Response to Comments for MolDX: Biomarkers in Cardiovascular Risk Assessment

Medicare limits cardiovascular risk assessment coverage to the basic lipid panel per NCD 90.1; however, individual specific biomarkers may be covered when ordered as targeted tests to characterize a lipid abnormality or disease (e.g., diabetes), to determine a treatment plan, or to assist intensification of therapy. Broad CV risk assessment panels are not a Medicare benefit, and several biomarkers are considered not used or investigational for CV risk assessment, though certain markers (e.g., ApoB, LDL particle number, Lp(a), BNP, microalbumin, Lp-PLA2, MPO, homocysteine, cystatin C) may be appropriate in defined clinical scenarios and must be documented as such.

"Medicare coverage for cardiovascular risk assessment is limited to the basic lipid panel in accordance with NCD 90."

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