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The rules say that 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) &#8804; 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 three (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 nonphysician
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% or higher. Additionally,
patients must not have:
-Had a CABG, or PCI with angioplasty and/or stenting, within the past three (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 cardiac arrest or
sustained VT, NYHA Class II or III heart failure, LVEF 35% or higher, been on optimal medical therapy for at
least three (3) months. Additionally, patients must not have:
-Had a CABG or PCI with angioplasty and/or stenting, within the past three (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.
You can find this rule in National Coverage Determination (NCD) for Implantable Automatic Defibrillators
(20.4) - Effective February 15, 2018.
The rules say that for each of the six 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 one (1) year; or,
-Supraventricular tachycardia such as atrial fibrillation with a poorly controlled ventricular rate.
You can find this rule in National Coverage Determination (NCD) for Implantable Automatic Defibrillators
(20.4) - Effective February 15, 2018.