Humana Cardiovascular Disease Risk Testing Form

Description

Cardiovascular disease (CVD) is a group of disorders that effect the heart and blood vessels (eg, cerebral vascular disease, coronary heart disease, peripheral arterial disease [PAD]) and is the most common cause of death among adults in the United States.68 CVD risk tests are utilized to screen for the chances of having a coronary event. The most common tests to determine cardiac risk are high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol and triglycerides (often referred to as a basic or standard lipid panel).

Additional laboratory screening methods include, but may not be limited to, the following:

• Apolipoprotein testing – An apolipoprotein is any of various proteins that combine with a lipid to form a lipoprotein, such as HDL or LDL. Apolipoproteins are important in the transport of cholesterol in the body and the regulation of the level of cholesterol in cells and blood. They are suggested as possible indicators of cardiovascular disease risk. One example is apolipoprotein B (apo B), the primary apolipoprotein of LDL, which is responsible for carrying cholesterol to tissues.
• High-sensitivity C-reactive protein (hs-CRP) testing – C-reactive protein (CRP) is produced by the liver. An elevated CRP level may be indicative of inflammation (nonspecific location). hs-CRP can detect the slight elevations in serum CRP that are associated with coronary artery disease (CAD), which can be within the normal range.32
• Serum glucose testing – Tests for diabetes which include, but may not be limited to:
  • Hemoglobin A1c (HbA1c)
  • Fasting plasma glucose test
  • Oral glucose tolerance test

HUM-0401-026

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

4 of 41

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Description

A major function of VLDL is to remove excess cholesterol from the blood and carry it to the liver for processing. Test(s) may include: c-peptide, glycated protein, islet cell antibodies, nonesterified fatty acids [free fatty acids], proinsulin and total insulin. Elevated levels of asymmetric dimethylarginine (ADMA) and symmetric dimethylarginine (SDMA) indicate damage to the endothelium, the inner lining of blood vessels. Made during the normal breakdown of red blood cells, bilirubin passes through the liver and is eventually excreted out of the body. Mildly elevated levels are suggested to act as an antioxidant and a target for CVD prevention and reduction by inhibiting endothelial dysfunction, low-density lipoprotein oxidation and vascular smooth muscle cell proliferation. A hormone produced in the body that, when elevated, may be an indication of congestive heart failure (CHF). BNP testing may be used to detect this hormone and aid in the diagnosis of CHF. NT-proBNP is the precursor molecule for BNP. BNP or NT-proBNP testing has been proposed for the determination of CVD risk and may be included in CVD risk testing panels.

A short chain of amino acids that is released into the blood as a byproduct of the formation of insulin by the pancreas. Can be measured in blood or urine. A marker of beta-cell function, c-peptide has been considered an indicator of insulin resistance which is associated with cardiovascular mortality.

A fat-soluble, vitamin-like substance required for normal mitochondrial function that occurs naturally in the body. Used to produce energy to fuel cell growth and maintenance. CoQ10 is also an antioxidant sold in the United States (US) as a dietary supplement. A deficiency of CoQ10 is associated with a number of diseases such as mitochondrial disease, heart failure and hypertension.

Testing CoQ10 levels has been proposed for determining CVD risk and statin-related myopathy. May include various tests such as apolipoproteins, glycosylated acute phase proteins (GlycA), HDL, homocysteine, LDL, lipoprotein remnants, lipoprotein subfractions, Lp(a), Lp-PLA2 and triglycerides. Increased levels of cortisol, a hormone from the adrenal cortex, have been proposed to indicate CVD risk, possibly as a response to increased mental stress. An enzyme expressed by various tissues and cell types that is used as a marker of damage in CK-rich tissue (eg, myocardial infarction [heart attack]).

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

5 of 41

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Description

Creatinine, urine: Measures how effectively creatinine is removed from the blood by the kidneys, usually as part of a creatinine clearance test.

Cyanocobalamin (vitamin B-12): Essential for red blood cell maturation and for gastrointestinal and neurologic health. Decreased levels may be indicative of certain anemias.

Cystatin C: A small protein produced by cells of the body; serum testing is proposed to diagnose impaired kidney function.

Dehydroepiandrosterone (DHEA): A circulating steroid hormone used to evaluate an individual’s adrenal gland function.

Dehydroepiandrosterone-sulfate (DHEA-S): 3B-sulphate ester of DHEA, also used to evaluate an individual’s adrenal gland function.

Estradiol: A form of the hormone estrogen, made by the adrenal glands, breasts and ovaries. Also called E2 or 17 beta-estradiol.

Estrogen is believed to have a positive effect on the inner layer of artery wall, helping to keep blood vessels flexible.

Ethylmalonic acid: Derived from the breakdown of butyrate, has a carnitine-dependent pathway and can accumulate with an insufficient amount of carnitine. Elevations of ethylmalonate in urine may indicate a cellular energy pathway blockage which can cause muscle weakness or damage.

F2-Isoprostane (column chromatography, including mass spectrometry): A product of polyunsaturated fatty acid peroxidation purported as an indicator and risk factor for coronary heart disease.

Fibrinogen: A protein in the blood that helps blood clot. Elevated fibrinogen may promote excessive clumping of platelets. This can cause clots to form in an artery, which may lead to heart attack or stroke. Suggested as a possible indicator of inflammation that accompanies atherosclerosis.

Folate (folic acid): Used to detect folic acid deficiency. Folic acid is a B vitamin necessary for normal red blood cell production. It is stored in the body as folates. Folic acid deficiency results in a form of megaloblastic anemia.

Follicle stimulating hormone (FSH): A hormone produced by the pituitary gland that is associated with reproduction and the development of eggs in women and sperm in men. Low FSH is being studied as a biomarker for CVD in postmenopausal women and men being treated for prostate cancer, with various forms of androgen deprivation therapy.

Galectin-3: A protein that is associated with the development and progression of heart failure, including progressive fibrosis (stiffening) of the heart muscle. Testing purportedly assists in assessing the prognosis of chronic heart failure.

Gamma-glutamyl transferase (GGT): An enzyme located on the external surface of cellular membranes that contributes to maintaining the physiological concentrations of cytoplasmic glutathione and cellular defense against oxidative stress.

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

6 of 41

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Increased GGT activity is purported as a marker of antioxidant inadequacy and increased oxidative stress.

Laboratory Test

Description

• Glycosylated acute phase proteins (GlycA) – A nuclear magnetic resonance (NMR) - measured glycoprotein biomarker of inflammation.
• HART CADhs – Plasma and algorithm analysis of three proteins (high sensitivity [hs] troponin, adiponectin and kidney injury molecule-1 [KIM-1]) reported as a risk score for obstructive CAD.

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

7 of 41

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• HART CVE – Plasma and algorithm analysis of four proteins (NT-proBNP, osteopontin, tissue inhibitor of metalloproteinase-1 [TIMP-1] and kidney injury molecule-1 [KIM-1]), reported as a risk score for major adverse cardiac event.
• Homocysteine – An amino acid used to make protein and to build and maintain tissue. Excess levels in the blood are purported to increase the risk of stroke, certain types of heart disease or PAD.
• Hydroxymethylglutarate (HMG) – The metabolic precursor of cholesterol used by cells to make CoQ10. Cholesterol-lowering statin drugs may block this process, causing HMG to become elevated and inhibiting the body’s production of CoQ10.
• Insulin – A hormone that is produced and stored in the beta cells of the pancreas which regulates cellular metabolism in multiple tissues. Insulin resistance is suggested to be a risk factor for CVD by causing oxidative stress and an inflammatory response that leads to cell damage.
• Iron – Excessive iron levels in the blood are a proposed risk factor for CVD; particularly in conditions such as hereditary hemochromatosis (HH). Testing may include ferritin and serum iron levels.
• Kynurenic acid – A product of the metabolism of L-tryptophan that is present in an individual with vitamin B6 deficiencies. Is being studied as a possible biomarker associated with CHF.
• LDL subclass testing (eg, NMR LipoProfile, VAP) – Suggested as part of an overall risk assessment for CVD, this test measures the cholesterol content of lipoprotein particles in the blood and determines the LDL particle size and/or density pattern.
• Lipoprotein(a) (Lp[a]) – An LDL cholesterol particle that is attached to a special protein called apo A. Elevated levels in the blood are purportedly linked to a greater likelihood of atherosclerosis and heart attacks.

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

8 of 41

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

It is proposed that lipoprotein remnants penetrate arterial walls more easily than larger lipoproteins and may be independent risk factors for CVD.

Lipoprotein subfraction-HDL subclass separates two of the commonly measured lipoprotein fractions, HDL and LDL, into subclasses based on their size, density and/or electrical charge. HDL subclass testing is suggested to provide information regarding CVD risk when utilized with standard lipoprotein tests, such as total cholesterol, HDL and LDL testing.

Liposcale is an advanced serum lipoprotein test based on nuclear magnetic resonance (NMR), which directly measures the normal lipid profile, in addition to the particle number and size, the cholesterol and triglyceride composition of the main lipoprotein classes and subclasses (VLDL, LDL, HDL), including 23 variables.

Description

An enzyme immunoassay for the quantitative determination of Lp-PLA2 in plasma; used in conjunction with clinical evaluation and individual risk assessment as a suggested aid in predicting risk for coronary heart disease (CHD). Triglyceride-rich lipoproteins that include intermediate density lipoproteins (IDL) and VLDL. It is proposed that lipoprotein remnants penetrate arterial walls more easily than larger lipoproteins and may be independent risk factors for CVD. Separates two of the commonly measured lipoprotein fractions, HDL and LDL, into subclasses based on their size, density and/or electrical charge. HDL subclass testing is suggested to provide information regarding CVD risk when utilized with standard lipoprotein tests, such as total cholesterol, HDL and LDL testing. Advanced serum lipoprotein test based on nuclear magnetic resonance (NMR), which directly measures the normal lipid profile, in addition to the particle number and size, the cholesterol and triglyceride composition of the main lipoprotein classes and subclasses (VLDL, LDL, HDL), including 23 variables.

A family of unsaturated fatty acids that have in common a carbon-carbon double bond in the third bond from the methyl end of the fatty acid. Omega-3 fatty acids cannot be manufactured by the body and are obtained from foods such as fish (eg, salmon, halibut), certain plants and nut oils. Suggested as a cardiac risk factor for sudden cardiac death.

Luteinizing hormone (LH) is a hormone produced by the pituitary gland that is associated with ovulation in women and the production of testosterone in men. Increased levels of LH are being studied as a marker of CVD risk in older men and women.

Magnesium is an enzyme activator found in body fluids and cells. Magnesium depletion is clinically associated with weakness and neuromuscular disorders including cardiac arrhythmias and seizures.

Methylmalonic acid is a compound that reacts with vitamin B-12 to produce coenzyme A (CoA). Increased levels are present in an individual with vitamin B-12 deficiency.

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

9 of 41

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Methylmalonic acid is being studied as a biomarker for oxidative stress and mitochondrial dysfunction.

Laboratory Test

Description

• Ml-heart ceramides – A blood test that quantifies plasma ceramides and is purported to evaluate for risk of major adverse cardiovascular events within the next 1 to 5 years.
• Microsomal antibodies (eg, thyroid) – Microsomes are found inside thyroid cells when there has been damage. The body produces antibodies to microsomes. The microsomal antibody test measures these antibodies in the blood and are being investigated as a biomarker for CVD.
• Myeloperoxidase (MPO) – An enzyme found in white blood cells that is purportedly linked to inflammation and cardiovascular disease.

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

10 of 41

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Laboratory Test

Description

• Organic acid – A quantitative test generally performed on a urine specimen to determine the concentration of metabolites excreted by the kidney and is purported to address the risks of cardiovascular disease and diabetes.
• Oxidized low-density lipoprotein (OxLDL) – Measures protein damage due to the oxidative modification of the ApoB subunit on LDL cholesterol. May be ordered for an individual with suspected metabolic syndrome.
• Parathyroid hormone (PTH) – A hormone secreted by the parathyroid glands that regulates the serum calcium concentration through its effects on bone, kidney, and intestine. It is suggested that high levels of PTH are associated with vascular calcification.
• Phosphorus inorganic (Phosphate) – A mineral that regulates the normal function of nerves and muscles, including the heart. High serum levels may be associated with the calcification (hardening) of arteries and
• Progesterone – A steroid sex hormone that is involved in the menstrual cycle and in pregnancy, however, decreases after menopause. The effects of this decrease are being studied as a
• Prolactin – An anterior pituitary hormone whose primary role is to promote lactation. Other essential functions include metabolism support, pancreatic development, and regulation of the immune system. High concentrations of serum prolactin have been inconsistently related to several adverse health outcomes including CVD.
• PULS (protein unstable lesion

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

11 of 41

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• HDL and HbA1c – Used to predict an immune system response to arterial injury and formation of cardiac lesions.
• Pyridoxal phosphate (vitamin B-6) – A coenzyme present in a variety of enzyme reactions related to protein metabolism, including the regulation of homocysteine levels.
• Pyroglutamic acid – Natural amino acid derivative that plays a part in glutathione production and recycling. Glutathione is a potent antioxidant that purportedly helps rid the body of toxins.

Increased serum levels are being investigated as a cause for coronary atherosclerosis.

Laboratory Test

Description

• Quinolinic acid – Produced following the metabolic breakdown of the amino acid tryptophan, via the kynurenine pathway. It has a potent neurotoxic effect and is the biosynthetic precursor to nicotine. Increased levels are purported to be associated with inflammation and subclinical atherosclerosis.
• Secretory type II phospholipase A2 (sPLA2-IIA) – A protein produced and secreted by epicardial adipose tissue (EAT) and excessive amounts are purported to indicate CVD due to inflammation in blood vessels.
• Serum sterol testing (eg, Boston heart cholesterol balance test) – Measures the levels of plant sterols, such as beta-sitosterol and campesterol, which supposedly indicate cholesterol absorption and potential cardiac disease risk.
• Sex hormone binding globulin (SHBG) – A protein made by the liver that binds to dihydrotestosterone (DHT), estrogen, and testosterone. Lower SHBG levels are proposed to be a risk factor for MI in men.
• Singulex SMC testing for risk of cardiac dysfunction and vascular inflammation (eg, SMC) – Purported to measure levels of cardiac disease biomarkers that may have been previously undetectable.

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

12 of 41

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Laboratory Test

Description

• Endothelin, SMC IL-6, SMC IL 17A, SMC c Tl and SMC TNF-a)
• Skin cholesterol (eg, PREVU) – An in-vitro diagnostic test and the only noninvasive method to assess skin cholesterol. Suggested to assess risk of CAD in an individual with a history of heart attack or with clinical symptoms or signs of CAD.
• Small density LDL (sdLDL) – Proposed to determine cardiovascular risk in an individual with metabolic syndrome or established/progressing CAD, an individual with triglyceride levels between 70 and 140 mg/dL, as well as an individual with a diet high in trans-fat or carbohydrates.
• SmartVascular Dx – A serum test that measures protein biomarkers (interleukin 16, FAS, Fas ligand, hepatocyte growth factor, cutaneous T-cell-attracting chemokine, eotaxin and monocyte chemotactic protein 3) by immunoassay combined with age, sex, family history and personal history of diabetes, along with an algorithm reported as a 5-year risk score for acute coronary syndrome.
• SomasScan Assay – Plasma analysis of protein biomarkers by aptamer-based microarray and algorithm reported as 4-year likelihood of coronary event in high-risk populations.
• Testosterone – The primary sex hormone and anabolic steroid in males. Maintaining normal testosterone levels in older men has been purported to promote the reduction of CVD risk factors by decreasing total cholesterol, decreasing visceral fat mass, increasing lean body mass and maintaining glycemic control.
• Thromboxane metabolite(s) – A urine test to measure the level of thromboxane production and which is purportedly useful in identifying individuals at risk.

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

13 of 41

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Laboratory Test
Description

• Thyroglobulin antibody – Thyroglobulin autoantibodies bind thyroglobulin (Tg), a major thyroid-specific protein. Tg plays a crucial role in thyroid hormone synthesis, storage and release. Excess secretion of thyroid antibodies is thought to be associated with pulmonary hypertension.
• Transferrin – A blood-plasma glycoprotein, which plays a central role in iron metabolism and is responsible for ferric-ion delivery. Is mainly used in screening for chronic iron overload diseases, particularly hereditary hemochromatosis. Iron overload and deficiency are being investigated as possible contributors to CVD.
• Trimethylamine-N-oxide (TMAO) (column chromatography, including mass spectrometry) – A compound produced by the liver after intestinal bacteria digest choline, which is a nutrient found in red meat, eggs, fish and poultry. Increased levels are thought to be correlated with a higher risk of CVD.
• Troponin | testing (PATHFAST cTnI-ll) – Determines the quantity of cardiac troponin I, a protein that is integral to cardiac muscle contraction, which is purportedly elevated in the bloodstream after damage to the myocardium (heart muscle).
• Uric acid – Used to evaluate gout, renal function and a number of other disorders and has been proposed as an independent risk factor for cardiovascular morbidity and death.
• Vanillylmandelic acid (VMA) – A breakdown product of epinephrine (adrenaline) and norepinephrine. This test measures the amount of VMA that is passed into the urine, typically over a 24-hour period, who remain at risk of a cardiovascular event despite being on aspirin therapy.

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

14 of 41

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Vitamin D – Decreased serum level of vitamin D is a purported risk factor for CVD, due to norepinephrine. Urine levels are being studied as a potential CVD risk marker.
• Xanthurenic acid – A metabolite of tryptophan that is elevated in vitamin B6 insufficiency. High urinary excretion of xanthurenic acid suggests abnormal tryptophan metabolism due to vitamin B6 insufficiency. Being studied as a possible biomarker associated with CVD.
  For information regarding vitamin D testing, please refer to Vitamin D Testing Medical Coverage Policy.

Nonlaboratory-based screening tests have also been proposed for CVD risk assessment including, but may not be limited to:

• Carotid intima media thickness (IMT) testing – Measures the thickness of the inner two layers of the wall of the carotid artery. The intima is the innermost layer and the media is the middle layer of the arterial wall. An ultrasound image is used to detect carotid IMT which can purportedly diagnose early stages of atherosclerosis before symptoms occur and assess for drug efficacy. It is thought that a thickening of the carotid intima media confirms the likelihood of atherosclerosis of other arteries, including the coronary and carotid arteries. This led to the theory that carotid IMT could be used to identify persons at high risk for cardiovascular and cerebrovascular disease.

Examples of US Food & Drug Administration (FDA) approved IMT devices include, but may not be limited to:

• ArterioVision
• CardioHealth Station

Electrocardiogram (ECG, EKG)

A noninvasive procedure where electrodes are placed on the skin of the chest and connected to a machine that measures the heart’s electrical activity. ECG screening has been proposed as a method of screening for CVD risk in an asymptomatic individual at low, intermediate or high-risk level.

(Refer to Coverage Limitations section)

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

15 of 41

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

For information regarding genotype tests for cardiovascular risk (eg, 4q25, 9p21 and LPA Intron-25), genetic tests for cardiovascular risk (eg, APOE, factor II, factor V, MTHFR, PAI-1) or single-nucleotide polymorphism (SNP) testing for cardiovascular risk (eg, Cardiac Healthy Weight DNA Insight), please refer to Genetic Testing for Cardiac Conditions Medical Coverage Policy.

For information regarding CYP2C19 genotype testing to predict response to clopidogrel (Plavix), please refer to Pharmacogenomics – Cytochrome P450 Polymorphisms and VKORC1 Medical Coverage Policy.

For information regarding coronary artery calcium (CAC) scoring and coronary computed tomography angiography (CCTA), please refer to Coronary CT Angiography, Fractional Flow Reserve with CT, Calcium Scoring, Calcium Scoring Medical Coverage Policy.

Coverage Determination

Humana members may be eligible under the Plan for CVD risk screening with a standard serum lipid panel which includes HDL, LDL, total cholesterol and triglycerides, in addition to serum glucose testing for an individual with CVD risk factors as determined by the following organizations:

• American Academy of Pediatrics (AAP); OR
• American Association of Clinical Endocrinologists (AACE); OR
• American College of Cardiology (ACC); OR
• American Diabetes Association (ADA); OR
• American Heart Association (AHA); OR
• US Preventive Services Task Force (USPSTF)

Humana members may be eligible under the Plan for apolipoprotein B (apo B) serum screening when the following criteria are met:

• HDL less than 40 mg/dL; AND any of the following:
• Documented CAD; OR
• Documented diabetes mellitus; OR
• Two cardiovascular disease risk factors (eg, current cigarette smoking, hypertension [blood pressure greater than or equal to 140/90 mmHg or on antihypertensive medication], first-degree relative with history of premature CVD [males 54 years of age or younger or females 64 years of age or younger])

Humana members may be eligible under the Plan for high-sensitivity C-reactive protein (hs-CRP) serum screening for an individual at intermediate risk for CVD (10% to 20% at 10 years per ASCVD Risk Estimator Plus).

Note: The criteria for CVD risk testing are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members.

Refer to the CMS Website for additional information.

Coverage Limitations

Humana members may NOT be eligible under the Plan for the following CVD risk tests (individually or as part of a CVD risk laboratory panel) including, but may not be limited to, the following:

• 3-HPMA
• 5-HIAA
• ADMA/SDMA
• Albumin, urine
• Apo A-1
• Apo E
• ASCVD risk testing (individual or panel) (eg, c-peptide, glycated protein, islet cell antibodies, nonesterified fatty acids [free fatty acids], proinsulin, total insulin)
• Bilirubin (total or direct)
• BNP/NT-proBNP
• C-peptide
• Carotid intima media thickness
• Coenzyme Q10 (CoQ10)
• Comprehensive lipid panel (eg, Cardio IQ Advanced Lipid Panel, NMR LipoProfile, VAP cholesterol test [0052U])
• Cortisol (free or total)
• Creatine kinase (CK) / creatine phosphokinase (CPK)
• Creatinine, urine
• Cyanocobalamin (vitamin B-12)
• Cystatin-C
• DHEA
• DHEA-S
• ECG
• Estradiol
• Ethylmalonic acid
• F2-Isoprostane
• Fibrinogen

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

18 of 41

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Folic acid, serum
• FSH
• Galectin-3
• GGT
• GlycA (0024U)
• HART CADhs (0308U)
• HART CVE (0309U)
• HDL subclass
• HMG
• Homocysteine
• IDL/sdLDL
• Insulin
• Iron studies (eg, ferritin, serum iron)
• Kynurenic acid
• LDL subclasses (eg, NMR)
• LH
• Liposcale
• Lp[a]

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

19 of 41

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Lp-PLA2/PLAC
• Long-chain omega-3 fatty acids
• Magnesium
• Methylmalonic acid
• MI-heart ceramides (0119U)
• Microsomal antibodies (eg, thyroid)
• MPO
• Organic acid
• OxLDL
• Phosphorus inorganic (Phosphate)
• Progesterone
• Prolactin
• PTH
• PULS cardiac test
• Pyridoxal phosphate (vitamin B-6)
• Pyroglutamic acid
• Quinolinic acid
• SdLDL
• Serum sterols (eg, Boston heart cholesterol balance test)

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

20 of 41

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• SHBG
• Singulex SMC testing for risk of cardiac dysfunction and vascular inflammation (eg, SMC endothelin, SMC IL-6, SMC IL 17A, SMC c TnI, SMC TNF-α)
• Skin cholesterol testing (eg, PREVU)
• SmartVascular Dx (0415U)
• SomaScan Assay (0019M)
• sPLA2-IIA
• Testosterone
• Thromboxane metabolite(s) testing
• Thyroglobulin antibody
• TMAO
• Transferrin
• Troponin I (eg, PATHFAST cTnI-II)
• Uric acid
• Vitamin D
• VMA
• Xanthurenic acid

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

Page:

21 of 41

Humana's documents are updated regularly online. These are considered not medically necessary as defined in the member's individual coverage policy.

When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Background

Additional information about CVD may be found from the following websites:

• American Heart Association
• National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

Provider Claims Codes

Cardiovascular Disease Risk Testing Effective Date:

11/02/2023

Revision Date:

11/02/2023

Review Date:

11/02/2023

Policy Number:

HUM-0401-026

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Column chromatography, includes mass spectrometry, if performed (eg, HPLC, LC, LC/MS, LC/MS-MS, GC, GC/MS-MS, GC/MS, HPLC/MS), non-drug analyte(s) not elsewhere specified, qualitative or quantitative, each specimen

Not Covered if used to report any test outlined in Coverage Limitations section

82550 Creatine kinase (CK), (CPK); total Not Covered if used to report any test outlined in Coverage Limitations section

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New Code Effective 10/01/2023
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CPT® Category III Code(s)
Description
Comments
No code(s) identified
HCPCS Code(s)
Description
Comments
No code(s) identified

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References

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American Diabetes Association (ADA)

Diabetes care 2023: cardiovascular disease and risk management. https://www.diabetes.org. Published January 2023. Accessed October 27, 2023.

American Heart Association (AHA)

• 2010 ACCF/AHA guideline for assessment of cardiovascular risk in asymptomatic adults. https://www.heart.org. Published November 12, 2010. Accessed October 27, 2023.
• 2022 AHA/ACC/HFSA Guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association joint committee on clinical practice guidelines. https://www.heart.org. Published May 3, 2022. Accessed October 27, 2023.
• AHA Scientific Statement. Atherosclerotic cardiovascular disease in South Asians in the United States: epidemiology, risk factors, and treatments. https://www.heart.org. Published July 3, 2018. Accessed October 27, 2023.
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• AHA/ASA Scientific Statement. Prevention of stroke in patients with silent cerebrovascular disease: a statement for healthcare professionals from the American Heart Association/American Stroke Association. https://www.stroke.org. Published December 15, 2016. Accessed October 27, 2023.

1. Guidelines for the primary prevention of stroke: a statement for healthcare professionals from the American Heart Association/American Stroke Association. https://www.heart.org. Published October 2014. Accessed October 27, 2023.
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6. ClinicalKey. Bansal P, Ferri FF. Hypercholesterolemia. In: Ferri FF. Ferri's Clinical Advisor 2024. Elsevier; 2024:705-710.e1. https://www.clinicalkey.com. Accessed October 24, 2023.
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9. ECRI Institute. Hotline Response (ARCHIVED). Low-density lipoprotein particle number and subfraction testing for assessing and managing cardiac risk. https://www.ecri.org. Published July 16, 2013. Updated August 15, 2014. Accessed November 9, 2021.
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13. Hayes, Inc. Evidence Analysis Research Brief. HART CADhs blood test (Prevencio Inc.) to predict risk of obstructive coronary artery disease. https://evidence.hayesinc.com. Published July 18, 2023. Accessed October 21, 2023.

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1. MI-Heart ceramides (Mayo Clinic Laboratories) to predict risk of major adverse cardiovascular events. https://evidence.hayesinc.com. Published July 7, 2023. Accessed October 21, 2023.
2. Hayes, Inc. Health Technology Brief (ARCHIVED). Galectin-3 in vitro diagnostic assay (BG Medicine Inc.) for the management of patients with chronic heart failure. https://evidence.hayesinc.com. Published October 24, 2013. Updated August 20, 2015. Accessed October 17, 2023.
3. Hayes, Inc. Health Technology Brief (ARCHIVED). Lipoprotein-associated phospholipase A2 (Lp-PLA2) test (PLAC Test) (diaDexus, Inc.) for prediction of ischemic stroke. https://evidence.hayesinc.com. Published July 31, 2009. Updated July 22, 2010. Accessed October 21, 2023.
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1. UpToDate, Inc. Atherosclerotic cardiovascular disease risk assessment for primary prevention in adults: our approach. https://www.uptodate.com. Updated September 2023. Accessed October 23, 2023.
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6. UpToDate, Inc. HDL cholesterol: clinical aspects of abnormal values. https://www.uptodate.com. Updated September 2023. Accessed October 24, 2023.
7. UpToDate, Inc. Inherited disorders of LDL-cholesterol metabolism other than familial hypercholesterolemia. https://www.uptodate.com. Updated September 2023. Accessed October 24, 2023.
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48. UpToDate, Inc. Measurement of blood lipids and lipoproteins. https://www.uptodate.com. Updated September 2023. Accessed October 24, 2023.
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57. UpToDate, Inc. Prevalence of and risk factors for coronary heart disease in diabetes mellitus. https://www.uptodate.com. Updated September 2023. Accessed October 24, 2023.

59. UpToDate, Inc. Psychosocial factors in acute myocardial infarction. https://www.uptodate.com. Updated September 2023. Accessed October 24, 2023.
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74. US Preventive Services Task Force (USPSTF). Recommendation Statement. Vitamin D deficiency: screening. https://www.uspreventiveservicestaskforce.org. Published April 2021. Accessed October 27, 2023.

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Accessed October 27, 2023.

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Appendix A – Family Relationships