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Implantable Cardioverter Defibrillators
MA05.027f

Policy

This policy uses coverage criteria developed solely based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents.​

MEDICALLY NECESSARY

An implantable cardioverter defibrillator (ICD) is considered medically necessary and, therefore, covered when any of the following criteria are met:

  • A personal history of sustained ventricular tachyarrhythmia (VT) or cardiac arrest due to ventricular fibrillation (VF) demonstrated by either of the following:
    • ​An episode of sustained VT, either spontaneous or induced by an electrophysiology (EP0 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.
  • ​A prior MI and a measured left ventricular ejection fraction (LVEF) ≤ 30%. The individual must not have any of the following:
    • ​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 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.
  • ​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%. The individual must not have any of the following:
    • ​Had a CABG, or PCI with angioplasty and/or stenting, within the past 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.
  • ​Severe, non-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%, been on optimal medical therapy for at least 3 months. The individual must not have any of the following:
    • ​Had a CABG or PCI with angioplasty and/or stenting, within the past 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.
    • 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.
  • An individual 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 covered indications above, the following additional criteria must also be met:
    • ​The individual must be clinically stable (e.g., not in shock, from any etiology);
    • LVEF must be measured by echocardiography, radionuclide (nuclear medicine) imaging, cardiac magnetic resonance imaging (MRI), or catheter angiography;
    • The individual must not have any of the following:
      • ​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 1 year; OR
      • Supraventricular tachycardia such as atrial fibrillation with a poorly controlled ventricular rate.

In the indications listed above with waiting periods (i.e., individual has had a CABG or PCI with angioplasty and/or stenting within the past 3 months, or had an MI within the past 40 days), exceptions to the waiting periods can be made for either of the following:

  • The individual meets the criteria for cardiac pacemakers, and meets the criteria for an ICD, may receive the combined devices in one procedure, at the time the pacemaker is clinically indicated; OR
  • The individual has an existing ICD may receive an ICD replacement if it is required due to the end of battery life, ERI, or device/lead malfunction. ​

NOTE: An ICD is considered medically necessary and, therefore, covered when an individual is a candidate for heart transplantation on the United Network for Organ Sharing (UNOS) transplant list awaiting a donor heart, as with cardiac resynchronization therapy, as a bridge-to-transplant to prolong survival until a donor becomes available.​


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

This policy is consistent with Medicare’s coverage determination for implantable automatic defibrillators. The Company’s payment methodology may differ from Medicare.

NEW YORK HEART ASSOCIATION FUNCTIONAL CLASSIFICATION

ClassPatient 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.

PACEMAKER CRITERIA

​​The covered indications, in accordance with NCD 20.8.3 Single Chamber and Dual Chamber Permanent Cardiac Pacemakers are:
  • ​Documented non-reversible symptomatic bradycardia due to sinus node dysfunction, and
  • Documented non-reversible symptomatic bradycardia due to second degree and/or third degree atrioventricular block.
BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, implantable cardioverter defibrillators are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

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 patients 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 EmblemTM 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 defibrillators

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 S-ICD has been developed that does not employ transvenous leads, with the goal of 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 EmblemTM 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 premarketing approval (PMA) through a PMA supplement for the EmblemTM 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 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 and secondary indications 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 assess, and for younger individuals for whom lead longevity is a concern.

In 2014, the Pediatric and Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS) published a consensus statement on the recognition and management of arrhythmias in adult congenital heart disease which states 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 Heart Rhythm Society published joint guidelines on the management of individuals with ventricular arrhythmias and the prevention of sudden cardiac death which 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 Aurora EV-ICD System includes Medtronic's proprietary MRI (magnetic resonance imaging) 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, 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. 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, spontaneous events and subsequent therapies are described. Efficacy of nondiscrete spontaneous episodes is not described; however, 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, Friedman et al. provided an analysis of the long-term follow up of the pivotal trial (described above). 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. One individual completed 4 years of follow-up. 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 one and 3 years, respectively. Inappropriate shocks were received by 46 individuals (135 episodes) through 3 years.


An inappropriate shock-reducing algorithm was developed that was not included in the pivotal trial, but is included in the Enlighten post-approval registry study.


In 2025, Crozier et al. reported the periprocedural outcomes of the postapproval study, reinforcing procedural outcomes from the pivotal trial in a real-world setting. The trial is estimated to be completed in 2030.

References

Akel T, Lafferty J. Implantable cardioverter defibrillators for primary prevention in patients with nonischemic cardiomyopathy: A systematic review and meta-analysis. Cardiovasc Ther. 2017;35(3).


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.


Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2017;72(14):1677-1749.

American Heart Association (AHA). Implantable cardioverter defibrillator (ICD)  [AHA Web site]. 10/29/2024. Available at: Implantable Cardioverter Defibrillator (ICD) | American Heart Association. Accessed January 15, 2026.

Aziz S, Leon AR, El-Chami MF. The subcutaneous defibrillator. A review of literature. [American College of Cardiology Web site]. 04/22/2014. Available at: The Subcutaneous Defibrillator: A Review of the Literature - American College of Cardiology (acc.org). Accessed January 15, 2026.

Bardy GH, Smith WM, Hood MA, et al. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010;363(1):36-44.

 

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.


Boersma LV, El-Chami M, Steinwender C, et al. Practical considerations, indications, and future perspectives for leadless and extravascular cardiac implantable electronic devices: a position paper by EHRA/HRS/LAHRS/APHRS. Europace. 2022;24(10):1691-1708.

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.

 

Centers for Medicare & Medicaid Services (CMS). MLN Matters: ICD-10 & Other Coding Revisions to National Coverage Determinations: April 2024 Update. [CMS Web site]. Available at: MM13390 - ICD-10 & Other Coding Revisions to National Coverage Determinations: April 2024 Update (CR 1 of 2) (cms.gov). Accessed January 15, 2026.

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.

Chang PM, Doshi R, Saxon LA. Subcutaneous implantable cardioverter-defibrillator. [American Heart Association Web site]. 06/09/2014. Available at: http://circ.ahajournals.org/content/129/23/e644.full. Accessed January 15, 2026.

ClinicalTrials.gov. S-ICD® emblSystem IDE Clinical Study. [Clinical Trials.gov Web site]. 10/08/12. Available at: https://clinicaltrials.gov/ct2/show/NCT010 64076. Accessed January 15, 2026.


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)

0571T, 0572T, 0573T, 0574T, 0575T, 0576T, 0577T, 0578T, 0579T, 0580T, 0614T, 33202, 33203, 33215, 33216, 33217, 33218, 33220, 33223, 33224, 33225, 33230, 33231, 33240, 33241, 33243, 33244, 33249, 33262, 33263, 33264, 33270, 33271, 33272, 33273 ​

ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)

NOT AN ALL INCLUSIVE LIST


G90.01 Carotid sinus syncope

I25.2 Old myocardial infarction

I25.5 Ischemic cardiomyopathy

I42.00 Dilated cardiomyopathy, unspecified

I42.01 Familial-genetic dilated cardiomyopathy

I42.09 Other dilated cardiomyopathy

I42.1 Obstructive hypertrophic cardiomyopathy

I42.2 Other hypertrophic cardiomyopathy

I42.6 Alcoholic cardiomyopathy

I42.7 Cardiomyopathy due to drug and external agent

I42.81 Arrhythmogenic cardiomyopathy

I42.89 Other cardiomyopathies not elsewhere classified

​I44.0 Atrioventricular block, first degree

I44.1 Atrioventricular block, second degree

I44.2 Atrioventricular block, complete

I44.30 Unspecified atrioventricular block

I44.7 Left bundle-branch block, unspecified

I45.10 Unspecified right bundle-branch block

I45.19 Other right bundle-branch block

I45.2 Bifascicular block

I45.3 Trifascicular block

I45.6 Pre-excitation syndrome

I45.81 Long QT syndrome

I45.89 Other specified conduction disorders

I46.2 Cardiac arrest due to underlying cardiac condition

I46.9 Cardiac arrest, cause unspecified

I47.10 Supraventricular tachycardia, unspecified

I47.11 Inappropriate sinus tachycardia, so stated

I47.19 Other supraventricular tachycardia

I47.20 Ventricular tachycardia, unspecified

I47.21 Torsades de pointes

I47.22 Catecholaminergic polymorphic ventricular tachycardia [CPVT]

I47.29 Other ventricular tachycardia

I47.9 Paroxysmal tachycardia, unspecified

I48.11 Longstanding persistent atrial fibrillation

I48.19 Other persistent atrial fibrillation

I48.3 Typical atrial flutter

I48.4 Atypical atrial flutter

I48.91 Unspecified atrial fibrillation

I48.92 Unspecified atrial flutter

I49.01 Ventricular fibrillation

I49.02 Ventricular flutter

I49.3 Ventricular premature depolarization

I49.5 Sick sinus syndrome

I49.9 Cardiac arrhythmia, unspecified

I50.21 Acute systolic (congestive) heart failure

I50.22 Chronic systolic (congestive) heart failure

I50.23 Acute on chronic systolic (congestive) heart failure

I50.41 Acute combined systolic (congestive) and diastolic (congestive) heart failure

I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure

I50.43 Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure

I50.84 End stage heart failure

I5A Non-ischemic myocardial injury (non-traumatic)

Q24.6 Congenital heart block

T82.110A Breakdown (mechanical) of cardiac electrode, initial encounter

T82.111A Breakdown (mechanical) of cardiac pulse generator (battery), initial encounter

T82.118A Breakdown (mechanical) of other cardiac electronic device, initial encounter

T82.119A Breakdown (mechanical) of unspecified cardiac electronic device, initial encounter

T82.120A Displacement of cardiac electrode, initial encounter

T82.121A Displacement of cardiac pulse generator (battery), initial encounter

T82.128A Displacement of other cardiac electronic device, initial encounter

T82.129A Displacement of unspecified cardiac electronic device, initial encounter

T82.190A Other mechanical complication of cardiac electrode, initial encounter

T82.191A Other mechanical complication of cardiac pulse generator (battery), initial encounter

T82.198A Other mechanical complication of other cardiac electronic device, initial encounter

T82.199A Other mechanical complication of unspecified cardiac device, initial encounter

T82.6XXA Infection and inflammatory reaction due to cardiac valve prosthesis, initial encounter

T82.7XXA Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts, initial encounter

Z45.02 Encounter for adjustment and management of automatic implantable cardiac defibrillator

Z76.82 Awaiting organ transplant status

Z86.74 Personal history of sudden cardiac arrest​

HCPCS Level II Code Number(s)

C7537 Insertion of new or replacement of permanent pacemaker with atrial transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (e.g., for upgrade to dual chamber system)

C7538 Insertion of new or replacement of permanent pacemaker with ventricular transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (e.g., for upgrade to dual chamber system)

C7539 Insertion of new or replacement of permanent pacemaker with atrial and ventricular transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (e.g., for upgrade to dual chamber system)

C7540 Removal of permanent pacemaker pulse generator with replacement of pacemaker pulse generator, dual lead system, with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (e.g., for upgrade to dual chamber system)

G0448 Insertion or replacement of a permanent pacing cardioverter-defibrillator system with transvenous lead(s), single or dual chamber with insertion of pacing electrode, cardiac venous system, for left ventricular pacing

Revenue Code Number(s)
N/A



Coding and Billing Requirements

Policy History

Revisions From MA05.027f:
10/01/2026
​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 10/01/2026. 


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

I42.0 Dilated cardiomyopathy

I42.8 Other cardiomyopathies​


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

​I42.00 Dilated cardiomyopathy, unspecified

I42.01 Familial-genetic dilated cardiomyopathy

I42.09 Other dilated cardiomyopathy

I42.81 Arrhythmogenic cardiomyopathy

I42.89 Other cardiomyopathies not elsewhere classified

I47.22 Catecholaminergic polymorphic ventricular tachycardia [CPVT]​



Revisions From MA05.027e:​
​04/01/2026
​The policy has been reviewed and reissued to communicare the Company's continuing position on Implantable Cardioverter Defibrillators.​​
10/20/2025
​​​​This version of the policy will become effective 10/20/2025.

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 MA05.027d:
​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 MA05.027c:
​01/01/2024
​Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.​
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 MA05.027b:
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 MA05.027a:
​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​.​
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 ion channelopathies in individuals considered to be at high risk for sudden cardiac death.
  • ​Coverage was added for the condition of cardiac sarcoid in individuals considered to be at high risk for sudden cardiac death.
In addition, language was modified regarding the indication for nonischemic dilated cardiomyopathy to incorporate ​NYHA functional class II or class III symptoms​ ​and three months treatment with optimized medical therapy.​​
​
The following ICD-10 Diagnosis codes were added to the policy:
​D86.85 Sarcoid myocarditis
I25.5 Ischemic cardiomyopathy
I42.0 Dilated cardiomyopathy
I42.2 Other hypertrophic cardiomyopathy
I45.81 Long QT syndrome
I49.8 Other specified cardiac arrhythmias
​
Revisions From MA05.027:
11/20/2019This policy has been reissued in accordance with the Company's annual review process.
08/31/2016The 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.
10/01/2015The following new policy has been developed to communicate the Company’s coverage criteria for subcutaneous implantable cardioverter defibrillator (S-ICD) for treating life-threatening ventricular tachyarrhythmia.

10/1/2026
10/1/2026
MA05.027
Medical Policy Bulletin
Medicare Advantage
No
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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.