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Implantable Cardioverter Defibrillators
05.00.77f

Policy

MEDICALLY NECESSARY

TRANSVENOUS AND SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Primary Prevention


An implantable cardioverter defibrillator (ICD) is considered medically necessary and, therefore, covered for any of the following conditions:

  • 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
  • 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
  • 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
  • Hypertrophic cardiomyopathy (HCM) with one 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 one of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death:
    • congenital long QT syndrome; OR
    • Brugada syndrome; OR
    • short QT syndrome; OR
    • catecholaminergic polymorphic ventricular tachycardia (VT)
  • Diagnosis of cardiac sarcoid and considered to be at high risk for sudden cardiac death:
    • Spontaneous sustained ventricular arrhythmias with or without prior cardiac arrest, if meaningful survival of greater than 1 year is expected; OR
    • 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; OR
    • LVEF greater than 35%, if meaningful survival of greater than 1 year is expected; AND syncope or near-syncope, believed to be arrhythmic in etiology OR evidence of myocardial scar by cardiac magnetic resonance imaging (MRI) or positron emission tomographic (PET) scan OR inducible sustained ventricular arrhythmias (>30 seconds of monomorphic VT or polymorphic VT) or clinically relevant ventricular fibrillation; OR
    • An indication for permanent pacemaker implantation.

Individuals must not have any of the following:

  • Cardiac revascularization procedure (e.g., coronary artery bypass graft [CABG], percutaneous coronary intervention [PCI] for primary and secondary prevention: with angioplasty and/or stenting) when performed, in the past 90 days before ICD treatment or are a candidate for cardiac revascularization; AND
  • History of MI less than 40 days before ICD treatment; AND
  • NYHA functional classification Class IV heart failure; AND
  • Noncardiac disease that would be associated with life expectancy of less than 1 year

Secondary Prevention


An ICD is considered medically necessary and, therefore, covered for individuals with a history of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia, after reversible causes (e.g., acute ischemia) have been excluded.

 

Additional Subcutaneous Implantable Cardioverter Defibrillator Criteria


A subcutaneous implantable cardioverter defibrillator (S-ICD) is considered medically necessary and, therefore, covered for the primary and secondary prevention indications above when all of the following criteria are met:

  • Individuals have a contraindication to a transvenous ICD due to one or more of the following:
    • Lack of adequate vascular access; OR
    • Compelling reason to preserve existing vascular access (e.g., need for chronic dialysis, younger individual with anticipated long-term need for ICD therapy); OR
    • High risk of bacteremia (e.g., individuals on hemodialysis or with chronic indwelling endovascular catheters); OR
    • History of need for explantation of a transvenous ICD due to a complication, with ongoing need for ICD therapy
  • Individuals must not have either of the following:
    • Indication for antibradycardia pacing; AND
    • Ventricular arrhythmias known (i.e., incessant VT or spontaneous, frequently recurring VT) or anticipated to respond to antitachycardia pacing

EXPERIMENTAL/INVESTIGATIONAL


All other uses for an ICD are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.


EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

The use of an extravascular ICD (i.e., Aurora EV-ICD™) is considered experimental/investigational and, therefore, not covered because its safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.


REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

NEW YORK HEART ASSOCIATION FUNCTIONAL CLASSIFICATION

Class​Patient Symptoms
Class I (Mild)No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath).
Class II (Mild)Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.
Class III (Moderate)Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.
Class IV (Severe)Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, transvenous and subcutaneous implantable cardioverter defibrillators are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

​Subject to the terms and conditions of the applicable benefit contract, an extravascular implantable cardioverter defibrillator is not eligible for payment under the medical benefits of the Company's products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration. 
US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Cameron Health (acquired by Boston Scientific)​​ S-ICD® System was approved by the FDA on September 28, 2012, for the treatment of life-threatening ventricular tachyarrhythmias in individuals who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with antitachycardia pacing.

Supplemental approvals for Emblem™ S-ICD System have since been issued by the FDA.

The Aurora EV-ICD™ System was approved by the FDA on October 20, 2023, for the automated treatment of patients who have experienced, or are at significant risk of developing, life-threatening ventricular tachyarrhythmias through the delivery of antitachycardia pacing, cardioversion, and defibrillation therapies. ​

Description

TRANSVENOUS AND SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

A traditional implantable cardioverter defibrillator (ICD) is implanted under the skin with the generator positioned underneath the collar bone. The defibrillator lead is inserted through the veins in the chest that course to the heart, permitting direct attachment to the right ventricle inside the heart. The leads sense and transmit information on cardiac rhythm to the generator, which analyzes the rhythm information and produces an electrical shock when a malignant arrhythmia is recognized.

A subcutaneous implantable cardioverter defibrillator (S-ICD) has been developed that does not employ transvenous leads, thus reducing lead-related complications such as dislodgement, insulation breakage, and fractures leading to device replacement and surgical revision. The S-ICD device provides an electric shock to the heart (defibrillation) for the treatment of life-threatening heart arrhythmias that originate from the lower chambers of the heart (ventricular tachyarrhythmias). The most common types of ventricular tachyarrhythmias are ventricular tachycardia and ventricular fibrillation. Ventricular tachycardia is a heart rhythm faster than 100 beats per minute along with three or more consecutive irregular beats, and ventricular fibrillation is the uncoordinated contraction of the muscles of the ventricles, making them quiver rather than contract; thus the heart pumps less blood to the body. Ventricular tachyarrhythmias are usually diagnosed by a detailed history and physical including a 12-lead electrocardiogram (ECG), cardiac enzyme levels, and an echocardiogram to assess for structural heart disease.

The S-ICD device consists of a titanium case containing a battery and electronic circuitry that provides defibrillation therapy and pacing at a rate of 50 beats per minute up to 30 seconds after a shock. The subcutaneous electrode has a proximal and distal ring electrode on each side of a 3-inch (8-cm) defibrillation coil electrode. Accessories include an electrode insertion tool, programmer, telemetry wand, magnet, suture sleeve, torque wrench, and memory card. The S-ICD is programmable as a single or dual-zone device that allows the professional provider to tailor the therapy for the individual. The S-ICD is implanted under the left breast, and the lead is placed under the skin along the left side of the breastbone. The lead does not course through the central veins in the chest, nor is it attached to the tissue within the heart chambers. There are currently two S-ICD devices manufactured by Boston Scientific: the Cameron Health S-ICD® System (first generation) and the Emblem™ S-ICD System (second generation).

In September 2012, the US Food and Drug Administration (FDA) approved the first-generation Cameron Health S-ICD® System (Cameron Health, San Clemente, CA; acquired by Boston Scientific Corp., San Clemente, CA) to provide defibrillation therapy for the life-threatening ventricular tachyarrhythmias in individuals who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with antitachycardia pacing (ATP). The FDA approval was based on an Investigational Device Examination (IDE) study (Weiss et al.), a single-arm, prospective, nonrandomized, multicenter clinical study reporting on the results of a 321-participant study in which 304 individuals were successfully implanted with the S-ICD® System. The safety endpoint was evaluated through the use of a 180-day S-ICD complication-free rate. The effectiveness endpoint was evaluated using an induced ventricular fibrillation conversion efficacy rate. Spontaneous episodes and chronic conversion testing data were evaluated using descriptive statistics to provide additional data supporting the continued chronic performance of the S-ICD. The S-ICD® System was successful at converting all abnormal heart rhythms that it detected back to normal rhythms. Investigators followed these study participants for 6 months following implantation, during which time the device detected and recorded 78 spontaneous arrhythmias in 21 individuals. All arrhythmias were either successfully converted back to normal by the defibrillator or resolved on their own. Because the S-ICD® System memory stores data from only the 22 most recent arrhythmia episodes, there may have been other detected episodes that could not be analyzed by investigators. In March 2015, the FDA granted marketing approval through a PMA supplement for the Emblem™ S-ICD System, the second-generation system. Results from a pooled analysis of the IDE study and EFFORTLESS (Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD) study (Lambiase et al.), reported by Burke et al. (2015), in which 889 individuals who underwent implantation were followed for over a 3-year period. Subcutaneous ICD showed high shock efficacy for spontaneous ventricular arrhythmias and a decreasing incidence of inappropriate shocks. The complication-free rate and low mortality rate extended beyond the first year. The rate of inappropriate shocks and the risks of infection and total complications decreased as professional providers who performed the procedure gained more experience with the device. These data provided further support for the safety and efficacy of the S-ICD in individuals with primary (i.e., individuals at high risk for sudden cardiac death but who have not yet experienced life-threatening ventricular tachyarrhythmia or ventricular fibrillation) and secondary indications (i.e., individuals who have experienced a potentially life-threatening episode of ventricular tachyarrhythmia) without pacing indications over a 3-year period. As part of the approval, the FDA is requiring the manufacturing company to conduct a postmarket study to assess the long-term safety and performance of the device and to assess differences in effectiveness across genders. The study will follow 1616 individuals for 5 years.

Subcutaneous ICD is intended for individuals who do have standard indications for an ICD, but do not require pacing for bradycardia, or antitachycardia overdrive pacing for ventricular tachycardia. Individuals who have comorbid conditions that preclude access to the vasculature or heart may now benefit from defibrillation therapy with S-ICD, because S-ICD does not require access to the vasculature or heart, and it is reported to avoid some risks associated with transvenous leads such as venous occlusion, embolic vascular events, and lead failure from subclavian crush. It can be used for individuals with congenital heart disease, individuals lacking venous access, and individuals with indwelling catheters who are at high risk for infection, along with individuals who are immunocompromised, who are on dialysis, who need to preserve venous access, and for younger individuals for whom lead longevity is a concern.

The PRAETORIAN (Randomized Trial to Study the Efficacy and Adverse Effects of the Subcutaneous and Transvenous Implantable Cardioverter Defibrillator [ICD] in Patients With a Class I or IIa Indication for ICD Without an Indication for Pacing) (2020) and PRAETORIAN-XL (2025) trials were noninferiority trials designed to establish clinical equivalence between a S-ICD and transvenous ICD (TV-ICD). In PRAETORIAN, 876 individuals were enrolled to receive a S-ICD or TV-ICD. Exclusion criteria largely reflected the capabilities of an S-ICD (i.e., no indication for antibradycardia pacing or antitachycardia pacing). The primary endpoint consisted of device-related complications and inappropriate shocks at 4 years (an endpoint that has not been previously utilized). Of note, early/expected battery depletions were not included in the device-related complications component, and 11.3% of individuals received a dual-chamber device. Both of these are significant, as they both would artificially inflate S-ICD safety. The primary endpoint occurred in 68 participants in both groups, leading to a noninferiority conclusion. An additional 4 years of device-related complications were studied in the PRAETORIAN-XL trial. While 528 individuals continued in the study, with a balance between groups, the 121 who decided not to continue were significantly different from those who chose to continue (introducing selection bias). Additionally, a significant portion of individuals from both groups switched devices. Both of these factors minimize the impact and interpretability of the intent-to-treat analysis. Ninety-eight complications (notwithstanding the above limitations of this endpoint) occurred through 8 years of follow-up. Thirty-three events occurred in those with an S-ICD, 58 with a TV-ICD, and seven with a CRT-D (some individuals upgraded devices). The authors conclude that a S-ICD should be considered in all individuals without a need for pacing, but also highlight that (1) adjudicators were not blind to device type, and (2) the power and sample size calculation was of PRAETORIAN, not PRAETORIAN-XL. Despite the attempt to provide exchangeability between treatment groups, the PRAETORIAN and PRAETORIAN-XL trials continued to introduce biases along the way.

The Pediatric and Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS) (2014) published a consensus statement on the recognition and management of arrhythmias in adult congenital heart disease, stating that the S-ICD may be a reasonable option in adults with congenital heart disease in whom transvenous access is not possible or desirable and in whom bradycardia and ATP functions are not essential.

In June 2013, the HRS submitted a letter supporting coverage of the S-ICD® System as a medically reasonable option for individuals who meet criteria for a standard transvenous ICD for primary or secondary prevention of sudden cardiac death.

In 2017, the American Heart Association, American College of Cardiology, and HRS published joint guidelines on the management of individuals with ventricular arrhythmias and the prevention of sudden cardiac death; the guidelines state that individuals who meet criteria for an ICD who have inadequate vascular access or are at high risk for infection, and in whom pacing for bradycardia or VT termination or as part of cardiac resynchronization therapy is neither needed nor anticipated, a subcutaneous ICD is recommended.​

The National Institute for Health and Care Excellence (NICE) 2017 Guideline states that the current evidence on the efficacy of the insertion of an S-ICD for the prevention of sudden cardiac death is adequate to support its use provided standard arrangements are in place for clinical governance, consent, and audit. 

EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
​​

The Aurora EV-ICD System (Medtronic Inc.) is a novel extravascular ICD indicated for the treatment of life-threatening ventricular arrhythmias that can lead to sudden cardiac arrest (SCA) and sudden cardiac death (SCD). The system includes a single-chamber implantable pulse generator, an extravascular quadripolar lead for sensing, pacing, and defibrillation, and sternal and transverse tunneling tools for positioning the leads. The safety and/or effectiveness of the Aurora EV-ICD System cannot be established by review of the available published peer-reviewed literature.


The Aurora EV-ICD System includes Medtronic's proprietary MRI SureScan technology, which allows individuals to safely undergo MRI when the EV-ICD is programmed and used according to specified MRI conditions. The EV-ICD implantation procedure may be performed in a cardiac catheterization laboratory or surgical suite using fluoroscopic guidance, during which the individual is sedated or under general anesthesia. The distal portion of the EV-ICD lead is implanted via a small incision between the inferior point of the xiphoid process and left costal margin with the use of the tunneling tool under fluoroscopic guidance. After the distal lead is positioned, tested, and secured, the proximal portion of the lead is tunneled to a subcutaneous device pocket near the left midaxillary line, where it is connected to the pulse generator.

 

Substernal placement of the lead enables pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of a transvenous implantable cardioverter defibrillator (TV-ICD). The Aurora EV-ICD System was designed to avoid certain risks of traditional transvenous ICDs, including long-term complications such as vessel occlusion and infection.


The Aurora EV-ICD System was initially approved by the FDA on October 20, 2023, under P220012, product code LWS (ICD [non-CRT]) and NVY (permanent defibrillator electrodes). 


In 2022 and subsequently in 2024, Friedman et al. published the results of the Aurora EV-ICD pivotal trial. The prospective, single-arm trial enrolled 356 individuals from various countries. The primary efficacy endpoint was successful defibrillation at implantation, and the primary safety endpoint was freedom from major system- or procedure-related complications at 6 months. The Aurora EV-ICD provides a unique opportunity to build upon the strengths of transvenous ICDs (namely antitachycardia pacing) and subcutaneous ICDs (namely lack of transvenous leads), yet the pivotal trial fails to study a primary efficacy endpoint supporting this clinical role. This is a major limitation, which is explored further below. Regarding the primary efficacy endpoint, 307 participants initiated testing, testing was completed in 302, and testing was successful in 298. Thus, successful defibrillation at implantation was greater than the established performance goal of 88%. The primary safety endpoint was also met, as freedom from major system- or procedure-related complications was significantly greater than the performance goal of 79%. Although not studied in a primary manner, as mentioned above, spontaneous events and subsequent therapies are described. All 18 episodes of discrete spontaneous episodes were successfully converted to sinus rhythm (78% of which were converted on the first shock). Additionally, antitachycardia pacing was delivered in 10 participants, successfully terminating 70% of episodes. Inappropriate therapy was also common as 9.7% of the participants received a total of 118 inappropriate shocks during an average 10.6 months of follow-up.
 
In 2024, analysis of long-term follow up of the pivotal trial was published. The analysis was carried out through 3 years, but it is worth noting that at 2 years, 252 individuals completed follow up, while at 3 years, only 48 individuals completed follow-up. The attrition of evaluable participants at 3 years severely limits the generalizability of the results given the increased likelihood of selection bias. Appropriate therapy was received by 24 participants for 82 spontaneous episodes through 3 years. Among discrete spontaneous episodes, all 17 participants (27 episodes) were successfully converted back to normal sinus rhythm after shock. Thirty-seven of 48 monomorphic ventricular tachycardia episodes were successfully terminated by antitachycardia pacing. Freedom from major system- or procedure-related complications was 91.9% and 89.0% at 1 and 3 years, respectively. Inappropriate shocks were received by 46 individuals (135 episodes) through 3 years.
 
There are several important limitations to the pivotal trial. First, as noted by the authors, there is a lack of a comparator in the trial (i.e., transvenous ICD or subcutaneous ICD). This is particularly important given the frequency of these devices used in the United States, the recency of other ICD head-to-head trials (i.e., PRAETORIAN and PRAETORIAN-XL trials), the severity of risks associated with device inadequacy, and the long-standing history of these comparators. Second, the Aurora EV-IVD has the potential to fill a unique gap between transvenous ICDs and subcutaneous ICDs—those with a contraindication to a transvenous ICD (of which a subcutaneous ICD is recommended) yet require antitachycardia pacing (which is a contraindication to a subcutaneous ICD). However, despite this clear clinical role, the inclusion/exclusion criteria does not select for this population. The pivotal trial of the subcutaneous ICD did select for a narrow population for its clinical role and thus serves as a precedence for trial design. Third, as briefly mentioned above, again considering the unique role that the Aurora EV-ICD has to fill, namely the availability of antitachycardia pacing, antitachycardia pacing effectiveness is not a primary endpoint, but rather ancillary. Rather than testing defibrillation at implantation (as important as it is), antitachycardia pacing effectiveness ought to have been the primary endpoint. The crux to this limitation is that the design of the trial, which is centered around an incorrect endpoint, precludes appraisal of the purported health improvements claimed by utilizing this novel EV-ICD system and thus would need to be substantiated in future trials. Fourth, when considering appropriate and inappropriate therapies, the Aurora EV-ICD provided more inappropriate therapy compared to both transvenous ICDs and subcutaneous ICDs described in the PRAETORIAN trial. Additionally, appropriate therapy was delivered less frequently than in the PRAETORIAN trial (in both antitachycardia pacing and shocks), which, as the authors of the Aurora EV-ICD pivotal trial suggest, may be due to the young population they selected. As such, generalizability is a concern.
 
An inappropriate shock-reducing algorithm was developed that was not included in the pivotal trial, but is included in the Enlighten postapproval registry study. In 2025, Crozier et al. reported the periprocedural outcomes of the postapproval study, but this study does not aid in the understanding of net health improvement. The trial is estimated to be completed in 2030.
 
Lastly, there are no clinical practice guidelines that support the use of the Aurora EV-ICD. The most recent appropriate use criteria provided by the ACC/AHA do not contain potential uses of the device (Russo et al., 2025).

References

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Angelini E, Albert K, Duncker D. The extravascular implantable cardioverter-defibrillator: technology, evidence, and clinical perspectives. Der extravaskuläre implantierbare Kardioverter-Defibrillator: Technik, Evidenz und klinische Perspektiven. Herz. 2025;50(6):417-426.


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Birnie DH, Sauer WH, Bogun F, et al. HRS expert consensus statement on the diagnosis and management of arrhythmias associated with cardiac sarcoidosis. Heart Rhythm. 2014;11(7):1305-1323.


Boersma L, Burke MC, Neuzil P, et al. Infection and mortality after implantation of a subcutaneous ICD after transvenous ICD extraction. Heart Rhythm. 2016;13(1):157-164.


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Burke MC, Gold MR, Knight BP, et al. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry. J Am Coll Cardiol. 2015;65(16):1605-1615.

 

Centers for Medicare & Medicaid Services (CMS). MLN Matters: ICD-10 & Other Coding Revisions to National Coverage Determinations: July 2023 Update. [CMS Web site]. February 2023. Available at: MM13070 - ICD-10 & Other Coding Revisions to National Coverage Determinations: July 2023 Update (cms.gov). Accessed January 15, 2026.

 

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Centers for Medicare & Medicaid Services. National Coverage Determination (NCD). Decision memo for implantable cardioverter defibrillators (CAG-00157R4). [CMS Web site]. 02/15/2018. Available at: https://www.cms.gov/medicare-coverage-database/details/n ca-decision-memo.aspx?NCAId=288. Accessed January 15, 2026.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD).20.4: Implantable Automatic Defibrillators (ICDs). [CMS Web site]. 07/31/2023. Available at: NCD - Implantable Cardioverter Defibrillators (ICDs) (20.4). Accessed January 15, 2026.

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Crozier I, Murgatroyd F, Amin A, et al. Periprocedural outcomes from the postmarket study of the extravascular implantable cardioverter-defibrillator: Preliminary Enlighten study results and meta-analysis. Heart Rhythm. 2026;23(1):180-185.


Epstein AE, DiMarco JP, Ellenbogen KA, et al. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2013;61(3):6-75.


Friedman P, Murgatroyd F, Boersma LVA, et al. Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator. N Engl J Med. 2022;387(14):1292-1302.


Friedman P, Murgatroyd F, Boersma LVA, et al. Performance and Safety of the Extravascular Implantable Cardioverter Defibrillator Through Long-Term Follow-Up: Final Results From the Pivotal Study. Circulation. 2024;151(4):322-332.


Gold MR, Aasbo JD, Weiss R, et al. Infection in patients with subcutaneous implantable cardioverter-defibrillator: Results of the S-ICD Post Approval Study. Heart Rhythm. 2022;19(12):1993-2001. 

Gold MR, Theuns DA, Knight BP, et al. Head-to-head comparison of arrhythmia discrimination performance of subcutaneous and transvenous ICD arrhythmia detection algorithms: the START study. J Cardiovasc Electrophysiol. 2012;23(4):359-366.

 

Gold MR, Lambiase PD, El-Chami MF, et al. Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial. Circulation. 2021;143(1):7-17. 

Groh CA, Sharma S, Pelchovitz DJ, et al. Use of an electrocardiographic screening tool to determine candidacy for a subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2014;11(8):1361-1366.

Heart Rhythm Society (HRS). Payment for the Subcutaneous Implantable Defibrillator (S-ICD™) System. [HRS Web site]. June 2017. Available at: Coverage and Payment for the Subcutaneous Implantable Defibrillator (S-ICD™) System - HRS. Accessed January 15, 2026.

 

Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;79(17):1757-1780.

Hernandez-Ojeda J, Arbelo E, Borras R, et al. Patients With Brugada syndrome and implanted cardioverter defibrillators: long-term follow-up. J Am Coll Cardiol. 2017;70(16):1991-2002.

Khairy P, Van Hare GF, Balaji S, et al. PACES/HRS expert consensus statement on the recognition and management of arrhythmias in adult congenital heart disease: developed in partnership between the Pediatric and Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS). Endorsed by the governing bodies of PACES, HRS, the American College of Cardiology (ACC), the American Heart Association (AHA), the European Heart Rhythm Association (EHRA), the Canadian Heart Rhythm Society (CHRS), and the International Society for Adult Congenital Heart Disease (ISACHD). Can J Cardiol. 2014;30(10):e1-e63.

 

Knight BP. Implantable cardioverter-defibrillators: Choosing a device and system descriptions. [UpToDate Web site]. 10/20/2023. Available at: https://www.uptodate.com/contents/subcutaneous-implantable-cardioverter-defibrillators?search=Subcutaneous Implantable Cardioverter Defibrillator&source=search_result&selectedTitle=1~20&usage_type=default&display_rank=1. Accessed January 15, 2026.

 

Knops RE, Olde Nordkamp LRA, Delnoy PHM, et al. Subcutaneous or transvenous defibrillator therapy. N Engl J Med. 2020;383(6):526-536. 

Kobe J, Reinke F, Meyer C, et al. Implantation and follow-up of totally subcutaneous versus conventional implantable cardioverter-defibrillators: a multicenter case-control study. Heart Rhythm. 2013;10(1):29-36.


Kooiman KM, Knops RE, Olde Nordkamp L, et al. Inappropriate subcutaneous implantable cardioverter-defibrillator shocks due to T-wave oversensing can be prevented: Implications for management. Heart Rhythm. 2014;11(3):426-434.

Lambiase PD, Srinivasan NT. Early experience with the subcutaneous ICD. Curr Cardiol Rep. 2014;16(8):516.

Lambiase PD, Theuns DAMJ, Barr C, et al. International experience with a subcutaneous ICD: preliminary results of the EFFORTLESS S-ICD Registry. Heart Rhythm. 2012;9(suppl):S15.

 

Mantini N, Williams B, Stewart J, et al. Cardiac sarcoid: a clinician's review on how to approach the patient with cardiac sarcoid. Clin Cardiol. 2012;35(7):410-415. 


Markman TM, Callahan TD. The extravascular ICD: Evolving paradigms in sudden death prevention. Heart Rhythm. 2026;23(1):186-193.

Mithani AA, Kath H, Hunter K, et al. Characteristics and early clinical outcomes of patients undergoing totally subcutaneous vs. transvenous single chamber implantable cardioverter defibrillator placement. Europace. 2018;20(2):308-314.


Monkhouse C, Ahsan S, Lambiase PD. Contemporary issues in implantable cardioverter-defibrillators: Personalising device therapy. Indian Heart J. Published online October 17, 2025.​

National Institute for Health and Clinical Excellence (NICE). Subcutaneous implantable cardioverter defibrillator insertion for preventing sudden cardiac death. [NICE Web site]. December 20, 2017. Available at: 1 Recommendations | Subcutaneous implantable cardioverter defibrillator insertion for preventing sudden cardiac death | Guidance | NICE. Accessed January 15, 2026.


Olde Nordkamp LRA, de Veld JA, Ghani A, et al. Device-related complications in transvenous versus subcutaneous defibrillator therapy during long-term follow-up: the PRAETORIAN-XL trial. Circulation. 2025. Available at: Device-related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-term Follow-up: the PRAETORIAN-XL Trial | Circulation. Accessed January 15, 2026.​


Ommen SR, Mital S, Burke MA, et al. 2020 AHA/ACC Guideline for the Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines Circulation. 2020;142(25):e558-e631.


Peigh G, Knight BP. Implantable Defibrillators: Which Is the Best Device for Each Patient?. J Cardiovasc Electrophysiol. 2025;36(10):2767-2775.

Plitt A, Dorbala S, Albert MA, et al. Cardiac sarcoidosis: case report, workup, and review of the literature. Cardiol Ther. 2013;2(2):181-197. 

Raphael C, Briscoe C, Davies J, et al. Limitations of the New York Heart Association functional classification system and self‐reported walking distances in chronic heart failure. Heart. 2007;93(4):476-482.

Russo AM, Stainback RF, Bailey SR, et al. ACCF/HRS/AHA/ASE/HFSA/SCAI/SCCT/SCMR 2013 appropriate use criteria for implantable cardioverter-defibrillators and cardiac resynchronization therapy: a report of the American College of Cardiology Foundation appropriate use criteria task force, Heart Rhythm Society, American Heart Association, American Society of Echocardiography, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance. J Am Coll Cardiol. 2013;61(12):1318-1368.


Russo AM, Desai MY, Do MM, et al. ACC/AHA/ASE/HFSA/HRS/SCAI/SCCT/SCMR 2025 Appropriate Use Criteria for Implantable Cardioverter-Defibrillators, Cardiac Resynchronization Therapy, and Pacing. J Am Coll Cardiol. 2025;85(11):1213-1285.

Saxon LA. The subcutaneous implantable defibrillator: a new technology that raises an existential question for the implantable cardioverter-defibrillator. Circulation. 2013;128(9):938-940.

 

Shah MJ, Silka MJ, Silva JNA, et al. 2021 PACES Expert Consensus Statement on the Indications and Management of Cardiovascular Implantable Electronic Devices in Pediatric Patients: Developed in collaboration with and endorsed by the Heart Rhythm Society (HRS), the American College of Cardiology (ACC), the American Heart Association (AHA), and the Association for European Paediatric and Congenital Cardiology (AEPC) Endorsed by the Asia Pacific Heart Rhythm Society (APHRS), the Indian Heart Rhythm Society (IHRS), and the Latin American Heart Rhythm Society (LAHRS). JACC Clin Electrophysiol. 2021;7(11):1437-1472.


Tang JE, Dodge RE 3rd, Guirguis F, et al. New Horizons in Nontransvenous Arrhythmia Management: Aurora Extravascular ICD. J Cardiothorac Vasc Anesth. 2025;39(6):1564-1570.


US Food and Drug Administration. Class 1 Device Recall EMBLEM. January 19, 2021. Available at: Class 1 Device Recall EMBLEM. Accessed January 15, 2026.


US Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Subcutaneous Implantable Defibrillator (S-ICD)® System. Premarket approval letter. [FDA Web site]. 09/28/2012. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110042a.pdf. Accessed January 15, 2026.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH).Subcutaneous Implantable Defibrillator (S-ICD®) System. Summary of safety and effectiveness. [FDA Web site]. 09/28/2012 Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110042b.pdf. Accessed January 15, 2026.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). A patient guide. Living with your Subcutaneous Implantable Defibrillator (S-ICD®) System. Labeling. [FDA Web site]. 2012. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110042c.pdf. Accessed January 15, 2026.​


Wasiak M, Tajstra M, Kosior D, et al. An implantable cardioverter-defibrillator for primary prevention in non-ischemic cardiomyopathy: A systematic review and meta-analysis. Cardiol J. 2023;30(1):117-124.

 

Weiss R, Knight BP, Gold MR, et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation. 2013;128(9):944-953.

Yaminisharif A, Nader S, Akbar S, et al. Generator and lead-related complications of implantable cardioverter defibrillators. Int Cardiovasc Res J. 2014;8(2):66-70.


Zeppenfeld K, Tfelt-Hansen J, de Riva M, et al. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J​. 2022;43(40):3997-4126.

Coding

CPT Procedure Code Number(s)
MEDICALLY NECESSARY

33216, 33217, 33218, 33220, 33223, 33230, 33240, 33241, 33243, 33244, 33249, 33262, 33263, 33270, 33271, 33272, 33273, 93260, 93261, 93282, 93283, 93297, 93640, 93641, 93642, 93644

EXPERIMENTAL/INVESTIGATIONAL

0571T, 0572T, 0573T, 0574T, 0575T, 0576T, 0577T, 0578T, 0579T, 0580T, 0614T
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)

NOT AN ALL INCLUSIVE LIST

D86.85 Sarcoid myocarditis

I25.5 Ischemic cardiomyopathy

I42.0 Dilated cardiomyopathy

I42.1 Obstructive hypertrophic cardiomyopathy

I42.2 Other hypertrophic cardiomyopathy

I45.81 Long QT syndrome

I47.10 Supraventricular tachycardia, unspe cified

I47.11 Inappropriate sinus tachycardia, so stated

I47.19 Other supraventricular tachycardia

I47.20 Ventricular tachycardia, unspecified

I47.21 Torsades de pointes

I47.29 Other ventricular tachycardia

I49.01 Ventricular fibrillation

I49.8 Other specified cardiac arrhythmias

I49.9 Cardiac arrhythmia, unspecified​

HCPCS Level II Code Number(s)

C1721 Cardioverter-defibrillator, dual chamber (implantable)

C1722 Cardioverter-defibrillator, single chamber (implantable)

C1895 Lead, cardioverter-defibrillator, endocardial dual coil (implan table)

C1896 Lead, cardioverter-defibrillator, other than endocardial single or dual coil (implantable)

Revenue Code Number(s)
N/A


Coding and Billing Requirements

Policy History

​Revisions From 05.00.77f:
​04/01/2026

​This version of the policy will become effective 04/01/2026.

The policy has been reviewed and reissued to communicate the Company's continuing position on implantable cardioverter defibrillators.
11/03/2025
​​​​This version of the policy will become effective 11/03/2025. 

The intent of this policy has changed. The policy now addresses transvenous, subcutaneous, and extravascular implantable cardioverter defibrillators.​​
​
As such, the title of this policy was revised.

Title Change: Implantable Cardioverter Defibrillators

Applicable codes have been added to the policy due to criteria changes.
​
Revisions From 05.00.77e:​
​04/02/2025
​This policy has been reissued in accordance with the Company's annual review process.​​
03/25/2024​​​​This version of the policy will become effective 03/25/2024. 

The intent of this policy has not changed, however, the policy criteria for cardiac sarcoid was revised to remove the indication for permanent pacemaker implantation.​​
​
In addition, the following ICD-10 Diagnosis code was added to the policy:

I47.11 Inappropriate sinus tachycardia, so stated​

Revisions From 05.00.77d:
10/01/2023
​I​nclusion of a policy in a Code Update memo does not imply that a full review of

the policy was completed at this time.

 

This policy has been identified for the ICD-10 code update, effective 10/01/2023. 


The following ICD-10 code has been termed and removed from this policy:

I47.1 Supraventricular tachycardia


The following ICD-10 codes have been added to this policy:

I47.10 Supraventricular tachycardia, unspecified

I47.19 Other supraventricular tachycardia​


Revisions From 05.00.77c:
03/22/2023​

The policy has been reviewed and reissued to communicate the Company’s continuing position on Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) for Treating Life-threatening Ventricular Tachyarrhythmia​.

​10/01/2022
​I​nclusion of a policy in a Code Update memo does not imply that a full review of

the policy was completed at this time.

 

This policy has been identified for the ICD-10 code update, effective 10/01/2022. 


The following ICD-10 code has been termed and removed from this policy:

I47.2 Ventricular tachycardia


The following ICD-10 codes have been added to this policy:

I47.20 Ventricular tachycardia, unspecified​

I47.21 Torsades de pointes

​I47.29 ​​Other ventricular tachycardia​​


Revisions From 05.00.77b:
06/15/2022

​The policy has been reviewed and reissued to communicate the Company’s continuing position on Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) for Treating Life-threatening Ventricular Tachyarrhythmia​.​
06/02/2021This policy has been reissued in accordance with the Company's annual review process.​
​03/22/2021

​This version of the policy will become effective 03/22/2021. This policy has been updated in consideration of a 2014 consensus statement from the Heart Rhythm Society (HRS) and 2017 joint guidelines from the American Heart Association, American College of Cardiology, and HRS:
  • ​Coverage was added for the condition of cardiac sarcoid in individuals considered to be at high risk for sudden cardiac death.
  • Language was modified regarding the indication for nonischemic dilated cardiomyopathy to incorporate that reversible causes have been excluded
The following medically necessary criteria have been added to this policy for the primary prevention of life-threatening ventricular tachyarrhythmia:​

  • Diagnosis of cardiac sarcoid and considered to be at high risk for sudden cardiac death

The following criteria have been added for primary prevention of life-threatening ventricular tachyarrhythmia, individuals must not have any of the following:​
  • Noncardiac disease that would be associated with life expectancy less than 1 year

Revisions From 05.00.77a:
11/20/2019This policy has been reissued in accordance with the Company's annual review process.
10/08/2018This version of the policy will become effective 10/08/2018.

The following criteria have been added as possible indications or requirements for subcutaneous implantable cardioverter defibrillator (S-ICD) for the treatment of life-threatening ventricular tachyarrhythmia:
  • New York Heart Association (NYHA) functional class II or class III symptoms added to current condition nonischemic dilated cardiomyopathy
  • Three months treatment with optimized medical therapy added to current condition nonischemic dilated cardiomyopathy and left ventricular ejection fraction of 35 percent or less
  • Diagnosis of a specified cardiac ion channelopathies and considered to be at high risk for sudden cardiac death
  • Current criterion, history of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia, after reversible causes (e.g., acute ischemia) have been excluded, clarified as S-ICD for secondary prevention of life threatening ventricular tachyarrhythmia
  • Contraindication to a transvenous ICD due to specified conditions
  • Cardiac revascularization procedure (coronary artery bypass graft [CABG], or percutaneous coronary intervention [PCI] with angioplasty and/or stenting), when performed, must be more than three months prior to S-ICD treatment
  • Individuals must not have NYHA functional classification Class IV heart failure (unless eligible to receive a combination cardiac resynchronization therapy ICD device)
  • Left ventricular ejection fraction must be measured by echocardiography, radionuclide (nuclear medicine) imaging, cardiac magnetic resonance imaging (MRI), or catheter angiography

Effective 10/05/2017 this policy has been updated to the new policy template format.
11/3/2025
11/3/2025
4/1/2026
05.00.77
Medical Policy Bulletin
Commercial
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Independence Blue Cross is a subsidiary of Independence Health Group, Inc. — independent licensees of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.