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The Medicare agency finalized plans to cancel its “alternative pathway” to new technology add-on and device pass-through payments for FDA breakthrough devices. However, it agreed to add a transitional period allowing firms to access the streamlined route for the next two years if they get a breakthrough designation by September.
The precision oncology market is estimated to be $80-100 billion, with less than 20% penetration. In a video interview, Kyle Mikson of Canaccord Genuity explains how top competitors like Guardant Health, Natera, Grail, Tempus, GeneDx, and others are set to benefit and the catalysts driving adoption.
CMS reiterates its plan to cancel the streamlined path. Excerpted from Pathways’ Picks June 8: MDUFA Agreement, Medicare Plans, EU Parliament Response, and More.