CMS and the FDA have launched a new coverage pathway to expedite Medicare access to certain medical devices.
The Regulatory Alignment for Predictable and Immediate Device coverage pathway is designed to accelerate access to FDA-designated Class II and Class III breakthrough devices by aligning regulatory review and Medicare coverage earlier in the development process, according to an April 23 CMS news release.
Under the pathway, CMS will issue a proposed national coverage determination the same day a participating device receives FDA market authorization, initiating a 30-day public comment period. The process could enable Medicare coverage and payment as soon as two months after authorization, compared to the current pathway’s timeline of about a year.
The pathway also requires eligible devices to be part of an investigational device exemption study enrolling Medicare beneficiaries and studying clinical outcomes agreed upon by both agencies.
CMS said the Transitional Coverage for Emerging Technologies pathway will be paused for new candidates as the agency focuses on implementing the new process.
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