Introduction
On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced a plan to create a new pathway to expedite Medicare coverage for certain medical devices designated by the FDA as breakthrough devices (the Announcement).1 Devices travelling the new Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway, which would in effect be run jointly by the two agencies, are expected to experience fewer delays between FDA market authorization and Medicare national coverage determinations than at present, as long as they meet certain requirements.
The two agencies would work closely together with sponsors earlier in the development process to align regulatory and coverage expectations in advance and to facilitate use by CMS of evidence generated for FDA review.2
This announcement anticipates publication in the Federal Register of a formal proposal detailing the pathway sometime “soon.” The proposal would be open for comments for 60 days and followed by a final notice. The agencies expect to launch the new pathway at the time the final notice is published, but the agencies have not provided any information about when that will be.
While the details available at present are incomplete, the following sections provide a high-level summary of the expected RAPID proposal and attempts to place this initiative in the context of a number of related proposals.
Summary of the RAPID Coverage Pathway
According to the Announcement, breakthrough devices eligible for the RAPID pathway would include Class III devices and certain Class II devices that participate in the FDA Total Product Life Cycle Advisory Program (TAP). In addition, the devices would need to be the subject of an Investigational Device Exemption (IDE) study enrolling Medicare beneficiaries and investigating clinical health outcomes agreed to by FDA and CMS.
The forthcoming RAPID coverage pathway proposal is likely to be most beneficial for high risk, evidence intensive breakthrough devices, particularly Class III products, which require PMA approval and target serious or life threatening conditions, many of which are common in the Medicare population. These include therapies and diagnostic tools where FDA review already depends on prospective IDE studies with meaningful clinical endpoints. For these technologies, RAPID may offer the greatest value by reducing the longstanding lags between FDA market authorization and Medicare coverage determinations, provided sponsors are willing to engage early with both agencies and generate evidence that satisfies FDA safety and effectiveness standards as well as CMS’ reasonable and necessary coverage criteria.
The pathway may also benefit a subset of Class II breakthrough devices,3 but only where those products participate in FDA’s (TAP) program, making TAP a critical gateway for such devices. For these devices, RAPID may provide a benefit that builds on the early, frequent FDA engagement already offered under TAP by formally including CMS in those discussions, particularly around endpoint selection, study design, and Medicare relevant outcomes. In practice, CMS’ inclusion will likely make RAPID participation of most benefit for complex Class II technologies, such as novel diagnostics or device enabled therapies, while reinforcing TAP’s role as the FDA mechanism for identifying Class II devices whose risk profile and clinical impact justify intensified attention.
The agencies expect that on the same day an eligible device receives FDA market authorization, CMS will issue a proposed National Coverage Determination (NCD) for the device, which will trigger a 30-day comment period. A final NCD may follow very shortly, which could enable Medicare coverage and payment in as little as two months following market authorization (versus a year or more at present).
The agencies note that CMS will continue to offer multiple pathways for coverage of devices, including the existing NCD process, so sponsors presumably will continue to be able to avail themselves of the existing pathways if RAPID appears unnecessary or too cumbersome for a particular device.
The agencies give no suggestion that the standards used by FDA for market authorization or those employed by CMS for coverage will change.
Related Proposals
The RAPID pathway proposal marks CMS’ third attempt to address concerns about coverage of breakthrough devices. In early 2021, near the end of the first Trump administration, CMS issued regulations setting up the Medicare Coverage for Innovative Technologies (MCIT) program. MCIT would have expedited coverage for all breakthrough devices, but it was never implemented. CMS replaced it with the narrower Transitional Coverage for Emerging Technologies (TCET) program, which tied coverage to the Coverage with Evidence Development pathway. TCET has been little used. The current announcement indicates that the TCET pathway will be “paused for new candidates” as CMS concentrates on implementing the RAPID program.
In Congress, policies that would bring greater certainty to the coverage prospects for breakthrough devices have received broad, bipartisan support. As recently as April 21, 2026, a bipartisan group of 82 lawmakers wrote to Secretary Kennedy and CMS Administrator Oz expressing support for “comprehensive Medicare coverage of breakthrough medical device technologies.”
In September 2025, the House Ways and Means Committee advanced H.R. 5343, the “Ensuring Patient Access to Critical Breakthrough Products Act” by a vote of 37-3. The legislation would create a four-year transitional coverage period during which breakthrough devices would be covered and impose a requirement to issue final coverage decisions during that time, provided certain procedural requirements are met. The Congressional Budget Office has estimated the total cost of the legislation to be just under $1 billion over 10 years, though the administration’s advancement of RAPID could lower the costs depending upon its final form.
In the proposed rule updating Medicare’s Inpatient Prospective Payment System (IPPS) for FY27, CMS has proposed changing the payment provisions applicable to certain new technologies to remove favorable treatment for breakthrough devices.4 At present, breakthrough devices are deemed to automatically meet an otherwise applicable requirement to demonstrate substantial clinical improvement in order to qualify for New Technology Add-on Payments under the IPPS and Transitional Pass-Through Payments under Medicare’s Outpatient Prospective Payment System (OPPS). These proposals, if adopted, would mean sponsors of breakthrough devices, in order to secure either of these special payment provisions, would have to provide evidence that their products met the improvement criterion on the same basis as devices without breakthrough designation. Note that these proposals affect payment, as distinct from the RAPID pathway, which would address coverage.
Proposals and Comment Opportunities
RAPID will likely be well received by industry and seen as a constructive step toward reducing longstanding delays between FDA market authorization and Medicare coverage for breakthrough devices, but the devil will be in the details. Specifications of many important aspects of the RAPID pathway have not yet been made available, and we expect great interest to attach to the details of how the IDE studies will be set up and followed (for instance, whether coverage may be removed at a later time if studies do not support long-term coverage and how devices newly covered under the RAPID pathway will fit in the existing Medicare payment systems, just to name a few considerations). We anticipate that stakeholders will closely scrutinize CMS’ plans for and execution of the pathway, particularly with respect to timelines, operational accountability, and coordination with existing payment policies. Stakeholders are also likely to object vociferously to removal of the special provisions favoring breakthrough devices under the IPPS and the OPPS.
Interested parties will be able to comment on both the forthcoming proposed RAPID notice and the IPPS Proposed Rule for FY27, which takes effect January 1, 2027. The comment window on the IPPS Proposed Rule is already open, and comments are due June 9, 2026. Arnold & Porter’s regulatory and reimbursement team will be following developments in this area, and we are available to consult about the proposals and possible comments.
Footnotes
1 See FDA News Release and CMS Press Release (Apr. 23, 2026).
2 CMS and FDA have previously attempted to more closely align their respective reviews as a means to facilitate a quicker access to
medical technology following FDA authorization, for example, under the Parallel Review Pilot Program and Program for Parallel Review
of Medical Devices.
3 As of this writing, the agencies have not provided details on which Class II devices would be eligible.
4 91 Fed Reg 19457-19459, April 14, 2026
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