Response to Comments: MolDX Biomarkers in Cardiovascular Risk Assessment

This policy denies coverage for cardiovascular risk assessment biomarker panels except the basic lipid panel; non-lipid biomarkers (biochemical, hematologic, immunologic, genetic) are not covered. Medicare Part B covers basic lipid panel screening (cholesterol/lipids/triglycerides) once every 5 years when ordered by a physician and NCD 190.23 allows basic lipid panels for evaluation of atherosclerotic CVD and monitoring lipid therapy; select individual lipid biomarkers (hs-CRP, Lp(a), Lp-PLA2, LDL particles, Apo B) may be covered only when specifically ordered with the clinical reason documented and used to characterize disease or guide/intensify treatment.

"Medicare Part B covers cardiovascular disease screening consisting of cholesterol, lipid, and triglyceride testing (basic lipid panel) when ordered by a physician, once every 5 years."

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