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.