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Pacific Edge Faces Setback with Novitas Draft Decision

Jan 10, 2025

Pacific Edge Limited (NZX: PEB) has encountered a major hurdle in the United States following the draft Local Coverage Determination (LCD) issued by Novitas, its Medicare administrative contractor. The LCD states that Pacific Edge's flagship product, Cxbladder, a diagnostic test for bladder cancer, is "not reasonable and necessary" for supporting effective patient outcomes and is therefore not eligible for Medicare reimbursement. This decision significantly challenges Pacific Edge’s prospects in the US market, as coverage for its primary product remains uncertain.

 

 

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