RAPID Coverage Pathway Comments Due October 10, 2026

The Centers for Medicare & Medicaid Services (CMS) on August 7, 2026, released a notice with comment period establishing the framework for the new Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway. Comments are due October 10, 2026. RAPID is intended to significantly shorten the period between U.S. Food and Drug Administration (FDA) market authorization and national Medicare coverage for certain innovative medical devices.

The central innovation is not simply faster Medicare decision-making. Rather, RAPID would move CMS coverage considerations substantially earlier in the product-development process. For eligible devices, FDA, CMS and manufacturers would engage beginning at the Investigational Device Exemption (IDE) pre-submission stage to identify clinical health outcomes relevant to Medicare beneficiaries. Manufacturers would then incorporate those outcomes into the clinical studies used to support FDA authorization and subsequent Medicare coverage.

If the resulting evidence demonstrates improvement in the agreed-upon health outcomes, CMS intends to issue a proposed National Coverage Determination (NCD) on the same day as FDA market authorization. Following a 30-day public comment period, CMS' goal is to issue a final NCD approximately 60 days following FDA authorization for eligible Class II devices and 90 days following authorization for Class III devices.

Importantly, RAPID does not guarantee Medicare coverage. The pathway is intended to align evidence development earlier in the product-development process, while CMS would continue to apply existing Medicare coverage standards in determining whether a device qualifies for conventional coverage or Coverage with Evidence Development (CED).

Resources

• Notice
• Fact Sheet
• Infographic

Background and Policy Rationale

CMS currently makes Medicare coverage decisions through several mechanisms, including claim-by-claim adjudication by Medicare Administrative Contractors (MACs), Local Coverage Determinations (LCDs) and NCDs. Traditional NCDs generally take approximately nine to 12 months, creating the potential for a substantial gap between FDA authorization and national Medicare coverage.

RAPID seeks to address that gap by beginning the Medicare evidence development process well before FDA authorization.

The pathway reflects a fundamental distinction between the evidence considered by FDA and CMS. FDA generally determines whether a medical device meets the applicable safety and effectiveness standards for market authorization. CMS separately determines whether an item or service is "reasonable and necessary" for Medicare beneficiaries.

CMS emphasizes in the notice that FDA authorization does not automatically establish that a device should be covered by Medicare. In particular, CMS is concerned that pivotal studies supporting FDA authorization may not sufficiently represent older Medicare beneficiaries or individuals with multiple comorbidities. Approximately half of Medicare beneficiaries have two or more diseases, according to research cited by CMS. Consequently, evidence sufficient for FDA authorization may not necessarily establish whether a device improves health outcomes for the Medicare population.

RAPID attempts to address this disconnect prospectively. Rather than having a manufacturer complete FDA development and then approach CMS to determine what additional evidence is required for Medicare coverage, the agencies would identify relevant outcomes before the pivotal IDE study begins.

This represents perhaps the most consequential aspect of RAPID for medical device manufacturers.

RAPID Eligibility

Participation in RAPID would be voluntary but narrowly limited.

Eligible technologies generally must be either:

• Presumptive Class II FDA Breakthrough-designated Devices participating in FDA's Total Product Life Cycle Advisory Program (TAP) and planning to submit a De Novo request
• Class III FDA Breakthrough-designated Devices planning to submit a Premarket Approval application, regardless of TAP participation

The pathway may also include certain 510(k) devices where the primary predicate was authorized through the De Novo classification pathway no earlier than 18 months before acceptance into RAPID.

Eligible devices generally must also be at the IDE pre-submission stage, with the manufacturer planning an IDE study that enrolls Medicare beneficiaries and evaluates clinical outcomes that FDA and CMS agree are relevant to the Medicare population. Devices must be separately payable under Medicare, fit within a potential Medicare benefit category, not already be subject to a controlling NCD and not otherwise be excluded from Medicare coverage.

The timing limitation is particularly significant. CMS generally does not intend RAPID to serve devices that have already progressed beyond IDE pre-submission, including technologies already being studied under an IDE or already market-authorized.

However, CMS specifically requests comment on whether it should create a temporary transitional process allowing devices that have already progressed beyond IDE pre-submission and are currently being studied under an IDE to enter RAPID. CMS also solicits comment on its broader approach to excluding technologies that have progressed beyond the IDE pre-submission stage and, if a temporary transition process is established, how long it should remain available.

IVDs Excluded

CMS expressly excludes in vitro diagnostic (IVD) products, including diagnostic laboratory tests, from RAPID. CMS believes coverage for most Breakthrough-designated IVDs should continue to be determined through specialized MACs and existing coverage pathways.

How RAPID Would Operate

RAPID would proceed through three primary stages.

IDE Pre-Submission

Following Breakthrough Device designation and TAP enrollment, where applicable, a manufacturer would express interest in RAPID to FDA before its IDE pre-submission.

FDA would conduct an initial eligibility assessment and consult with CMS. Assuming the device appears eligible, FDA, CMS and the manufacturer would participate in a RAPID kickoff meeting focused on the proposed clinical study.

Before the RAPID kickoff meeting, CMS would also conduct a preliminary Medicare benefit-category assessment to determine whether available information makes clear that the device cannot fall within a Medicare benefit category. CMS emphasizes that this is an interim assessment and that acceptance into RAPID should not be viewed as a final Medicare benefit category determination.

This is where RAPID differs meaningfully from existing coverage pathways.

CMS would provide input before the IDE study begins regarding whether the proposed clinical health outcomes would be sufficient to support a future Medicare NCD. FDA and CMS could also identify potential evidence gaps that the manufacturer could address through the pivotal IDE study or subsequent post-market studies.

The manufacturer would therefore have an opportunity to design a clinical development program that addresses both FDA and CMS requirements rather than learning after FDA authorization that additional Medicare-specific evidence is necessary.

Formal IDE Submission

The manufacturer would then proceed through FDA's normal IDE process. FDA would share its IDE decision and relevant study-design considerations with CMS.

Once outstanding issues are addressed, the manufacturer would submit the IDE protocol to CMS through the existing Medicare IDE review process. Assuming CMS' IDE requirements and RAPID eligibility requirements are satisfied, CMS would issue an approval letter that includes its intention to issue a proposed NCD concurrently with FDA market authorization.

Importantly, material changes to the study protocol after CMS approval would require agreement from both FDA and CMS for continued RAPID participation.

Transition to Medicare Coverage

After completion of the IDE study, FDA would share the final study report with CMS. CMS would evaluate whether the evidence demonstrates improvement in the clinical outcomes previously agreed upon by FDA and CMS.

For a qualifying device that continues through RAPID, CMS intends to publish an NCD tracking sheet and proposed NCD on the same day FDA grants market authorization. This timing is contingent on the relevant FDA Decision Summary or Summary of Safety and Effectiveness Data being made publicly available on the date of authorization. RAPID national coverage would also be limited to the device's FDA-authorized indications for use.

Following the 30-day comment period:

• Class II devices could receive a final NCD approximately 60 days after FDA authorization.
• Class III devices could receive a final NCD approximately 90 days after FDA authorization.

This would represent a substantial acceleration compared with the conventional nine- to-12-month NCD process.

CED

RAPID does not guarantee unconditional national coverage.

CMS indicates that the strength of the evidence and relative risk of a device will determine whether a RAPID NCD provides conventional coverage or requires CED.

Lower-risk devices may have sufficient evidence at authorization to demonstrate that they are reasonable and necessary under Medicare's traditional coverage standard. Higher-risk technologies may be more likely to have outstanding evidence gaps and therefore receive coverage through CED while additional evidence is generated.

CMS emphasizes that CED should be time-limited rather than indefinite. Additional evidence would ultimately be expected to support reconsideration and a determination as to whether conventional Medicare coverage is warranted.

Manufacturers would also retain flexibility to withdraw from RAPID before CMS issues a proposed NCD, including where the evidence is insufficient or the manufacturer determines that pursuing coverage through MACs at the local level would be more advantageous.

Relationship with TCET and Other Coverage Pathways

CMS intends to pause acceptance of new candidates into the Transitional Coverage for Emerging Technologies (TCET) pathway as it focuses resources on RAPID.

Manufacturers that are too advanced in development to qualify for RAPID may continue to pursue other mechanisms, including conventional NCD requests, LCDs, claim-by-claim coverage and Parallel Review. CMS also indicates that it intends to consider updates to Parallel Review and other mechanisms to improve coordination with FDA.

The suspension of new TCET candidates is significant because RAPID appears to become CMS' principal accelerated national coverage mechanism for qualifying Breakthrough Devices.

CMS also proposes to prioritize RAPID NCDs over other NCDs on its wait list if agency resources are insufficient to process the total volume of pending NCDs.

Key Issues for Stakeholders and Comment

The notice raises several issues that manufacturers and other stakeholders may wish to consider in evaluating RAPID, including:

• whether the pathway's eligibility criteria are appropriately tailored, particularly the requirement that manufacturers enter at the IDE pre-submission stage
• whether CMS should establish a temporary process for devices that have progressed beyond IDE pre-submission and are already being studied under an IDE
• how the requirement that devices be separately payable under Medicare may affect the universe of technologies able to participate
• how manufacturers should approach Medicare-specific patient representation and clinical health outcomes when designing pivotal studies
• the degree of certainty provided by early CMS engagement, particularly given that the preliminary benefit category assessment is not binding
• how remaining evidence gaps will affect whether a device receives conventional coverage or CED
• how increased coordination and information sharing among manufacturers, FDA and CMS may affect clinical development, regulatory and market-access strategies

CMS' requests for comment are relatively focused, including whether devices beyond the IDE pre-submission stage should remain excluded and whether the agency should establish a temporary eligibility process for devices already being studied under an IDE.

Key Takeaway

RAPID represents a significant shift in the timing of Medicare coverage engagement for eligible medical devices. Its principal innovation is not simply an accelerated NCD timeline but the integration of CMS coverage and evidence considerations into clinical development before pivotal IDE studies begin. For qualifying manufacturers, this could reduce the risk that evidence developed to support FDA authorization ultimately proves insufficient to support Medicare coverage.

At the same time, RAPID is deliberately narrow. Eligibility is limited to specified Breakthrough Devices at an early stage of development, participation does not guarantee Medicare coverage, and unresolved evidence gaps may result in CED rather than conventional coverage. The notice therefore creates both a potentially valuable new pathway and an important opportunity for stakeholders to shape how CMS implements accelerated device coverage going forward.

For more information or questions, please contact the author.

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