Medicare coverage for Breakthrough devices changed three ways in 2026, and the change everyone is talking about is the one that hasn't happened yet. RAPID, the CMS and FDA plan to cover Breakthrough devices from the day FDA authorizes them, is still a proposal. The other two changes are already in force: TCET, CMS's existing coverage route for Breakthrough devices, is closed to new candidates, and the Breakthrough shortcut to Medicare's new-technology add-on payment (NTAP) has been repealed.
If you're planning a pivotal study, those two matter more today than RAPID does. Here is where each change stands, read from CMS's own documents as of November 1, 2026, and what to do depending on where your device is.
Key takeaways
- RAPID is not final. CMS proposed it on August 11, 2026; comments closed October 13. No final notice yet.
- TCET is closed to new devices as of August 11, 2026.
- The NTAP shortcut is gone for devices designated after September 30, 2026. They must show substantial clinical improvement, like any other device.
- Designated by September 30, 2026? You keep the shortcut if FDA authorizes your device by May 1, 2028.
- Plan coverage at the IDE pre-submission, not after approval.
How we got here
In August 2025, AdvaMed and 66 other organizations wrote to the Centers for Medicare & Medicaid Services (CMS) asking for faster Medicare coverage of Breakthrough devices. In April 2026, CMS and FDA announced RAPID. The formal proposal followed on August 11, 2026, and on the same day CMS stopped taking new devices into TCET. A week earlier, the hospital payment rule for FY 2027 had ended the Breakthrough shortcut to add-on payments.
The three changes at a glance
| Change | Status | Date |
|---|---|---|
| TCET closed to new Breakthrough devices | In force | August 11, 2026 |
| RAPID proposed: Medicare coverage proposed on the day of FDA authorization | Proposed; comments closed | Notice August 11, 2026; comments closed October 13, 2026 |
| NTAP and TPT shortcut repealed for Breakthrough devices | Final | From FY 2028 add-on applications; pass-through applications after September 30, 2026 |
What is the RAPID coverage pathway?
Today, a national coverage determination (NCD) generally takes 9 to 12 months, by CMS's own account, and it usually starts after FDA has authorized the device. Under RAPID, CMS would post a proposed NCD on the same day as FDA authorization and the public release of FDA's decision summary. It would aim to finalize the NCD about 60 days later for a Class II device and 90 days later for a Class III device.
Two limits come with it. Coverage would apply only to the indications FDA authorized. And depending on the evidence and the device's risk, the NCD could still require further evidence development as a condition of coverage.
Who is eligible for RAPID?
The proposed pathway is narrow. A device must meet every one of these conditions:
- Breakthrough designation, on the right route. Either it is a Class II device in FDA's Total Product Life Cycle Advisory Program (TAP) heading for a De Novo request, or it is a Class III device heading for a PMA, in TAP or not.
- Before the IDE. It is still at the stage before its investigational device exemption (IDE) submission.
- Medicare patients in the pivotal study. Its IDE study will enroll Medicare beneficiaries and measure health outcomes that FDA considers appropriate and CMS confirms would show benefit for Medicare patients.
- A Medicare benefit, not already covered. Nothing shows it falls outside a Medicare benefit category, no controlling NCD already covers it, and it is separately payable.
In vitro diagnostics are excluded. CMS says most Breakthrough IVDs should continue through the regional Medicare Administrative Contractors. A manufacturer can withdraw from RAPID at any point until CMS posts the proposed NCD.
Here's the catch. If your pivotal study is already designed or running without Medicare patients and CMS-agreed outcomes, RAPID, as proposed, is not open to that study. The coverage conversation has to happen before the IDE, not after approval.
TCET is closed to new Breakthrough devices
CMS created the Transitional Coverage for Emerging Technologies (TCET) pathway in August 2024 for Breakthrough devices with limited or developing evidence. The RAPID notice paused it for new candidates on the day it was published, August 11, 2026, while CMS focuses on RAPID. Parallel Review, the older joint FDA–CMS route, remains available.
So for now, a Breakthrough device that isn't already in TCET has no dedicated fast route to Medicare coverage until RAPID is final.
The NTAP alternative pathway for Breakthrough devices is repealed
Coverage decides whether Medicare pays for a device at all. Hospitals are paid for new technology through two further mechanisms: the new-technology add-on payment (NTAP) for inpatient stays, and transitional pass-through payment (TPT) for outpatient use. Since 2020, a Breakthrough device could qualify for either through an "alternative pathway" that did not require it to show substantial clinical improvement.
The FY 2027 hospital payment final rule (August 4, 2026) repeals that alternative pathway. From NTAP applications for FY 2028, and from TPT applications submitted after September 30, 2026, a Breakthrough device must meet the same criteria as any other, including substantial clinical improvement. An NTAP application also needs FDA authorization by May 1 before the fiscal year it is for.
There is a limited exception. A device that held Breakthrough designation on September 30, 2026 keeps the old route:
- NTAP through FY 2029, provided FDA authorizes it by May 1, 2028;
- TPT through calendar year 2029, once it is authorized.
A worked example. Say your Class III device received Breakthrough designation in September 2026, and you expect PMA approval in spring 2028. You are inside the exception, but for NTAP only if FDA authorizes the device by May 1, 2028. If approval slips past that date, the shortcut is gone and your add-on payment application has to show substantial clinical improvement like any other. That date belongs in your regulatory plan now, not in 2028.
What to do now, depending on where your device is
| Your position | What it means |
|---|---|
| Breakthrough designation on or before September 30, 2026 | You keep the NTAP shortcut if FDA authorizes you by May 1, 2028. Work back from that date: it is now a hard edge in the plan. |
| Designated after September 30, 2026, or planning to apply | Plan to prove substantial clinical improvement for any NTAP or TPT application. Designation still brings FDA's Breakthrough program benefits; it no longer brings the payment shortcut. |
| Before your pivotal study, with Medicare patients in your market | Raise coverage outcomes with FDA and CMS at the IDE pre-submission. If RAPID is finalized as proposed, that is the entry point. |
| Pivotal study already designed or running | RAPID, as proposed, is not open to that study. Plan for the standard NCD process or local coverage, and for the evidence those need. |
| Breakthrough IVD | RAPID will not accept it; coverage continues through the Medicare Administrative Contractors. |
Beyond the US: payers everywhere are moving earlier
Medicare is not the only payer moving into the period before the pivotal study.
- European Union. A joint scientific consultation under the HTA Regulation lets a developer of a high-risk device shape the comparator and endpoints a later joint clinical assessment will ask about. It has to be requested while the pivotal study is still a plan. The first devices were picked for joint assessment in October 2026.
- Japan. PMDA's October 2026 guidance on companion diagnostics for cancer drugs expects the test to be covered by national health insurance by the date the drug is price-listed, so the test's filing is planned back from that date.
The pattern is the same in all three markets: the evidence a payer needs is cheapest to collect in the study you haven't started yet.
Every change on this page, with its source
We read each regulatory change at the authority's own document and keep the result, dated, on one page across our markets: what changed, when, and what to do.
See the regulatory changes tracker →Frequently asked questions
Is the RAPID coverage pathway final?
No. CMS published RAPID as a notice with comment period (CMS-3487-NC) on August 11, 2026, and comments closed on October 13, 2026. As of November 1, 2026, CMS had not published a final notice.
Can a Breakthrough IVD use RAPID?
No. In vitro diagnostics are excluded from RAPID as proposed. CMS says most Breakthrough IVDs should continue through the regional Medicare Administrative Contractors.
Does Breakthrough designation still qualify a device for NTAP?
Only for devices designated on or before September 30, 2026: they keep the alternative pathway through FY 2029 if FDA authorizes them by May 1, 2028. Other Breakthrough devices must meet the standard criteria, including substantial clinical improvement.
Can new devices still enter TCET?
No. CMS paused TCET for new candidates on August 11, 2026, while it focuses on RAPID. Parallel Review remains available.
The short version
RAPID is a proposal. TCET is closed to new devices. The Breakthrough shortcut to NTAP and TPT ends for devices designated after September 30, 2026. Approval gets you to market. Coverage gets you paid. Plan both at the pre-submission.
Sources, read on October 30, 2026: CMS, Medicare Program; Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway, notice with comment period, CMS-3487-NC, 91 FR 51710 (August 11, 2026); CMS, Hospital Inpatient Prospective Payment Systems … FY 2027 Rates, final rule, 91 FR 49570 (August 4, 2026); CMS–FDA joint announcement of the RAPID coverage pathway (April 23, 2026); AdvaMed's announcement of the 67-organization letter to CMS (August 20, 2025). The EU and Japan section draws on Implementing Decision C(2026) 7113, the HTA Coordination Group's 2026 work program and PMDA's companion diagnostics Early Consideration of October 5, 2026, as recorded on our regulatory changes tracker. This is a summary for planning, not legal or reimbursement advice; check the final RAPID notice when CMS publishes it.