CMS and FDA Announce RAPID Coverage Pathway for Breakthrough Medical Devices

April 24, 2026

CMS and FDA Announce RAPID Coverage Pathway to Accelerate Medicare Coverage for Breakthrough Medical Devices

Thomas Barker, Caroline Farell, Bryant Godfrey, Matthew Piscitelli Foley Hoag LLP + Follow Contact LinkedIn Facebook X ;) Embed

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).

;) ;) Report

Latest Posts

• CMS and FDA Announce RAPID Coverage Pathway to Accelerate Medicare Coverage for Breakthrough Medical Devices
• DOJ Immediately Reschedules State-Licensed Medical Cannabis to Schedule III — and Restarts the Clock on Broader Rescheduling
• New DEI Compliance Requirements for Federal Contractors and Grant Recipients: What You Need to Know Before Key Deadlines Hit
• SEC Provides Interpretive Guidance on the Application of Federal Securities Laws to Certain Types of Crypto Assets and Transactions
• DOJ Announces First False Claims Act Settlement Under Civil Rights Fraud Initiative: IBM to Pay $17 Million to Resolve Allegations of Discrimination Through DEI Practices See more »

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.
Attorney Advertising.

©
Foley Hoag LLP

Written by:

Foley Hoag LLP Contact + Follow Thomas Barker + Follow Caroline Farell + Follow Bryant Godfrey + Follow Matthew Piscitelli + Follow more less

PUBLISH YOUR CONTENT ON JD SUPRA

• ✔ Increased readership
• ✔ Actionable analytics
• ✔ Ongoing writing guidance Join more than 70,000 authors publishing their insights on JD Supra

Start Publishing »

Published In:

Centers for Medicare & Medicaid Services (CMS) + Follow Comment Period + Follow Food and Drug Administration (FDA) + Follow Health Insurance + Follow Health Technology + Follow Healthcare + Follow Innovative Technology + Follow Life Sciences + Follow Medical Devices + Follow Medicare + Follow New Guidance + Follow Regulatory Oversight + Follow Regulatory Requirements + Follow Administrative Agency + Follow Health + Follow Science, Computers & Technology + Follow more less

Foley Hoag LLP on:

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra: Sign Up Log in ** By using the service, you signify your acceptance of JD Supra's Privacy Policy.* - hide - hide