National Coverage Determination (NCD)

Digoxin Therapeutic Drug Assay


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Tracking Information

Publication Number
Manual Section Number
Manual Section Title
Digoxin Therapeutic Drug Assay
Version Number
Effective Date of this Version
Implementation Date

Description Information

Benefit Category
Diagnostic Laboratory Tests

Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

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

Indications and Limitations of Coverage


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 for the treatment of other supraventricular arrhythmias, particularly in the presence of heart failure.


This test is not appropriate for patients on digitoxin or treated with digoxin FAB (fragment antigen binding) antibody.

Note: Scroll down for links to the quarterly Covered Code Lists (including narrative).

Cross Reference

Also see the Medicare Claims Processing Manual, Chapter 120, Clinical Laboratory Services Based on Negotiated Rulemaking.

Transmittal Information

Transmittal Number
Revision History

07/2002 - Implemented NCD. Effective date 11/25/02. Implementation date 1/01/03. (TN AB-02-110) (CR 2130)

07/2004 - Published NCD in the NCD Manual without change to narrative contained in PM AB-02-110. Coding guidance now published in Medicare Lab NCD Manual. Effective and Implementation dates NA. (TN 17) (CR 2130)


Covered Code Lists (including narrative)

January 2023 (PDF) (ICD-10)
October 2022 (PDF) (ICD-10)
July 2022 (PDF) (ICD-10)
April 2022 (PDF) (ICD-10)
January 2022 (PDF) (ICD-10)
October 2021 (PDF) (ICD-10)
July 2021 (PDF) (ICD-10)
April 2021 (PDF) (ICD-10)
January 2021 (PDF) (ICD-10)
October 2020 (PDF) (ICD-10)
July 2020 (PDF) (ICD-10)
April 2020 (PDF) (ICD-10)
January 2020 (PDF) (ICD-10)
October 2019 (PDF) (ICD-10)
July 2019 (PDF) (ICD-10)
April 2019 (PDF) (ICD-10)
January 2019 (PDF) (ICD-10)
October 2018 (PDF) (ICD-10)
July 2018 (PDF) (ICD-10)
April 2018 (PDF) (ICD-10)
January 2018 (ICD-10)
October 2017 (ICD-10)
July 2017 (ICD-10)
April 2017 (ICD-10)
January 2017 (ICD-10)
October 2016 (ICD-10)
January 2016 (ICD-10)
October 2015 (ICD-10, ICD-9)
October 2014 (ICD-10, ICD-9)

Changes to Lab NCD Edit Software

January 2023
October 2022
April 2022
January 2022
October 2021
July 2021
October 2020
April 2020
January 2020
October 2019
July 2019
January 2019
October 2018
April 2018
January 2018
July 2017
April 2017
January 2017
January 2016
October 2014

Additional Information

Other Versions
Title Version Effective Between
Digoxin Therapeutic Drug Assay 1 11/25/2002 - N/A You are here