Posted on by The ACG News Team

A separate CMS change could make it harder for these devices to receive enhanced Medicare payments.

In April 2026, the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway.

RAPID would expedite national Medicare coverage for certain FDA Breakthrough Devices by aligning CMS and FDA administrative review processes. According to CMS, instead of taking a year or more, RAPID could allow for Medicare coverage as soon as 60-90 days after FDA approval.

What is the current process?

CMS currently has 3 traditional pathways for coverage determinations:

1) National coverage determinations (NCDs)

The most comprehensive pathway, an NCD provides nationwide Medicare coverage for an item or service. Although it is officially granted by the Secretary of the Department of Health and Human Services, CMS traditionally relies heavily on health outcomes data to make NCDs. Generally, the NCD process takes 9 to 12 months to complete.

2) Local coverage determinations (LCDs)

In accordance with federal law, LCDs are regional decisions made by Medicare Administrative Contractors (MACs) to provide coverage for a particular item or service. This provides flexibility when there is no national policy or to address gaps within an existing NCD.

3) Claim-by-claim adjudication

In the absence of an NCD or LCD, contractors can make coverage decisions on a claim-by- claim basis. The MAC reviews the claim to determine if the item or service is reasonable and necessary for the individual patient. Despite being handled on a claim-by-claim basis, the majority of all Medicare Parts A and B claims have coverage determined through this pathway.

Transitional Coverage for Emerging Technologies (TCET)

  • In April 2026, CMS paused the TCET Pathway. Originally finalized in August 2024, the pathway coordinated coverage, coding, and evidence development so that medical device manufacturers can secure Medicare coverage more quickly after receiving U.S. Food and Drug Administration (FDA) market authorization.

RAPID Overview: How Will RAPID Change the Process?

RAPID would align CMS and FDA evidence requirements in advance to shorten the time for the FDA to issue market authorization and for CMS to issue a national coverage determination (NCD). This means a proposed NCD could be issued the same day as the FDA market authorization.

Which devices are impacted by RAPID?

The RAPID coverage pathway applies to FDA-designated Breakthrough Devices that address unmet medical needs for Medicare beneficiaries. The program is designed to accelerate the development, assessment, and review of novel devices with the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Eligible products include all Class III devices and certain Class II devices participating in the FDA Total Product Life Cycle Advisory Program (TAP) — currently, there are 159 devices in the pilot, with a target of 325 for FY 2027.

Agencies coordinate review process

The procedural notice describes a process in which CMS and the FDA would continue to use their existing processes but would closely engage and coordinate. The FDA would use the proposed Investigational Device Exemption (IDE) studies conducted by the manufacturer to assess clinical outcomes. CMS would review the IDE plan before the study launches, and the FDA would share the final IDE report and other information with CMS to inform the NCD process. Allowing CMS review of the study before it launches is a new feature of the process and is considered a critical aspect of aligning and speeding up the processes. It is expected that the device would receive FDA market authorization on the same day that CMS posts a proposed NCD.

What is the decision timeline?

There will be a 30-day public comment period for the proposed NCD. Under the proposed plan, CMS would issue the final NCD approximately 60 days after FDA market authorization for Class II devices and 90 days for Class III devices. RAPID does not guarantee unconditional national coverage. CMS indicates that the strength of the evidence and relative risk of a device will determine whether a RAPID NCD provides conventional coverage or requires coverage with evidence development (CED). In certain circumstances when CMS may find data insufficient, CMS may approve an NCD but determine coverage of an item or service only in the context of a clinical study.

Important: RAPID does not apply to devices already in progress

CMS generally does not intend RAPID to serve devices that have already progressed beyond IDE pre-submission, including technologies already being studied under an IDE or already market-authorized. However, CMS specifically requests comment on whether it should create a temporary transitional process allowing devices that have already progressed beyond IDE pre-submission and are currently being studied under an IDE to enter RAPID.

Will it be Harder to Get an Enhanced Payment for Technologies?

While the agency is issuing a notice and seeking comments on a faster approval process for breakthrough devices, it is raising the bar for these devices to receive supplemental payments.

To qualify for a Medicare New Technology Add-on Payment (NTAP), an applicant must satisfy three core statutory and regulatory criteria: newness, cost, and substantial clinical improvement. Currently, FDA Breakthrough Devices can qualify for NTAP without demonstrating substantial clinical improvement, provided they meet the standard cost and newness criteria.

GI Devices Granted FDA Breakthrough Status

  • According to data from the FDA, as of March 31, 2026, 1,284 Breakthrough Device designations have been granted. Of these, 119 were assigned to the Gastroenterology & Urology Clinical Panel.

In the recently issued payment rules, CMS is phasing out the alternative pathway for new technology add-on payments for breakthrough devices in 2028. Moving forward, breakthrough devices will need to meet the traditional criteria of being new, costly, and demonstrating substantial clinical improvement over existing options. Stakeholders have raised concerns that this could reduce access to breakthrough devices.

Putting RAPID Through a Pro/Con Review

In our analysis of the RAPID coverage pathway, we identified several benefits, as well as potential concerns:

Benefits Concerns
  • Faster patient access to life-changing medical technology.
  • Simultaneous review by CMS and FDA, means decisions should arrive at around the same time.
  • Coordination from the beginning of the process means that clinical testing will satisfy the requirements of both agencies at the same time.
  • Developers and manufacturers may benefit from a more predictable timeline.
  • It is restricted to a limited number of early-stage breakthrough devices.
  • Acceptance into program does not guarantee coverage.
  • These devices are still at risk for coverage with evidence development (CED). CED conditions reimbursement to ongoing mandatory data collection.
  • By prioritizing RAPID, CMS may de-prioritize coverage decisions for non-RAPID technology, resulting in delays for devices on the NCD waitlist.

In short, RAPID could expedite Medicare beneficiaries’ access to life-saving medical technology, but concerns remain about whether CMS has the capacity to launch and manage RAPID without slowing its ongoing NCD review process. Additionally, with the proposed changes to new technology add-on payments, there is concern that these devices, even if they receive expedited coverage, may no longer be eligible for enhanced payments. 

ACG would like to thank Sheila Madhani (Madhani Healthcare Consulting, LLC) for her contributions in drafting this article.