**B. Nationally Covered Indications**

1\. Post-cardiotomy (effective for services performed on or after October 18,
1993)

Post-cardiotomy is the period following open-heart surgery. VADs used for
support of blood circulation post-cardiotomy are covered only if they have
received approval from the Food and Drug Administration (FDA) for that
purpose, and the VADs are used according to the FDA-approved labeling
instructions.

2\. Left ventricular assist devices (LVADs) are covered if they are FDA
approved for short-term (e.g., bridge-to-recovery and bridge-to-transplant) or
long-term (e.g., destination therapy) mechanical circulatory support for heart
failure patients who meet the following criteria:

  * Have New York Heart Association (NYHA) Class IV heart failure; and
  * Have a left ventricular ejection fraction (LVEF)  25%; and
  * Are inotrope dependent  
OR  
have a Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes, and also
meet one of the following:

    * Are on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond; or
    * Have advanced heart failure for at least 14 days and are dependent on an intra-aortic balloon pump (IABP) or similar temporary mechanical circulatory support for at least 7 days.

Beneficiaries receiving a VAD must be managed by an explicitly identified,
cohesive, multidisciplinary team of medical professionals with appropriate
qualifications, training, and experience. The team embodies collaboration and
dedication across medical specialties to offer optimal patient-centered care.
Collectively, the team must ensure that patients and caregivers have the
knowledge and support necessary to participate in informed decision making.
The team members must be based at the facility and must include individuals
with experience working with patients before and after placement of a VAD.

The team must include, at a minimum:

  * At least one physician with cardiothoracic surgery privileges and individual experience implanting at least 10 durable, intracorporeal, left ventricular assist devices over the course of the previous 36 months with activity in the last year.
  * At least one cardiologist trained in advanced heart failure with clinical competence in medical- and device-based management including VADs, and clinical competence in the management of patients before and after placement of a VAD.
  * A VAD program coordinator.
  * A social worker.
  * A palliative care specialist.

Facilities must be credentialed by an organization approved by CMS. The
process for organizations to apply for CMS approval to be designated as a
credentialing organization for LVAD facilities is posted on our web site along
with a list of approved credentialing organizations, approved standard
versions, and credentialed facilities: [http://www.cms.gov/Medicare/Medicare-
General-Information/MedicareApprovedFacilitie/VAD-Destination-Therapy-
Facilities.html](https://www.cms.gov/Medicare/Medicare-General-
Information/MedicareApprovedFacilitie/VAD-Destination-Therapy-Facilities.html)

**C. Nationally Non-Covered Indications**

All other indications for the use of VADs not otherwise listed remain non-
covered, except in the context of Category B investigational device exemption
clinical trials (42 CFR 405) or as a routine cost in clinical trials defined
under section 310.1 of the National Coverage Determinations (NCD) Manual.

**D. Other**

This policy does not address coverage of VADs for right ventricular support,
biventricular support, use in beneficiaries under the age of 18, use in
beneficiaries with complex congenital heart disease, or use in beneficiaries
with acute heart failure without a history of chronic heart failure. Coverage
under section 1862(a)(1)(A) of the Act for VADs in these situations will be
made by local Medicare Administrative Contractors within their respective
jurisdictions.