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Breakthrough Devices, NTAP/TPT, and RAPID:

Breakthrough Devices, NTAP/TPT, and RAPID:

What Medtech Entrepreneurs Need to Know

For medtech entrepreneurs developing a novel medical device, FDA strategy and reimbursement strategy have always been closely connected. A significant change coming in October 2026 makes that connection even more important.

CMS is ending the alternative reimbursement pathway that allowed FDA-designated Breakthrough Devices to qualify for certain NTAP and TPT benefits without separately demonstrating substantial clinical improvement (SCI). Importantly, NTAP and TPT themselves are not going away. Instead, Breakthrough Devices will generally have to meet the traditional requirements, including the SCI criterion.

 

What Is Changing?

For the past several years, Breakthrough Device designation provided an important reimbursement advantage. Sponsors could leverage their FDA Breakthrough designation to satisfy the substantial clinical improvement requirement for the Medicare New Technology Add-On Payment (NTAP) program for inpatient technologies and the Transitional Pass-Through Payment (TPT) program for outpatient technologies.

That alternative pathway ends in October 2026.

There is a transition period. According to CMS, Breakthrough Devices designated by September 30, 2026 can remain eligible for the alternative NTAP pathway if they receive FDA marketing authorization for the designated indication by May 1, 2028, with eligibility continuing through FY2029. The corresponding TPT transition extends to January 1, 2029.

For companies developing devices today, however, the practical takeaway is straightforward: Breakthrough designation can no longer be viewed as a standalone regulatory strategy. Reimbursement implications need to be considered much earlier.

 

Enter RAPID

In April 2026, FDA and CMS announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway. RAPID is intended to bring FDA and CMS into the development process earlier so that clinical evidence can potentially support both FDA authorization and Medicare coverage.

But RAPID is considerably narrower than the former NTAP/TPT alternative pathway.

Current FDA guidance indicates that RAPID is available to certain Class II Breakthrough Devices participating in FDA's Total Product Life Cycle Advisory Program (TAP) and eligible Class III Breakthrough Devices, with additional requirements. Devices must be studied under an Investigational Device Exemption involving Medicare beneficiaries and clinical health outcomes agreed upon by FDA and CMS.

That means RAPID is not simply a replacement for the old reimbursement advantage. It represents a different approach: integrating regulatory and coverage planning much earlier in device development.

 

What This Means for Medtech Entrepreneurs

The reimbursement landscape makes early regulatory strategy more important than ever.

If your device may qualify for FDA Breakthrough Device designation, the designation should be evaluated not only in terms of FDA interaction and review benefits, but also in the context of your clinical evidence, Medicare population, coverage strategy, and commercialization timeline.

FDA continues to describe Breakthrough Device designation as a program intended to accelerate development, assessment, and review of eligible devices.

For entrepreneurs, the key questions now include:

  • Does the device meet the criteria for Breakthrough Device designation?

  • What evidence will be needed to support the FDA marketing submission?

  • Will Medicare beneficiaries be an important target population?

  • Could the device potentially fit the RAPID pathway?

  • If RAPID is not applicable, what reimbursement strategy will address the period between FDA authorization and broader Medicare coverage?

These questions should be considered before pivotal clinical and regulatory decisions are locked in.

 

Why Breakthrough Strategy Still Matters

The end of the NTAP/TPT alternative pathway does not make Breakthrough Device designation irrelevant. It makes strategic planning around the designation more important.

A well-developed Breakthrough Device request can help establish the regulatory strategy for an innovative device and create opportunities for earlier interaction with FDA. For companies pursuing emerging technologies, understanding how that designation interacts with clinical development and reimbursement planning can be critical.

At Rook Quality Systems, we help medtech companies evaluate Breakthrough Device opportunities and prepare FDA designation requests, including the supporting rationale and submission materials.

If you are developing a device that may qualify for Breakthrough Device designation, now is a good time to evaluate the regulatory and reimbursement strategy together, rather than treating reimbursement as a post-clearance problem.

 

 

 

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