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How CMS Is Tackling 'Coverage Purgatory' for Medical Devices

Published

10 August 2026

Topic

opportunities

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at medcitynews.com →

◆ Verified

Fusion42 · 24 August 2026 · Fusion42 review

CMS has introduced the RAPID pathway to speed up Medicare coverage for breakthrough medical devices by aligning FDA and CMS review processes, allowing shared clinical evidence to be used for both FDA approval and Medicare coverage.

This Wire brief sits within Fusion42's coverage of Medtech, and 4 sources have reported it between 7 Aug 2026 and 12 Aug 2026.

◆ ◆ The Wire takeaway

Medical device founders gain a rare chance to shorten the Medicare coverage wait by syncing clinical trial plans with FDA and CMS early on. You must engage regulators at the start to avoid years stuck in coverage purgatory.

◆ Coverage

4 sources · first reported 7 Aug 2026 · latest 12 Aug 2026

◆ Related on Wire

◆ Topics

Medtechmedicarecmsmedical-devicesregulatory-pathwayfda-alignment