BDX-XL2

Covered: The Medicare contractor provides limited coverage for the BDX-XL2 plasma assay to manage solitary lung nodules 8–30 mm in patients aged ≥40 with a Mayo Clinic pre-test cancer risk ≤50%, and it is not authorized for uses outside that population. Key requirements: documentation of Mayo pre-test risk ≤50%, validated plasma specimen from K2 EDTA tubes (≥20 µL), physician must intend to act on the result, results report “Likely Benign” only if post-test benign probability ≥90% (with expectation to surveil when ≥98% in ≥80% of patients), and coverage is subject to annual evidence review.

"This Medicare contractor will provide limited coverage for the BDX-XL2 test (Biodesix, Seattle, WA) for the management of a lung nodule, between 8 and 30mm in diameter, in patients 40 years or olde..."

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