CMS Pub. 100-03, ch. 1, § 190.23

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. Therapy to reduce these risk parameters includes diet,

exercise and medications, and fat weight loss, which is particularly powerful when

combined with diet and exercise.

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 (total cholesterol +

HDL cholesterol) when total cholesterol is determined to be high (>240 mg/dL), or

borderline-high (200-140 mg/dL) plus two or more coronary heart disease risk factors, or

an HDL cholesterol, <35 mg/dL.

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 the 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.

Effective January 1, 2005, the Medicare law expanded coverage to cardiovascular

screening services. Several of the procedures included in this NCD may be covered for

screening purposes subject to specified frequencies. See 42 CFR 410.17 and section 100,

chapter 18, of the Claims Processing Manual, for a full description of this benefit.

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 by

Medicare. While lipid screening may be medically appropriate, Medicare by statute does

not pay for it. 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 of 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 pharmacologic 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.

190.24 - Digoxin Therapeutic Drug Assay

(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable)

PM AB-02-110

A digoxin therapeutic drug assay is useful for diagnosis and prevention of digoxin

toxicity and/or prevention for under dosage of digoxin.

Indications

Digoxin levels may be performed to monitor drugs levels of individuals receiving digoxin

therapy because the margin of safety between side effects and toxicity is narrow or

because the blood level may not be high enough to achieve the desired clinical effect.

Clinical indications may include individuals on digoxin:

• With symptoms, signs or electrocardiogram (ECG) suggestive of digoxin toxicity

• Taking medications that influence absorption, bioavailability, distribution, and/or

elimination of digoxin

• With impaired renal, hepatic, gastrointestinal, or thyroid function

• With pH and/or electrolyte abnormalities

• With unstable cardiovascular status, including myocarditis

• Requiring monitoring of patient compliance

Clinical indication may include individuals:

• Suspected of accidental or intended overdose

• Who have an acceptable cardiac diagnosis and for whom an accurate history of

use of digoxin is unobtainable

The value of obtaining regular serum digoxin levels is uncertain, but it may be reasonable

to check levels once yearly after a steady state is achieved. In addition, it may be

reasonable to check the level if:

• Heart failure status worsens

• Renal function deteriorates

• Additional medications are added that could affect the digoxin level

• Signs or symptoms of toxicity develop

Steady state will be reached in approximately 1 week in patients with normal renal

function, although 2-3 weeks may be needed in patients with renal impairment. After

changes in dosages or the addition of a medication that could affect the digoxin level, it is

reasonable to check the digoxin level one week after the change or addition. Based on

the clinical situation, in cases of digoxin toxicity, testing may need to be done more than

once a week.

Digoxin is indicated for the treatment of patients with heart failure due to systolic

dysfunction and for reduction of the ventricular response in patients with atrial fibrillation

of flutter. Digoxin may also be indicated for the treatment of other supraventricular

arrhythmias, particularly in the presence of heart failure.

Limitations

This test is not appropriate for patients on digitoxin or treated with digoxin FAB

(fragment antigen binding) antibody.

190.25 - Alpha-fetoprotein

(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable)

PM AB-02-110

Alpha-fetoprotein (AFP) is a polysaccharide found in some carcinomas. It is effective as

a biochemical marker for monitoring the response of certain malignancies to therapy.

Indications

The AFP is useful for the diagnosis of hepatocellular carcinoma in high-risk patients

(such as alcoholic cirrhosis, cirrhosis of viral etiology, hemochromatosis, and alpha 1-antitrypsin deficiency) and in separating patients with benign hepatocellular neoplasms or

metastases from those with hepatocellular carcinoma and, as a non-specific tumor

associated antigen, serves in marking germ cell neoplasms of the testis, ovary,

retroperitoneum, and mediastinum.

190.26 - Carcinoembryonic Antigen

(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable)

PM AB-02-110

Carcinoembryonic antigen (CEA) is a protein polysaccharide found in some carcinomas.

It is effective as a biochemical marker for monitoring the response of certain

malignancies to therapy.

Indications

The CEA may be medically necessary for follow-up of patients with colorectal

carcinoma. It would however only be medically necessary at treatment decision-making

points. In some clinical situations (e.g., adenocarcinoma of the lung, small cell

carcinoma of the lung, and some gastrointestinal carcinomas) when a more specific

marker is not expressed by the tumor, CEA may be a medically necessary alternative

marker for monitoring. Preoperative CEA may also be helpful in determining the post-operative adequacy of surgical resection and subsequent medical management. In

general, a single tumor marker will suffice in following patients with colorectal

carcinoma or other malignancies that express such tumor markers.

In following patients who have had treatment for colorectal carcinoma, ASCO guideline

suggests that if resection of liver metastasis would be indicated, it is recommended that

post-operative CEA testing be performed every two to three months in patients with

initial stage II or stage III disease for at least two years after diagnosis.

For patients with metastatic solid tumors, which express CEA, CEA may be measured at

the start of the treatment and with subsequent treatment cycles to assess the tumor’s

response to therapy.

Limitations

Serum CEA determinations are generally not indicated more frequently than once per

chemotherapy treatment cycle for patients with metastatic solid tumors which express

CEA or every two months post-surgical treatment for patients who have had colorectal

carcinoma. However, it may be proper to order the test more frequently in certain

situation, for example, when there has been a significant change from prior CEA level or

a significant change in patient status which could reflect disease progression or

recurrence.

Testing with a diagnosis of an in situ carcinoma is not reasonably done more frequently

than once, unless the result is abnormal, in which case the test may be repeated once.

190.27 - Human Chorionic Gonadotropin

(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable)

PM AB-02-110

Human Chorionic Gonadotropin (hCG) is useful for monitoring and diagnosis of germ

cell neoplasms of the ovary, testis, mediastinum, retroperitoneum, and central nervous

system. In addition, hCG is useful for monitoring pregnant patients with vaginal

bleeding, hypertension and/or suspected fetal loss.

It is not reasonable and necessary to perform hCG testing more than once per month for

diagnostic purposes. It may be performed as needed for monitoring of patient progress

and treatment. Qualitative hCG assays are not appropriate for medically managing

patients with known or suspected germ cell neoplasms.