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CMS Transmittals



National Coverage Determination
Procedure Code: 80162
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.

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.

    ICD-10Descriptor
    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
    E03.3 Postinfectious hypothyroidism
    E03.5 Myxedema coma
    E03.8 Other specified hypothyroidism
    E03.9 Hypothyroidism, unspecified
    E05.00 Thyrotoxicosis w diffuse goiter w/o thyrotoxic crisis
    E05.01 Thyrotoxicosis w diffuse goiter w thyrotoxic crisis or storm
    E05.10 Thyrotxcosis w toxic sing thyroid nodule w/o thyrotxc crisis
    E05.11 Thyrotxcosis w toxic single thyroid nodule w thyrotxc crisis
    E05.20 Thyrotxcosis w toxic multinod goiter w/o thyrotoxic crisis
    E05.21 Thyrotxcosis w toxic multinodular goiter w thyrotoxic crisis
    E05.30 Thyrotxcosis from ectopic thyroid tissue w/o thyrotxc crisis
    E05.31 Thyrotxcosis from ectopic thyroid tissue w thyrotoxic crisis
    E05.40 Thyrotoxicosis factitia without thyrotoxic crisis or storm
    E05.41 Thyrotoxicosis factitia with thyrotoxic crisis or storm
    E05.80 Other thyrotoxicosis without thyrotoxic crisis or storm
    E05.81 Other thyrotoxicosis with thyrotoxic crisis or storm
    E05.90 Thyrotoxicosis, unsp without thyrotoxic crisis or storm
    E05.91 Thyrotoxicosis, unspecified with thyrotoxic crisis or storm
    E06.0 Acute thyroiditis
    E06.1 Subacute thyroiditis
    E06.2 Chronic thyroiditis with transient thyrotoxicosis
    E06.3 Autoimmune thyroiditis
    E06.4 Drug-induced thyroiditis
    E06.5 Other chronic thyroiditis
    E06.9 Thyroiditis, unspecified
    E20.1 Pseudohypoparathyroidism
    E83.40 Disorders of magnesium metabolism, unspecified
    E83.41 Hypermagnesemia
    E83.42 Hypomagnesemia
    E83.49 Other disorders of magnesium metabolism
    E83.50 Unspecified disorder of calcium metabolism
    E83.51 Hypocalcemia
    E83.52 Hypercalcemia
    E83.59 Other disorders of calcium metabolism
    E83.81 Hungry bone syndrome
    E86.0 Dehydration
    E86.1 Hypovolemia
    E86.9 Volume depletion, unspecified
    E87.0 Hyperosmolality and hypernatremia
    E87.1 Hypo-osmolality and hyponatremia
    E87.2 Acidosis
    E87.3 Alkalosis
    E87.4 Mixed disorder of acid-base balance
    E87.5 Hyperkalemia
    E87.6 Hypokalemia
    E87.70 Fluid overload, unspecified
    E87.71 Transfusion associated circulatory overload
    E87.79 Other fluid overload
    E87.8 Oth disorders of electrolyte and fluid balance, NEC
    E89.0 Postprocedural hypothyroidism
    F05 Delirium due to known physiological condition
    F51.5 Nightmare disorder
    G44.1 Vascular headache, not elsewhere classified
    G44.40 Drug-induced headache, NEC, not intractable
    G44.41 Drug-induced headache, not elsewhere classified, intractable
    H53.16 Psychophysical visual disturbances
    H53.71 Glare sensitivity
    H53.72 Impaired contrast sensitivity
    H53.8 Other visual disturbances
    H53.9 Unspecified visual disturbance
    I08.1 Rheumatic disorders of both mitral and tricuspid valves
    I08.2 Rheumatic disorders of both aortic and tricuspid valves
    I08.3 Comb rheumatic disord of mitral, aortic and tricuspid valves
    I08.8 Other rheumatic multiple valve diseases
    I08.9 Rheumatic multiple valve disease, unspecified
    I09.0 Rheumatic myocarditis
    I09.1 Rheumatic diseases of endocardium, valve unspecified
    I09.81 Rheumatic heart failure
    I11.0 Hypertensive heart disease with heart failure
    I12.0 Hyp chr kidney disease w stage 5 chr kidney disease or ESRD
    I12.9 Hypertensive chronic kidney disease w stg 1-4/unsp chr kdny
    I13.0 Hyp hrt & chr kdny dis w hrt fail and stg 1-4/unsp chr kdny
    I13.10 Hyp hrt & chr kdny dis w/o hrt fail, w stg 1-4/unsp chr kdny
    I13.11 Hyp hrt and chr kdny dis w/o hrt fail, w stg 5 chr kdny/ESRD
    I13.2 Hyp hrt & chr kdny dis w hrt fail and w stg 5 chr kdny/ESRD
    I20.0 Unstable angina
    I20.1 Angina pectoris with documented spasm
    I20.8 Other forms of angina pectoris
    I20.9 Angina pectoris, unspecified
    I21.01 STEMI involving left main coronary artery
    I21.02 STEMI involving left anterior descending coronary artery
    I21.09 STEMI involving oth coronary artery of anterior wall
    I21.11 STEMI involving right coronary artery
    I21.19 STEMI involving oth coronary artery of inferior wall
    I21.21 STEMI involving left circumflex coronary artery
    I21.29 STEMI involving oth sites
    I21.3 ST elevation (STEMI) myocardial infarction of unsp site
    I21.4 Non-ST elevation (NSTEMI) myocardial infarction
    I22.0 Subsequent STEMI of anterior wall
    I22.1 Subsequent STEMI of inferior wall
    I22.2 Subsequent non-ST elevation (NSTEMI) myocardial infarction
    I22.8 Subsequent STEMI of sites
    I22.9 Subsequent STEMI of unsp site
    I23.1 Atrial septal defect as current complication following AMI
    I23.2 Ventricular septal defect as current comp following AMI
    I23.4 Rupture of chord tendne as current comp following AMI
    I23.5 Rupture of papillary muscle as current comp following AMI
    I24.0 Acute coronary thrombosis not resulting in myocardial infrc
    I24.1 Dressler's syndrome
    I24.8 Other forms of acute ischemic heart disease
    I24.9 Acute ischemic heart disease, unspecified
    I25.10 Athscl heart disease of native coronary artery w/o ang pctrs
    I25.110 Athscl heart disease of native cor art w unstable ang pctrs
    I25.111 Athscl heart disease of native cor art w ang pctrs w spasm
    I25.118 Athscl heart disease of native cor art w oth ang pctrs
    I25.119 Athscl heart disease of native cor art w unsp ang pctrs
    I25.700 Atherosclerosis of CABG, unsp, w unstable angina pectoris
    I25.701 Athscl CABG, unsp, w angina pectoris w documented spasm
    I25.708 Atherosclerosis of CABG, unsp, w oth angina pectoris
    I25.709 Atherosclerosis of CABG, unsp, w unsp angina pectoris
    I25.710 Athscl autologous vein CABG w unstable angina pectoris
    I25.711 Athscl autologous vein CABG w ang pctrs w documented spasm
    I25.718 Athscl autologous vein CABG w oth angina pectoris
    I25.719 Athscl autologous vein CABG w unsp angina pectoris
    I25.720 Athscl autologous artery CABG w unstable angina pectoris
    I25.721 Athscl autologous artery CABG w ang pctrs w documented spasm
    I25.728 Athscl autologous artery CABG w oth angina pectoris
    I25.729 Athscl autologous artery CABG w unsp angina pectoris
    I25.730 Athscl nonautologous biological CABG w unstable ang pctrs
    I25.731 Athscl nonaut biological CABG w ang pctrs w documented spasm
    I25.738 Athscl nonautologous biological CABG w oth angina pectoris
    I25.739 Athscl nonautologous biological CABG w unsp angina pectoris
    I25.750 Athscl native cor art of txplt heart w unstable angina
    I25.751 Athscl native cor art of txplt heart w ang pctrs w spasm
    I25.758 Athscl native cor art of transplanted heart w oth ang pctrs
    I25.759 Athscl native cor art of transplanted heart w unsp ang pctrs
    I25.760 Athscl bypass of cor art of txplt heart w unstable angina
    I25.761 Athscl bypass of cor art of txplt heart w ang pctrs w spasm
    I25.768 Athscl bypass of cor art of txplt heart w oth ang pctrs
    I25.769 Athscl bypass of cor art of txplt heart w unsp ang pctrs
    I25.790 Atherosclerosis of CABG w unstable angina pectoris
    I25.791 Atherosclerosis of CABG w angina pectoris w documented spasm
    I25.798 Atherosclerosis of CABG w oth angina pectoris
    I25.799 Atherosclerosis of CABG w unsp angina pectoris
    I25.84 Coronary atherosclerosis due to calcified coronary lesion
    I27.83 Eisenmenger's syndrome
    I40.0 Infective myocarditis
    I40.1 Isolated myocarditis
    I40.8 Other acute myocarditis
    I40.9 Acute myocarditis, unspecified
    I41 Myocarditis in diseases classified elsewhere
    I42.0 Dilated cardiomyopathy
    I42.1 Obstructive hypertrophic cardiomyopathy
    I42.2 Other hypertrophic cardiomyopathy
    I42.3 Endomyocardial (eosinophilic) disease
    I42.4 Endocardial fibroelastosis
    I42.5 Other restrictive cardiomyopathy
    I42.6 Alcoholic cardiomyopathy
    I42.7 Cardiomyopathy due to drug and external agent
    I42.8 Other cardiomyopathies
    I42.9 Cardiomyopathy, unspecified
    I43 Cardiomyopathy in diseases classified elsewhere
    I44.0 Atrioventricular block, first degree
    I44.1 Atrioventricular block, second degree
    I44.2 Atrioventricular block, complete
    I44.30 Unspecified atrioventricular block
    I44.39 Other atrioventricular block
    I44.4 Left anterior fascicular block
    I44.5 Left posterior fascicular block
    I44.60 Unspecified fascicular block
    I44.69 Other fascicular block
    I44.7 Left bundle-branch block, unspecified
    I45.0 Right fascicular block
    I45.10 Unspecified right bundle-branch block
    I45.19 Other right bundle-branch block
    I45.2 Bifascicular block
    I45.3 Trifascicular block
    I45.4 Nonspecific intraventricular block
    I45.5 Other specified heart block
    I45.6 Pre-excitation syndrome
    I45.81 Long QT syndrome
    I45.89 Other specified conduction disorders
    I45.9 Conduction disorder, unspecified
    I46.2 Cardiac arrest due to underlying cardiac condition
    I46.8 Cardiac arrest due to other underlying condition
    I46.9 Cardiac arrest, cause unspecified
    I47.0 Re-entry ventricular arrhythmia
    I47.1 Supraventricular tachycardia
    I47.2 Ventricular tachycardia
    I47.9 Paroxysmal tachycardia, unspecified
    I48.0 Paroxysmal atrial fibrillation
    I48.1 Persistent atrial fibrillation
    I48.2 Chronic atrial fibrillation
    I48.3 Typical atrial flutter
    I48.4 Atypical atrial flutter
    I48.91 Unspecified atrial fibrillation
    I48.92 Unspecified atrial flutter
    I49.01 Ventricular fibrillation
    I49.02 Ventricular flutter
    I49.1 Atrial premature depolarization
    I49.2 Junctional premature depolarization
    I49.3 Ventricular premature depolarization
    I49.40 Unspecified premature depolarization
    I49.49 Other premature depolarization
    I49.5 Sick sinus syndrome
    I49.8 Other specified cardiac arrhythmias
    I49.9 Cardiac arrhythmia, unspecified
    I50.1 Left ventricular failure, unspecified
    I50.20 Unspecified systolic (congestive) heart failure
    I50.21 Acute systolic (congestive) heart failure
    I50.22 Chronic systolic (congestive) heart failure
    I50.23 Acute on chronic systolic (congestive) heart failure
    I50.30 Unspecified diastolic (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
    I50.40 Unsp combined systolic and diastolic (congestive) hrt fail
    I50.41 Acute combined systolic and diastolic (congestive) hrt fail
    I50.42 Chronic combined systolic and diastolic hrt fail
    I50.43 Acute on chronic combined systolic and diastolic hrt fail
    I50.814 Right heart failure due to left heart failure
    I50.82 Biventricular heart failure
    I50.84 End stage heart failure
    I50.89 Other heart failure
    I50.9 Heart failure, unspecified
    I51.0 Cardiac septal defect, acquired
    I51.1 Rupture of chordae tendineae, not elsewhere classified
    I51.2 Rupture of papillary muscle, not elsewhere classified
    I74.01 Saddle embolus of abdominal aorta
    I74.09 Other arterial embolism and thrombosis of abdominal aorta
    I74.10 Embolism and thrombosis of unspecified parts of aorta
    I74.19 Embolism and thrombosis of other parts of aorta
    I97.0 Postcardiotomy syndrome
    I97.110 Postproc cardiac insufficiency following cardiac surgery
    I97.111 Postprocedural cardiac insufficiency following other surgery
    I97.120 Postprocedural cardiac arrest following cardiac surgery
    I97.121 Postprocedural cardiac arrest following other surgery
    I97.130 Postprocedural heart failure following cardiac surgery
    I97.131 Postprocedural heart failure following other surgery
    I97.190 Oth postproc cardiac functn disturb fol cardiac surgery
    I97.191 Oth postproc cardiac functn disturb following oth surgery
    J81.1 Chronic pulmonary edema
    K52.21 Food protein-induced enterocolitis syndrome
    K52.22 Food protein-induced enteropathy
    K52.29 Other allergic and dietetic gastroenteritis and colitis
    K52.89 Other specified noninfective gastroenteritis and colitis
    K76.81 Hepatopulmonary syndrome
    K90.9 Intestinal malabsorption, unspecified
    N17.0 Acute kidney failure with tubular necrosis
    N17.1 Acute kidney failure with acute cortical necrosis
    N17.2 Acute kidney failure with medullary necrosis
    N17.8 Other acute kidney failure
    N17.9 Acute kidney failure, unspecified
    N18.1 Chronic kidney disease, stage 1
    N18.2 Chronic kidney disease, stage 2 (mild)
    N18.3 Chronic kidney disease, stage 3 (moderate)
    N18.4 Chronic kidney disease, stage 4 (severe)
    N18.5 Chronic kidney disease, stage 5
    N18.6 End stage renal disease
    N18.9 Chronic kidney disease, unspecified
    N19 Unspecified kidney failure
    N25.0 Renal osteodystrophy
    N25.1 Nephrogenic diabetes insipidus
    N25.81 Secondary hyperparathyroidism of renal origin
    N25.89 Oth disorders resulting from impaired renal tubular function
    N25.9 Disorder rslt from impaired renal tubular function, unsp
    N26.1 Atrophy of kidney (terminal)
    N26.9 Renal sclerosis, unspecified
    O36.8329 Matern care for abnlt of fetl hrt rate or rhym, 2nd tri, oth
    O36.8330 Matern care for abnlt fetl hrt rate or rhym, 3rd tri, unsp
    O36.8331 Matern care for abnlt fetl hrt rate or rhym, 3rd tri, fts1
    O36.8332 Matern care for abnlt fetl hrt rate or rhym, 3rd tri, fts2
    O36.8333 Matern care for abnlt fetl hrt rate or rhym, 3rd tri, fts3
    O36.8334 Matern care for abnlt fetl hrt rate or rhym, 3rd tri, fts4
    O36.8335 Matern care for abnlt fetl hrt rate or rhym, 3rd tri, fts5
    O36.8339 Matern care for abnlt of fetl hrt rate or rhym, 3rd tri, oth
    R00.1 Bradycardia, unspecified
    R11.0 Nausea
    R11.10 Vomiting, unspecified
    R11.11 Vomiting without nausea
    R11.12 Projectile vomiting
    R11.14 Bilious vomiting
    R11.2 Nausea with vomiting, unspecified
    R19.7 Diarrhea, unspecified
    R40.0 Somnolence
    R40.1 Stupor
    R40.20 Unspecified coma
    R40.2110 Coma scale, eyes open, never, unspecified time
    R40.2111 Coma scale, eyes open, never, in the field
    R40.2112 Coma scale, eyes open, never, EMR
    R40.2113 Coma scale, eyes open, never, at hospital admission
    R40.2114 Coma scale, eyes open, never, 24+hrs
    R40.2120 Coma scale, eyes open, to pain, unspecified time
    R40.2121 Coma scale, eyes open, to pain, in the field
    R40.2122 Coma scale, eyes open, to pain, EMR
    R40.2123 Coma scale, eyes open, to pain, at hospital admission
    R40.2124 Coma scale, eyes open, to pain, 24+hrs
    R40.2210 Coma scale, best verbal response, none, unspecified time
    R40.2211 Coma scale, best verbal response, none, in the field
    R40.2212 Coma scale, best verbal response, none, EMR
    R40.2213 Coma scale, best verbal response, none, admit
    R40.2214 Coma scale, best verbal response, none, 24+hrs
    R40.2220 Coma scale, best verb, incomprehensible words, unsp time
    R40.2221 Coma scale, best verb, incomprehensible words, in the field
    R40.2222 Coma scale, best verb, incomprehensible words, EMR
    R40.2223 Coma scale, best verb, incomprehensible words, admit
    R40.2224 Coma scale, best verb, incomprehensible words, 24+hrs
    R40.2310 Coma scale, best motor response, none, unspecified time
    R40.2311 Coma scale, best motor response, none, in the field
    R40.2312 Coma scale, best motor response, none, EMR
    R40.2313 Coma scale, best motor response, none, at hospital admission
    R40.2314 Coma scale, best motor response, none, 24+hrs
    R40.2320 Coma scale, best motor response, extension, unspecified time
    R40.2321 Coma scale, best motor response, extension, in the field
    R40.2322 Coma scale, best motor response, extension, EMR
    R40.2323 Coma scale, best motor response, extension, admit
    R40.2324 Coma scale, best motor response, extension, 24+hrs
    R40.2340 Coma scale, best motor, flexion withdrawal, unsp time
    R40.2341 Coma scale, best motor, flexion withdrawal, in the field
    R40.2342 Coma scale, best motor response, flexion withdrawal, EMR
    R40.2343 Coma scale, best motor response, flexion withdrawal, admit
    R40.2344 Coma scale, best motor response, flexion withdrawal, 24+hrs
    R40.4 Transient alteration of awareness
    R42 Dizziness and giddiness
    R44.0 Auditory hallucinations
    R44.1 Visual hallucinations
    R44.2 Other hallucinations
    R44.3 Hallucinations, unspecified
    R45.0 Nervousness
    R45.3 Demoralization and apathy
    R45.4 Irritability and anger
    R45.86 Emotional lability
    R45.87 Impulsiveness
    R45.89 Other symptoms and signs involving emotional state
    R48.3 Visual agnosia
    R51 Headache
    R53.1 Weakness
    R53.2 Functional quadriplegia
    R53.81 Other malaise
    R53.82 Chronic fatigue, unspecified
    R53.83 Other fatigue
    R55 Syncope and collapse
    R63.0 Anorexia
    R94.31 Abnormal electrocardiogram [ECG] [EKG]
    T46.0X1A Poisoning by cardi-stim glycos/drug simlar act, acc, init
    T46.0X2A Poisn by cardi-stim glycos/drug simlar act, self-harm, init
    T46.0X3A Poisn by cardi-stim glycos/drug simlar act, assault, init
    T46.0X4A Poisoning by cardi-stim glycos/drug simlar act, undet, init
    T46.0X5A Adverse effect of cardi-stim glycos/drug simlar act, init
    T46.0X5S Adverse effect of cardi-stim glycos/drug simlar act, sequela
    T46.1X5A Adverse effect of calcium-channel blockers, init encntr
    T46.2X1A Poisoning by oth antidysrhythmic drugs, accidental, init
    T46.2X2A Poisoning by oth antidysrhythmic drugs, self-harm, init
    T46.2X3A Poisoning by oth antidysrhythmic drugs, assault, init encntr
    T46.2X4A Poisoning by oth antidysrhythmic drugs, undetermined, init
    T46.2X5A Adverse effect of other antidysrhythmic drugs, init encntr
    T50.905A Adverse effect of unsp drug/meds/biol subst, init
    T50.995A Adverse effect of drug/meds/biol subst, init
    T78.41XA Arthus phenomenon, initial encounter
    T88.52XA Failed moderate sedation during procedure, initial encounter
    Z79.84 Long term (current) use of oral hypoglycemic drugs
    Z79.899 Other long term (current) drug therapy

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