Medicare's RAPID Rush for Instant Innovative Device Coverage Pathway
Published Date: 8/11/2026
Notice
Summary
This notice with comment period provides information to the public on the process CMS will use to provide accelerated Medicare coverage through the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway for new innovative technologies. The RAPID coverage pathway leverages existing processes to provide expedited national Medicare coverage for eligible technologies. This notice with comment period solicits public comment on the proposed RAPID coverage pathway.
Analyzed Economic Effects
4 provisions identified: 1 benefits, 2 costs, 1 mixed.
Faster Medicare Coverage for Breakthrough Devices
If a qualifying Breakthrough-designated device meets the pathway rules and FDA gives market authorization, CMS will post a proposed National Coverage Determination (NCD) the same day as FDA authorization. CMS aims to finalize the NCD about 60 days later for Class II devices and about 90 days later for Class III devices, which could speed Medicare beneficiary access to those devices.
Who Can Use the RAPID Pathway
Only certain devices are eligible: presumptive Class II FDA Breakthrough-designated devices in TAP planning a De Novo request, or Class III FDA Breakthrough-designated devices planning a PMA application. The device must be in the IDE presubmission stage and the manufacturer must plan an IDE study that enrolls Medicare beneficiaries and evaluates clinical health outcomes that FDA and CMS agree are appropriate.
Diagnostic Tests (IVDs) Are Excluded
In vitro diagnostic products (IVDs), including diagnostic laboratory tests, will not be accepted into the RAPID coverage pathway in most cases. If an IVD and CMS agree an NCD is appropriate, the manufacturer may instead submit a traditional NCD request following existing procedures.
Higher-Risk Devices May Need More Evidence
Whether CMS requires additional evidence development (Coverage with Evidence Development, CED) will depend on device risk and the strength of IDE study results. Lower-risk devices are more likely to have enough evidence at FDA authorization, while higher-risk devices are more likely to need further evidence and aligned postmarket studies.
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Key Dates
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