Response to Comments: MolDX: Biomarkers in Cardiovascular Risk Assessment

Medicare Part B covers the basic lipid panel (cholesterol/lipid/triglyceride testing) as preventive cardiovascular screening every 5 years and under NCD 190.23 for evaluation and monitoring of atherosclerotic cardiovascular disease and therapy response. All cardiovascular risk assessment biomarker panels are non-covered except the basic lipid panel; select individual lipid biomarkers (e.g., Lp(a), Lp-PLA2, LDL particle testing, Apo B, and in this policy text hs-CRP) may be covered for targeted clinical management when specifically ordered and the reason is documented. Non-lipid biochemical/hematologic/immunologic/genetic biomarkers and routine or universal biomarker panels for all patients or asymptomatic individuals are denied.

"Basic lipid panel (cholesterol, lipid and triglyceride levels) is covered as a Medicare Part B cardiovascular disease screening test when ordered by a physician."