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National Coverage Determination (NCD)

Artificial Hearts and Related Devices

65-15

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Tracking Information

Publication Number
6
Manual Section Number
65-15
Manual Section Title
Artificial Hearts and Related Devices
Version Number
1
Effective Date of this Version
01/01/2001
Ending Effective Date of this Version
10/01/2003
Implementation Date
01/01/2001
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 ventricular assist device (VAD) is used to assist a damaged or weakened heart in pumping blood. VADs are used as either a bridge to a heart transplant or for support of blood circulation postcardiotomy, which is the period following open heart surgery.

Indications and Limitations of Coverage

VADs used for support of blood circulation postcardiotomy are covered only if they have received approval from the FDA for that purpose, and the VADs are used according to the FDA approved labeling instructions. Since there is no authoritative evidence substantiating the safety and effectiveness of a VAD used as a replacement for the human heart, Medicare does not cover this device when used as an artificial heart.

All of the following criteria must be fulfilled in order for Medicare coverage to be provided for a VAD used as a bridge to transplant:

  1. The VAD must be used in accordance with the FDA approved labeling instructions. This means that the VAD is used as a temporary mechanical circulatory support for approved transplant candidates as a bridge to cardiac transplantation;
  2. The patient is approved and listed as a candidate for heart transplantion by a Medicare approved heart transplant center; and
  3. The implanting site, if different than the Medicare approved transplant center, must receive written permission from the Medicare approved heart transplant center under which the patient is listed prior to implantation of the VAD.

The Medicare approved heart transplant center should make every reasonable effort to transplant patients on such devices as soon as medically reasonable. Ideally, the centers should determine patient-specific timetables for transplantation and should not maintain such patients on VADs if suitable hearts become available.
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
134
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R134CIM.pdf
Revision History

12/2000 - Allowed sites other than Medicare approved heart transplant centers to implant VADs in patients who are approved and listed as candidates for heart transplant by a Medicare approved heart transplant center. Also, implanting site must receive written permission from Medicare approved heart transplant center under which patient is listed prior to implantation of VAD. Effective and implementation dates 01/01/2001. (TN 134) (CR 1378)

04/1997 - Clarified that VADs covered only if FDA approval received and used according to FDA-approved labeling instructions. Also deleted specific product names and hemodynamic criteria. Effective date 05/05/1997. (TN 94)

11/1995 - Removed words "not covered" from title, and allowed exceptions for use of HeartMate IP LVAS for use as bridge to cardiac transplantation. Effective date 01/22/1996. (TN 82)

10/1993 - Provided coverage of FDA-approved VAD only when used in patients suffering from postcardiotomy ventricular dysfunction. Device intended for short use and not covered when used as bridge to cardiac transplantation. Effective date 10/18/1993. (TN 65)

05/1986 - Specified that artificial hearts not covered, either as permanent replacements or as temporary life-support systems. Also, ventricular assist devices (VADs) not covered when used as temporary life-support systems in patients awaiting heart transplants. Effective date 05/19/1986. (TN 7)
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 View
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 You are here
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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.
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