The CMS and FDA have unveiled the RAPID pathway to accelerate Medicare coverage for FDA-designated breakthrough medical devices, coordinating early with manufacturers during the device review to shorten timelines.

RAPID aims to enable national Medicare coverage and payment as soon as two months after FDA market authorization, a significant acceleration from the current roughly one-year pace.

A 30-day public comment period will follow FDA approval before Medicare decisions are finalized, with the goal of delivering National Coverage Determinations for breakthrough devices within months rather than years.

Industry reaction is cautiously optimistic, with AdvaMed praising improved access but urging clear timelines, accountability, and effective implementation to ensure patient benefits.

Cardiology accounts for the largest share of devices in the Breakthrough Devices Program, totaling nearly 250, underscoring the impact on heart-related technologies.

Medicare Deputy Administrator John Brooks said RAPID will clarify targets manufacturers must hit to obtain coverage, aligning investment timelines with regulatory expectations.

CMS stresses this is a coordinated effort to streamline access while upholding evidence standards, noting that the Transitional Coverage for Emerging Technologies pathway will be paused to focus on RAPID.

The initiative builds on the FDA Breakthrough Devices program and aims to align evidence collection with Medicare coverage needs by engaging CMS experts early and identifying clinically meaningful outcomes for beneficiaries.

RAPID addresses long-standing industry complaints that Medicare reimbursement decisions for breakthrough devices take too long.

The program seeks to streamline access to life-changing medical technology by aligning FDA and CMS early, reducing hurdles for innovators and patients.

Historically, it can take about five years from FDA authorization to Medicare and commercial coverage, highlighting RAPID’s potential to expand patient access.

The public can comment on the proposed procedural notice after its Federal Register publication, with a 60-day window; the scope targets certain FDA-designated Class II and Class III Breakthrough Devices for Medicare beneficiaries.