

CMS published its formal procedural notice for RAPID on August 7, 2026, opening a 60-day public comment period. The agency said it will respond to comments in a subsequent final notice.¹

Until that process is complete, RAPID remains a proposed pathway.

The final notice will be important for determining how the program will operate in practice, including how CMS and FDA coordinate with manufacturers, how evidence requirements are applied, and how effectively the pathway can shorten the interval between FDA authorization and national Medicare coverage.

A More Coordinated Path From Authorization to Coverage

RAPID reflects an effort to address a recurring challenge in medical technology adoption: FDA market authorization and Medicare coverage depend on different standards and may require different evidence.^1,2

By moving Medicare discussions earlier in device development, CMS and FDA aim to make those expectations more predictable before pivotal studies are complete.¹

For managed care stakeholders, the significance of RAPID may therefore extend beyond faster coverage decisions. The pathway could influence how manufacturers design evidence programs, how quickly new technologies enter Medicare, and how payers evaluate breakthrough devices as clinical data and coverage policies develop.

References

1. Centers for Medicare & Medicaid Services. Regulatory alignment for predictable and immediate device coverage pathway (CMS-3487-NC) procedural notice inviting comment. Published August 7, 2026. Accessed August 147, 2026. https://www.cms.gov/newsroom/fact-sheets/regulatory-alignment-predictable-immediate-device-coverage-pathway-cms-3487-nc-procedural-notice
2. Aguilar M, Palmer K. CMS, FDA team up to fast-track reimbursement for breakthrough devices. STAT. Published April 23, 2026. Accessed August 14, 2026. https://www.statnews.com/2026/04/23/cms-fda-propose-new-faster-breakthrough-devices-coverage
3. Zipp R. CMS, FDA unveil speedier Medicare coverage pathway for breakthrough devices. MedTech Dive. Published April 23, 2026. Accessed August 14, 2026. https://www.medtechdive.com/news/cms-fda-unveil-speedier-medicare-coverage-pathway-for-breakthrough-devices/818324
4. Levine GH, Curry N, Hinckley D, Sager L. CMS and FDA propose major changes for breakthrough devices with proposed repeal of NTAP “Alternative Pathway” and new “RAPID” coverage pathway. Ropes & Gray LLP. Published May 2026. Accessed August 14, 2026. https://www.ropesgray.com/en/insights/alerts/2026/05/cms-and-fda-propose-major-changes-for-breakthrough-devices-with-proposed-repeal-of-ntap-alternative