BioCentury
ARTICLE | Politics, Policy & Law

Proposed CMS pathway could be expanded to give therapies, diagnostics immediate, national coverage

Comments due Nov. 2 on rule seeking to speed reimbursement for breakthrough devices

September 1, 2020 10:50 PM UTC

A medical devices reimbursement rule proposed by CMS could lay the groundwork for innovative medicines to be covered by Medicare immediately after FDA approval.

The proposed rule, which applies only to medical devices with breakthrough designation, aims to close the months-long coverage gap after authorization and ensure that coverage is consistent nationally. And CMS is leaving the door open to expand the pathway to therapies...