National Coverage Determination (NCD)

Artificial Hearts and Related Devices

20.9

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Tracking Information

Publication Number
100-3
Manual Section Number
20.9
Manual Section Title
Artificial Hearts and Related Devices
Version Number
7
Effective Date of this Version
12/01/2020
Ending Effective Date of this Version
04/10/2023
Implementation Date
07/27/2021
Implementation QR Modifier Date

Description Information

Benefit Category
Prosthetic Devices


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

Item/Service Description

A. General

An artificial heart is a biventricular replacement device which requires removal of a substantial part of the native heart, including both ventricles. Removal of this device is not compatible with life, unless the patient has a heart transplant.

Indications and Limitations of Coverage

20.9 – Artificial Hearts and Related Devices
(Rev.10837; Issued: 06-11-21; Effective: 12-01-20; Implementation: 07-27-21)
Effective December 1, 2020, Artificial Hearts has been removed from the NCD Manual.

Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
10837
Revision History

Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Artificial Hearts and Related Devices - RETIRED 8 04/10/2023 - N/A View
Artificial Hearts and Related Devices 7 12/01/2020 - 04/10/2023 You are here
Artificial Hearts and Related Devices 6 10/30/2013 - 12/01/2020 View
Artificial Hearts and Related Devices 5 11/09/2010 - 10/30/2013 View
Artificial Hearts and Related Devices 4 05/01/2008 - 11/09/2010 View
Artificial Hearts and Related Devices 3 03/27/2007 - 05/01/2008 View
Artificial Hearts and Related Devices 2 10/01/2003 - 03/27/2007 View
Artificial Hearts and Related Devices 1 01/01/2001 - 10/01/2003 View
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.