Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1. Many non-traditional lipid markers are considered investigational and are not covered. 
2. These biomarkers have been proposed for screening, assessment, or management of cardiovascular disease. While these measurements may provide some risk prediction, such measurement has not been shown to improve health outcomes compared to standard risk assessment with measurement of traditional lipid levels such as LDL and HDL cholesterol.
3. The American College of Cardiology (ACC) and the American Heart Association (AHA) jointly published the Guidelines on Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (Circulation 11/12/2013).  These are the most current and updated practice guidelines.  Their emphasis of risk determination to guide treatment decisions does not include any of the non-traditional lipid markers.  Estimation of 10 year risk of atherosclerotic cardiovascular disease (ASCVD) should use the following calculator available online:  http://www.cvriskcalculator.com/  

1)    Numerous lipid biomarkers have been proposed as potential risk markers for cardiovascular disease.  Traditional risk factors, such as total cholesterol, LDL-cholesterol, and HDL-cholesterol have established utility in predicting individuals at increased risk, and certain types of treatments of these risk factors has been demonstrated to improve clinical outcomes.  Many other lipid markers have been proposed as useful for screening or risk segregation.  In order for these markers to be clinically useful, they must be demonstrated to add to the utility of traditional risk factors. 

2)    QualChoice, the ACC and the AHA do not consider such biomarkers to meet this criterion, including but not limited to:

a)    Lipoprotein (a)

b)    Apolipoprotein B

c)     Apolipoprotein E

d)    LDL subclasses

e)    HDL subclasses

f)      Lipoprotein-associated phospholipase A2

 

3)     Estimation of 10 year risk for ASCVD risk (per the ACC/AHA guideline) should use the following calculator:   http://www.cvriskcalculator.com/

Codes Used in This Policy:

2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults available for download at: http://circ.ahajournals.org/content/129/25_suppl_2/S1

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

 

Bolibar I, von Eckardstein A, Assmann G et al. (2000) Short term prognostic value of lipid measurements in patients with angina pectoris. The ECAT Angina Pectoris Study Group: European Concerted Action on Thrombosis and Disabilities. Thromb Haemost 2000; 84(6):955-60.

Chiodini BD, Franzosi MG, Barlera S et al. (2007) Apolipoprotein E polymorphisms influence effect of pravastatin on survival after myocardial infarction in a Mediterranean population: the GISSI-Prevenzione study. Eur Heart J 2007; 28(16):1977-83.

 

Di Angelantonio E GP, Pennells L, et al. (2012) Lipid-Related Markers and Cardiovascular Disease Prevention. JAMA 2012; 307(23):2499-506.

Lamarche B, Moorjani S, Lupien PJ et al.(1996) Apolipoprotein A-I and B levels and the risk of ischemic heart disease during a five-year follow-up of men in the Quebec cardiovascular study. Circulation 1996; 94(3):273-8.

Mora S, Glynn RJ, Boekholdt SM et al.(2012) 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):1521-8.

Mora S, Otvos JD, Rifai N et al. (2009) Lipoprotein particle profiles by nuclear magnetic resonance compared with standard lipids and apolipoproteins in predicting incident cardiovascular disease in women. Circulation 2009; 119(7):931-9.

Mora S, Wenger NK, Demicco DA et al. (2012) Determinants of residual risk in secondary prevention patients treated with high- versus low-dose statin therapy: the Treating to New Targets (TNT) study. Circulation 2012; 125(16):1979-87.

Ohira T, Schreiner PJ, Morrisett JD et al.(2006) Lipoprotein(a) and incident ischemic stroke: the Atherosclerosis Risk in Communities (ARIC) study. Stroke 2006; 37(6):1407-12.

 

Ridker PM, Hennekens CH, Stampfer MJ. (1993) A prospective study of lipoprotein (a) and the risk of myocardial infarction. JAMA 1993; 270(18):2195-9.

Rigal M, Ruidavets JB, Viguier A et al.(2007) Lipoprotein (a) and risk of ischemic stroke in young adults. J Neurol Sci 2007; 252(1):39-44.

 

Salonen JT, Salonen R, Seppanen K et al.(1991) HDL, HDL-2 and HDL-3 sub fractions and the risk of acute myocardial infarction. A prospective study in eastern Finnish men. Circulation 1991; 84(1):129-39.

 

Schaefer EJ, Lamon-Fava S, Jenner JL et al.(1994) Lipoprotein (a) levels and risk of coronary heart disease in men. The Lipid Research Clinics Coronary Primary Prevention Trial. JAMA 1994; 271(13):999-1003.

Sharrett AR, Ballantyne CM, Coady SA et al. (2001) Coronary heart disease prediction from lipoprotein cholesterol levels, triglycerides, lipoprotein (a), apolipoproteins A-I and B, and HDL sub fractions: the Atherosclerosis Risk in Communities (ARIC) study. Circulation 2001; 104(10):1108-13.

Stampfer MJ, Krauss RM, Ma J, et al. (1996) A prospective study of triglyceride level, low density lipoprotein particle diameter, and risk of myocardial infarction. JAMA 1996; 276:882-88.

 

Stampfer MJ, Sacks FM, Salvini S et al. (1991) A prospective study of cholesterol apolipoproteins, and the risk of myocardial infarction. N Engl J Med 1991; 325(6):373-81.

 

Suk Danik J, Rifai N, Buring JE et al.(2006) Lipoprotein(a), measured with an assay independent of apolipoprotein(a) isoform size, and risk of future cardiovascular events among initially healthy women. JAMA, 2006; 296(11):1363-70.

Sweetnam PM, Bolton CH, Yarnell JW et al. (1994) Associations of the HDL-2 and HDL-3 cholesterol sub fractions with the development of ischemic heart disease in British men. The Caerphilly and Speedwell Collaborative Heart Disease Studies. Circulation 1994; 90(2):769-74.

Addendum:

1)    Effective 01/01/2017: Information added regarding latest treatment guideline from ACC/AHA.