LCD Reference Article Response To Comments Article

Response to Comments: MolDX: Biomarkers in Cardiovascular Risk Assessment (L36523)

A55003

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Article ID
A55003
Original ICD-9 Article ID
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Article Title
Response to Comments: MolDX: Biomarkers in Cardiovascular Risk Assessment (L36523)
Article Type
Response to Comments
Original Effective Date
06/16/2016
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This article summarizes the comments WPS received for draft Local Coverage Determination (LCD) MolDx: Biomarkers in Cardiovascular Risk Assessment. Thank you for the comments.

Response To Comments

Number Comment Response
1 Diadexus commended WPS for clarifying the appropriate Medicare coverage of cardiovascular biomarkers when used to support treatment decision-making by clinicians. In particular, they support the proposed coverage of Lp-PLA2 in the draft and provided additional relevant literature supporting its usage. Generally agree.
2 The American College of Cardiology (ACC) commented that the policy is unnecessarily restrictive and urges WPS to not finalize the policy. ACC feels that cardiovascular risk assessment tests in general would be eliminated; hs-CRP would be restricted to a defined patient population only and BNP usage for acute care versus screening should both be covered when appropriate. ACC requests that clarification be made to ensure that hs-CRP and BNP are covered under other conditions when appropriate. The policy does intend to restrict usage of cardiovascular risk screening tests to only those outlined under Group I Paragraph CPT/HCPCS codes. Regarding BNP usage for acute care and hs-CRP for indications other than cardiovascular screening, the following has been added to Group I Paragraph ICD 10 codes for clarification: ICD-10 Codes that Support Medical Necessity Group 1 Paragraph: The following ICD-10 codes are covered when used for cardiac risk assessment. Please note, 83880 and 86141 are used for other medically necessary services that are not addressed in this LCD.
3 Quest Diagnostics requests that ICD 10 codes for pre-diabetes, diabetes, obesity and smoking be included in the ICD 10 list for coverage as they are important co-morbidities that contribute to Coronary Heart Disease (CHD) risk. WPS agrees that diabetes, obesity and smoking contribute to heart disease risk. However, there is no Medicare benefit for cardiovascular disease screening other than Lipid Testing. Pre-diabetes, obesity and smoking are not indications in and of themselves for any specific screening for asymptomatic individuals. The diagnosis of diabetes would allow for many medically necessary treatments and diagnostic testing per physician discretion and is not included in this LCD as this LCD addresses the use of lipid and non-lipid biomarker panels in CV risk assessment. In addition, even though there is evidence that some of the biomarkers may alter risk categorization (higher or lower) compared to traditional risk prediction, it has not been established that changes in categorization provides any clinically actionable information beyond that of traditional lipid measures.
4 Labcorp commented that they agree with the policy in general, including restrictions on coverage for certain “non-traditional biomarkers” for CV “risk assessment” but are seeking clarification regarding coverage of LDL particle number (NMR LDL-P) and apolipoprotein B (Apo B). Under “Summary of Lipoprotein Testing” it indicates lipoprotein testing is considered “investigational and not covered.” This is the general consensus from the literature with only two exceptions noted below: This contractor will cover Apo B testing in patients with triglyceride or HDL-C concentrations as specified by AACE to assess residual risk in patients for CAD when the triglyceride concentration is > 150mg/dL or the HDL-C concentration is <40mg/dL. This contractor will not cover Apo B testing for asymptomatic adults as part of a cardiovascular risk assessment. This contractor will cover LDL-P for statin treated diabetic patients at high cardiovascular risk only. This contractor will not cover LDL-P testing for any other group of asymptomatic adults as part of a cardiovascular risk assessment.
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ICD-10-CM Codes that Support Medical Necessity

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ICD-10-CM Codes that DO NOT Support Medical Necessity

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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