Highmark Commercial Medical Policy in Delaware


 
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Section: Laboratory
Number: L-96
Version: 001
Topic: Biomarkers in Risk Assessment and Management of Cardiovascular Disease
Effective Date: March 3, 2014
Issued Date: March 3, 2014
Date Last Reviewed: 11/2013

General Policy Guidelines

Indications and Limitations of Coverage

Measurement of novel lipid and non-lipid risk factors (i.e., apolipoprotein B, apolipoprotein A-I, apolipoprotein E, B-type natriuretic peptide, cystatin C, leptin, LDL subclass, HDL subclass, lipoprotein[a]) are considered experimental/investigational as an adjunct to LDL cholesterol in the risk assessment and management of cardiovascular disease. The available scientific evidence does not provide adequate data to establish that the use of panels that include lipid and non-lipid cardiovascular risk markers improve outcomes when used in clinical care. A participating, preferred, or network provider can bill the member for the denied service.

Description

Non-traditional risk factors for cardiovascular disease are used increasingly to determine patient risk, in part because of an assumption that many patients with cardiovascular disease lack traditional risk factors (e.g., cigarette smoking, diabetes, hyperlipidemia, and hypertension).

Risk factors other than LDL cholesterol are referred to as “emerging risk factors” and include a variety of tests such as serum inflammatory markers, comprehensive lipoprotein testing, angiotensin gene testing and prothrombotic factors.

Numerous cardiovascular (CV) risk panels are commercially available. These panels report results for multiple individual CV risk markers, and have wide variability in the risk factors included in the panel.  Low-density lipoproteins (LDL) have been identified as the major atherogenic lipoproteins and have long been identified by the National Cholesterol Education Project (NCEP) as the primary target of cholesterol- lowering therapy. LDL particles consist of a surface coat composed of phospholipids, free cholesterol, and apolipoproteins surrounding an inner lipid core composed of cholesterol ester and triglycerides. Traditional lipid risk factors such as LDL-cholesterol (LDL-C), while predictive on a population basis, are weaker markers of risk on an individual basis. Only a minority of subjects with elevated LDL and cholesterol levels will develop clinical disease, and up to 50% of cases of coronary artery disease (CAD) occur in subjects with ‘normal’ levels of total and LDL-C. Thus, there is considerable potential to improve the accuracy of current cardiovascular risk prediction models.


NOTE:
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Procedure Codes

8140182172 83520 836958369883700
83701 83704 83719 838800126T 

Traditional Guidelines

Refer to General Policy Guidelines

FEP Guidelines

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

EPO/PPO Guidelines

Refer to General Policy Guidelines

Any reference in this bulletin to non-billable services by a network provider may not be applicable to Major Medical.

HMO/POS Guidelines

Refer to General Policy Guidelines

Publications

Provider Medical Policies Update

12/2013, Cardiovascular risk panels for risk assessment and management of cardiovascular disease considered experimental/investigational

References

Lamarche B, Tchernof A, Moorjani S, et al. Small, dense low-density lipoprotein particles as a predictor of the risk of ischemic heart disease in men. Prospective results from the Quebec Cardiovascular Study. Circulation. 1997;95(1):69-75.

Sarkkinen E, Korhonen M, Erkkila A, et al. Effect of apolipoprotein E polymorphism on serum lipid response to the separate modification of dietary fat and dietary cholesterol. Am J Clin Nutr. 1998;68(6):1215-22.

Sharrett AR, Ballantyne CM, Coady SA, et al. Coronary heart disease prediction from lipoprotein cholesterol levels, triglycerides, lipoprotein(a), apolipoproteins A-I and B, and HDL density subfractions: The Atherosclerosis Risk in Communities (ARIC) Study. Circulation. 2001;104(10):1108-1113.

Benn M, Nordestgaard BG, Jensen GB, et al. Improving prediction of ischemic cardiovascular disease in the general population using apolipoprotein B: the Copenhagen City Heart Study. Arterioscler Thromb Vasc Biol. 2007;27(3):661-70.

Bennet AM, Di Angelantonio E, Ye Z, et al. Association of apolipoprotein E genotypes with lipid levels and coronary risk. JAMA. 2007;298(11):1300-1311.

El Harchaoui, van der Steeg WA, Stroes ESG, et al. Value of low-density lipoprotein particle number and size as predictors of coronary artery disease in apparently healthy men and women: The EPIC-Norfolk Prospective Population Study. J Am Coll Cardiol. 2007;49(5):547-553.

Mora S, Otvos JD, Rifai N, et al. Lipoprotein particle profiles by nuclear magnetic resonance compared with standard lipids and apolipoproteins in predicting incident cardiovascular disease in women. Circulation. 2009;119(7):931-939.

Sattar N,  Wannamethee G, Sarwar N, et al. Leptin and coronary heart disease: Prospective study and systematic review. J Am Coll Cardiol. 2009;53(2):167-175.

Vasunilashorn S, Glei DA, Lan CY, et al. Apolipoprotein E is associated with blood lipids and inflammation in Taiwanese older adults. Atherosclerosis. 2011;219(1):349-54.

Lee M, Saver JL, Huang WH, et al. Impact of elevated cystatin C level on cardiovascular disease risk in predominantly high cardiovascular risk populations: A meta-analysis. Circulation. 2010;3:675-683.

Greenland P, Alpert JS, Beller GA, et al. 2010 ACCF/AHA guideline for assessment of cardiovascular risk in asymptomatic adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2010;56(25):50-103.

Lan CY, et al. Apolipoprotein E is associated with blood lipids and inflammation in Taiwanese older adults. Atherosclerosis. 2011;219(1):349-54.

Di Angelantonio E, Gao P, Pennells L, et al. Lipid-related markers and cardiovascular disease prevention. JAMA. 2012;307(23):2499-2506.

Mora S, Glynn RJ, Boekholdt SM, et al. On-treatment non-high-density lipoprotein cholesterol, apolipoprotein B, triglycerides, and lipid ratios in relation to residual vascular risk after treatment with potent statin therapy: JUPITER (justification for the use of statins in prevention: an intervention trial evaluating rosuvastatin). J Am Coll Cardiol. 2012;59(17):1521-1528.

Boekholdt SM, Arsenault BJ, Mora S, et al. Association of LDL cholesterol, non-HDL cholesterol, and apolipoprotein B levels with risk of cardiovascular events among patients treated with statins: a meta-analysis. JAMA. 2012;307(12):1302-1309.

Biccard BM, Lurati Buse GA, Burkhart C, et al. The influence of clinical risk factors on pre-operative B-type natriuretic peptide risk stratification of vascular surgical patients. Anesthesia. 2012;67:55-59.

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This policy is intended to document those medical guidelines used by Highmark Blue Cross Blue Shield Delaware for the purpose of coverage and reimbursement determinations under Highmark Blue Cross Blue Shield Delaware health benefit plans. These guidelines are appropriate for the majority of individuals with a particular disease, illness, or condition; however, each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Highmark Blue Cross Blue Shield Delaware retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark Blue Cross Blue Shield Delaware. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.



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