Stakeholders Urge Broader Scope for CMS RAPID Pathway
Device and diagnostic firms are requesting that the CMS expedite reimbursement for products still in pivotal studies.
Updated on Oct. 20, 2026 in Healthcare
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The Centers for Medicare and Medicaid Services (CMS) received 168 public comments regarding its proposed Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway. This initiative aims to streamline the approval process for medical technologies, impacting how device and diagnostic manufacturers navigate federal reimbursement.
Why it matters
Stakeholders are pushing to broaden the RAPID pathway's eligibility to include devices and diagnostics currently in pivotal studies, signaling a clear industry demand for faster access to reimbursement. This debate over the scope of the pathway directly influences when and how new medical innovations can reach the market and achieve commercial viability.
Stakeholders submitted 168 comments on the proposed CMS RAPID reimbursement pathway. The current volume of feedback marks the first major industry response to the proposal, though the final eligibility criteria remain unknown.
The players
Centers for Medicare and Medicaid Services
A federal agency within the U.S. Department of Health and Human Services that oversees national healthcare programs and establishes regulatory reimbursement standards for medical providers and suppliers.
The details
The RAPID proposal introduces a mechanism that prioritizes specific medical technologies for coverage, effectively moving them ahead of the standard national coverage determination wait list. By attempting to accelerate these reviews, CMS intends to reduce the time between product clearance and Medicare reimbursement. Industry participants are currently lobbying to ensure that products still in pivotal studies are explicitly included in this expedited queue.
Timeline
October 13, 2026: Deadline for filing stakeholder comments on the RAPID proposal.
Market Landscape
The proposed RAPID pathway represents a departure from the traditional CMS national coverage determination process by shifting specific devices to an expedited review queue. This move reflects a broader regulatory shift toward shortening the gap between technology clearance and federal reimbursement eligibility.
Device and diagnostic manufacturers should monitor the pending final rule to determine if their current pipeline products qualify for expedited coverage status. Firms with technology in pivotal studies should prepare for potential shifts in commercialization timelines based on the eventual eligibility criteria.
The takeaway
The industry is actively seeking to expand the RAPID pathway to include devices in pivotal stages rather than only those fully cleared. Operators should track upcoming CMS guidance on the final eligibility scope to adjust their projected reimbursement timelines accordingly.
Further reading
For broader trends in medical device reimbursement, explore the Healthcare section.
Source note: This article includes information reported by Insights.
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Should federal regulators prioritize new device pathways over existing national coverage determination wait lists?
