CMS and FDA introduce RAPID pathway to streamline Medicare access for breakthrough devices

In a move aimed at reducing delays between regulatory approval and patient access, 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. The initiative is designed to accelerate Medicare coverage for select FDA-designated Breakthrough Devices, particularly those addressing unmet clinical needs.

The new pathway targets a long-standing challenge in the medtech ecosystem: the gap between FDA market authorization and Medicare reimbursement decisions. By aligning both processes earlier, RAPID aims to bring greater predictability and speed to patient access.

Early coordination to reduce delays

A central feature of the RAPID pathway is earlier collaboration between CMS, FDA, and device manufacturers. Instead of working sequentially, the two agencies will now engage with innovators during the development phase to align on evidence requirements.

Dr. Mehmet Oz, CMS Administrator, emphasized the importance of this coordination, noting that both agencies “play a critical role in getting new medical devices to patients” and that earlier alignment can help cut administrative burden while improving access.

Under RAPID, CMS will participate in ongoing discussions traditionally led by the FDA, helping manufacturers understand what clinical endpoints and outcomes are most relevant for Medicare beneficiaries. This ensures that data generated during clinical development can serve both regulatory approval and coverage decisions.

Who qualifies for RAPID?

The pathway is open to certain Class II and Class III devices that have received FDA Breakthrough designation, specifically those addressing unmet medical needs among Medicare populations.

Eligibility criteria include:

• Participation in an Investigational Device Exemption (IDE) study
• Enrollment of Medicare beneficiaries in clinical trials
• Alignment on clinical endpoints agreed upon by CMS and FDA

Class II devices must also be part of the FDA’s Total Product Life Cycle Advisory Program (TAP), while Class III devices can qualify regardless of TAP participation.

Faster, more predictable coverage decisions

One of the most notable aspects of the RAPID pathway is its synchronized timeline. CMS will issue a proposed National Coverage Determination (NCD) on the same day a qualifying device receives FDA market authorization.

This triggers a mandatory 30-day public comment period, after which coverage decisions can be finalized. The result: Medicare coverage could be established in as little as two months—significantly shorter than the typical timeline of a year or more.

Marty Makary, FDA Commissioner, underscored the broader goal of the initiative, stating that patients “deserve timely access to meaningful treatments without red tape or high costs,” adding that closer collaboration between the FDA and CMS supports faster delivery of life-saving technologies.

Implications for innovators and patients

By reducing duplication in evidence generation and clarifying expectations upfront, the RAPID pathway offers several potential benefits:

• For innovators: greater transparency, lower development uncertainty, and faster time to reimbursement
• For clinicians: quicker access to reimbursed technologies
• For patients: earlier availability of clinically beneficial devices

The approach also reflects a broader policy direction toward integrating regulatory and reimbursement pathways, an area of increasing focus as device complexity and development costs continue to rise.

What happens next?

CMS plans to publish a proposed procedural notice in the Federal Register outlining the RAPID pathway. Stakeholders will have 60 days to submit public comments, after which a final notice will be issued.

The Transitional Coverage for Emerging Technologies (TCET) pathway will be paused for new candidates while CMS prioritizes implementation of RAPID. However, existing Medicare coverage routes will remain available.

If successfully implemented, RAPID could mark a shift in how breakthrough medical technologies move from approval to real-world use, bringing a more coordinated and predictable framework to one of the most critical stages in the medtech lifecycle.

Source

FDA

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