I. Transvenous ICD — Adults
Implantable cardiac defibrillation therapy using an FDA-approved transvenous ICD is medically necessary when all applicable requirements below are met.
ALL of the following
Member is not a candidate for cardiac revascularization; coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) is not clinically appropriate.
ONE of the following
Primary prevention: high SCD risk without a prior life-threatening VT or VF
No prior life-threatening ventricular tachycardia (VT) or ventricular fibrillation (VF).
At least ONE of the following
ALL of the following
Ischemic cardiomyopathy with NYHA functional Class I symptoms.
History of myocardial infarction (MI) at least 40 days before ICD treatment.>= 40 days
Left ventricular ejection fraction (LVEF) is 30% or less.<= 30%
ALL of the following
Ischemic cardiomyopathy with NYHA functional Class II or Class III symptoms.
History of MI at least 40 days before ICD treatment.>= 40 days
LVEF is 35% or less.<= 35%
ALL of the following
Nonischemic dilated cardiomyopathy.
LVEF is 35% or less.<= 35%
Reversible causes have been excluded.
Condition is refractory to optimal medical therapy, defined as 3 months of maximally titrated doses, as tolerated, of an ACE inhibitor, beta blocker, and diuretic.3 months
ALL of the following
Hypertrophic cardiomyopathy (HCM).
At least ONE major SCD risk factor
History of premature HCM-related sudden death in at least one first-degree relative younger than 50 years.
Left ventricular hypertrophy (LVH) is at least 30 mm.>= 30 mm
Documented VT with heart rates of at least 120 beats per minute on 24-hour Holter monitoring.>= 120 beats per minute
Left ventricular wall thickness is at least 3 cm.>= 3 cm
ALL of the following
Documented LMNA gene mutation (lamin A/C deficiency).
At least ONE of the following
Symptomatic cardiac arrhythmias.
ALL of the following
At least ONE of the following
Syncope and/or VT while receiving beta blocker pharmacotherapy.
ALL of the following
At least ONE SCD risk factor
QTc greater than 500 msec.> 500 msec
ALL of the following
At least ONE of the following
Spontaneous sustained VT with or without syncope.
Spontaneous diagnostic type 1 ECG with a positive history of syncope, seizure, or nocturnal agonal respiration after noncardiac causes have been ruled out.
Development of VF during programmed electrical stimulation.
ALL of the following
Catecholaminergic polymorphic ventricular tachycardia (CPVT).
At least ONE of the following
Polymorphic or bidirectional VT unresponsive to medical management or left cardiac sympathetic denervation.
Cardiac sarcoidosis, giant cell myocarditis, or Chagas disease, regardless of LVEF.
ALL of the following
Left ventricular non-compaction cardiomyopathy.
At least ONE of the following
Positive family history of sudden cardiac death.
Impaired LVEF less than 50%.< 50%
Arrhythmogenic right ventricular dysplasia (ARVD).
Secondary prevention
Member has experienced a life-threatening clinical event associated with ventricular arrhythmic events, such as sustained VT.
Reversible causes, such as acute ischemia, drug toxicity, and electrolyte abnormalities, have been excluded.
II. Transvenous ICD — Pediatrics
A transvenous ICD is medically necessary when at least one of the following criteria is met.
At least ONE of the following
Prior cardiac arrest after reversible causes have been excluded.
ALL of the following
Symptomatic sustained VT in association with congenital heart disease.
Member has undergone hemodynamic and electrophysiologic evaluation.
ALL of the following
Congenital heart disease with recurrent syncope of undetermined origin.
At least ONE of the following
III. S-ICD — Adults or Pediatrics
An S-ICD is medically necessary when all of the following requirements are met.
ALL of the following
Member meets the applicable transvenous ICD clinical criteria above.
Member does not have symptomatic bradycardia.
Member does not have incessant VT, or spontaneous frequently recurring VT, that is reliably terminated with antitachycardia pacing.
Member does not have previous endocarditis or infection associated with a conventional ICD.
ICD With Cardiac Resynchronization Therapy
ConnectiCare considers an FDA-approved ICD combined with cardiac resynchronization therapy (CRT/ICD) medically necessary when all of the following are met.
ALL of the following
An FDA-approved implantable cardioverter-defibrillator is used.
Applicable cardiac resynchronization therapy (CRT), also called resynchronization or biventricular pacing, criteria are met.
Replacement of an ICD pulse generator or leads is medically necessary when one or more of the following applies:
1. Equipment is damaged or malfunctioning.
2. Manufacturer product labeling details a medically necessary replacement scenario.
3. The member's medical condition has changed.
ConnectiCare covers face-to-face or remote surveillance of ICDs to monitor device behavior, investigate symptoms such as post-event shock or syncope, evaluate ICD malfunction or device failure, program or adjust the device, and modify or disable the device before surgery or other procedures. Remote interrogation is a single 90-day service; in-person interrogation may be reported for each day it is performed.
ICD pulse generator or lead replacement is limited to medically necessary scenarios involving damaged or malfunctioning equipment, a replacement scenario specified in manufacturer product labeling, or a change in the member's medical condition.
The use of either a subcutaneous or transvenous ICD is investigational and not medically necessary for clinical conditions other than those listed above or when the specific criteria are not met.
An implantable cardioverter-defibrillator with a built-in ST-segment monitoring feature, also called an ICD-based ischemia monitor, is not medically necessary for any indication in adults or children because of insufficient evidence of therapeutic value.
Cardioverter-defibrillator therapy is not medically necessary when another disease process clearly and severely limits estimated life expectancy to less than one year.
ICD use is investigational and not medically necessary for clinical conditions other than those listed in this policy or when the specific criteria are not met.
ICD-based ischemia monitors and built-in ST-segment monitoring features are not medically necessary for any indication because insufficient evidence demonstrates therapeutic value.
Cardioverter-defibrillators are not medically necessary when another disease process clearly and severely limits estimated life expectancy to less than one year.
Unlisted clinical conditions, unmet policy criteria, and excluded device features are not covered as medically necessary under this policy.
Use of a subcutaneous or transvenous ICD is not medically necessary when the specific policy criteria are not met.
Covered ICD surveillance includes face-to-face or remote monitoring of device behavior; investigation of post-event shock, syncope, malfunction, or device failure; programming evaluation and adjustment; and modification or disabling of the device before surgery or other procedures. Remote interrogation is a single 90-day service, while in-person interrogation may be reported for each day performed.