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. 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.
Indications and Limitations of Coverage B. Nationally Covered Indications
1. Postcardiotomy(effective for services performed on or after October 18, 1993)
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.
2. Bridge-to-Transplant (effective for services performed on or after January 22, 1996)
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 patient is approved and listed as a candidate for heart transplantation by a Medicare-approved heart transplant center; and
- 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 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.
3. Destination Therapy (effective for services performed on or after October 1, 2003 with facility criteria updated March 27, 2007)
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:
- 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;
- The patient has a left ventricular ejection fraction (LVEF) < 25%;
- 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,
- The patient has the appropriate body size ( >1.5 m2) to support the VAD implantation.
Facility Criteria
- 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;
- Facilities must be a member of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS); and
- 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)
1. Artificial Heart
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.)
