CMS Proposes Changes to VAD Coverage

The Centers for Medicare & Medicaid Services (CMS) is considering changes to the Medicare coverage policy for ventricular assist devices (VAD) as destination therapy in end-stage heart failure patients.

In a proposed decision memo dated Aug. 19, CMS proposes removing the requirement that patients must have a body size greater than 1.5 m² and raising the peak oxygen-consumption threshold from 12 mL/kg/min to 14 mL/kg/min.

CMS states in the decision memo:

“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:

a. 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,

b. Have a left ventricular ejection fraction (LVEF) < 25%; and,

c. Have demonstrated functional limitation with a peak oxygen consumption of ≤ 14 ml/kg/min.”

A comparison of the current and proposed policies can be viewed in Appendix A of the decision memo.

CMS is soliciting public comments on these proposed changes to the VAD National Coverage Determination (NCD) until Sept. 18 and expects to release a final decision by Nov. 17.


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