Original publication here: https://foleyhoag.com/news-and-insights/publications/alerts-and-updates/2026/april/cms-and-fda-announce-rapid-coverage-pathway-to-accelerate-medicare-coverage-for-breakthrough-medical/
Key Takeaways:
- Faster Medicare Coverage. The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) have announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, which could enable national Medicare coverage and payment for medical devices as soon as two months after FDA market authorization, compared to approximately a year or more under the current process.
- Earlier Agency Coordination on Evidence Requirements. Under the RAPID pathway, CMS will participate in early and frequent engagement between the FDA and device manufacturers, allowing the agencies to align on the clinical evidence needed for both FDA premarket review and Medicare coverage decisions before a product reaches market.
- CMS Coverage Process to Immediately Follow FDA Market Authorization. Under the RAPID pathway, CMS will open a national coverage decision the day that the FDA clears a medical device, potentially leading to Medicare coverage within 60 days of market authorization.
- TCET Pathway Paused. CMS has announced it will pause the Transitional Coverage for Emerging Technologies (TCET) pathway for new candidates as the agency shifts its focus to implementing the RAPID coverage pathway.
Background
On April 23, 2026, CMS and the FDA jointly announced in a press release the RAPID coverage pathway, a new initiative designed to expedite Medicare coverage for certain FDA-designated Class II and Class III Breakthrough Devices. The announcement reflects the agencies’ commitment to accelerating and adding predictability to Medicare coverage following FDA market authorization for breakthrough technologies. A proposed notice outlining the pathway is expected to be published in the Federal Register in the near term, with a 60-day public comment period to follow.
How the RAPID Pathway Works
The RAPID coverage pathway is designed to address the historically significant lag (sometimes referred to as the “valley of death”) between the point at which a medical device receives FDA market authorization and the point at which it obtains a Medicare national coverage determination (NCD). It does so in two principal ways: early alignment on evidence requirements and a streamlined NCD timeline.
- Early Evidence Alignment. Under the current framework, device manufacturers often generate sufficient evidence for FDA clearance or approval only to discover that CMS requires different or additional clinical data to support a Medicare coverage determination. The RAPID pathway addresses this problem by bringing CMS into the conversation between the FDA and device innovators at an early stage of product development. This coordinated engagement is intended to ensure that the clinical outcomes studied in premarket trials are relevant to both agencies, reducing duplication of effort and minimizing post-authorization delays. For example, ensuring that Medicare beneficiaries are adequately represented in clinical trials will enhance agency coordination.
- Streamlined NCD Process. Under the RAPID pathway, CMS will issue a proposed NCD on the same day that an eligible device receives FDA market authorization. This triggers the statutorily required 30-day public comment period. According to CMS, this streamlined process could allow Medicare national coverage and payment to be finalized as soon as two months after market authorization, a dramatic reduction from the current timeline of approximately one year or more.
Eligibility
The RAPID coverage pathway is available for Breakthrough Devices that address unmet medical needs among Medicare beneficiaries. Specifically, the pathway is available for certain Class II Breakthrough Devices that are participating in the FDA’s Total Product Life Cycle Advisory Program (TAP) and for Class III Breakthrough Devices regardless of whether they participate in TAP. To be eligible, a 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.
Impact on Existing Coverage Pathways
CMS has stated that it will continue to offer multiple pathways to support access to medical technologies, including the standard NCD process. However, the TCET pathway, which CMS finalized in 2023 as a mechanism for providing transitional Medicare coverage for certain FDA-designated Breakthrough Devices, will be paused for new candidates while CMS focuses on implementing the RAPID pathway. CMS has indicated that it will apply lessons learned across its various coverage pathways to strengthen Medicare coverage processes over time.
Next Steps
A proposed procedural notice describing the RAPID coverage pathway will be published in the Federal Register. The public will have 60 days from publication to submit comments. CMS will respond to public comments in a subsequent final notice, and the RAPID pathway is expected to take effect upon publication of that final notice. Device manufacturers, healthcare providers, and other interested parties should monitor the Federal Register for the forthcoming publication and consider whether to submit comments during the public comment period.
What This Means
The RAPID pathway represents a potentially significant development for medical device manufacturers with products in the FDA’s Breakthrough Devices Program. By establishing a coordinated, predictable process for aligning FDA review and Medicare coverage, the pathway could substantially reduce the time and uncertainty currently associated with obtaining Medicare reimbursement for novel devices. Manufacturers with Breakthrough Device designations—particularly those at early stages of clinical development—should evaluate whether their products may be eligible for the RAPID pathway and consider engaging with CMS and the FDA accordingly. In addition, organizations that may be affected by the pause of the TCET pathway should assess the implications for any pending or planned TCET applications.
Finally, it is worth highlighting that this favorable policy announcement for Breakthrough Devices comes on the heels of CMS’s proposal to repeal the alternative pathway for New Technology Add-on Payment and device pass-through payment applications beginning with applications received for FY 2028 (for NTAP) and on or after October 1, 2026 (for OPPS device pass-through). Under the current alternative pathway, FDA-designated Breakthrough Devices, Qualified Infectious Disease Products (QIDPs), and drugs approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) are considered not substantially similar to existing technologies and are exempt from the substantial clinical improvement criterion. Under the proposed repeal, beginning with FY 2028 NTAP applications, all applicants would need to satisfy all three eligibility criteria: (1) the technology must be new; (2) it must be costly such that the DRG rate is inadequate; and (3) it must demonstrate a substantial clinical improvement over existing services or technologies. Similarly, all OPPS device pass-through applications received on or after October 1, 2026 would need to demonstrate substantial clinical improvement under § 419.66(c)(2)(i).
Foley Hoag’s Healthcare Department is continuing to monitor these developments and is happy to consult with you about how these regulatory changes may affect your organization’s coverage and reimbursement strategy and assist you with filing comments in response to these proposed changes.