Lipoproteins are a class of heterogeneous particles of varying sizes and densities containing lipid and protein. These lipoproteins include cholesterol esters and free cholesterol, triglycerides, phospholipids and A, C, and E apoproteins. Total cholesterol comprises all the cholesterol found in various lipoproteins.

Factors that affect blood cholesterol levels include age, sex, body weight, diet, alcohol and tobacco use, exercise, genetic factors, family history, medications, menopausal status, the use of hormone replacement therapy, and chronic disorders such as hypothyroidism, obstructive liver disease, pancreatic disease (including diabetes), and kidney disease.

In many individuals, an elevated blood cholesterol level constitutes an increased risk of developing coronary artery disease. Blood levels of total cholesterol and various fractions of cholesterol, especially low density lipoprotein cholesterol (LDL -C) and high density lipoprotein cholesterol (HDL-C), are useful in assessing and monitoring treatment for that risk in patients with cardiovascular and related diseases. Blood levels of the above cholesterol components including triglyceride have been separated into desirable, borderline and high risk categories by the National Heart, Lung and Blood Institute in their report in 1993. These categories form a useful basis for evaluation and treatment of patients with hyperlipidemia (See Reference). Therapy to reduce these risk parameters includes diet, exercise and medication, and fat weight loss, which is particularly powerful when combined with diet and exercise.

Cardiovascular Disease Screening

Cardiovascular screening tests are defined as testing for the early detection of cardiovascular disease or abnormalities associated with an elevated risk for that disease.  This includes, but is not limited to, blood tests for cholesterol and other lipid or triglycerides levels.

Indications

The medical community recognizes lipid testing as appropriate for evaluating atherosclerotic cardiovascular disease. Conditions in which lipid testing may be indicated include:

• Assessment of patients with atherosclerotic cardiovascular disease
• Evaluation of primary dyslipidemia
• Any form of atherosclerotic disease, or any disease leading to the formation of atherosclerotic disease 
• Diagnostic evaluation of diseases associated with altered lipid metabolism, such as: nephrotic syndrome, pancreatitis, hepatic disease, and hypo and hyperthyroidism
• Secondary dyslipidemia, including diabetes mellitus, disorders of gastrointestinal absorption, chronic renal failure
• Signs or symptoms of dyslipidemias, such as skin lesions
• As follow-up to the initial screen for coronary heart disease when total cholesterol is determined to be high, or borderline-high plus two or more coronary heart disease risk factors.

To monitor the progress of patients on anti-lipid dietary management and pharmacologic therapy for the treatment of elevated blood lipid disorders, total cholesterol, HDL cholesterol and LDL cholesterol may be used. Triglycerides may be obtained if this lipid fraction is also elevated or if the patient is put on drugs (for example, thiazide diuretics, beta blockers, estrogens, glucocorticoids, and tamoxifen) which may raise the triglyceride level.

When monitoring long term anti-lipid dietary or pharmacologic therapy and when following patients with borderline high total or LDL cholesterol levels, it may be reasonable to perform the lipid panel annually. A lipid panel at a yearly interval will usually be adequate while measurement of the serum total cholesterol or a measured LDL should suffice for interim visits if the patient does not have hypertriglyceridemia.

Any one component of the panel or a measured LDL may be reasonable and necessary up to six times the first year for monitoring dietary or pharmacologic therapy. More frequent total cholesterol HDL cholesterol, LDL cholesterol and triglyceride testing may be indicated for marked elevations or for changes to anti-lipid therapy due to inadequate initial patient response to dietary or pharmacologic therapy. The LDL cholesterol or total cholesterol may be measured three times yearly after treatment goals have been achieved.

Electrophoretic or other quantitation of lipoproteins may be indicated if the patient has a primary disorder of lipoid metabolism.

Cardiovascular Disease Screening

Coverage will be provided for the following cardiovascular screening blood test when ordered by the physician who is treating the member for the purpose of early detection of cardiovascular disease in individuals without apparent signs or symptoms:

• Total Cholesterol Test (82465)
• Cholesterol Test for High Density Lipoproteins (83718); and,
• Triglycerides (84478)

These tests should be performed as a lipid panel (80061) and only following a 12-hour fast.  Although the tests should be performed as a panel, they may be performed and reported as individual tests.  One or more of screening diagnosis codes V81.0, V81.1, V81.2 should be reported for cardiovascular disease screening.

Limitations

Lipid panel and hepatic panel testing may be used for patients with severe psoriasis which has not responded to conventional therapy and for which the retinoid etretinate has been prescribed and who have developed hyperlipidemia or hepatic toxicity. Specific examples include erythrodermia and generalized pustular type and psoriasis associated with arthritis.

Routine screening and prophylactic testing for lipid disorder are not covered.  Lipid testing in asymptomatic individuals is considered to be screening regardless of the presence of other risk factors such as family history, tobacco use, etc.

Once a diagnosis is established, one or several specific tests are usually adequate for monitoring the course of the disease. Less specific diagnoses (for example, other chest pain) alone do not support medical necessity of these tests.

When monitoring long term anti-lipid dietary or pharmacologic therapy and when following patients with borderline high total or LDL cholesterol levels, it is reasonable to perform the lipid panel annually. A lipid panel at a yearly interval will usually be adequate while measurement of the serum total cholesterol or a measured LDL should suffice for interim visits if the patient does not have hypertriglyceridemia.

Any one component of the panel or a measured LDL may be medically necessary up to six times the first year for monitoring dietary or pharmacologic therapy. More frequent total cholesterol HDL cholesterol, LDL cholesterol and triglyceride testing may be indicated for marked elevations or for changes to anti-lipid therapy due to inadequate initial patient response to dietary or pharmacologic therapy. The LDL cholesterol or total cholesterol may be measured three times yearly after treatment goals have been achieved.

If no dietary or pharmacological therapy is advised, monitoring is not necessary.

When evaluating non-specific chronic abnormalities of the liver (for example, elevations of transaminase, alkaline phosphatase, abnormal imaging studies, etc.), a lipid panel would generally not be indicated more than twice per year.

With the exception of routine or screening, any diagnosis other than those listed under the “Covered Diagnosis Codes” section will be denied as not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost.  The member must agree in writing to assume financial responsibility, in advance of receiving the service.  The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Lipid testing for routine or screening purposes is excluded from coverage.  Therefore, any diagnosis code listed under the “Screening Diagnosis Codes” section will deny as not covered.

Cardiovascular Disease Screening

When reported for cardiovascular disease screening (diagnosis codes V81.0, V81.1, or V81.2), coverage is provided for each of the three blood tests (i.e., 82465, 83718, and 84478) or for the lipid panel (80061), once every five years.

Payment for cardiovascular disease screening is limited to codes 82465, 83718, 84478 and 80061.  All other blood tests reported for cardiovascular disease screening remain noncovered.

NOTE:

A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without a diagnosis code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. Also, if a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency.

Documentation Requirements

Failure to provide documentation of the medical necessity of tests may result in denial of claims. Such documentation may include notes documenting relevant signs, symptoms or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial.

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.

The following procedure codes should be reported for cardiovascular disease screening:

80061 -  Lipid Panel

82465 - Cholesterol, serum or whole blood, total

83718 - Lipoprotein, direct measurement, high density cholesterol

84478 - Triglycerides

One or more screening diagnosis codes V81.0, V81.1, or V81.2 should be reported for cardiovascular disease screening.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Transmittal 28, CR 3690

Transmittal 651, CR 4005

Transmittal 458, 4161

Transmittal 864, 4328

Transmittal 1050, CR 5293

Transmittal 1606, CR 6213

Transmittal 1645, CR 6304

Transmittal 1684, CR 6383

Transmittal 1735, CR 6481

Transmittal 1766, CR 6548

Transmittal 1963, CR 6964

Transmittal 2001, CR 7057

Transmittal 2298, CR 7507

Covered Diagnosis Codes

(Applicable to 80061, 82465, 83700, 83701, 83704, 83718, 83721, 84478)

Covered Diagnosis Codes

(Applicable to 80061, 82465, 83718, 84478)

Non-covered Diagnosis Codes

(Non-covered diagnosis codes V81.0, V81.1, and V81.2 are not applicable to 80061, 82465, 83718, 84478)

Screening Diagnosis Codes