CMS Pub. 100-03, ch. 1, § 20.9.1

A. General

A ventricular assist device (VAD) is surgically attached to one or both intact ventricles

and is used to assist or augment the ability of a damaged or weakened native heart to

pump blood. Improvement in the performance of the native heart may allow the device to

be removed.

Indications and Limitations of Coverage

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:

o 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

o 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

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.

Destination therapy (DT) is for patients that require mechanical cardiac support. The

VADs used for DT are covered only if they have received approval from the FDA for that

purpose.

Patient Selection (effective November 9, 2010):

The VADs are covered for patients who have chronic end-stage heart failure (New York

Heart Association Class IV end-stage left ventricular failure) who are not candidates for

heart transplantation at the time of VAD implant, and meet the following conditions:

• Have failed to respond to optimal medical management (including beta-blockers and

ACE inhibitors if tolerated) for 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.

Facility Criteria (effective October 30, 2013):

Facilities currently credentialed by the Joint Commission for placement of VADs as DT

may continue as Medicare-approved facilities until October 30, 2014. At the conclusion

of this transition period, these facilities must be in compliance with the following criteria

as determined by a credentialing organization. As of the effective date, new facilities

must meet the following criteria as a condition of coverage of this procedure as DT under

section 1862(a)(1)(A) of the Social Security Act (the Act):

Beneficiaries receiving VADs for DT must be managed by an explicitly identified

cohesive, multidisciplinary team of medical professionals with the 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 shared decision making and to provide appropriate informed consent. 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 VADs as BTT or

DT 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 heart

transplant.

• A VAD program coordinator.

• A social worker.

• A palliative care specialist.

Facilities must be credentialed by an organization approved by the Centers for Medicare

& Medicaid Services.

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 A/B MACs within their respective

jurisdictions.