Ventricular Assist Devices as Destination Therapy

CMS NCA document | source_status=Closed | review_type=New | public_comment_open=False | document_id=CAG-00119N

CMS has determined that the evidence is adequate to conclude that implantation of a left ventricular assist device (LVAD) approved by the Food and Drug Administration (FDA) for destination therapy is reasonable and necessary as permanent mechanical cardiac support (destination therapy) for Medicare beneficiaries 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 two 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 m 2 ) to support the LVAD implantation. In addition, CMS has determined that LVAD implantation as destination therapy is reasonable and necessary only when the procedure is performed in a Medicare-approved heart transplant facility that, between January 1, 2001 and September 30, 2003, implanted at least 15 LVADs as a bridge to transplant or as destination therapy. These LVADs must have been approved by the FDA for destination therapy or as a bridge to transplant or have been implanted as part of an FDA investigational device exemption (IDE) trial for one of these two indications. LVADs implanted for support of blood circulation post cardiotomy or other investigational indications do not satisfy the volume requirement for this purpose. Since the relationship between volume and outcomes has not been well-established for LVAD use, facilities that have minimal deficiencies in meeting this standard may apply to the CMS Administrator for an exception based upon additional factors. Some of the factors we will consider are geographic location of the center, number of destination procedures done and patient outcomes from LVAD procedures completed. Also, this facility must be an active, continuous member of a national, audited registry that requires submission of health data on all LVAD destination therapy patients from the date of implantation throughout the remainder of their lives. Such facility also must have in place staff and procedures that assure that prospective LVAD recipients receive all information necessary to assist them in giving an 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 LVAD implantation. CMS plans to develop accreditation standards for facilities that implant LVADs and, when implemented, LVAD implantation will be considered reasonable and necessary only at accredited facilities.