Ventricular Assist Device Conditions Expand

The Centers for Medicare & Medicaid Services (CMS) has expanded the conditions for coverage of Ventricular Assist Device (VAD) as Destination Therapy.

Medicare covers VADs for three general indications: 1) postcardiotomy; 2) bridge to transplantation; and 3) destination therapy.

VAD implantation as destination therapy is a Medicare covered service only when performed in a Medicare-approved hospital and certain other requirements are met. Effective Nov. 9 those requirements include:

  • The device must be approved by the Food and Drug Administration (FDA).
  • Patients must be diagnosed with New York Health Association (NYHA) Class IV end-stage ventricular heart failure who are not candidates for heart transplant, and who meet all of the following newly-expanded conditions:
    • Have failed to respond to optimal medical management (including beta-blockers, and ACE inhibitors) for at least 45 days of the last 60 days, or have been balloon pump dependent for 7 days, or IV inotrope dependent for 14 days
    • Have a left ventricular ejection fraction (LVEF) less than 25 percent
    • Have demonstrated functional limitation with a peak oxygen consumption of less than or equal to 14 mL/kg/min unless balloon pump or inotrope dependent or physically unable to perform the test.

A decision memo issued Nov. 9 summarizes the changes being made to section 20.9 in Pub. 100-03 of the Medicare NCD Manual. The final policy is available in Appendix A of the Medicare NCD Manual with changes appearing in section 3. See also Transmittal 128, Change Request 7220, issued Nov. 19.


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3 Responses to “Ventricular Assist Device Conditions Expand”

  1. Terri says:

    Ok. I got locked out of the test for 12 hours because of the question pertaining to this article. My first answer was D. The article says “less than” or equal to 14 mL. The test answer for D said “greater than” 14 mL. What am I missing?

  2. Rhonda O'Brien says:

    I agree the 4 options listed are part of the acceptable 5 conditions. I too picked D.

  3. Carla Dunn says:

    The answer is A – the LVEF requirement is less than 25%. The option says greater than 25%.

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