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October 2023
July 2023

CMS Transmittals

National Coverage Determination
Procedure Code: 8XXXX
Digoxin Therapeutic Drug Assay
CMS Policy Number: 190.24
Back to NCD List

Description: A digoxin therapeutic drug assay is useful for diagnosis and prevention of digoxin toxicity, and/or prevention for under dosage of digoxin.

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.

    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.

    A18.84Tuberculosis of heart
    E00.0Congenital iodine-deficiency syndrome, neurological type
    E00.1Congenital iodine-deficiency syndrome, myxedematous type
    E00.2Congenital iodine-deficiency syndrome, mixed type
    E00.9Congenital iodine-deficiency syndrome, unspecified
    E01.8Oth iodine-deficiency related thyroid disord and allied cond
    E02Subclinical iodine-deficiency hypothyroidism
    E03.0Congenital hypothyroidism with diffuse goiter
    E03.1Congenital hypothyroidism without goiter
    E03.2Hypothyroidism due to meds and oth exogenous substances
    .... and many more.

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