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CurrentCignaPolicy 0431

Cardioverter-Defibrillator Devices (ICD, S-ICD, substernal ICD, wearable ICD, AED)

Cigna coverage policy for implantable, subcutaneous, substernal, wearable cardioverter-defibrillators and pediatric AEDs specifying medical necessity criteria for secondary and primary prevention of sudden cardiac death, device-specific restrictions, and related replacement guidance.

Policy Summary

PayerCigna

PolicyCardioverter-Defibrillator Devices (ICD, S-ICD, substernal ICD, wearable ICD, AED)

Policy CodePolicy 0431

Change TypeAnnual reviewFocused reviewPolicy merge

Effective DateJul 15, 2025

Next Review DateJul 15, 202630d

Key ActionDocument LVEF, timing relative to MI/revascularization, EP study results, diagnoses, and completion of guideline-directed medical therapy where required for coverage decisions.

SourceLink

POLICY UPDATE CHANGES

Annual Review 7/15/2025: No clinical policy statement changes.

Focused Review 12/15/2024: Added policy statement for pediatric wearable cardioverter-defibrillators and revised policy statement for Automatic external defibrillators.

Annual Review 8/15/2024: Combined with content from CP 0181 Implantable Cardioverter Defibrillator (ICD) and retired CP 0181; expanded coverage for home AEDs by removing the age limitation.

MultipleCovered Indications

Substernal ICDExperimental/Investigational

S-ICDS-ICD conditional

WCDPlan-dependent coverage (WCD)

5Median first-generation S-ICD longevity (yrs)

3-16%Reported inappropriate shock rates

Coverage Summary

Scope: This policy covers transvenous ICDs, subcutaneous ICDs (S-ICD), substernal/extravascular ICDs (EV-ICD), wearable cardioverter-defibrillators (WCD), and automatic external defibrillators (AED) in the home setting and summarizes medical necessity criteria, device-specific limitations, evidence, guideline positions, and coding references. Coverage stance: mixed — transvenous ICDs and many S-ICD uses are covered when criteria are met, substernal/EV-ICD is treated as experimental/investigational for indications outside available evidence, WCD coverage is plan-dependent, and AED coverage has specific pediatric and home-use considerations. Effective/last review/next review dates: Effective 7/15/2025; Last review 7/15/2025; Next review 7/15/2026. High-level, plan-conditional distinctions: transvenous ICDs are the standard covered devices when guideline-based indications and timing thresholds (e.g., LVEF and post-MI windows) are met; S-ICD is an alternative when the member meets ICD criteria but has no pacing/CRT/ATP indication and passes device-specific screening; EV-ICD/substernal systems have limited published evidence and recent FDA PMA for a specific system but are presented with conditional coverage language pending more long-term comparative data; WCDs are covered only if the member’s plan provides WCD benefits and criteria for temporary bridging or contraindication to implantation are met (including pediatric chest circumference/weight minimums); AEDs require FDA-approved devices and have limited home benefit evidence, with pediatric nonwearable AEDs covered under narrow criteria.

Quick thresholds & coverage flags

LVEF thresholds (common bins)≤30%; ≤35%; ≤40%; 31–35%; 36–40%; 36–49%; >50%

Post-MI timing windows

Transvenous ICD — Secondary Prevention (Medically Necessary Criteria)

A transvenous implantable cardioverter defibrillator (ICD) is considered medically necessary for the secondary prevention of sudden cardiac death when ALL of the following apply:

ALL of the following

Individual with cardiac arrest due to ventricular fibrillation (VF) or hemodynamically unstable sustained ventricular tachycardia (VT) after reversible causes (e.g., myocardial ischemia, electrolyte disorder) have been excluded.
Individual with structural heart disease (e.g., prior myocardial infarction, cardiomyopathy, valvular heart disease, adult congenital heart disease) and spontaneous sustained VT, whether hemodynamically stable or unstable.
Individual with genetic conditions associated with sustained VT/VF (e.g., congenital long QT syndrome, short QT, catecholaminergic polymorphic VT, Brugada syndrome, arrhythmogenic right ventricular cardiomyopathy, hypertrophic cardiomyopathy).
Individuals without structural heart disease
- Bradycardia-dependent VT/VF.
- Idiopathic VF/VT with normal ventricular function (LVEF > 50%).
Individuals with unexplained syncope due to ANY of the following
- Cardiac sarcoidosis with documented spontaneous sustained ventricular tachycardia.
- Ischemic heart disease with inducible sustained monomorphic VT on electrophysiological study.
- Left ventricular non-compaction.
- Nonischemic dilated cardiomyopathy, LVEF ≤ 49%.
Structural heart disease considerations
- Structural heart disease (e.g., prior MI) with LVEF ≤ 35%.
- Structural heart disease (e.g., prior MI) with LVEF 36%–49% and inducible sustained VT/VF on electrophysiological study.
- Tetralogy of Fallot with prior corrective surgery.
Syncope of suspected arrhythmic cause with ANY of the following
- Arrhythmogenic right ventricular cardiomyopathy (ARVC).
- Brugada ECG pattern.
- Cardiac amyloidosis.
- Catecholaminergic polymorphic VT (CPVT).
- Hypertrophic cardiomyopathy (HCM).
- Long QT Syndrome (LQTS) and either: syncope while receiving beta-blockers OR beta-blockers are contraindicated.
  This leaf represents either subcriterion being sufficient.

Subcutaneous ICD (S-ICD) — Criteria, Contraindications, and Coverage Considerations

Subcutaneous ICD - Not Medically Necessary

S-ICD is considered not medically necessary for ANY other indication.

Any indication not meeting the S-ICD medically necessary criteria above

Includes patients who need bradycardia pacing, CRT, or ATP

S-ICD candidacy and limitations: S-ICD is intended for patients who meet standard ICD indications but do not require bradycardia pacing, cardiac resynchronization therapy, or antitachycardia pacing. Limitations include inability to provide pacing/ATP, absence of advanced diagnostics/remote RF interrogation, shorter battery longevity (median first-generation system ~5 years), and higher rates of inappropriate shocks largely due to T-wave oversensing. Reported complications include reintervention (~6.4% within 360 days in EFFORTLESS), inappropriate shocks (~4–16% across studies), pocket infections (reported 1–10% with 1–4% complicated infections), lead migration/dislodgement (3–11%), skin erosion, premature battery depletion, and explantation if pacing/CRT becomes required. Regulatory snapshot: the S-ICD System received FDA PMA approval (P110042) on September 28, 2012.

S-ICD Coverage Considerations summary: S-ICD is covered when the individual meets standard ICD indications and has none of the S-ICD exclusions (no symptomatic bradycardia, no incessant VT, and no spontaneous frequent recurrent VT reliably terminated with ATP). Pre-implant screening is explicitly required with sensing criteria met in ≥1 of 3 leads in 2 different postures (for example supine and sitting or standing); additional disease-specific screening (e.g., stress testing for hypertrophic cardiomyopathy to exclude T-wave oversensing) is recommended. Other listed considerations include avoiding S-ICD use when bradycardia pacing/CRT/ATP is needed, and factoring patient activity, infection/vascular access risk, and device longevity into device selection.

Substernal / Extravascular (EV) ICD — Policy Position & Evidence

Substernal Implantable Cardioverter Defibrillator

Coverage stance:

A substernal implantable cardioverter-defibrillator is considered experimental, investigational or unproven for ANY indication

EV-ICD evidence and regulatory summary: The Aurora EV-ICD System (Medtronic) received FDA PMA (P220012) in October 2023 for use with the Epsila EV lead for pacing, cardioversion, and defibrillation in the anterior mediastinum. The pivotal published study by Friedman et al. (2022) was a single-group, nonrandomized premarket trial (n=316 attempted implants) that met its prespecified performance goals: successful defibrillation at implantation (~98.7% with lower CI bound 96.6%) and freedom from major complications at six months (~92.6% with lower CI bound 89.0%); observed limitations included lack of a control group, expert-center implantation, modest spontaneous arrhythmia event counts, limited long-term follow-up, and limited generalizability. Given these evidence limitations, coverage is described as conditional — consideration may be given when patient indications align with approved use and where EV-ICD advantages (extravascular placement with some pacing capability) are relevant, but recognition remains that larger long-term randomized data are needed.

Wearable Cardioverter-Defibrillator (WCD) — Criteria and Limitations

Wearable Cardioverter-Defibrillator (WCD)

Coverage varies by plan; if coverage is available, WCD is medically necessary when ANY of the following criteria are met:

ANY of the following

High risk but not candidate for ICD: Individual is at high risk for sudden cardiac death and meets criteria for ICD placement but is not currently a suitable candidate for ICD placement because of one of: awaiting heart transplantation; awaiting ICD reimplantation following infection-related explantation; systemic infectious process or other temporary medical condition precludes implantation
Bridge to ICD risk stratification post-MI: As a bridge to ICD risk stratification and possible implantation for patients immediately following myocardial infarction (MI) for either history of VT/VF after first 48 hours OR LVEF ≤ 35%
Bridge for newly diagnosed dilated cardiomyopathy: For primary prevention, as a bridge to ICD risk stratification and possible implantation for newly diagnosed dilated cardiomyopathy with LVEF ≤ 35%
Pediatric contraindication to implantation: Pediatric individual meets criteria for ICD however implantation is contraindicated AND chest circumference ≥ 26 inches (66 cm) AND weight ≥ 41.3 lb (18.75 kg)

Wearable Cardioverter-Defibrillator - Not Medically Necessary

WCD is considered not medically necessary for any other indication.

Any indication not listed in the medically necessary WCD criteria above

Includes contraindications: need for an ICD or existing operating ICD; under age 18 except specific FDA-approved pediatric criteria; vision/hearing or medication issues interfering with response buttons; inability/unwillingness to wear device; exposure to excessive EMI; provides no pacing/ATP

WCD coverage considerations and device limitations: WCD coverage is plan-dependent and, when available, WCDs are medically necessary for high-risk patients who meet ICD criteria but are temporarily unsuitable for implantation (examples: awaiting heart transplant, awaiting reimplantation after infection-related explantation, systemic infection precluding implant) and as a bridge for early post-MI risk stratification (e.g., history of VT/VF after first 48 hours or LVEF ≤35%) or newly diagnosed dilated cardiomyopathy with LVEF ≤35%. WCDs do not provide pacing or ATP. Contraindications/limitations include active ICD presence, age <18 (except for specific FDA pediatric approval), inability/unwillingness to wear device continuously, vision/hearing or medication issues that prevent responding to alarms, pregnancy/breastfeeding per device labeling, and exposure to excessive electromagnetic interference. Pediatric-specific criteria: FDA supplemental approval for certain LifeVest models (2015) permits pediatric use only when chest circumference is ≥ 26 inches (66 cm) and weight is ≥ 41.3 pounds (18.75 kg).

Automatic External Defibrillator (AED) — Pediatric and Home Considerations

Automatic External Defibrillator (Pediatric nonwearable AED)

A pediatric nonwearable AED is medically necessary when BOTH criteria are met:

Individual weighs less than 55 pounds (25 kilograms) AND meets criteria for ICD but implantation is contraindicated AND does not meet criteria for a wearable cardioverter-defibrillator

AED considerations and evidence/regulatory summary: All AEDs and AED accessories require FDA PMA. Example PMA: the HeartStart Home Defibrillator (Model M5068A) received PMA (P160029) on June 6, 2019 and is indicated for adults over 55 pounds (25 kg) and for infants/children under 55 lb with optional pads. Randomized and community trials (HAT and PAD) and observational studies show AEDs can terminate VF and are feasible for lay use, with PAD showing improved survival in public access settings; the HAT home AED randomized trial did not demonstrate an overall survival benefit in an intermediate-risk home population despite some survivors who received appropriate shocks. Home AED evidence is therefore limited and does not uniformly support improved overall mortality in residential settings.

Guideline-Based Indications & Evidence Summary

Evidence synthesis: Strength of evidence varies by device. S-ICD has moderate observational and registry support (prospective registries, pooled analyses, and systematic reviews) showing high shock efficacy (90–100% for first/final shock), complication-free rates (~30-day ~96%, 1-year ~92.5%), and inappropriate shock rates in the single-digit to mid-teens range; guideline statements endorse S-ICD for selected patients without pacing needs. EV-ICD pivotal data (Friedman 2022) are promising for implant defibrillation success and 6-month safety but are single-group, nonrandomized results with limited long-term and comparative data, and pilot/ASD2 studies show feasibility but small cohorts and short follow-up. WCD support is based mainly on observational registries and consensus guidance for bridging scenarios; randomized data are lacking for many indications. RCTs of AEDs in public-access settings (PAD) show benefit in public locations; the HAT home RCT did not show an overall survival benefit for home AEDs in an intermediate-risk population, highlighting gaps in residential AED effectiveness evidence.

Coding — CPT / HCPCS / Category III

Medically Necessary CPT/HCPCS/CodesmixedCovered

33249	Insertion or replacement of implanted single or dual chamber cardioverter-defibrillator pulse generator, with transvenous lead(s), with existing leads and simple removal of existing pulse generator
33245	Insertion or replacement of implanted cardioverter-defibrillator pulse generator only, without lead system; single chamber
33246	Insertion or replacement of implanted cardioverter-defibrillator pulse generator only, without lead system; dual chamber
33240	Insertion of new or replacement/transvenous ICD lead, single lead, with connection to pulse generator
33241	Insertion of new or replacement/transvenous ICD lead, dual lead, with connection to pulse generator
33207	Insertion of implantable cardioverter-defibrillator (subcutaneous) pulse generator only
33270	Removal of implantable subcutaneous cardioverter-defibrillator pulse generator
33289	Revision or replacement of subcutaneous lead for ICD system
A9276	Wearable external defibrillator, includes all supplies and accessories

Experimental/Investigational (Category III) CodesCPTExperimental

C1777	Implantable substernal cardioverter-defibrillator system — unique-note: code associated with substernal ICD approaches; substernal ICDs are considered experimental, investigational or unproven for ANY indication per policy.
0618T	Insertion or replacement of substernal lead for implantable cardioverter-defibrillator (Category III)

Coding applicability: Providers must bill using current AMA and CMS coding conventions; the codes listed above reflect commonly used CPT/HCPCS and Category III codes relevant to this policy but may not be exhaustive. Cigna reserves the right to require billing with the most specific, up-to-date code(s) and to deny reimbursement for services billed with codes that are inconsistent with the coverage criteria.

Determination	Effective Date / Number / Type
Implantable Automatic Defibrillators — NCD 20.4 — effective 2019-03-26
Automatic External Defibrillators — LCD L33690 — effective 2022-01-01

Evidence & Outcome Metrics

Selected numeric evidence metrics

Perioperative mortality (transvenous ICD)0.2%–0.4%

Procedural complication rates (CIEDs)2%–6%

Lead failure rates1–9% at 2 yrs; 2–15% at 5 yrs; 5–40% at 8–10 yrs

S-ICD complication-free rates~96.2% at 30 days; ~92.5% at 1 year

Inappropriate shock incidence (S-ICD studies)3.1%–16.9% (in studies); reported range 4–16%

EV-ICD pivotal (Friedman 2022)Successful defib at implant 98.7%; freedom from major complications at 6 months 92.6%; 7.3% major complications at 6 months; ATP success ~50.8%

WCD evidence summaryObservational registries support bridge use; randomized data limited; HAT home AED trial showed no overall survival benefit for home AEDs in intermediate-risk group

OpenPayer

Cardioverter-Defibrillator Devices (ICD, S-ICD, substernal ICD, wearable ICD, AED)

Coverage Summary

Transvenous ICD — Secondary Prevention (Medically Necessary Criteria)

Transvenous ICD — Primary Prevention (Medically Necessary Criteria)

Transvenous ICD — Not Medically Necessary

Subcutaneous ICD (S-ICD) — Criteria, Contraindications, and Coverage Considerations

Substernal / Extravascular (EV) ICD — Policy Position & Evidence

Wearable Cardioverter-Defibrillator (WCD) — Criteria and Limitations

Automatic External Defibrillator (AED) — Pediatric and Home Considerations

Guideline-Based Indications & Evidence Summary

Coding — CPT / HCPCS / Category III

Provider Actions — Documentation, Prior Authorization & Billing

Definitions & Thresholds

Medicare Determinations

Revision History

Evidence & Outcome Metrics