RAPS

FDA, CMS propose new parallel review pathway for breakthrough devices

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel review program to expedite certain Class II and Class III breakthrough ...
JD Supra

CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices

The Background: The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") ...
JD Supra

CMS and FDA Announce RAPID Coverage Pathway to Accelerate Medicare Coverage for Breakthrough Medical Devices

The RAPID coverage pathway is designed to address the historically significant lag (sometimes referred to as the “valley of death”) between the point at which a medical device receives FDA market ...