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Policy & oversight

CMS Publishes Plan to Speed Medicare Coverage for Breakthrough Medical Devices

A new pathway would give FDA-cleared breakthrough devices a national Medicare coverage decision within weeks of regulatory approval, rather than waiting years under the standard process.

By the Goodsurance editorial teamAugust 7, 2026

On August 7, 2026, the Centers for Medicare and Medicaid Services released a procedural notice outlining the Regulatory Alignment for Predictable and Immediate Device, or RAPID, coverage pathway. CMS developed the pathway jointly with the Food and Drug Administration to sharply reduce the time between FDA market authorization and a Medicare national coverage determination for certain breakthrough devices.

Under existing rules, a device that clears FDA review may wait years before CMS issues a national coverage determination. The RAPID pathway targets a defined class of devices: Class II products participating in the FDA Total Product Life Cycle Advisory Program and Class III breakthrough-designated devices regardless of program participation.

To qualify, a device must have been studied under an Investigational Device Exemption trial that enrolled Medicare beneficiaries and examined clinical outcomes agreed on in advance by both FDA and CMS. By aligning coverage work with the device development and regulatory process at an earlier stage, CMS said it expects to deliver national coverage decisions within roughly 60 to 90 days of FDA approval.

The notice was scheduled for Federal Register publication on August 11, 2026, with a 60-day public comment window to follow. The pathway builds on, but is separate from, the 2024 Transitional Coverage for Emerging Technologies program, which offered time-limited conditional coverage while clinical evidence developed.

For people on Medicare, faster national coverage determinations could mean access to certain innovative devices no longer depends on geography or plan type during the period between FDA clearance and CMS action.

In plain words

Right now, when the FDA approves a new medical device, Medicare often takes years before it will pay for it. CMS just released a plan to change that for certain breakthrough devices. The plan is called the RAPID pathway. Under this process, Medicare would try to make a coverage decision within about 60 to 90 days of FDA approval. To qualify, a device had to be studied in clinical trials that included Medicare patients. CMS is asking the public to comment, and that window opens August 11, 2026.

Understand the basics first

Source: CMS
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