An implantable cardioverter defibrillator (ICD) is a device designed to monitor a patient's heart rate, recognize ventricular fibrillation or ventricular tachycardia, and deliver an electric shock to terminate these arrhythmias to reduce the risk of sudden death. A subcutaneous ICD (S-ICD), which lacks transvenous leads, is intended to reduce lead-related complications.
For individuals who have a high risk of sudden cardiac death (SCD) due to ischemic or nonischemic cardiomyopathy in adulthood who receive transvenous implantable cardioverter defibrillator (T-ICD) placement for primary prevention, the evidence includes multiple well-designed and well-conducted randomized controlled trials (RCTs) as well as systematic reviews of these trials. Relevant outcomes are overall survival (OS), morbid events, quality of life, and treatment-related mortality and morbidity. Multiple well-done RCTs have shown a benefit in overall mortality for patients with ischemic cardiomyopathy and reduced ejection fraction. Randomized controlled trials assessing early implantable cardioverter defibrillator (ICD) use following recent myocardial infarction (MI) did not support a benefit for immediate versus delayed implantation for at least 40 days. For nonischemic cardiomyopathy (NICM), there are less clinical trial data, but pooled estimates of available evidence from RCTs enrolling patients with NICM and from subgroup analyses of RCTs with mixed populations have supported a survival benefit for this group. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have a high risk of SCD due to hypertrophic cardiomyopathy (HCM) in adulthood who receive T-ICD placement for primary prevention, the evidence includes several large registry studies. Relevant outcomes are OS, morbid events, quality of life, and treatment-related mortality and morbidity. In these studies, the annual rate of appropriate ICD discharge ranged from 3.6% to 5.3%. Given the long-term high risk of SCD in patients with HCM, with the assumption that appropriate shocks are life-saving, these studies are considered adequate evidence to support the use of T-ICDs in patients with HCM. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have a high risk of SCD due to an inherited cardiac ion channelopathy who receive T-ICD placement for primary prevention, the evidence includes small cohort studies of patients with these conditions treated with ICDs. Relevant outcomes are OS, morbid events, quality of life, and treatment-related mortality and morbidity. The limited evidence for patients with long QT syndrome, catecholaminergic polymorphic ventricular tachycardia, and Brugada syndrome has reported high rates of appropriate shocks. No studies were identified on the use of ICDs for patients with short QT syndrome. Studies comparing outcomes between patients treated and untreated with ICDs are not available. However, given the relatively small patient populations with these channelopathies and the high risk of cardiac arrhythmias, clinical trials are unlikely. Given the long-term high risk of SCD in patients with inherited cardiac ion channelopathy, with the assumption that appropriate shocks are life-saving, these studies are considered adequate evidence to support the use of T-ICDs in patients with inherited cardiac ion channelopathy. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have a high risk of SCD due to cardiac sarcoid who receive T-ICD placement for primary prevention, the evidence includes small cohort studies of patients with cardiac sarcoid treated with ICDs who received appropriate shocks. Studies comparing outcomes between patients treated and untreated with ICDs are not available. However, given the relatively small number of patients with cardiac sarcoid (5% of those with systemic sarcoidosis), clinical trials are unlikely. Given the long-term high risk of SCD in patients with cardiac sarcoid, with the assumption that appropriate shocks are life-saving, these studies are considered adequate evidence to support the use of T-ICDs in patients with cardiac sarcoid who have not responded to optimal medical therapy. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have had symptomatic life-threatening sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) or who have been resuscitated from sudden cardiac arrest (secondary prevention) who receive T-ICD placement, the evidence includes multiple well-designed and well-conducted RCTs as well as systematic reviews of these trials. Relevant outcomes are OS, morbid events, quality of life, and treatment-related mortality and morbidity. Systematic reviews of RCTs have demonstrated a 25% reduction in mortality for ICD compared with medical therapy. Analysis of data from a large administrative database has confirmed that this mortality benefit is generalizable to the clinical setting. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who need an ICD and have a contraindication to a T-ICD but no indications for antibradycardia pacing and no antitachycardia pacing-responsive arrhythmias who receive subcutaneous ICD (S-ICD) placement, the evidence includes an RCT, nonrandomized studies, and case series. Relevant outcomes are OS, morbid events, quality of life, and treatment-related mortality and morbidity. An RCT found that S-ICD significantly decreases the risk of lead-related perioperative complications compared to T-ICD. However, this study was not powered to detect differences in the rates of failed shocks or inappropriate shocks and an extension study is ongoing. Nonrandomized controlled studies have reported success rates in terminating laboratory-induced VF that are similar to T-ICD. Case series have reported high rates of detection and successful conversion of VF, and inappropriate shock rates in the range reported for T-ICD. Given the need for ICD placement in this population at risk for SCD, with the assumption that appropriate shocks are life-saving, these studies are considered adequate evidence to support the use of S-ICDs in patients with contraindication to T-ICD. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who need an ICD and have no indications for antibradycardia pacing or antitachycardia pacing-responsive arrhythmias with no contraindication to a T-ICD, who receive S-ICD placement, the evidence includes 1 RCT, nonrandomized studies, and case series. Relevant outcomes are OS, morbid events, quality of life, and treatment-related mortality and morbidity. The Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy (PRAETORIAN) trial is the only RCT on the effect of an S-ICD with health outcomes. PRAETORIAN found that S-ICD was noninferior to T-ICD on a composite outcome of complications and inappropriate shock at 48 months (hazard ratio [HR], 0.99; 95% confidence interval [CI], 0.71 to 1.39; noninferiority margin, 1.45; p=.01 for noninferiority; p=.95 for superiority). There were more device related complications in the T-ICD group and more inappropriate shocks in the S-ICD group, but the trial was not powered for these endpoints. There is uncertainty over the applicability and interpretation of PRAETORIAN based on the choice of a composite outcome with discordant results, unclear rationale for choice of the noninferiority margin, inadequate length of follow-up to determine rates of complications, and lack of reporting of quality of life data. Comparative observational studies are insufficient to draw conclusions on whether there are small differences in efficacy between the 2 types of devices, and reported variable adverse event rates. Ongoing studies could provide additional evidence on complications and device safety over the longer term. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who need an ICD who receive an extravascular ICD (E-ICD), the evidence includes nonrandomized studies. Relevant outcomes are OS, morbid events, quality of life, and treatment-related mortality and morbidity. The largest available study with an E-ICD reported high rates of defibrillation after implantation and a low rate of major complications, with a numerically similar rate of inappropriate shocks compared to studies with T-ICD and S-ICD. The major limitation of the study is the lack of an active control group. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
The use of the automatic implantable cardioverter defibrillator (ICD) may be considered medically necessary in individuals who meet the following criteria:
Ischemic cardiomyopathy with New York Heart Association (NYHA) functional class II or III symptoms, a history of myocardial infarction (MI) at least 40 days before ICD treatment, and left ventricular ejection fraction (LVEF) of 35% or less; or
Ischemic cardiomyopathy with NYHA functional class I symptoms, a history of MI at least 40 days before ICD treatment, and LVEF of 30% or less; or
Nonischemic dilated cardiomyopathy and LVEF of 35% or less, after reversible causes have been excluded, and the response to optimal medical therapy has been adequately determined; or
Hypertrophic cardiomyopathy (HCM) with 1 or more major risk factors for sudden cardiac death (history of premature HCM-related sudden death in ≥1 first-degree relatives younger than 50 years; left ventricular hypertrophy >30 mm; ≥1 runs of nonsustained ventricular tachycardia at heart rates of ≥120 beats per minute on 24-hour Holter monitoring; prior unexplained syncope inconsistent with neurocardiogenic origin) and judged to be at high risk for sudden cardiac death by a physician experienced in the care of individuals with HCM.
Diagnosis of any 1 of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death (see Policy Guidelines section):
congenital long QT syndrome; OR
Brugada syndrome; OR
short QT syndrome; OR
catecholaminergic polymorphic ventricular tachycardia.
Individuals with a history of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia, after reversible causes (eg, acute ischemia) have been excluded.
The use of the ICD is considered investigational in primary prevention individuals who:
have had an acute MI (ie, <40 days before ICD treatment);
have NYHA class IV congestive heart failure (unless the individual is eligible to receive a combination cardiac resynchronization therapy ICD device);
have had a cardiac revascularization procedure in the past 3 months (coronary artery bypass graft or percutaneous transluminal coronary angioplasty) or are candidates for a cardiac revascularization procedure; or
have noncardiac disease that would be associated with life expectancy less than 1 year.
The use of the ICD for secondary prevention is considered investigational for individuals who do not meet the criteria for secondary prevention.
The use of the ICD may be considered medically necessary in pediatric individuals who meet any of the following criteria:
survivors of cardiac arrest due to ventricular tachycardia or ventricular fibrillation, after reversible causes have been excluded;
long QT syndrome in individuals who are survivors of sudden cardiac arrest (in combination with beta-blockers);
long QT syndrome in individuals who cannot take beta-blockers and for whom cardiac sympathetic denervation or other medications are not considered appropriate;
catecholaminergic polymorphic ventricular tachycardia in individuals who experience cardiac arrest despite maximally tolerated beta-blockers, flecainide, or cardiac sympathetic denervation;
Brugada syndrome in individuals who are survivors of sudden cardiac arrest or have documented spontaneous sustained ventricular tachycardia;
hypertrophic cardiomyopathy in individuals who are survivors of sudden cardiac arrest or have documented spontaneous sustained ventricular tachycardia;
arrhythmogenic cardiomyopathy in individuals who are survivors of sudden cardiac arrest or sustained ventricular tachycardia that is not hemodynamically tolerated;
nonischemic dilated cardiomyopathy in individuals who are survivors of sudden cardiac arrest or have documented spontaneous sustained ventricular tachycardia that is not due to completely reversible causes;
congenital heart disease in individuals who are survivors of sudden cardiac arrest, after reversible causes have been excluded;
symptomatic, sustained ventricular tachycardia in association with congenital heart disease in individuals who have undergone hemodynamic and electrophysiologic evaluation;
The use of the ICD is considered investigational for all other indications in pediatric individuals.
Subcutaneous Implantable Cardioverter Defibrillator
The use of a subcutaneous ICD may be considered medically necessary for adult or pediatric individuals who have an indication for ICD implantation for primary or secondary prevention for any of the above reasons and meet all of the following criteria:
Have a contraindication to a transvenous ICD due to 1 or more of the following: (1) lack of adequate vascular access; (2) compelling reason to preserve existing vascular access (ie, need for chronic dialysis; younger individual with anticipated long-term need for ICD therapy); or (3) history of need for explantation of a transvenous ICD due to a complication, with ongoing need for ICD therapy;
Have no indication for antibradycardia pacing;
Do not have ventricular arrhythmias known or anticipated to respond to antitachycardia pacing.
The use of a subcutaneous ICD is considered investigational for individuals who do not meet the criteria outlined above.
The use of an extravascular ICD is considered investigational.
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CPT |
33216 |
Insertion of a single transvenous electrode, permanent pacemaker or implantable defibrillator |
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33217 |
Insertion of 2 transvenous electrodes, permanent pacemaker or implantable defibrillator |
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33218 |
Repair of single transvenous electrode, permanent pacemaker or implantable defibrillator |
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33220 |
Repair of 2 transvenous electrodes for permanent pacemaker or implantable defibrillator |
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33223 |
Revision of skin pocket for implantable defibrillator |
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33230 |
Insertion of implantable defibrillator pulse generator only; with existing dual leads |
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33231 |
Insertion of implantable defibrillator pulse generator only; with existing multiple leads |
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33240 |
Insertion of implantable defibrillator pulse generator only; with existing single lead |
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33241 |
Removal of implantable defibrillator pulse generator only |
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33243 |
Removal of single or dual chamber implantable defibrillator electrode(s); by thoracotomy |
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33244 |
; by transvenous extraction |
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33249 |
Insertion or replacement of permanent implantable defibrillator system with transvenous lead(s), single or dual chamber |
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33262 |
Removal of implantable defibrillator pulse generator with replacement of implantable defibrillator pulse generator; single lead system |
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33263 |
Removal of implantable defibrillator pulse generator with replacement of implantable defibrillator pulse generator; dual lead system |
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33264 |
Removal of implantable defibrillator pulse generator with replacement of implantable defibrillator pulse generator; multiple lead system |
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33270 |
Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed |
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33271 |
Insertion of subcutaneous implantable defibrillator electrode |
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33272 |
Removal of subcutaneous implantable defibrillator electrode |
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33273 |
Repositioning of previously implanted subcutaneous implantable defibrillator electrode |
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93260 |
Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; implantable subcutaneous lead defibrillator system |
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93261 |
Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; implantable subcutaneous lead defibrillator system |
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93282-93284; |
Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional, codes specific to the type of device |
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93287 |
Peri-procedural device evaluation (in person) and programming of device system parameters before or after a surgery, procedure, or test with analysis, review and report by a physician or other qualified health care professional; single, dual, or multiple lead implantable defibrillator system |
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93289; |
Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; codes specific to the type of device |
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93295-93297 |
Interrogation device evaluation(s) (remote), up to 90 days; code series |
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93640-93644 |
Electrophysiologic evaluation; codes specific to the type of device |
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ICD-10-PCS |
ICD-10-PCS codes are only used for inpatient services |
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02H40ME, 02H43ME, 02H44ME, 02H60ME, 02H63ME, 02H64ME, 02H70ME, 02H73ME, 02H74ME, 02HK0ME, 02HK3ME, 02HK4ME, 02HL0ME, 02HL3ME, 02HL4ME, 02HN0ME, 02HL3ME, 02HL4ME, 02HN0ME, 02HN3ME, 02HN4ME |
Surgical, heart & great vessels, insertion, defibrillator lead, code by body part and approach |
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0JH60P4, 0JH63P4, 0JH80P4, 0JH83P4 |
Surgical, subcutaneous tissue & fascia, insertion, defibrillator generator, code by body part and approach |
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02PA0MZ, 02PA3MZ, 02PA4MZ, 02PAXMZ, |
Surgical, heart & great vessels, removal, cardiac lead, code by approach |
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0JPT0PZ, 0JPT3PZ |
Surgical, subcutaneous tissue & fascia, removal, cardiac rhythm related device, trunk, code by approach |
| HCPCS | C1721 | Cardioverter-defibrillator, dual chamber (implantable) |
| C1722 | Cardioverter-defibrillator, single chamber (implantable) | |
| C1824 | Generator, cardiac contractility modulation (implantable) | |
| C1882 | Cardioverter-defibrillator, other than single or dual chamber (implantable) | |
| C1895 | Lead, cardioverter-defibrillator, endocardial dual coil (implantable) | |
| C1896 | Lead, cardioverter-defibrillator, other than endocardial single or dual coil (implantable) | |
| C1899 | Lead, pacemaker/cardioverter-defibrillator combination (implantable) |
| CD-10 CM | I25.5 | Ischemic cardiomyopathy |
| I42.1-I42.2 | Hypertrophic cardiomyopathy code range. | |
| I42.8 | Other cardiomyopathies (best choice for nonischemic cardiomyopathy) | |
| I42.9 | Cardiomyopathy, unspecified | |
| I45.81 | Long QT syndrome | |
| I45.89 | Other specified conduction disorders | |
| I46.2, I46.8, I46.9 | Cardiac arrest code range | |
| I47.2 | Ventricular tachycardia | |
| I49.01 | Ventricular fibrillation | |
| I49.9 | Cardiac arrhythmia, unspecified | |
| Q20.0-Q20.9 | Congenital malformations of cardiac chambers and connections code range | |
| Q21.0-Q21.9 | Congenital malformations of cardiac septa code range | |
| Q22.0-Q22.9 | Congenital malformations of pulmonary and tricuspid valves code range | |
| Q23.0-Q23.9 | Congenital malformations of aortic and mitral valves code range | |
| Q24.0-Q24.9 | Other congenital malformations of heart code range |
This evidence review addresses the use of implantable cardioverter defibrillator (ICD) devices as stand-alone interventions, not as combination devices to treat heart failure (ie, cardiac resynchronization devices) or in combination with pacemakers. Unless specified, the policy statements and rationale refer to transvenous ICDs.
Indications for pediatric ICD use are based on the 2021 Pediatric and Congenital Electrophysiology Society and Heart Rhythm Society guidance on ICDs in children.1,
Individuals with cardiac ion channelopathies may have a history of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia, after reversible causes, in which case they should be considered for ICD implantation for secondary prevention, even if they do not meet criteria for primary prevention.
Criteria for ICD placement in individuals with cardiac ion channelopathies derive from results of clinical input, a 2013 consensus statement from the HRS, European Heart Rhythm Association (EHRA), and the Asia-Pacific Heart Rhythm Society on the diagnosis and management of individuals with inherited primary arrhythmia syndromes, and a report from the HRS and EHRA's Second Consensus Conference on Brugada syndrome.
Indications for consideration for ICD placement for each cardiac ion channelopathy are as follows:
Long QT syndrome (LQTS):
Individuals with a diagnosis of LQTS who are survivors of cardiac arrest;
Individuals with a diagnosis of LQTS who experience recurrent syncopal events while on β-blocker therapy.
Brugada syndrome (BrS):
Individuals with a diagnosis of BrS who are survivors of cardiac arrest;
Individuals with a diagnosis of BrS who have documented spontaneous sustained ventricular tachycardia (VT) with or without syncope;
Individuals with a spontaneous diagnostic type 1 electrocardiogram (ECG) who have a history of syncope, seizure, or nocturnal agonal respiration judged to be likely caused by ventricular arrhythmias (after noncardiac causes have been ruled out);
Individuals with a diagnosis of BrS who develop ventricular fibrillation during programmed electrical stimulation.
Catecholaminergic polymorphic ventricular tachycardia (CPVT):
Individuals with a diagnosis of CPVT who are survivors of cardiac arrest;
Individuals with a diagnosis of CPVT who experience recurrent syncope or polymorphic/bidirectional VT despite optimal medical management, and/or left cardiac sympathetic denervation.
Short QT syndrome (SQTS):
NOTE: For congenital LQTS, individuals may have 1 or more clinical or historical findings other than those outlined above that could, alone or in combination, put them at higher risk for sudden cardiac death. They can include individuals with a family history of sudden cardiac death due to LQTS, infants with a diagnosis of LQTS with functional 2:1 atrioventricular block, individuals with a diagnosis of LQTS in conjunction with a diagnosis of Jervell and Lange-Nielsen syndrome or Timothy syndrome, and individuals with a diagnosis of LQTS with profound QT prolongation (>550 ms). These factors should be evaluated on an individualized basis by a clinician with expertise in LQTS when considering the need for ICD placement.
Criteria for ICD placement in individuals with cardiac sarcoid derive from a 2014 consensus statement from the HRS and 2017 joint guidelines from the AHA, ACC, and HRS.
Indications for consideration of ICD placement in individuals diagnosed with cardiac sarcoid are as follows:
Spontaneous sustained ventricular arrhythmias, including prior cardiac arrest, if meaningful survival of greater than 1 year is expected;
Left ventricular ejection fraction (LVEF) 35% or less, despite optimal medical therapy and a period of immunosuppression (if there is active inflammation), if meaningful survival of greater than 1 year is expected;
LVEF greater than 35%, if meaningful survival of greater than 1 year is expected; AND
syncope or near-syncope, felt to be arrhythmic in etiology; OR
Inducible sustained ventricular arrhythmias (>30 seconds of monomorphic VT or polymorphic VT) or clinically relevant ventricular fibrillation.
An indication for permanent pacemaker implantation.
