Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report 190.24 - Digoxin Therapeutic Drug Assay Previously Listed as Edit 13 Description
A digoxin therapeutic drug assay is useful for diagnosis and prevention of digoxin toxicity, and/or prevention for under dosage of digoxin.
HCPCS Codes (Alphanumeric, CPT AMA) Description ICD-9-CM Codes Covered by Medicare Program
The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS’ website under
Downloads: Lab Code List. The link is: http://www.cms.hhs.gov/CoverageGenInfo
Description
Transfusion associated circulatory overload
Electrolyte and fluid disorders not elsewhere classified
Delirium due to conditions classified elsewhere
Other dysfunctions of sleep stages or arousal from sleep
Drug induced headache, not elsewhere classified
NCD 190.24 *October 11 Change Fu Associates, Ltd. October 2011 Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report Description
Hypertensive heart disease, malignant with heart failure
Hypertensive heart disease, benign with heart failure
Hypertensive heart disease, unspecified with heart failure
Hypertensive heart and chronic kidney disease
Other acute & subacute forms of ischemic heart disease
*Coronary atherosclerosis due to calcified coronary lesion
425.0, *425.11, *425.18, *Cardiomyopathy *Saddle embolus of abdominal aorta *Other arterial embolism and thrombosis of abdominal aorta *Hepatopulmonary syndrome
Acute kidney failure with lesion of tubular necrosis
Acute kidney failure with lesion of renal cortical necrosis
Acute kidney failure with lesion of renal medullary (papillary) necrosis
Acute kidney failure with other specified pathological lesion in kidney
Secondary hyperparathyroidism (of renal origin)
NCD 190.24 *October 11 Change Fu Associates, Ltd. October 2011 Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report Description
Other specified disorders resulting from impaired renal function
Unspecified disorder resulting from impaired renal function
Other ill-defined general symptoms (drowsiness, semicoma, somnolence, stupor, unconsciousness)
Other signs and symptoms involving emotional state
Poisoning by cardiotonic glycosides & drugs of similar action
Unspecified adverse effect of unspecified drug, medicinal and biological substance
Failed moderate sedation during procedure
Unspecified adverse effect of other drug, medicinal & biological substance
Adverse effect of cardiotonic glycosides and drugs of similar action
Encounter long term - medication use (not elsewhere classified)
*Code may not be reported as a stand-alone or first-listed code on the claim
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.
NCD 190.24 *October 11 Change Fu Associates, Ltd. October 2011 Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report
Clinical indications may include individuals on digoxin:
xWith symptoms, signs or electrocardiogram (ECG) suggestive of digoxin toxicity xTaking medications that influence absorption, bioavailability, distribution, and/or
xWith impaired renal, hepatic, gastrointestinal, or thyroid function xWith pH and/or electrolyte abnormalities xWith unstable cardiovascular status, including myocarditis xRequiring monitoring of patient compliance
Clinical indications may include individuals:
xSuspected of accidental or intended overdose xWho have an acceptable cardiac diagnosis (as listed) and for whom an accurate history of
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:
xHeart failure status worsens xRenal function deteriorates xAdditional medications are added that could affect the digoxin level xSigns 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.
ICD-9-CM Codes That Do Not Support Medical Necessity
Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections.
Sources of Information
Doherty JE. Digitalis serum levels: clinical use. Ann Intern Med 1971 May; 74(5):787-789.
Duhme DW, Greenblatt DJ, Koch-Weser J. Reduction of digoxin toxicity associated with measurement of serum levels. A report from the Boston Collaborative Drug Surveillance Program. Ann Intern Med 1974 Apr; 80(4):516-519
Goldman RH, Use of Serum Digoxin Levels in Clinical Practice. JAMA 1974, Jul 15, 229(3).
NCD 190.24 *October 11 Change Fu Associates, Ltd. October 2011 Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report
Howanitz PJ, Steindel SJ. Digoxin therapeutic drug monitoring practices. A College of American Pathologists Q-Probes study of 666 institutions and 18,679 toxic levels. Arch Pathol Lab Med 1993 Jul; 117(7):684-690.
Marcus FI. Pharmacokinetic interactions between digoxin and other drugs. J Am Coll Cardiol 1985 May; 5(5 Suppl A):82A-90A.
Rodin SM, Johnson BF. Pharmacokinetic interactions with digoxin. Clin Pharmaco-kinet 1988 Oct; 15(4):227-244.
Smith TW, Butler VP Jr, Haber E. Determination of therapeutic and toxic serum digoxin concentrations by radioimmunoassay. N Engl J Med 1969 Nov 27; 281(22):1212-1216.
Smith TW, Haber E. Digoxin intoxication: the relationship of clinical presentation to serum digoxin concentration. J Clin Invest 1970, Dec; 49 (12):2377-2386.
Valdes R. Jr, Jortani SA, Gheorghiade M. Standards of laboratory practice: cardiac drug monitoring. National Academy of Clinical Biochemistry. Clin Chem 1998 May; 44(5): 1096-1109.
Konstam M, Dracup K, Baker D, et al. Heart Failure: Evaluation and Care of Patients with Left-Ventricular Systolic Dysfunction. Clinical Practice Guideline No.11. AHCPR Pub. No. 94-0612. Rockville, MD: Agency for Health Care Policy & Research, Public Health Service, U.S. Dept. of Health and Human Services. June 1994.
NCD 190.24 *October 11 Change Fu Associates, Ltd. October 2011
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Medicare National Coverage Determinations (NCD)
Medicare National Coverage Determinations (NCD)
Medicare National Coverage Determinations (NCD)
Medicare National Coverage Determinations (NCD)
Medicare National Coverage Determinations (NCD)