By : Elle Winn & Susan Lubejko PhD- Mittal Consulting

On Thursday April 23, the United States Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) announced a new, expedited Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway for certain FDA-designated Class II and III Breakthrough Devices. The announcement of RAPID is an exciting development in the MedTech industry, bringing increased collaboration between FDA and CMS to the forefront of development of novel technologies. The implementation of the RAPID pathway is expected to streamline the planning of outcomes for clinical studies in such a way that ensures clinical studies which satisfy FDA authorization requirements also satisfy requirements for Medicare coverage. Finally, the rollout of RAPID is expected to substantially shorten the amount of time required to obtain proposed coverage determinations under the current reimbursement framework. 

Many device manufacturers are familiar with the intimidating “valley of death” that faces medical devices between FDA clearance and entry to the US market. Much of this treacherous terrain is driven by long timelines to achieve reimbursement for novel medical devices, one step of which is gaining coverage for the device. Obtaining coverage for novel medical devices has long been a challenge. A 2023 cross-sectional study by Sexton, et al. found that following authorization by FDA, novel medical devices only acquired nominal (explicit or implicit) Medicare coverage after a significant 5.7 years, with some devices requiring up to 7 years to receive coverage. While recent programs from CMS have attempted to address this challenge, RAPID holds promise to further pave a smoother path to initial coverage for novel medical devices.

Historical Solutions to the Problem:

There have been a few attempts to expedite coverage pathways for novel medical devices.

The Medicare Coverage of Innovative Technology (MCIT) pathway was a short-lived policy introduced in January 2021 and repealed in November of the same year. MCIT was designed to accelerate coverage by providing immediate, automatic coverage for up to four years without requiring a separate Medicare coverage determination for FDA Breakthrough-designated novel technologies. MCIT centered on the idea that the four-year automatic coverage would act as a transitional period in which CMS could gather evidence and decide on long-term coverage. Unfortunately, MCIT was repealed before it was fully implemented due to concerns of insufficient evidence standards, limited ability for CMS to restrict or withdraw coverage if later evidence showed limited device effectiveness, and concerns about delegating Medicare coverage decisions to the FDA.

Following the repeal of MCIT, CMS developed and finalized in 2024 the currently active approach to accelerating Medicare coverage to novel devices: the Transitional Coverage for Emerging Technologies (TCET) pathway. TCET is a voluntary pathway for FDA Breakthrough-designated medical devices, rather than an automatic coverage program. TCET relies on two existing coverage determination frameworks, National Coverage Determination (NCD) and Coverage with Evidence (CED), which judge whether the device is “reasonable and necessary” to determine coverage or provide conditional coverage while additional clinical data are collected to support a future coverage decision.

A disadvantage of the current TCET pathway is that it only takes effect following FDA market authorization for medical devices and is linked to ongoing evidence collection. While sponsors can (and should) interact with CMS ahead of FDA authorization, under the current TCET framework, Medicare coverage determination processes do not begin until after FDA authorization, usually within a few months. This systemic requirement causes coverage delays for many medical device sponsors and requires careful planning to obtain timely coverage. Furthermore, the TCET pathway is highly selective, meaning it is competitive to obtain coverage.

A New Pathway Emerges

On April 23, 2026, FDA and CMS released a joint press release announcing the development of the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, which is designed to expedite Medicare coverage for some Class II and Class III FDA Breakthrough-designated devices. During the implementation of RAPID, TCET will be paused for new candidates.

As the name implies, RAPID aims to align FDA and CMS earlier in medical device development, specifically seeking to collaboratively generate one clinical evidence package that supports both regulatory approval and Medicare coverage. Under RAPID, CMS will join discussions with FDA and sponsors to identify what clinical outcomes matter for Medicare patients in medical device clinical studies, so sponsors are equipped with the knowledge of what evidence will satisfy both FDA and CMS requirements. 

Additionally, with the early collaboration between FDA, CMS, and device sponsors, the regulatory and coverage processes become synchronized under RAPID, meaning that devices receive a proposed National Coverage Determination (NCD) the same day as they receive FDA authorization. Following the proposed NCD, there will be a 30-day public comment period, leading to potential final coverage in a time frame of a couple of months, rather than years as has been the historical median. 

Devices which will be eligible for RAPID include Class II Breakthrough-designated devices which are also enrolled in the FDA’s Total Product Life Cycle Advisory Program (TAP), as well as Class III Breakthrough Designated Devices regardless of TAP enrollment. Sponsors of Class II Breakthrough-designated devices that would like to access the RAPID pathway but are not currently enrolled in TAP are encouraged to seek enrollment in TAP through the standard enrollment process, or they can reach out to FDA for consideration of devices that would otherwise qualify for RAPID but are not currently eligible for TAP. Importantly, the devices participating in RAPID must be the subject of an Investigational Device Exemption (IDE) clinical study that enrolls Medicare beneficiaries such that both FDA and CMS can weigh in on the outcomes to be addressed in the study. Breakthrough-designated and TAP-enrolled medical devices that don’t require clinical data will not be able to reap the benefits of this program.

Looking Forward:

There are still many questions about the implementation of the RAPID program that remain to be answered; however, this joint announcement from FDA and CMS shows exciting collaborative momentum that could benefit medical device sponsors if implemented as described. Notably, the major benefits of RAPID will include collaboration to generate one evidence base that supports FDA and CMS requirements, as well as an extremely expedited pathway to coverage as the first step in the device reimbursement process.

While we currently don’t know the exact details of RAPID implementation, we can expect the proposed pathway to be published in the Federal Register with more precise information soon, following which a 60-day public comment period will begin. Subsequently, a final notice in the Federal Register incorporating public feedback will be released, setting the effective date of this new program.

References

1. CMS and FDA announce rapid coverage pathway to accelerate patient access to life-changing medical devices. U.S. Food and Drug Administration. April 23, 2026. https://www.fda.gov/news-events/press-announcements/cms-and-fda-announce-rapid-coverage-pathway-accelerate-patient-access-life-changing-medical-devices.