Artificial Hearts and Related Devices

A. General

A ventricular assist device(VAD) or left ventricular device(LVAD) is used to assist a damaged or weakened heart in pumping blood. These devices are used for support of blood circulation post-cardiotomy, as a bridge to a heart transplant, or as destination therapy.

B. Nationally Covered Indications

Post-cardiotomy is the period following open-heart surgery. VADs used for support of blood circulation post-cardiotomy are covered only if they have received approval from the Food and Drug Administration (FDA) for that purpose, and the VADs are used according to the FDA- approved labeling instructions.

The VADs used for bridge-to-transplant 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. 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:

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

Destination therapy is for patients that require permanent mechanical cardiac support. The VADs used for destination therapy are covered only if they have received approval from the FDA for that purpose, and the device is used according to the FDA-approved labeling instructions.

Patient Selection

The VADs are covered for patients who have chronic end-stage heart failure (New York Heart Association Class IV end-stage left ventricular failure for at least 90 days with a life expectancy of less than 2 years), are not candidates for heart transplantation, and meet all of the following conditions:

1. The patient’s Class IV heart failure symptoms have failed to respond to optimal medical management, including dietary salt restriction, diuretics, digitalis, beta-blockers, and ACE inhibitors (if tolerated) for at least 60 of the last 90 days;
2. The patient has a left ventricular ejection fraction (LVEF) < 25%;
3. The patient has demonstrated functional limitation with a peak oxygen consumption of < 12 ml/kg/min; or the patient has a continued need for intravenous inotropic therapy owing to symptomatic hypotension, decreasing renal function, or worsening pulmonary congestion; and,
4. The patient has the appropriate body size (≥ 1.5 m2) to support the VAD implantation.

Facility Criteria

1. Facilities must have at least one member of the VAD team with experience implanting at least 10 VADs (as bridge to transplant or destination therapy) or artificial hearts over the course of the previous 36 months;
2. Facilities must be a member of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS); and
3. By March 27, 2009, all facilities must meet the above facility criteria and be credential by the Joint Commission under the Disease Specific Certification Program for Ventricular Assist Devices (standards dated February 2007).

The Web site

http://www.cms.gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage will be updated continuously to list all approved facilities. Facilities gaining Joint Commission certification (including prior to March 27, 2009) will be added to the Web site when certification is obtained.

Hospitals also must have in place staff and procedures that ensure that prospective VAD recipients receive all information necessary to assist them in giving appropriate informed consent for the procedure so that they and their families are fully aware of the aftercare requirements and potential limitations, as well as benefits, following VAD implantation.

C. Nationally Non-Covered Indications (effective for services performed on or after May 19, 1986)

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 other indications for the use of VADs not otherwise listed remain noncovered, except in the context of Category B IDE clinical trials (42 CFR 405) or as a routine cost in clinical trials defined under section 310.1 of the NCD manual (old CIM 30-1).

(This NCD last reviewed March 2007.)

04/2007 - New facility criteria is established and hospitals must now receive certification from the Joint Commission on Accreditation of Healthcare Organizations under their Disease Specific Certification Program for VADs. Currently approved hospitals will have until March 27, 2009, to become certified by the Joint Commission or they will be removed from the approved list. Effective date 03/27/2007. Implementation date 05/14/2007. (TN 68) (CR5516)

11/2003 - Issued provider education article that discusses expansion in coverage of VADs for destination therapy. Effective date 10/01/03. Implementation date 11/21/03. (TN 4) (CR 2985)

10/2003 - Expanded coverage of VADs for destination therapy if FDA approval received for that purpose, used according to FDA-approved labeling instructions, patient meets specified criteria, and procedure performed in specified facilities. All other indications remain the same. Effective and implementation dates 10/01/2003. (TN 2 ) (CR 2958)

12/2000 - Allowed sites other than Medicare approved heart transplant centers to implant VADs in patients approved and listed as candidates for heart transplant by 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 "not covered" from title, and allowed exception for HeartMate IP LVAS when used 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)