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National Coverage Determination (NCD) for Artificial Hearts and Related Devices (65-15)

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Publication Number

6

Manual Section Number

65-15

Manual Section Title

Artificial Hearts and Related Devices


Version Number

1

Effective Date of this Version

1/1/2001

Ending Effective Date of this Version

10/1/2003


Implementation Date

1/1/2001


Benefit Category
Prosthetic Devices
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
  1. 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.
Transmittal Number

134

Coverage Transmittal Link

http://www.cms.gov/transmittals/downloads/R134CIM.pdf

Revision History

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)

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)

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)

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)

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)

 


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.

Other Versions
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