Ventricular Assist Devices as Destination Therapy

CMS NCA document | source_status=Closed | review_type=2nd Recon | public_comment_open=False | document_id=CAG-00119R2

The Centers for Medicare & Medicaid Services (CMS) is issuing the following decision: The evidence is adequate to conclude that VAD implantation as destination therapy improves health outcomes and is reasonable and necessary when the device has received FDA approval for a destination therapy indication and only for patients with New York Heart Association (NYHA) Class IV end-stage ventricular heart failure who are not candidates for heart transplant and who meet all of the following conditions: Have failed to respond to optimal medical management (including beta-blockers, and ACE inhibitors if tolerated) for at least 45 of the last 60 days, or have been balloon pump dependent for 7 days, or IV inotrope dependent for 14 days; and, Have a left ventricular ejection fraction (LVEF) < 25%; and, Have demonstrated functional limitation with a peak oxygen consumption of ≤ 14 ml/kg/min unless balloon pump or inotrope dependent or physically unable to perform the test. CMS is not changing any other parts of Section 20.9 "Artificial Hearts and Related Devices" of the National Coverage Determinations Manual. The final policy in its entirety is available in Appendix A with changes appearing in Section 3.