CMS Pub. 100-03, ch. 1, § 20.4

A. General

An implantable cardioverter defibrillator (ICD) is an electronic device designed to

diagnose and treat life-threatening ventricular tachyarrhythmias.

B. Nationally Covered Indications

Effective for services performed on or after February 15, 2018 CMS has determined that

the evidence is sufficient to conclude that the use of ICDs, (also referred to as

defibrillators) is reasonable and necessary:

1. Patients with a personal history of sustained ventricular tachyarrhythmia (VT)

or cardiac arrest due to ventricular fibrillation (VF). Patients must have

demonstrated:

• An episode of sustained VT, either spontaneous or induced by an

electrophysiology (EP) study, not associated with an acute myocardial

infarction (MI) and not due to a transient or reversible cause; or

• An episode of cardiac arrest due to VF, not due to a transient or

reversible cause.

2. Patients with a prior MI and a measured left ventricular ejection fraction

(LVEF) ≤ 0.30. Patients must not have:

• New York Heart Association (NYHA) classification IV heart failure;

or,

• Had a coronary artery bypass graft (CABG), or percutaneous coronary

intervention (PCI) with angioplasty and/or stenting, within the past 3

months; or,

• Had an MI within the past 40 days; or,

• Clinical symptoms and findings that would make them a candidate for

coronary revascularization.

For these patients identified in B2, a formal shared decision making encounter

must occur between the patient and a physician (as defined in Section

1861(r)(1) of the Social Security Act (the Act))or qualified non-physician

practitioner (meaning a physician assistant, nurse practitioner, or clinical

nurse specialist as defined in §1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior to initial ICD implantation. The shared

decision making encounter may occur at a separate visit.

3. Patients who have severe, ischemic, dilated cardiomyopathy but no personal

history of sustained VT or cardiac arrest due to VF, and have NYHA Class II

or III heart failure, LVEF < 35%. Additionally, patients must not have:

• Had a CABG, or PCI with angioplasty and/or stenting, within the past

3 months; or,

• Had an MI within the past 40 days; or,

• Clinical symptoms and findings that would make them a candidate for

coronary revascularization.

For these patients identified in B3, a formal shared decision making encounter

must occur between the patient and a physician (as defined in Section

1861(r)(1) of the Act) or qualified non-physician practitioner (meaning a

physician assistant, nurse practitioner, or clinical nurse specialist as defined in

§1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior

to initial ICD implantation. The shared decision making encounter may occur

at a separate visit.

4. Patients who have severe, non-ischemic, dilated cardiomyopathy but no

personal history of sustained VT or cardiac arrest due to VF, and have NYHA

Class II or III heart failure, LVEF < 35%, been on optimal medical therapy for

at least 3 months. Additionally, patients must not have:

• Had a CABG or PCI with angioplasty and/or stenting, within the past

3 months; or,

• Had an MI within the past 40 days; or,

• Clinical symptoms and findings that would make them a candidate for

coronary revascularization.

For these patients identified in B4, a formal shared decision making encounter

must occur between the patient and a physician (as defined in Section

1861(r)(1) of the Act) or qualified non-physician practitioner (meaning a

physician assistant, nurse practitioner, or clinical nurse specialist as defined in

§1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior

to initial ICD implantation. The shared decision making encounter may occur

at a separate visit.

5. Patients with documented, familial or genetic disorders with a high risk of

life-threatening tachyarrhythmias (sustained VT or VF), to include, but not

limited to, long QT syndrome or hypertrophic cardiomyopathy.

For these patients identified in B5, a formal shared decision making encounter

must occur between the patient and a physician (as defined in Section

1861(r)(1) of the Act) or qualified non-physician practitioner (meaning a

physician assistant, nurse practitioner, or clinical nurse specialist as defined in

§1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior

to initial ICD implantation. The shared decision making encounter may occur

at a separate visit.

6. Patients with an existing ICD may receive an ICD replacement if it is required

due to the end of battery life, elective replacement indicator (ERI), or

device/lead malfunction.

For each of the 6 covered indications above, the following additional criteria must also be

met:

1. Patients must be clinically stable (e.g., not in shock, from any etiology);

2. LVEF must be measured by echocardiography, radionuclide (nuclear

medicine) imaging, cardiac magnetic resonance imaging (MRI), or catheter

angiography;

3. Patients must not have:

• Significant, irreversible brain damage; or,

• Any disease, other than cardiac disease (e.g., cancer, renal failure, liver

failure) associated with a likelihood of survival less than 1 year; or,

• Supraventricular tachycardia such as atrial fibrillation with a poorly

controlled ventricular rate.

Exceptions to waiting periods for patients that have had a CABG, or PCI with

angioplasty and/or stenting, within the past 3 months, or had an MI within the past 40

days:

Cardiac Pacemakers: Patients who meet all CMS coverage requirements for

cardiac pacemakers, and who meet the criteria in this national coverage

determination for an ICD, may receive the combined devices in one procedure, at

the time the pacemaker is clinically indicated;

Replacement of ICDs: Patients with an existing ICD may receive an ICD

replacement if it is required due to the end of battery life, ERI, or device/lead

malfunction.

C. Nationally Non-Covered Indications

N/A

D. Other

For patients that are candidates for heart transplantation on the United Network for Organ

Sharing (UNOS) transplant list awaiting a donor heart, coverage of ICDs, as with cardiac

resynchronization therapy, as a bridge-to-transplant to prolong survival until a donor

becomes available, is determined by the local Medicare Administrative Contractors

(MACs).

All other indications for ICDs not currently covered in accordance with this decision may

be covered under Category B investigational device exemption (IDE) trials (42 CFR

405.201).

(This NCD last reviewed February 2018.)