CMS and FDA Announce New RAPID Program for Medicare Coverage of Breakthrough Medical Devices

On April 23, 2026, the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) jointly announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. RAPID aims to compress the gap between FDA authorization and Medicare national coverage from a year or more to as little as two months for certain Class II and Class III breakthrough devices — certain novel devices determined by FDA to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions (Breakthrough Devices).FDA, CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices (Apr. 23, 2026), https://www.fda.gov/news-events/press-announcements/cms-and-fda-announce-rapid-coverage-pathway-accelerate-patient-access-life-changing-medical-devices. Devices that meet certain criteria are eligible for designation by FDA as a breakthrough device, which entitles the device to certain expedited development incentives and priority review.  21 U.S.C. § 360e-3. To be eligible for breakthrough device designation, a device must “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions” and either “represent breakthrough technologies,” have “no approved or cleared alternatives,” “offer significant advantages over existing approved or cleared alternatives,” or have its “availability” be deemed “in the best interest of patients.” Id. § 360e-3(b). RAPID intends to align regulatory and coverage expectations in advance, such that evidence generated for FDA review can also support and provide a more predictable path to Medicare coverage. Medicare coverage decisions, in turn, often inform whether commercial payers will cover a device.

Previously, the evidence required to support FDA authorization could materially differ from the evidence needed to support Medicare coverage, leading manufacturers to take a sequential approach to evidence generation, which led to delays, often of a year or more, in obtaining reimbursement. RAPID seeks to reduce the timeframe to as little as two months through early engagement with both CMS and FDA during premarket development to support coordinated evidence generation and shortened CMS timelines.

Unlike most prior proposals, RAPID does not provide automatic Medicare coverage upon FDA authorization; rather, it synchronizes CMS’s National Coverage Determination (NCD) process with FDA review so that a proposed NCD can issue on the same day as FDA authorization, with a final NCD targeted within 60-90 days. The NCD remains subject to public comment and CMS discretion after a 60-day comment period.

On April 10, 2026, CMS also proposed repealing the alternative New Technology Add-On Payment (NTAP) pathway for Breakthrough Devices in both inpatient and outpatient settings through the FY 2027 Inpatient Prospective Payment System (IPPS) proposed rule.91 Fed. Reg. 19312 (Apr. 14, 2026). The NTAP pathway had allowed Breakthrough Devices to receive add-on payments without demonstrating substantial clinical improvement over existing technologies. This proposed repeal, if finalized, poses a significant threat to Breakthrough Device manufacturers by forcing a return to the prior burdensome practice of meeting the same eligibility criteria as other available technologies to receive the additional payments.

The RAPID Program

The FDA’s Breakthrough Device program expedites the agency’s review process for these novel devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. However, FDA authorization does not guarantee Medicare coverage. Medicare coverage requires a successful coverage decision from CMS based on a finding of medical necessity. Obtaining a coverage decision, particularly an NCD that provides nationwide coverage, has historically been slow and uncertain.

Previous Government Initiatives

CMS and Congress took various steps to address the gap between authorization and coverage for Breakthrough Devices prior to issuing the recent RAPID announcement:

• CMS and FDA introduced the Parallel Review program in 2011 to incentivize medical device innovation.76 Fed. Reg. 62808 (Oct. 11, 2011); 76 Fed. Reg. 66309 (Oct. 26, 2011). The program was initially limited to a small number of candidates per year and is available to devices authorized via the premarket approval or de novo classification premarket review pathways.CMS made the Parallel Review program permanent in 2016, with a capacity limit of accepting no more than five candidates per year. 81 Fed. Reg. 73113 (Oct. 24, 2016). The Parallel Review program provides for simultaneous FDA and CMS review of clinical data in an effort to decrease the time between FDA’s review of an eligible application and CMS’s subsequent issuance of an NCD. To date, very few devices have successfully gone through the program.
• In January 2021, the first Trump administration finalized the Medicare Coverage of Innovative Technology (MCIT) rule, which would have granted automatic, national Medicare coverage for Breakthrough Devices for up to four years from FDA authorization.86 Fed. Reg. 2987 (Jan. 14, 2021).
• The Biden administration repealed the MCIT rule in November 2021. In August 2024, CMS finalized the Transitional Coverage for Emerging Technologies (TCET) pathway as an alternative approach.86 Fed. Reg. 62944 (Nov. 15, 2021); 89 Fed. Reg. 65724 (Aug. 12, 2024). The TCET pathway provides an expedited — but still relatively burdensome — pathway for up to five Breakthrough Devices per year. The TCET program, which used the existing NCD and Coverage with Evidence Development (CED) processes, was criticized by industry for its limited capacity and CMS’s failure to coordinate with the FDA or manufacturers on pivotal trial design before coverage review. In the RAPID announcement, the administration stated it intends to “pause” accepting new candidates into the TCET pathway.
• Bipartisan legislation, the Ensuring Patient Access to Critical Breakthrough Products Act, has also been introduced in Congress that, if enacted, would provide four years of automatic transitional Medicare coverage for Breakthrough Devices upon FDA authorization.Ensuring Patient Access to Critical Breakthrough Products Act of 2025, S. 1717, 119th Cong. (2025).

RAPID Approach

RAPID, in contrast to many of the recent previous efforts, synchronizes FDA premarket review with CMS’s NCD process starting at the beginning of the Investigational Device Exemption (IDE) stage, so that pivotal clinical trials generate the evidence necessary for both FDA authorization and a Medicare coverage determination. This coordination is intended to eliminate the longstanding problem of companies completing FDA review only to find their clinical evidence was insufficient to support CMS coverage.

Key features of the RAPID pathway, as compared to the existing (but now paused) TCET framework, include:

RAPID vs. TCET

To be eligible for RAPID, a device must be a Breakthrough Device, address an unmet need among Medicare beneficiaries, and be the subject of an IDE study enrolling Medicare beneficiaries and studying clinical health outcomes agreed upon by both FDA and CMS. All Class III devices that meet these criteria are eligible for RAPID; Class II devices must also participate in FDA’s Total Product Life Cycle Advisory Program. CMS will pause TCET for new candidates while it implements RAPID, and CMS will publish a proposed procedural notice in the Federal Register with a 60-day public comment period.

Why It Matters

RAPID represents a significant federal effort to close the gap between FDA authorization and Medicare coverage. RAPID could provide permanent Medicare coverage within 60-90 days of FDA authorization, addressing the historic gap between authorization and coverage. Because Medicare coverage often informs commercial payer policies, faster Medicare access may also support broader commercial uptake for certain devices.

For investors, this dynamic may materially shorten the gap between capital deployment and commercial inflection. RAPID’s capacity — approximately 40 to 60 eligible devices versus TCET’s five per year — also signals CMS’s intent to operate at a scale that could meaningfully impact the medtech innovation ecosystem. However, the historical record showing limited successful utilization of the Parallel Review program is a reminder that structural alignment between the two agencies has not, on its own, been sufficient to move devices through the coverage process at scale and underscores the importance of RAPID’s additional features and ultimate execution.

Proposed Repeal of Breakthrough Device Add-On Payment Provision

In a related action, on April 10, 2026, CMS proposed to repeal the NTAP pathway for Breakthrough Devices as part of the FY 2027 IPPS proposed rule. The NTAP pathway had allowed such devices to receive add-on payments without demonstrating substantial clinical improvement over existing technologies. If finalized, the repeal would take effect in FY 2028. Comments are due by June 9, 2026. CMS also indicated this repeal will apply to the hospital Outpatient Prospective Payment System.

These two proposals address distinct CMS levers: RAPID determines whether Medicare will pay for a Breakthrough Device, while the NTAP alternative pathway determines how much Medicare pays hospitals that adopt one. Faster coverage under RAPID with lower payment due to an NTAP repeal could leave a device nominally reimbursable but commercially unadopted — a risk that investors should model as both proposals move through final rulemaking.

Next Steps

The 60-day public comment period on the RAPID procedural notice will be a critical window, as will the comment period on the proposed NTAP repeal. Effective RAPID implementation may reduce congressional urgency around the Ensuring Patient Access to Critical Breakthrough Products Act; a tradeoff, since manufacturers will gain a faster administrative pathway but could lose momentum on statutory four-year automatic coverage that a future administration cannot rescind.