Response to Comments: MolDX Biomarkers in Cardiovascular Risk Assessment

Response to Comments received by Noridian on Biomarkers in CV Risk Assessment (JE-DL36358; JF-DL36360). CV risk assessment biomarker panels, except the basic lipid panel, are non-covered per this policy. Under preventative services, Medicare Part B covers cardiovascular disease screening, consisting of tests for cholesterol, lipid and triglyceride levels, every 5 years when ordered by a doctor. NCD 190.23 covers basic lipid panel testing for evaluating atherosclerotic CV disease, to monitor the progress of patients on anti-lipid dietary management and pharmacologic therapy for various lipid disorders. “Routine screening and prophylactic testing for lipid disorders are not covered by Medicare. Lipid testing in asymptomatic individuals is considered to be screening regardless of the presence of other risk factors such as family history, tobacco use, etc.” This policy denies coverage for all CV risk assessment panels , except the basic lipid panel. Additionally, the policy defines the medical necessity for individual lipid biomarkers for CV risk assessment, each of which must be specifically ordered and the reason for the test order documented in the patient’s medical record. The policy denies coverage (not reasonable and necessary) for non-lipid biomarkers including biochemical, hematologic, immunologic, and genetic biomarkers for CV risk assessment. A lipid biomarker may be covered to characterize a given lipid abnormality or disease, to determine a treatment plan or to assist with intensification of therapy. These markers include hs-CRP, Lp(a), Lp-PLA2, LDL particles, and Apo B. For each of these biomarkers, professional association recommendations and evidence from the scientific literature guide the limited use of these biomarkers. Wholesale use for every patient at every patient visit is not supported in the literature and is not anticipated per this policy.