# 2026-16368: Medicare's RAPID Rush for Instant Innovative Device Coverage Pathway

2026-16368, Medicare Program; Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway, is a Federal Register notice from Health and Human Services Department, Centers for Medicare & Medicaid Services published 2026-08-11, effective To be assured consideration, comments must be received at one of the addresses provided below, by October 13, 2026.; PRIA reads it as touching household money (as of 2026-08-18).

- Canonical: https://policyrisk.com/federal-register/2026-16368
- As of: 2026-08-18
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-16368
- Title: Medicare Program; Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway
- Type: Notice
- Agencies: Health and Human Services Department; Centers for Medicare & Medicaid Services
- Citation: 91 FR 51710
- Published: 2026-08-11
- Effective: To be assured consideration, comments must be received at one of the addresses provided below, by October 13, 2026.
- Comments close: 2026-10-13
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-08-18

## In one line

Medicare's RAPID Rush for Instant Innovative Device Coverage Pathway

## 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.

## Effects PRIA read

- Faster Medicare Coverage for Breakthrough Devices: benefit, high. 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…
- Who Can Use the RAPID Pathway: mixed, medium. 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 t…
- Diagnostic Tests (IVDs) Are Excluded: cost, medium. 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: cost, medium. 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…

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## Sources
- [2026-16368 on federalregister.gov](https://www.federalregister.gov/documents/2026/08/11/2026-16368/medicare-program-regulatory-alignment-for-predictable-and-immediate-device-rapid-coverage-pathway)
- [2026-16368 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-08-11/pdf/2026-16368.pdf)

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- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-16368 (as of 2026-08-18).