CMS Pub. 100-03, ch. 1, § 190.20

This policy is intended to apply to blood samples used to determine glucose levels.

Blood glucose determination may be done using whole blood, serum or plasma. It may

be sampled by capillary puncture, as in the fingerstick method, or by vein puncture or

arterial sampling. The method for assay may be by color comparison or an indicator

stick, by meter assay of whole blood or a filtrate of whole blood, using a device approved

for home monitoring, or by using a laboratory assay system using serum or plasma. The

convenience of the meter or stick color method allows a patient to have access to blood

glucose values in less than a minute or so and has become a standard of care for control

of blood glucose, even in the inpatient setting.

Indications

Blood glucose values are often necessary for the management of patients with diabetes

mellitus, where hyperglycemia and hypoglycemia are often present. They are also

critical in the determination of control of blood glucose levels in the patient with

impaired fasting glucose (FPG 110-125 mg/dL), the patient with insulin resistance

syndrome and/or carbohydrate intolerance (excessive rise in glucose following ingestion

of glucose or glucose sources of food), in the patient with a hypoglycemia disorder such

as nesidioblastosis or insulinoma, and in patients with a catabolic or malnutrition state.

In addition to those conditions already listed, glucose testing may be medically necessary

in patients with tuberculosis, unexplained chronic or recurrent infections, alcoholism,

coronary artery disease (especially in women), or unexplained skin conditions (including

pruritis, local skin infections, ulceration and gangrene without an established cause).

Many medical conditions may be a consequence of a sustained elevated or depressed

glucose level. These include comas, seizures or epilepsy, confusion, abnormal hunger,

abnormal weight loss or gain, and loss of sensation. Evaluation of glucose may also be

indicated in patients on medications known to affect carbohydrate metabolism.

Effective January 1, 2005, the Medicare law expanded coverage to diabetic screening

services. Some forms of blood glucose testing covered under this national coverage

determination may be covered for screening purposes subject to specified frequencies.

See 42 CFR 410.18 and section 90, chapter 18, of the Claims Processing Manual, for a

full description of this screening benefit.

Limitations

Frequent home blood glucose testing by diabetic patients should be encouraged. In

stable, non-hospitalized patients who are unable or unwilling to do home monitoring, it

may be reasonable and necessary to measure quantitative blood glucose up to four times

annually.

Depending upon the age of the patient, type of diabetes, degree of control, complications

of diabetes, and other co-morbid conditions, more frequent testing than four times

annually may be reasonable and necessary.

In some patients presenting with nonspecific signs, symptoms, or diseases not normally

associated with disturbances in glucose metabolism, a single blood glucose test may be

medically necessary. Repeat testing may not be indicated unless abnormal results are

found or unless there is a change in clinical condition. If repeat testing is performed, a

specific diagnosis code (e.g., diabetes) should be reported to support medical necessity.

However, repeat testing may be indicated where results are normal in patients with

conditions where there is a confirmed continuing risk of glucose metabolism abnormality

(e.g., monitoring glucocorticoid therapy).

190.21 - Glycated Hemoglobin/Glycated Protein

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

PM AB-02-110

The management of diabetes mellitus requires regular determinations of blood glucose

levels. Glycated hemoglobin/protein levels are used to assess long-term glucose control

in diabetes. Alternative names for these tests include glycated or glycosylated

hemoglobin or Hgb, hemoglobin glycated or glycosylated protein, and fructosamine.

Glycated hemoglobin (equivalent to hemoglobin A1) refers to total glycosylated

hemoglobin present in erythrocytes, usually determined by affinity or ion-exchange

chromatographic methodology. Hemoglobin A1c refers to the major component of

hemoglobin A1, usually determined by ion-exchange affinity chromatography,

immunoassay or agar gel electrophoresis. Fructosamine or glycated protein refers to

glycosylated protein present in a serum or plasma sample. Glycated protein refers to

measurement of the component of the specific protein that is glycated usually by

colorimetric method or affinity chromatography.

Glycated hemoglobin in whole blood assesses glycemic control over a period of 4-8

weeks and appears to be the more appropriate test for monitoring a patient who is capable

of maintaining long-term, stable control. Measurement may be medically necessary

every 3 months to determine whether a patient’s metabolic control has been on average

within the target range. More frequent assessment, every 1-2 months, may be appropriate

in the patient whose diabetes regimen has been altered to improve control or in whom

evidence is present that intercurrent events may have altered a previously satisfactory

level of control (for example, post-major surgery or a s a result of glucocorticoid

therapy). Glycated protein in serum/plasma assesses glycemic control over a period of 1-

2 weeks. It may be reasonable and necessary to monitor glycated protein monthly in

pregnant diabetic women. Glycated hemoglobin/protein test results may be low,

indicating significant, persistent hypoglycemia, in nesidioblastosis or insulinoma,

conditions which are accompanied by inappropriate hyperinsulinemia. A below normal

test value is helpful in establishing the patient’s hypoglycemic state in those conditions.

Indications

Glycated hemoglobin/protein testing is widely accepted as medically necessary for the

management and control of diabetes. It is also valuable to assess hyperglycemia, a

history of hyperglycemia or dangerous hypoglycemia. Glycated protein testing may be

used in place of glycated hemoglobin in the management of diabetic patients, and is

particularly useful in patients who have abnormalities of erythrocytes such as hemolytic

anemia or hemoglobinopathies.

Limitations

It is not considered reasonable and necessary to perform glycated hemoglobin tests more

often than every 3 months on a controlled diabetic patient to determine whether the

patient’s metabolic control has been on average within the target range. It is not

considered reasonable and necessary for these tests to be performed more frequently than

once a month for diabetic pregnant women. Testing for uncontrolled type one or two

diabetes mellitus may require testing more than four times a year. The above section

provides the clinical basis for those situations in which testing more frequently than four

times per annum is indicated, and medically necessary documentation must support such

testing in excess of the above guidelines.

Many methods for the analysis of glycated hemoglobin show significant interference

from elevated levels of fetal hemoglobin or by variant hemoglobin molecules. When the

glycated hemoglobin assay is initially performed in these patients, the laboratory may

inform the ordering physician of a possible analytical interference. Alternative testing,

including glycated protein, for example, fructosamine, may be indicated for the

monitoring of the degree of glycemic control in this situation. It is therefore conceivable

that a patient will have both a glycated hemoglobin and glycated protein ordered on the

same day. This should be limited to the initial assay of glycated hemoglobin, with

subsequent exclusive use of glycated protein. These tests are not considered to be

medically necessary for the diagnosis of diabetes.

190.22 - Thyroid Testing

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

PM AB-02-110

Thyroid function studies are used to delineate the presence of absence of hormonal

abnormalities of the thyroid and pituitary glands. These abnormalities may be either

primary or secondary and often but not always accompany clinically defined signs and

symptoms indicative of thyroid dysfunction.

Laboratory evaluation of thyroid function has become more scientifically defined. Tests

can be done with increased specificity, thereby reducing the number of tests needed to

diagnose and follow treatment of most thyroid disease. Measurements of serum sensitive

thyroid-stimulating hormone (TSH) levels, complemented by determination of thyroid

hormone levels [free thyroxine (fT-4) or total thyroxine (T4) with Triiodothyronine (T3)

uptake] are used for diagnosis and follow-up of patients with thyroid disorders.

Additional tests may be necessary to evaluate certain complex diagnostic problems or on

hospitalized patients, where many circumstances can skew tests results. When a test for

total thyroxine (total T4 or T4 radioimmunoassay) or T3 uptake is performed, calculation

of the free thyroxine index (FTI) is useful to correct for abnormal results for either total

T4 or T3 uptake due to protein binding effects.

Indications

Thyroid function tests are used to define hyper function, euthyroidism, or hypofunction

of thyroid disease. Thyroid testing may be reasonable and necessary to:

• Distinguish between primary and secondary hypothyroidism

• Confirm or rule our primary hypothyroidism

• Monitor thyroid hormone levels (for example, patients with goiter, thyroid

nodules, or thyroid cancer)

• Monitor dug therapy in patients with primary hypothyroidism

• Confirm or rule out primary hyperthyroidism

• Monitor therapy in patients with hyperthyroidism

Thyroid function testing may be medically necessary in patients with disease or neoplasm

of the thyroid and other endocrine glands. Thyroid function testing may also be

medically necessary in patients with metabolic disorders; malnutrition; hyperlipidemia;

certain types of anemia; psychosis and non-psychotic personality disorders; unexplained

depression; ophthalmologic disorders; various cardiac arrhythmias; disorders of

menstruation; skin conditions; myalgias; and a wide array of signs and symptoms,

including alterations in consciousness; malaise; hypothermia; symptoms of the nervous

and musculoskeletal system; skin and integumentary system; nutrition and metabolism;

cardiovascular; and gastrointestinal system.

It may be medically necessary to do follow-up thyroid testing in patients with a personal

history of malignant neoplasm of the endocrine system and in patients on long-term

thyroid drug therapy.

Limitations

Testing may be covered up to two times a year in clinically stable patients; more frequent

testing may be reasonable and necessary for patients whose thyroid therapy has been

altered or in whom symptoms or signs of hyperthyroidism of hypothyroidism are noted.