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National Coverage Determination
Procedure Code:
8XXXX
Digoxin Therapeutic Drug Assay
CMS Policy Number: 190.24
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Description: 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.
To review all requirements of this policy, please see:
CMS NCD listing by Chapter
Covered ICD-10 Codes.
| A18.84 | Tuberculosis of heart |
| E00.0 | Congenital iodine-deficiency syndrome, neurological type |
| E00.1 | Congenital iodine-deficiency syndrome, myxedematous type |
| E00.2 | Congenital iodine-deficiency syndrome, mixed type |
| E00.9 | Congenital iodine-deficiency syndrome, unspecified |
| E01.8 | Oth iodine-deficiency related thyroid disord and allied cond |
| E02 | Subclinical iodine-deficiency hypothyroidism |
| E03.0 | Congenital hypothyroidism with diffuse goiter |
| E03.1 | Congenital hypothyroidism without goiter |
| E03.2 | Hypothyroidism due to meds and oth exogenous substances |
.... and many more.
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