CAR039 Comprehensive Lipid Profile Testing in the Evaluation of ...
CAR039 Comprehensive Lipid Profile Testing in the Evaluation of ...
CAR039 Comprehensive Lipid Profile Testing in the Evaluation of ...
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disease due to <strong>in</strong>adequate cl<strong>in</strong>ical evidence <strong>of</strong> safety and/or efficacy <strong>in</strong> published peer-reviewed<br />
medical literature.<br />
Components <strong>of</strong> fractionated lipoprote<strong>in</strong> analysis may <strong>in</strong>clude:<br />
• LDL-C gradient gel electrophoresis (GGE) for low-density lipoprote<strong>in</strong> (LDL) subclasses<br />
• HDL-C GGE for HDL subclasses<br />
• lipoprote<strong>in</strong>(a) [Lp(a)] assay<br />
• apo A-I<br />
• apo B<br />
• apoE is<strong>of</strong>orms (E2, E3, E4)<br />
• total plasma homocyste<strong>in</strong>e<br />
• lipoprote<strong>in</strong>-associated phospholipase A2 (Lp-PLA2)<br />
• non-HDL cholesterol<br />
• hs-CRP<br />
• K<strong>in</strong>es<strong>in</strong>-like prote<strong>in</strong> 6 (KIF6)<br />
• LDL particle number<br />
MEDICARE & MEDICAID COVERAGE RATIONALE<br />
Medicare has a National Coverage Determ<strong>in</strong>ation (NCD) for <strong>Lipid</strong> <strong>Test<strong>in</strong>g</strong> (190.23). Medicare does<br />
not have a Local Coverage Determ<strong>in</strong>ation (LCD) for Nevada for <strong>Lipid</strong> <strong>Test<strong>in</strong>g</strong> at this time. Accessed<br />
March 2012. The National Coverage Determ<strong>in</strong>ation is as follows:<br />
Item/Service Description<br />
Lipoprote<strong>in</strong>s are a class <strong>of</strong> heterogeneous particles <strong>of</strong> vary<strong>in</strong>g sizes and densities conta<strong>in</strong><strong>in</strong>g lipid and<br />
prote<strong>in</strong>. These lipoprote<strong>in</strong>s <strong>in</strong>clude cholesterol esters and free cholesterol, triglycerides, phosphor<br />
lipids and A, C, and E apoprote<strong>in</strong>s. Total cholesterol comprises all <strong>the</strong> cholesterol found <strong>in</strong> various<br />
lipoprote<strong>in</strong>s.<br />
Factors that affect blood cholesterol levels <strong>in</strong>clude age, sex, body weight, diet, alcohol and tobacco<br />
use, exercise, genetic factors, family history, medications, menopausal status, <strong>the</strong> use <strong>of</strong> hormone<br />
replacement <strong>the</strong>rapy, and chronic disorders such as hypothyroidism, obstructive liver disease,<br />
pancreatic disease (<strong>in</strong>clud<strong>in</strong>g diabetes), and kidney disease.<br />
In many <strong>in</strong>dividuals, an elevated blood cholesterol level constitutes an <strong>in</strong>creased risk <strong>of</strong> develop<strong>in</strong>g<br />
coronary artery disease. Blood levels <strong>of</strong> total cholesterol and various fractions <strong>of</strong> cholesterol,<br />
especially low density lipoprote<strong>in</strong> cholesterol (LDL-C) and high density lipoprote<strong>in</strong> cholesterol (HDL-<br />
C), are useful <strong>in</strong> assess<strong>in</strong>g and monitor<strong>in</strong>g treatment for that risk <strong>in</strong> patients with cardiovascular and<br />
related diseases. Blood levels <strong>of</strong> <strong>the</strong> above cholesterol components <strong>in</strong>clud<strong>in</strong>g triglyceride have been<br />
separated <strong>in</strong>to desirable, borderl<strong>in</strong>e and high risk categories by <strong>the</strong> National Heart, Lung and Blood<br />
Institute <strong>in</strong> <strong>the</strong>ir report <strong>in</strong> 1993. These categories form a useful basis for evaluation and treatment <strong>of</strong><br />
patients with hyperlipidemia. Therapy to reduce <strong>the</strong>se risk parameters <strong>in</strong>cludes diet, exercise and<br />
medication, and fat weight loss, which is particularly powerful when comb<strong>in</strong>ed with diet and exercise.<br />
<strong>Comprehensive</strong> <strong>Lipid</strong> <strong>Pr<strong>of</strong>ile</strong> <strong>Test<strong>in</strong>g</strong> <strong>in</strong> <strong>the</strong> <strong>Evaluation</strong> <strong>of</strong> Cardiovascular Disease Page 2 <strong>of</strong> 14