Appeal type: unknown
Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
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:  
o 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 
o 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) less than or equal to 
0.30. Patients must not have: 
o New York Heart Association (NYHA) classification IV heart failure; or, 
o Had a Coronary Artery Bypass Graft (CABG), or Percutaneous Coronary Intervention (PCI) 
with angioplasty and/or stenting, within the past three (3) months; or, 
o Had an MI within the past 40 days; or, 
o 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 less than or equal to 35%. 
Additionally, patients must not have: 
o Had a CABG, or PCI with angioplasty and/or stenting, within the past three (3) months; or, 
o Had an MI within the past 40 days; or, o 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 less than or equal to 35%, been on 
optimal medical therapy for at least three (3) months. Additionally, patients must not have: 
o Had a CABG or PCI with angioplasty and/or stenting, within the past three (3) months; or, 
o Had an MI within the past 40 days; or, 
o 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 six (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: 
o Significant, irreversible brain damage; or, 
o 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, 
o Supraventricular tachycardia such as atrial fibrillation with a poorly controlled ventricular rate. 
You can find this rule in the Centers for Medicare and Medicaid Services, Internet Only Manual, Publication 
100-03, Medicare National Coverage Determinations Manual, Section 20.4. 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 The Plan contract says that the Plan covers items and services in accordance with Medicare rules.