Labrad Diagnostics reserves the right to refuse testing for invalid or incomplete ICD-10 codes or patient information. If a lab test is not covered due to lack of medical necessity information provided, Labrad Diagnostics will bill patient for charges incurred. Tests that do not meet medical necessity will require an ABN signed by patient in order for services to be provided and payment is required by credit card for patient responsible charges. 

Labrad Diagnostics does not recommend any diagnosis codes and will only submit diagnosis information provided to us by the ordering physician or his/her designated staff.

VITAMIN D ASSAY TESTING
CPT: 82306
Coverage Indications, Limitations, and/or Medical Necessity Vitamin D is called a "vitamin" because of its exogenous source, predominately from oily fish in the form of vitamin D 2 and vitamin D 3. It is more accurate to consider fat-soluble Vitamin D as a steroid hormone, synthesized by the skin and metabolized by the kidney to an active hormone, calcitriol. Clinical disorders related to vitamin D may arise because of altered availability of the parent vitamin D, altered conversion of vitamin D to its predominant metabolites, altered organ responsiveness to dihydroxylated metabolites and disturbances in the interactions of the vitamin D metabolites with PTH and calcitonin. Normal levels of Vitamin D range from 20 – 50 ng/dl. This LCD identifies the indications and limitations of Medicare coverage and reimbursement for the lab assay. 
Coverage Indications, Limitations, and/or Medical Necessity Vitamin D is called a "vitamin" because of its exogenous source, predominately from oily fish in the form of vitamin D 2 and vitamin D 3. It is more accurate to consider fat-soluble Vitamin D as a steroid hormone, synthesized by the skin and metabolized by the kidney to an active hormone, calcitriol. Clinical disorders related to vitamin D may arise because of altered availability of the parent vitamin D, altered conversion of vitamin D to its predominant metabolites, altered organ responsiveness to dihydroxylated metabolites and disturbances in the interactions of the vitamin D metabolites with PTH and calcitonin. Normal levels of Vitamin D range from 20 – 50 ng/dl. This LCD identifies the indications and limitations of Medicare coverage and reimbursement for the lab assay. Indications Measurement of 25-OH Vitamin D, CPT 82306, level is indicated for patients with: chronic kidney disease stage III or greater; cirrhosis; hypocalcemia; hypercalcemia; hypercalciuria; hypervitaminosis D; parathyroid disorders; malabsorption states; obstructive jaundice; osteomalacia; osteoporosis if: i. T score on DEXA scan 3% 10-year probability of hip fracture or 20% 10-year probability of other major osteoporotic fracture or iv. FRAX > 3% (any fracture) with T-score 60 ng/dl, a subsequent level(s) may be reimbursed until the level is within the normal range.
Most Common ICD-10 Codes Used by providers:
E21.0 Primary hyperparathyroidism
E21.1 Secondary hyperparathyroidism, not elsewhere classified
E21.2 Other hyperparathyroidism
E21.3 Hyperparathyroidism, unspecified
E55.9 Vitamin D deficiency, unspecified
E67.3 Hypervitaminosis D
E83.51 Hypocalcemia
E83.52 Hypercalcemia
K90.9 Intestinal malabsorption, unspecified
M81.0 Age-related osteoporosis without current pathological fracture
M81.8 Other osteoporosis without current pathological fracture
M83.9 Adult osteomalacia, unspecified
M85.80 Other specified disorders of bone density and structure, unspecified site
M85.88 Other specified disorders of bone density and structure, other site
N18.3 Chronic kidney disease, stage 3 (moderate)
N18.4 Chronic kidney disease, stage 4 (severe)
N25.81 Secondary hyperparathyroidism of renal origin
Z79.4 Long term (current) use of insulin
Z79.890 Hormone replacement therapy (postmenopausal)
Z79.899 Other long term (current) drug therapy

Digoxin Therapeutic Drug Assay

CPT: 80162

 

Coverage Indications, Limitations, and/or Medical Necessity

 

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 drug 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 indications may include individuals: • Suspected of accidental or intended overdose • Who have an acceptable cardiac diagnosis (as listed) 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 or flutter. Digoxin may also be indicated to treat other supraventricular arrhythmias, particularly with heart failure. Limitations This test is not appropriate for patients on digitoxin or treated with digoxin FAB (fragment antigen binding) antibody. www.cms.gov 

 

Medicare National Coverage Determination Policy

 

The ICD10 codes listed below are the top diagnosis codes currently utilized by ordering physicians for the limited coverage test highlighted above that are also listed as medically supportive under Medicare’s limited coverage policy. If you are ordering this test for diagnostic reasons that are not covered under Medicare policy, an Advance Beneficiary Notice form is required. *Note—Bolded diagnoses below have the highest utilization Disclaimer: This diagnosis code reference guide is provided as an aid to physicians and office staff in determining when an ABN (Advance Beneficiary Notice) is necessary. Diagnosis codes must be applicable to the patient’s symptoms or conditions and must be consistent with documentation in the patient’s medical record. Labrad Diagnostics does not recommend any diagnosis codes and will only submit diagnosis information provided to us by the ordering physician or his/her designated staff. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

 

E03.9 Hypothyroidism, unspecified

I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris

I42.0 Dilated cardiomyopathy

I42.9 Cardiomyopathy, unspecified

I47.1 Supraventricular tachycardia

I48.0 Paroxysmal atrial fibrillation

I48.11 Longstanding persistent atrial fibrillation

I48.19 Other persistent atrial fibrillation

I48.20 Chronic atrial fibrillation

I48.21 Permanent atrial fibrillation

I48.91 Unspecified atrial fibrillation

I48.92 Unspecified atrial flutter

I50.20 Unspecified systolic (congestive) heart failure

I50.22 Chronic systolic (congestive) heart failure

I50.32 Chronic diastolic (congestive) heart failure

I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure

I50.9 Heart failure, unspecified

N18.3 Chronic kidney disease, stage 3 (moderate) \

R53.83 Other fatigue

Z79.899 Other long term (current) drug therapy

Blood Glucose Testing

CPT: 82947, 82948, 82962

Coverage Indications, Limitations, and/or Medical Necessity 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 of 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 patient with impaired fasting glucose (FPG 110-125 mg/dL), patient with insulin resistance syndrome and/or carbohydrate intolerance (excessive rise in glucose following ingestion of glucose/glucose sources of food), in patient with a hypoglycemia disorder such as nesidioblastosis or insulinoma, and in patients with a catabolic or malnutrition state. In addition to conditions 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 (i.e.: pruritis, skin infections, ulceration and gangrene without cause). Many medical conditions may be a consequence of a sustained elevated or depressed glucose level, including comas, seizures or epilepsy, confusion, abnormal hunger, abnormal weight loss or gain, and loss of sensation. Evaluation of glucose may 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 NCD may be covered for screening purposes subject to specified frequencies. See 42 CFR410.18, sec. 90 ch.18 Claims Processing Manual for screening benefit description. Limitations Frequent home blood glucose testing by diabetic patients should be encouraged. In stable, non-hospitalized patients unable or unwilling to do home monitoring, it may necessary to measure quantitative blood glucose up to 4 times a year. Depending upon patient’s age, type of diabetes, complications, degree of control, and other co-morbid conditions, more frequent testing than 4 times a year may be reasonable and necessary. In patients presenting 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 there is a change in clinical condition. If repeat testing is performed, a 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 of a continuing risk of glucose metabolism abnormality (e.g., monitoring glucocorticoid therapy).

The ICD10 codes listed below are the top diagnosis codes currently utilized by ordering physicians for the limited coverage test highlighted above that are also listed as medically supportive under Medicare’s limited coverage policy. If you are ordering this test for diagnostic reasons that are not covered under Medicare policy, an Advance Beneficiary Notice form is required. *Note—Bolded diagnoses below have the highest utilization

E11.22 Type 2 diabetes mellitus with diabetic chronic kidney disease

E11.65 Type 2 diabetes mellitus with hyperglycemia

E11.69 Type 2 diabetes mellitus with other specified complication

E11.9 Type 2 diabetes mellitus without complications

E78.00 Pure hypercholesterolemia, unspecified

E78.2 Mixed hyperlipidemia

E78.5 Hyperlipidemia, unspecified

I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris

N39.0 Urinary tract infection, site not specified

R53.83 Other fatigue

R73.01 Impaired fasting glucose

R73.03 Prediabetes

R73.09 Other abnormal glucose

R73.9 Hyperglycemia, unspecified

R79.89 Other specified abnormal findings of blood chemistry

R79.9 Abnormal finding of blood chemistry, unspecified

R80.9 Proteinuria, unspecified

Z13.1 Encounter for screening for diabetes mellitus

Z79.4 Long term (current) use of insulin

Z79.899 Other long term (current) drug therapy

Blood Counts

CPT: 85004, 85007, 85008, 85013 , 85014, 85018, 85025, 85027, 85032, 85048, 85049

D50.9 Iron deficiency anemia, unspecified

D64.9 Anemia, unspecified

E03.9 Hypothyroidism, unspecified

E11.65 Type 2 diabetes mellitus with hyperglycemia

E11.9 Type 2 diabetes mellitus without complications

E53.8 Deficiency of other specified B group vitamins

E55.9 Vitamin D deficiency, unspecified

E78.00 Pure hypercholesterolemia, unspecified

E78.2 Mixed hyperlipidemia

E78.5 Hyperlipidemia, unspecified

I10 Essential (primary) hypertension

I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris

N18.3 Chronic kidney disease, stage 3 (moderate)

N39.0 Urinary tract infection, site not specified

R53.83 Other fatigue

R73.01 Impaired fasting glucose

R73.09 Other abnormal glucose

R73.9 Hyperglycemia, unspecified

R79.89 Other specified abnormal findings of blood chemistry

Z79.899 Other long term (current) drug therapy

B-type Natriuretic Peptide (BNP) Testing

CPT: 83880

Coverage Indications, Limitations, and/or Medical Necessity B-type natriuretic peptide (BNP) is a cardiac neurohormone produced mainly in the left ventricle. It is secreted in response to ventricular volume expansion and pressure overload, conditions often present in congestive heart failure (CHF). Used in conjunction with other clinical information, measurement of BNP levels (either total or N-terminal) is useful in rapidly establishing or excluding the diagnosis or worsening of CHF in patients with acute exacerbation of dyspnea. Also, BNP levels determined in the first few days after an acute coronary syndrome or event (ACS) may be useful in the prediction of longer-term cardiovascular risk but this risk assessment does not change the management of ACS and is non-covered by regulation. BNP measurements may be considered reasonable and necessary when used in combination with other medical data such as medical history, physical examination, laboratory studies, and chest x-ray.to diagnose or to differentiate heart failure from other potential clinical conditions if the patient’s signs and/or symptoms are consistent with both heart failure and one or more other conditions, e.g., acute dyspnea in a patient with known or suspected pulmonary disease.to diagnose or differentiate worsening heart failure if use of the test replaces other diagnostic tests, such as chest film; and/or to confirm the diagnosis when other diagnostic tests are equivocal.

Indications BNP measurements must be assessed in conjunction with standard diagnostic tests, medical history and clinical findings. The efficacy of BNP measurement as a stand-alone test has not been established yet. BNP measurements for monitoring and management of CHF are non-covered. Treatment guided by BNP has not been shown to be superior to symptom-guided treatment in either clinical or quality-of-life outcomes. The efficacy but not the utility of BNP as a risk stratification tool (to assess risk of death, myocardial infarction or congestive heart failure) among patients with acute coronary syndrome (myocardial infarction with or without T-wave elevation and unstable angina) has been established. However, the assessment of BNP level has not been shown to alter patient management. The BNP is not sufficiently sensitive to either preclude or necessitate any other evaluation or treatment in this group of patients. Screening examinations are statutorily non-covered.

The ICD10 codes listed below are the top diagnosis codes currently utilized by ordering physicians for the limited coverage test highlighted above that are also listed as medically supportive under Medicare’s limited coverage policy. If you are ordering this test for diagnostic reasons that are not covered under Medicare policy, an Advance Beneficiary Notice form is required. *Note—Bolded diagnoses below have the highest utilization

I11.0 Hypertensive heart disease with heart failure

I42.0 Dilated cardiomyopathy

I42.8 Other cardiomyopathies

I50.1 Left ventricular failure

I50.21 Acute systolic (congestive) heart failure

I50.22 Chronic systolic (congestive) heart failure

I50.23 Acute on chronic systolic (congestive) heart failure

I50.31 Acute diastolic (congestive) heart failure

I50.32 Chronic diastolic (congestive) heart failure

I50.33 Acute on chronic diastolic (congestive) heart failure

I50.41 Acute combined systolic (congestive) and diastolic (congestive) heart failure

I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure

I50.43 Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure

I50.9 Heart failure, unspecified

J44.1 Chronic obstructive pulmonary disease with (acute) exacerbation

R06.00 Dyspnea, unspecified

R06.01 Orthopnea

R06.02 Shortness of breath

R06.09 Other forms of dyspnea

R06.2 Wheezing

Gamma Glutamyl Transferase GGT

CPT: 82977

Coverage Indications, Limitations, and/or Medical Necessity Gamma glutamyl transferase (GGT) is an intracellular enzyme that appears in blood following leakage from cells. Renal tubules, liver, and pancreas contain high amounts, although the measurement of GGT in serum is almost always used for assessment of Hepatobiliary function. Unlike other enzymes which are found in heart, skeletal muscle, and intestinal mucosa as well as liver, the appearance of an elevated level of GGT in serum is almost always the result of liver disease or injury. It is specifically useful to differentiate elevated alkaline phosphatase levels when the source of the alkaline phosphatase increase (bone, liver, or placenta) is unclear. The combination of high alkaline phosphatase and a normal GGT does not, however, rule out liver disease completely. As well as being a very specific marker of Hepatobiliary function, GGT is also a very sensitive marker for hepatocellular damage. Abnormal concentrations typically appear before elevations of other liver enzymes or biliuria are evident. Obstruction of the biliary tract, viral infection (e.g., hepatitis, mononucleosis), metastatic cancer, exposure to hepatotoxins (e.g., organic solvents, drugs, alcohol), and use of drugs that induce microsomal enzymes in the liver (e.g., cimetidine, barbiturates, phenytoin, and carbamazepine) all can cause a moderate to marked increase in GGT serum concentration. In addition, some drugs can cause or exacerbate liver dysfunction (e.g., atorvastatin, troglitazone, and others as noted in FDA Contraindications and Warnings.) GGT is useful for diagnosis of liver disease or injury, exclusion of hepatobiliary involvement related to other diseases, and patient management during the resolution of existing disease or following injury. Indications 1. To provide information about known or suspected hepatobiliary disease, for example: a. Following chronic alcohol or drug ingestion b. Following exposure to hepatotoxins c. When using medication known to have a potential for causing liver toxicity (e.g., following the drug manufacturer’s recommendations) d. Following infection (e.g., viral hepatitis and other specific infections such as amebiasis, tuberculosis, psittacosis, and similar infections) 2. To assess liver injury/function following diagnosis of primary or secondary malignant neoplasms 3. To assess liver injury/function in a wide variety of disorders and diseases known to cause liver involvement (e.g., diabetes mellitus, malnutrition, disorders of iron and mineral metabolism, sarcoidosis, amyloidosis, lupus, and hypertension) 4. To assess liver function related to gastrointestinal disease 5. To assess liver function related to pancreatic disease 6. To assess liver function in patients subsequent to liver transplantation 7. To differentiate between the different sources of elevated alkaline phosphatase activity Limitations When used to assess liver dysfunction secondary to existing non-hepatobiliary disease with no change in signs, symptoms, or treatment, it is generally not necessary to repeat a GGT determination after a normal result has been obtained unless new indications are present. If the GGT is the only “liver” enzyme abnormally high, it is generally not necessary to pursue further evaluation for liver disease for this specific indication. When used to determine if other abnormal enzyme tests reflect liver abnormality rather than other tissue, it generally is not necessary to repeat a GGT more than one time per week. Because of the extreme sensitivity of GGT as a marker for cytochrome oxidase induction or cell membrane permeability, it is generally not useful in monitoring patients with known liver

disease

The ICD10 codes listed below are the top diagnosis codes currently utilized by ordering physicians for the limited coverage test highlighted above that are also listed as medically supportive under Medicare’s limited coverage policy. If you are ordering this test for diagnostic reasons that are not covered under Medicare policy, an Advance Beneficiary Notice form is required. *Note—Bolded diagnoses below have the highest utilization 

E11.65 Type 2 diabetes mellitus with hyperglycemia

E11.69 Type 2 diabetes mellitus with other specified complication

E11.9 Type 2 diabetes mellitus without complications

E78.00 Pure hypercholesterolemia, unspecified

E78.2 Mixed hyperlipidemia

E78.49 Other hyperlipidemia

E78.5 Hyperlipidemia, unspecified

E83.40 Disorders of magnesium metabolism, unspecified

E83.42 Hypomagnesemia

E83.52 Hypercalcemia

K74.60 Unspecified cirrhosis of liver

K75.81 Nonalcoholic steatohepatitis (NASH)

K76.0 Fatty (change of) liver, not elsewhere classified

K76.89 Other specified diseases of liver

K76.9 Liver disease, unspecified

R74.0 Nonspecific elevation of levels of transaminase and lactic acid dehydrogenase [LDH]

R74.8 Abnormal levels of other serum enzymes

Z79.01 Long term (current) use of anticoagulants

Z79.899 Other long term (current) drug therapy

Z94.4 Liver transplant status

CMS National Coverage Policy

Hemoglobin A1c Glycated Hemoglobin/Glycated Protein

CPT: 82985, 83036

 

Coverage Indications, Limitations, and/or Medical Necessity 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 assessments, 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 as 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 accepted as medically necessary for management and control of diabetes and 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 useful in patients with abnormalities of erythrocytes such as hemolytic anemia or hemoglobinopathies. Limitations It is not reasonable and necessary to perform glycated hemoglobin tests more often than every three months on a controlled diabetic patient to determine if the patient’s metabolic control has been on average within the target range. It is not 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 Description Section provides the clinical basis for those situations in which testing more frequently than four times per annum is indicated, and medical necessity documentation must support such testing in excess of the above guidelines. Many analytical methods of glycated hemoglobin show 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 monitoring the degree of glycemic control. 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.

 

The ICD10 codes listed below are the top diagnosis codes currently utilized by ordering physicians for the limited coverage test highlighted above that are also listed as medically supportive under Medicare’s limited coverage policy. If you are ordering this test for diagnostic reasons that are not covered under Medicare policy, an Advance Beneficiary Notice form is required. *Note—Bolded diagnoses below have the highest utilization

E10.9 Type 1 diabetes mellitus without complications

E11.21 Type 2 diabetes mellitus with diabetic nephropathy

E11.22 Type 2 diabetes mellitus with diabetic chronic kidney disease

E11.29 Type 2 diabetes mellitus with other diabetic kidney complication

E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified

E11.42 Type 2 diabetes mellitus with diabetic polyneuropathy

E11.59 Type 2 diabetes mellitus with other circulatory complications

E11.65 Type 2 diabetes mellitus with hyperglycemia

E11.69 Type 2 diabetes mellitus with other specified complication

E11.8 Type 2 diabetes mellitus with unspecified complications

E11.9 Type 2 diabetes mellitus without complications

R73.01 Impaired fasting glucose

R73.02 Impaired glucose tolerance (oral)

R73.03 Prediabetes

R73.09 Other abnormal glucose

R73.9 Hyperglycemia, unspecified

R79.89 Other specified abnormal findings of blood chemistry

R79.9 Abnormal finding of blood chemistry, unspecified

Z79.4 Long term (current) use of insulin

Z79.899 Other long term (current) drug therapy

Vitamin D Assay Testing

Vitamin D; 1, 25 dihydroxy

CPT: 82652

 

Coverage Indications, Limitations, and/or Medical Necessity Vitamin D is called a "vitamin" because of its exogenous source, predominately from oily fish in the form of vitamin D 2 and vitamin D 3. It is more accurate to consider fat-soluble Vitamin D as a steroid hormone, synthesized by the skin and metabolized by the kidney to an active hormone, calcitriol. Clinical disorders related to vitamin D may arise because of altered availability of the parent vitamin D, altered conversion of vitamin D to its predominant metabolites, altered organ responsiveness to dihydroxylated metabolites and disturbances in the interactions of the vitamin D metabolites with PTH and calcitonin. Normal levels of Vitamin D range from 20 – 50 ng/dl. This LCD identifies the indications and limitations of Medicare coverage and reimbursement for the lab assay. Indications Measurement of 25-OH Vitamin D, CPT 82306, level is indicated for patients with: chronic kidney disease stage III or greater; cirrhosis; hypocalcemia; hypercalcemia; hypercalciuria; hypervitaminosis D; parathyroid disorders; malabsorption states; obstructive jaundice; osteomalacia; osteoporosis if: i. T score on DEXA scan 3% 10-year probability of hip fracture or 20% 10-year probability of other major osteoporotic fracture or iv. FRAX > 3% (any fracture) with T-score 60 ng/dl, a subsequent level(s) may be reimbursed until the level is within the normal range.

The ICD10 codes listed below are the top diagnosis codes currently utilized by ordering physicians for the limited coverage test highlighted above that are also listed as medically supportive under Medicare’s limited coverage policy. If you are ordering this test for diagnostic reasons that are not covered under Medicare policy, an Advance Beneficiary Notice form is required. *Note—Bolded diagnoses below have the highest utilization

E55.0 Rickets, active

E55.9 Vitamin D deficiency, unspecified

E83.50 Unspecified disorder of calcium metabolism

E83.52 Hypercalcemia

M83.0 Puerperal osteomalacia

M83.1 Senile osteomalacia

M83.2 Adult osteomalacia due to malabsorption

M83.3 Adult osteomalacia due to malnutrition

M83.4 Aluminum bone disease

M83.5 Other drug-induced osteomalacia in adults

M83.8 Other adult osteomalacia

M83.9 Adult osteomalacia, unspecified

N20.0 Calculus of kidney

N20.1 Calculus of ureter

N20.2 Calculus of kidney with calculus of ureter

N20.9 Urinary calculus, unspecified

N22 Calculus of urinary tract in diseases classified elsewhere

Lipid Testing

CPT: 80061, 82465, 83700, 83701, 83704, 83718, 83721, 84478

Coverage Indications, Limitations, and/or Medical Necessity 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 medication, 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 (200-240 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 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. 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 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.

The ICD10 codes listed below are the top diagnosis codes currently utilized by ordering physicians for the limited coverage test highlighted above that are also listed as medically supportive under Medicare’s limited coverage policy. If you are ordering this test for diagnostic reasons that are not covered under Medicare policy, an Advance Beneficiary Notice form is required. *Note—Bolded diagnoses below have the highest utilization

E03.8 Other specified hypothyroidism

E03.9 Hypothyroidism, unspecified

E11.22 Type 2 diabetes mellitus with diabetic chronic kidney disease

E11.65 Type 2 diabetes mellitus with hyperglycemia

E11.69 Type 2 diabetes mellitus with other specified complication

E11.8 Type 2 diabetes mellitus with unspecified complications

E11.9 Type 2 diabetes mellitus without complications

E66.9 Obesity, unspecified

E78.00 Pure hypercholesterolemia, unspecified

E78.1 Pure hyperglyceridemia

E78.2 Mixed hyperlipidemia

E78.49 Other Hyperlipidemia

E78.5 Hyperlipidemia, unspecified

I10 Essential (primary) hypertension

I11.9 Hypertensive heart disease without heart failure

I12.9 Hypertensive chronic kidney disease with stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease

I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris

R79.89 Other specified abnormal findings of blood chemistry

R79.9 Abnormal finding of blood chemistry, unspecified

Z79.899 Other long term (current) drug therapy

Serum Magnesium

CPT: 83735

Coverage Indications, Limitations, and/or Medical Necessity Magnesium is a mineral required by the body for the use of adenosine triphosphate (ATP) as a source of energy. It is also necessary for neuromuscular irritability and blood clotting. Magnesium deficiency produces neuromuscular disorders. It may cause weakness, tremors, tetany, and convulsions. Hypomagnesemia is associated with hypocalcemia, hypokalemia, long-term hyperalimentation, intravenous therapy, diabetes mellitus (especially during treatment of ketoacidosis); alcoholism and other types of malnutrition; malabsorption; hyperparathyroidism; dialysis; pregnancy; and hyperaldosteronism. The following are other conditions that may cause magnesium deficiencies. • Renal loss of magnesium occurs with cis-platinum therapy. • Hypomagnesemia may also be induced by amphotericin or anti-EGFR (some monoclonal antibodies) toxicity. • Magnesium deficiency is described with cardiac arrhythmias. There is evidence that magnesium may cause arrhythmias. Indications • Utilization of certain cardiac drugs which cause adverse effects in the presence of low magnesium (i.e., quinidine, procainamide, and disopyramide phosphate or Norpace). Patients taking these drugs should have their magnesium checked approximately once every six months. • Long term parenteral nutrition. Patients on long term parenteral nutrition that are otherwise asymptomatic should have their serum magnesium checked monthly. • Malabsorption syndrome. The frequency should depend on the severity of the syndrome, but once the patient's level is stabilized, a monthly check should be adequate. • Renal loss secondary to diuretic use. • Chronic alcoholism, diabetic acidosis, and renal tubular acidosis. These patients should be followed on an as needed basis according to their symptomatology. Without symptoms, they should be checked no more than annually. • Chronic diarrhea, otherwise unexplained and persistent. • Prolonged nasogastric suction greater than five days. These patients should have a magnesium check every two to three weeks. • Cisplatin treatment. • Amphotericin treatment • EGFR monoclonal antibodies • Patients receiving IV magnesium therapy for a low serum level. Serum level should be monitored appropriately. • Patients with hypocalcemia. If the hypocalcemia persists, the level should probably be checked on a six-month basis as long as the patient does not have symptoms of arrhythmias that would warrant closer follow up. • Lethargy and confusion that are not otherwise explained. Once a patient has been diagnosed with mental health processes such as Alzheimer or psychotic depression, etc., there is no indication to follow their magnesium level on a regular basis. • Patients receiving oral magnesium in the face of impaired renal function should have their magnesium level checked on a monthly basis. Other clinical situations: • Pre-eclampsia • Unexplained muscular paralysis • Neuromuscular irritability • Blood clotting abnormalities • Evidence (mixed) that magnesium levels are low and increased magnesium may benefit patients with sickle cell anemia, beta thalassemia and hypersplenism– more recent articles dispute this. • Long Q-T syndrome, torsades de pointes and ventricular arrhythmias.

The ICD10 codes listed below are the top diagnosis codes currently utilized by ordering physicians for the limited coverage test highlighted above that are also listed as medically supportive under Medicare’s limited coverage policy. If you are ordering this test for diagnostic reasons that are not covered under Medicare policy, an Advance Beneficiary Notice form is required. *Note—Bolded diagnoses below have the highest utilization

E11.65 Type 2 diabetes mellitus with hyperglycemia

E11.9 Type 2 diabetes mellitus without complications

E83.42 Hypomagnesemia

E83.51 Hypocalcemia

E87.6 Hypokalemia

I10 Essential (primary) hypertension

I48.0 Paroxysmal atrial fibrillation

I50.22 Chronic systolic (congestive) heart failure

N18.2 Chronic kidney disease, stage 2 (mild)

N18.3 Chronic kidney disease, stage 3 (moderate)

N18.4 Chronic kidney disease, stage 4 (severe)

N25.81 Secondary hyperparathyroidism of renal origin

R25.2 Cramp and spasm

R53.1 Weakness

R53.83 Other fatigue

R79.89 Other specified abnormal findings of blood chemistry

Z51.11 Encounter for antineoplastic chemotherapy

Z79.899 Other long term (current) drug therapy

Z94.0 Kidney transplant status

Z94.4 Liver transplant status

Partial Thromboplastin Time (PTT)

CPT: 85730

Coverage Indications, Limitations, and/or Medical Necessity Basic plasma coagulation function is readily assessed with a few simple laboratory tests: The Partial Thromboplastin Time (PTT), Prothrombin Time (PT), Thrombin Time (TT), or a quantitative fibrinogen determination. The PTT test is an in vitro laboratory test used to assess the intrinsic coagulation pathway and monitor heparin therapy. Indications 1. The PTT is most commonly used to quantitate the effect of therapeutic unfractionated heparin and to regulate its dosing. Except during transitions between heparin and warfarin therapy, in general both the PTT and PT are not necessary together to assess the effect of anticoagulation therapy. PT and PTT must be justified separately. 2. A PTT may be used to assess patients with signs or symptoms of hemorrhage orthrombosis. For example: • Abnormal bleeding, hemorrhage or hematoma petechiae or other signs ofthrombocytopenia that could be due to Disseminated Intravascular Coagulation • Swollen extremity with or without prior trauma 3. A PTT may be useful in evaluating patients who have a history of a condition known tobe associated with the risk of hemorrhage or thrombosis that is related to the intrinsiccoagulation pathway. Such abnormalities may be genetic or acquired. For example: • Dysfibrinogenemia; Afibrinogenemia (complete) • Acute or chronic liver dysfunction or failure, including Wilson’s disease • Hemophilia • Liver disease and failure; • Infectious processes • Bleeding disorders • Disseminated intravascular coagulation • Lupus erythematosus or other conditions associated with circulating inhibitors, e.g., factor VIII Inhibitor, lupus-like anticoagulant • Sepsis • Von Willebrand’s disease • Arterial and venous thrombosis, including the evaluation of hypercoagulable states • Clinical conditions associated with nephrosis or renal failure • Other acquired and congenital coagulopathies as well as thrombotic states 4. A PTT may be used to assess the risk of thrombosis or hemorrhage in patients who are going to have a medical intervention known to be associated with increased risk of bleeding or thrombosis. An example is as follows: evaluation prior to invasive procedures or operations of patients with personal or family history of bleeding or who are on heparin therapy. Limitations 1. The PTT is not useful in monitoring the effects of warfarin on a patient’s coagulation routinely. However, a PTT may be ordered on a patient being treated with warfarin as heparin therapy is being discontinued. A PTT may also be indicated when the PT is markedly prolonged due to warfarin toxicity. 2. The need to repeat this test is determined by changes in the underlying medical condition and/or the dosing of heparin. 3. Testing prior to any medical intervention associated with a risk of bleeding and thrombosis (other than thrombolytic therapy) will generally be considered medically necessary only where there are signs or symptoms of a bleeding or thrombotic abnormality or a personal history of bleeding, thrombosis or a condition associated with a coagulopathy. Hospital/clinic-specific policies, protocols, etc., in and of themselves, cannot alone justify coverage.

The ICD10 codes listed below are the top diagnosis codes currently utilized by ordering physicians for the limited coverage test highlighted above that are also listed as medically supportive under Medicare’s limited coverage policy. If you are ordering this test for diagnostic reasons that are not covered under Medicare policy, an Advance Beneficiary Notice form is required. *Note—Bolded diagnoses below have the highest utilization

D68.59 Other primary thrombophilia

D68.8 Other specified coagulation defects

D68.9 Coagulation defect, unspecified

D69.6 Thrombocytopenia, unspecified

E11.65 Type 2 diabetes mellitus with hyperglycemia

I48.0 Paroxysmal atrial fibrillation

I48.91 Unspecified atrial fibrillation

I50.9 Heart failure, unspecified

I82.409 Acute embolism and thrombosis of unspecified deep veins of unspecified lower extremity

K74.60 Unspecified cirrhosis of liver

M32.9 Systemic lupus erythematosus, unspecified

M79.609 Pain in unspecified limb

N18.9 Chronic kidney disease, unspecified

R06.02 Shortness of breath

R10.9 Unspecified abdominal pain

R23.3 Spontaneous ecchymoses

R31.9 Hematuria, unspecified

R79.1 Abnormal coagulation profile

Z51.81 Encounter for therapeutic drug level monitoring

Z79.01 Long term (current) use of anticoagulants

Prostate Specific Antigen​

CPT: 84153

Coverage Indications, Limitations, and/or Medical Necessity Prostate Specific Antigen (PSA), a tumor marker for adenocarcinoma of the prostate, can predict residual tumor in the post-operative phase of prostate cancer. Three to 6 months after radical prostatectomy, PSA is reported to provide a sensitive indicator of persistent disease. Six months following introduction of antiandrogen therapy, PSA is reported of distinguishing patients with favorable response from those in whom limited response is anticipated. PSA when used in conjunction with other prostate cancer tests, such as digital rectal examination, may assist in the decision-making process for diagnosing prostate cancer. PSA also, serves as a marker in following the progress of most prostate tumors once a diagnosis has been established. This test is also an aid in the management of prostate cancer patients and in detecting metastatic or persistent disease in patients following treatment. Indications PSA is of proven value in differentiating benign from malignant disease in men with lower urinary tract signs & symptoms (e.g., hematuria, slow urine stream, hesitancy, urgency, frequency, nocturia & incontinence) as well as with patients with palpably abnormal prostate glands on physician exam, and in patients with other laboratory or imaging studies that suggest the possibility of a malignant prostate disorder. PSA is also a marker used to follow the progress of prostate cancer once a diagnosis has been established, such as detecting metastatic or persistent disease in patients who may require additional treatment. PSA testing may also be useful in the differential diagnosis of men presenting with as yet undiagnosed disseminated metastatic disease. Limitations Generally, for patients with lower urinary tract signs or symptoms, the test is performed only once per year unless there is a change in the patient’s medical condition. Testing with a diagnosis of 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.

The ICD10 codes listed below are the top diagnosis codes currently utilized by ordering physicians for the limited coverage test highlighted above that are also listed as medically supportive under Medicare’s limited coverage policy. If you are ordering this test for diagnostic reasons that are not covered under Medicare policy, an Advance Beneficiary Notice form is required. *Note—Bolded diagnoses below have the highest utilization.

C61 Malignant neoplasm of prostate

C79.51 Secondary malignant neoplasm of bone

N40.0 Benign prostatic hyperplasia without lower urinary tract symptoms

N40.1 Benign prostatic hyperplasia with lower urinary tract symptoms

N40.2 Nodular prostate without lower urinary tract symptoms

N41.9 Inflammatory disease of prostate, unspecified

N42.9 Disorder of prostate, unspecified

R31.0 Gross hematuria

R31.29 Other microscopic hematuria

R31.9 Hematuria, unspecified

R33.9 Retention of urine, unspecified

R35.0 Frequency of micturition

R35.1 Nocturia

R39.12 Poor urinary stream

R39.14 Feeling of incomplete bladder emptying

R39.15 Urgency of urination

R97.20 Elevated prostate specific antigen [PSA]

R97.21 Rising PSA following treatment for malignant neoplasm of prostate

Z12.5 Encounter for screening for malignant neoplasm of prostate

Z85.46 Personal history of malignant neoplasm of prostate

Prothrombin Time (PT)

CPT: 85610

Coverage Indications, Limitations, and/or Medical Necessity Basic plasma coagulation function is readily assessed with a few simple laboratory tests: the Partial Thromboplastin Time (PTT), Prothrombin Time (PT), Thrombin Time (TT), or a quantitative fibrinogen determination. The PT test is one in-vitro laboratory test used to assess coagulation. While the PTT assesses the intrinsic limb of the coagulation system, the PT assesses the extrinsic or tissue factor dependent pathway. Both tests also evaluate the common coagulation pathway involving all the reactions that occur after the activation of factor X.Extrinsic pathway factors are produced in the liver and their production is dependent on adequate vitamin K activity. Deficiencies of factors may be related to decreased production or increased consumption of coagulation factors. The PT/INR is most commonly used to measure the effect of warfarin and regulate its dosing. Warfarin blocks the effect of vitamin K on hepatic production of extrinsic pathway factors. A PT is expressed in seconds and/or as an international normalized ratio (INR). The INR is the PT ratio that would result if the WHO reference thromboplastin was used in performing the test. Current medical information does not clarify the role of laboratory PT testing in patients who are self monitoring. Therefore, the indications for testing apply regardless of whether or not the patient is also PT self-testing. Indications 1. A PT may be used to assess patients taking warfarin. The PT is generally not useful in monitoring patients receiving heparin who are not taking warfarin. 2. A PT may be used to assess patients with signs or symptoms of abnormal bleeding or thrombosis. For example: • Swollen extremity with or without prior trauma • Unexplained bruising • Abnormal bleeding, hemorrhage or hematoma • Petechiae or other signs of thrombocytopenia that could be due to Disseminated Intravascular Coagulation

A PT may be useful in evaluating patients who have a history of a condition known to be associated with the risk of bleeding or thrombosis that is related to the extrinsic coagulation pathway. Such abnormalities may be genetic or acquired. For example: • Dysfibrinogenemia • Afibrinogenemia (complete) • Acute or chronic liver dysfunction or failure, including Wilson’s disease and Hemochromatosis • Disseminated intravascular coagulation (DIC) • Congenital and acquired deficiencies of factors II, V, VII, X • Vitamin K deficiency • Lupus erythematosus • Hypercoagulable state • Paraproteinemia • Lymphoma • Amyloidosis • Acute and chronic leukemias • Plasma cell dyscrasia • HIV infection • Malignant neoplasms • Hemorrhagic fever • Salicylate poisoning • Obstructive jaundice • Intestinal fistula • Malabsorption syndrome • Colitis • Chronic diarrhea • Presence of peripheral venous or arterial thrombosis or pulmonary emboli or myocardial infarction • Patients with bleeding or clotting tendencies • Organ transplantation • Presence of circulating coagulation inhibitors 4. A PT may be used to assess the risk of hemorrhage or thrombosis in patients who are going to have a medical intervention known to be associated with increased risk of bleeding or thrombosis. For example: • Evaluation prior to invasive procedures or operations of patients with personal history of bleeding or a condition associated with coagulopathy. • Prior to the use of thrombolytic medication Limitations 1. When an ESRD patient is tested for PT, testing more frequently than weekly requires documentation of medical necessity, e.g., other than chronic renal failure or renal failure unspecified. 2. The need to repeat this test is determined by changes in the underlying medical condition and/or the dosing of warfarin. In a patient on stable warfarin therapy, it is ordinarily not necessary to repeat testing more than every two to three weeks. When testing is performed to evaluate a patient with signs or symptoms of abnormal bleeding or thrombosis and the initial test result is normal, it is ordinarily not necessary to repeat testing unless there is a change in the patient’s medical status. 3. Since the INR is a calculation, it will not be paid in addition to the PT when expressed in seconds, and is considered part of the conventional PT test. 4. Testing prior to any medical intervention associated with a risk of bleeding and thrombosis (other than thrombolytic therapy) will generally be considered medically necessary only where there are signs or symptoms of a bleeding or thrombotic abnormality or a personal history of bleeding, thrombosis or a condition associated with a coagulopathy. Hospital/clinic-specific policies, protocols, etc., in and of themselves, cannot alone justify coverage

The ICD10 codes listed below are the top diagnosis codes currently utilized by ordering physicians for the limited coverage test highlighted above that are also listed as medically supportive under Medicare’s limited coverage policy. If you are ordering this test for diagnostic reasons that are not covered under Medicare policy, an Advance Beneficiary Notice form is required. *Note—Bolded diagnoses below have the highest utilization

D50.9 Iron deficiency anemia, unspecified

D68.9 Coagulation defect, unspecified

I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris

I26.99 Other pulmonary embolism without acute cor pulmonale

I48.0 Paroxysmal atrial fibrillation

I48.19 Other persistent atrial fibrillation

I48.20 Chronic atrial fibrillation, unspecified

I48.21 Permanent atrial fibrillation

I48.91 Unspecified atrial fibrillation

I48.92 Unspecified atrial flutter

I50.9 Heart failure, unspecified

I73.9 Peripheral vascular disease, unspecified

I82.409 Acute embolism and thrombosis of unspecified deep veins of unspecified lower extremity

K74.60 Unspecified cirrhosis of liver

R79.1 Abnormal coagulation profile

Z51.81 Encounter for therapeutic drug level monitoring

Z79.01 Long term (current) use of anticoagulants

Z86.718 Personal history of other venous thrombosis and embolism

Z95.2 Presence of prosthetic heart valve

Z95.811 Presence of heart assist device

Serum Iron Studies

CPT: 82728, 83540, 83550, 84466

Coverage Indications, Limitations, and/or Medical Necessity Serum iron studies are useful in the evaluation of disorders of iron metabolism, particularly iron deficiency and iron excess. Iron studies are best performed when the patient is fasting in the morning and has abstained from medications that may influence iron balance. Iron deficiency is the most common cause of anemia. In young children on a milk diet, iron deficiency is often secondary to dietary deficiency. In adults, iron deficiency is usually the result of blood loss and is only occasionally secondary to dietary deficiency or malabsorption. Following major surgery the patient may have iron deficient erythropoietin for months or years if adequate iron replacement has not been given. High doses of supplemental iron may cause the serum iron to be elevated. Serum iron may also be altered in acute and chronic inflammatory and neoplastic conditions. Total Iron Binding Capacity (TIBC) is an indirect measure of transferring, a protein that binds and transports iron. TIBC quantifies transferring by the amount of iron that it can bind. TIBC and transferring are elevated in iron deficiency, and with oral contraceptive use, and during pregnancy. TIBC and transferring may be decreased in malabsorption syndromes or in those affected with chronic diseases. The percent saturation represents the ratio of iron to the TIBC. Assays for ferreting are also useful in assessing iron balance. Low concentrations are associated with iron deficiency and are highly specific. High concentrations are found in hemosiderosis (iron overload without associated tissue injury) and hemochromatosis (iron overload with associated tissue injury). In these conditions the iron is elevated, the TIBC and transferrin are within the reference range or low, and the percent saturation is elevated. Serum ferritin can be useful for both initiating and monitoring treatment for iron overload. Transferrin and ferritin belong to a group of serum proteins known as acute phase reactants, and are increased in response to stressful or inflammatory conditions and also can occur with infection and tissue injury due to surgery, trauma or necrosis. Ferritin and iron/TIBC (or transferrin) are affected by acute and chronic inflammatory conditions, and in patients with these disorders, tests of iron status may be difficult to interpret. Indications Ferritin, iron and either iron binding capacity or transferrin are useful in the differential diagnosis of iron deficiency, anemia, and for iron overload conditions. a. The following presentations are examples that may support the use of these studies for evaluating iron deficiency: • Certain abnormal blood count values (i.e., decreased Mean Corpuscular Volume (MCV), decreased hemoglobin/hematocrit when the MCV is low or normal, or increased Red cell Distribution Width (RDW) and low or normal MCV) Abnormal appetite (pica) • Acute or chronic gastrointestinal blood loss • Hematuria • Menorrhagia • Malabsorption • Status post-gastrectomy • Status post-gastrojejunostomy • Malnutrition • Preoperative autologous blood collection(s) • Malignant, chronic inflammatory and infectious conditions associated with anemia which may present in a similar manner to iron deficiency anemia • Following a significant surgical procedure where blood loss had occurred and had not been repaired with adequate iron replacement

 

The following presentations are examples that may support the use of these studies for evaluating iron overload: • Chronic Hepatitis • Diabetes • Hyperpigmentation of skin • Arthropathy • Cirrhosis • Hypogonadism • Hypopituitarism • Impaired porphyrin metabolism • Heart failure • Multiple transfusions • Sideroblastic anemia • Thalassemia major • Cardiomyopathy, cardiac dysrhythmias and conduction disturbances 2. Follow-up testing may be appropriate to monitor response to therapy, e.g., oral or parenteral iron, ascorbic acid, and erythropoietin. 3. Iron studies may be appropriate in patients after treatment for other nutritional deficiency anemias, such as folate and vitamin B12, because iron deficiency may not be revealed until such a nutritional deficiency is treated. 4. Serum ferritin may be appropriate for monitoring iron status in patients with chronic renal disease with or without dialysis. 5. Serum iron may also be indicated for evaluation of toxic effects of iron and other metals (e.g., nickel, cadmium, aluminum, and lead) whether due to accidental, intentional exposure or metabolic causes. Limitations 1. Iron studies should be used to diagnose and manage iron deficiency or iron overload states. These tests are not to be used solely to assess acute phase reactants where disease management will be unchanged. For example, infections and malignancies are associated with elevations in acute phase reactants such as ferritin, and decreases in serum iron concentration, but iron studies would only be medically necessary if results of iron studies might alter the management of the primary diagnosis or might warrant direct treatment of an iron disorder or condition. 2. If a normal serum ferritin level is documented, repeat testing would not ordinarily be medically necessary unless there is a change in the patient’s condition, and ferritin assessment is needed for the ongoing management of the patient. For example, a patient presents with new onset insulin-dependent diabetes mellitus and has a serum ferritin level performed for the suspicion of hemochromatosis. If the ferritin level is normal, the repeat ferritin for diabetes mellitus would not be medically necessary. 3. When an End Stage Renal Disease (ESRD) patient is tested for ferritin, testing more frequently than every three months requires documentation of medical necessity (e.g., other than chronic renal failure or renal failure, unspecified). 4. It is ordinarily not necessary to measure both transferrin and TIBC at the same time because TIBC is an indirect measure of transferrin. When transferrin is ordered as part of the nutritional assessment for evaluating malnutrition, it is not necessary to order other iron studies unless iron deficiency or iron overload is suspected as well. 5. It is not ordinarily necessary to measure either iron/TIBC (or transferrin) and ferritin in initial patient testing. If clinically indicated after evaluation of the initial iron studies, it may be appropriate to perform additional iron studies either on the initial specimen or on a subsequently obtained specimen. After a diagnosis of iron deficiency or iron overload is established, either iron/TIBC (or transferrin) or ferritin may be medically necessary for monitoring, but not both. 6. It would not ordinarily be considered medically necessary to do a ferritin as a preoperative test except in the presence of anemia or recent autologous blood collections prior to the surgery.

The ICD10 codes listed below are the top diagnosis codes currently utilized by ordering physicians for the limited coverage test highlighted above that are also listed as medically supportive under Medicare’s limited coverage policy. If you are ordering this test for diagnostic reasons that are not covered under Medicare policy, an Advance Beneficiary Notice form is required. *Note—Bolded diagnoses below have the highest utilization

D50.0 Iron deficiency anemia secondary to blood loss (chronic)

D50.8 Other iron deficiency anemias

D50.9 Iron deficiency anemia, unspecified

D51.0 Vitamin B12 deficiency anemia due to intrinsic factor deficiency

D51.8 Other vitamin B12 deficiency anemias

D51.9 Vitamin B12 deficiency anemia, unspecified

D52.9 Folate deficiency anemia, unspecified

D53.9 Nutritional anemia, unspecified

D63.1 Anemia in chronic kidney disease

D64.9 Anemia, unspecified

E11.22 Type 2 diabetes mellitus with diabetic chronic kidney disease

E11.65 Type 2 diabetes mellitus with hyperglycemia

E11.9 Type 2 diabetes mellitus without complications .

E61.1 Iron deficiency

I48.91 Unspecified atrial fibrillation

M25.50 Pain in unspecified joint

N18.4 Chronic kidney disease, stage 4 (severe)

N18.9 Chronic kidney disease, unspecified

R79.89 Other specified abnormal findings of blood chemistry

R79.9 Abnormal finding of blood chemistry, unspecified

Thyroid Testing

84436, 84439, 84443, 84479

Coverage Indications, Limitations, and/or Medical Necessity Thyroid function studies are used to delineate the presence or 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 thyroidstimulating 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 out primary hypothyroidism • Monitor thyroid hormone levels (for example, patients with goiter, thyroid nodules, or thyroid cancer) • Monitor drug 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 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 or hypothyroidism are noted.

The ICD10 codes listed below are the top diagnosis codes currently utilized by ordering physicians for the limited coverage test highlighted above that are also listed as medically supportive under Medicare’s limited coverage policy. If you are ordering this test for diagnostic reasons that are not covered under Medicare policy, an Advance Beneficiary Notice form is required. *Note—Bolded diagnoses below have the highest utilization

D64.9 Anemia, unspecified

E03.8 Other specified hypothyroidism

E03.9 Hypothyroidism, unspecified

E04.2 Nontoxic multinodular goiter

E05.90 Thyrotoxicosis, unspecified without thyrotoxic crisis or storm

E06.3 Autoimmune thyroiditis

E07.9 Disorder of thyroid, unspecified

E11.65 Type 2 diabetes mellitus with hyperglycemia

E11.9 Type 2 diabetes mellitus without complications

E78.00 Pure hypercholesterolemia, unspecified

E78.2 Mixed hyperlipidemia

E78.49 Other hyperlipidemia

E78.5 Hyperlipidemia, unspecified

E89.0 Postprocedural hypothyroidism

I10 Essential (primary) hypertension

R53.81 Other malaise

R53.83 Other fatigue

R73.03 Prediabetes

R94.6 Abnormal results of thyroid function studies

Z79.899 Other long term (current) drug therapy

Urine Culture, Bacterial

CPT: 87086, 87088

Coverage Indications, Limitations, and/or Medical Necessity A bacterial urine culture is a laboratory test service performed on a urine specimen to establish the probable etiology of a presumed urinary tract infection. It is common practice to do a urinalysis prior to a urine culture. A urine culture for bacteria might also be used as part of the evaluation and management of another related condition. The procedure includes aerobic agarbased isolation of bacteria or other cultivable organisms present, and quantitation of types present based on morphologic criteria. Isolates deemed significant may be subjected to additional identification and susceptibility procedures as requested by the ordering physician. The physician’s request may be through clearly documented and communicated laboratory protocols Indications 1. A beneficiary’s urinalysis is abnormal suggesting urinary tract infection, for example, abnormal microscopic (hematuria, pyuria, bacteriuria); abnormal biochemical urinalysis (positive leukocyte esterase, nitrite, protein, blood); a Gram’s stain positive for microorganisms; positive bacteriuria screen by a non-culture technique; or other significant abnormality of a urinalysis. While it is not essential to evaluate a urine specimen by one of these methods before a urine culture is performed, certain clinical presentations with highly suggestive signs and symptoms may lend themselves to an antecedent urinalysis procedure where follow-up culture depends upon an initial positive or abnormal test result 2. A beneficiary has clinical signs and symptoms indicative of a possible urinary tract infection (UTI). Acute lower UTI may present with urgency, frequency, nocturia, dysuria, discharge or incontinence. These findings might also be noted in upper UTI with additional systemic symptoms (for example, fever, chills, lethargy); or pain in the costovertebral, abdominal, or pelvic areas. Signs and symptoms might overlap considerably with other inflammatory conditions of the genitourinary tract (for example, prostatitis, urethritis, vaginitis, or cervicitis). Elderly or immunocompromised beneficiaries or those with neurologic disorders might present atypically (for example, general debility, acute mental status changes, declining functional status). 3. The beneficiary is being evaluated for suspected urosepsis, fever of unknown origin, or other systemic manifestations of infection but without a known source. Signs and symptoms used to define sepsis have been well established. 4. A test of cure is generally not indicated in an uncomplicated infection. However, it may be indicated if the beneficiary is being evaluated for response to therapy and there is a complicating co-existing urinary abnormality including structural or functional abnormalities, calculi, foreign bodies, or ureteral/renal stents or there is clinical or laboratory evidence of failure to respond as described in Indications 1 and 2. 5. In surgical procedures involving major manipulations of the genitourinary tract, preoperative examination to detect occult infection may be indicated in selected cases (for example, prior to renal transplantation, manipulation or removal of kidney stones, or transurethral surgery of the bladder or prostate). 6. Urine culture may be indicated to detect occult infection in renal transplant recipients on immunosuppressive therapy Limitations 1. CPT© code 87086 may be used one time per encounter. 2. Colony count restrictions on coverage of CPT© code 87088 do not apply as they maybe highly variable according to syndrome or other clinical circumstances (for example,antecedent therapy, collection time, and degree of hydration). 3. CPT© code 87088 may be used multiple times in association with or independent of87086, as urinary tract infections may be polymicrobial. 4. Testing for asymptomatic bacteriuria as part of a prenatal evaluation may be medicallyappropriate but is considered screening and therefore not covered by Medicare. TheU.S. Preventive Services Task Force has concluded that screening for asymptomaticbacteriuria outside of the narrow indication for pregnant women is generally notindicated. There are insufficient data to recommend screening in ambulatory elderlybeneficiaries including those with diabetes. Testing may be clinically indicated on othergrounds including likelihood of recurrence or potential adverse effects of antibiotics, butis considered screening in the absence of clinical or laboratory evidence of infection. 5. To detect a clinically significant post-transplant occult infection in a renal allograftrecipient on long-term immunosuppressive therapy, use code Z79.899.

N30.00 Acute cystitis without hematuria

N30.01 Acute cystitis with hematuria

N39.0 Urinary tract infection, site not specified

N40.1 Benign prostatic hyperplasia with lower urinary tract symptoms

R10.9 Unspecified abdominal pain

R30.0 Dysuria

R30.9 Painful micturition, unspecified

R31.0 Gross hematuria

R31.29 Other microscopic hematuria

R31.9 Hematuria, unspecified

R32 Unspecified urinary incontinence

R35.0 Frequency of micturition

R39.15 Urgency of urination

R39.9 Unspecified symptoms and signs involving the genitourinary system

R53.83 Other fatigue

R80.9 Proteinuria, unspecified

R82.79 Other abnormal findings on microbiological examination of urine

R82.90 Unspecified abnormal findings in urine

R82.998

Z79.899 Other long term (current) drug therapy

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