CurrentBlue Cross Blue Shield - MassachusettsPolicy 070

Implantable Cardioverter Defibrillators (ICD) including subcutaneous and extravascular systems — Coverage and Prior Authorization

Clinical coverage and prior authorization guidance for implantation of automatic implantable cardioverter defibrillators (transvenous, subcutaneous, extravascular) for adults and pediatrics in Commercial members of Blue Cross Blue Shield - Massachusetts.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyImplantable Cardioverter Defibrillators (ICD) including subcutaneous and extravascular systems — Coverage and Prior Authorization

Policy CodePolicy 070

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrecertification/preauthorization is required for inpatient procedures described in this policy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Adults + Pediatricspopulations addressed

Prior auth required (inpatient)precertification rule

S-ICD covereddevice-specific stance

InsufficientEV-ICD evidence

CPT/HCPCS/ICD lists

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coding tables present

Coverage Criteria for Implantable Cardioverter-Defibrillators (ICD)

Primary Prevention

Adults — Primary prevention: Covered when ANY of the following are met

Ischemic cardiomyopathy post-MI (LVEF <= 30%): Ischemic cardiomyopathy with New York Heart Association (NYHA) functional class symptoms, history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction (LVEF) <= 30%LVEF <= 30%

Ischemic cardiomyopathy NYHA II–III (LVEF <= 35%): Ischemic cardiomyopathy with NYHA Class II or III symptoms, history of myocardial infarction at least 40 days before ICD treatment, and LVEF <= 35%LVEF <= 35%

Nonischemic dilated cardiomyopathy (NIDCM): Nonischemic dilated cardiomyopathy with LVEF <= 35% after reversible causes have been excluded and response to optimal medical therapy has been adequately determinedLVEF <= 35%

Reversible causes excluded and optimal medical therapy trial documented

Hypertrophic cardiomyopathy (HCM) with high-risk features: Hypertrophic cardiomyopathy with one or more major risk factors for sudden cardiac death (examples: family history of premature HCM-related sudden death <50 years, maximal left ventricular wall thickness >30 mm, documented runs of non-sustained VT, prior unexplained syncope) and judged high risk by an experienced physicianmajor risk factors (eg, LV wall thickness >30 mm)

High-risk cardiac ion channelopathies: Diagnosis of a cardiac ion channelopathy considered high risk for sudden cardiac death (eg, Brugada syndrome, congenital long QT syndrome, short QT syndrome, catecholaminergic polymorphic VT)

Cardiac sarcoid at high risk for SCD: Diagnosis of cardiac sarcoid and judged to be at high risk for sudden cardiac death

Secondary Prevention

Adults — Secondary prevention: Covered when ALL of the following are met

Secondary prevention: History of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia or ventricular fibrillation, after reversible causes (eg, acute ischemia) have been excluded

Subcutaneous ICD Criteria

Subcutaneous ICD: Covered when ALL of the following are met

No indication for antibradycardia pacing: The individual has no indication for antibradycardia pacing

Contraindication to transvenous ICD or need to preserve vascular access: The individual has a contraindication to a transvenous ICD due to lack of adequate vascular access or there is a compelling reason to preserve existing vascular access (eg, need for explantation of a transvenous ICD with ongoing need for ICD therapy)

Arrhythmia not expected to respond to antitachycardia pacing: The individual does not have ventricular arrhythmias that are known or anticipated to respond to antitachycardia pacing

Extravascular ICD

Extravascular ICD: Use of an extravascular implantable cardioverter-defibrillator (E‑ICD) is considered investigational

Pediatric Indications

Pediatrics: Covered when ANY of the following are met

Pediatric survivors of cardiac arrest: Survivors of cardiac arrest due to ventricular tachycardia or ventricular fibrillation, after reversible causes have been excluded

Pediatric inherited arrhythmia syndromes or cardiomyopathies: Pediatric individuals who are survivors of sudden cardiac arrest or have documented sustained VT not due to reversible causes with diagnoses such as long QT syndrome, Brugada syndrome, catecholaminergic polymorphic VT (CPVT), arrhythmogenic cardiomyopathy, hypertrophic cardiomyopathy, congenital heart disease, or nonischemic dilated cardiomyopathy, as specified

Pediatric LQTS refractory or intolerant to beta‑blockers: Individuals with long QT syndrome who are survivors of sudden cardiac arrest, or who cannot take beta‑blockers and for whom sympathetic denervation or other medications are not appropriate

Pediatric CPVT with recurrent events despite therapy:

Medically Necessary Indications

Covered when meeting established indications based on evidence:

Secondary prevention evidence: ICD placement is supported for patients resuscitated from sudden cardiac arrest or with symptomatic life‑threatening sustained VT/VF; systematic reviews and RCTs demonstrate mortality reduction (~25%) compared with medical therapy

Primary prevention — ischemic cardiomyopathy: Transvenous ICDs reduce overall mortality for patients with ischemic cardiomyopathy and reduced LVEF; multiple randomized controlled trials support coverage

Primary prevention — nonischemic cardiomyopathy: Pooled RCTs and subgroup analyses support a survival benefit for some patients with nonischemic dilated cardiomyopathy; evidence supports coverage though data are less extensive than for ischemic disease

Hypertrophic cardiomyopathy evidence: Registry studies report appropriate ICD discharges and presumed life‑saving therapy supporting T‑ICD placement for primary prevention in high‑risk HCM patients

Device-specific stance

Device-type specific coverage considerations:

S‑ICD vs T‑ICD: S‑ICD is an option for patients who require ICD therapy but have no indications for antibradycardia pacing or arrhythmias expected to respond to antitachycardia pacing; the PRAETORIAN RCT found S‑ICD noninferior to T‑ICD on a composite outcome but uncertainties remain regarding specific endpoints

S‑ICD when contraindication to T‑ICD: S‑ICD is supported for patients with contraindication to transvenous systems and no need for pacing therapies; evidence sufficient to determine improvement in net health outcome in this subgroup

Extravascular ICD: Evidence for extravascular ICDs is limited to nonrandomized studies; current evidence is insufficient to determine improved net health outcome and E‑ICD is considered investigational

The policy designates several specific circumstances where ICD therapy for primary prevention is considered investigational. This includes adults with NYHA Class IV heart failure unless the patient is eligible for a combination CRT‑D device, individuals who have undergone cardiac revascularization within the prior 3 months or who remain candidates for revascularization, and patients with noncardiac disease associated with a life expectancy of <1 year. These investigational statements also clarify that use of an ICD for secondary prevention is investigational when the individual does not meet the policy’s defined secondary prevention criteria (i.e., a history of a life‑threatening ventricular arrhythmic event after reversible causes have been excluded).

Procedures using substernal or other extravascular approaches are listed with Category III CPT codes (for example 0571T, 0572T, 0574T, 0580T, 0614T), and the policy states that extravascular/substernal ICD procedures are considered investigational because evidence is limited and insufficient to determine an improvement in net health outcome.

The reference list and evidence citations in the policy window do not include any standalone explicit coverage exclusion statements beyond the investigational language elsewhere; literature references summarize complications and safety data but do not themselves specify additional explicit exclusions in the policy text.

The policy clarifies that ICD use outside of the defined secondary prevention criteria is considered investigational. In addition, extravascular ICD systems are explicitly described as investigational, indicating that secondary‑prevention use that does not meet criteria or that uses extravascular approaches may be subject to investigational coverage stance and potential denial.

Randomized trials assessing very early ICD implantation after myocardial infarction did not demonstrate a survival benefit for immediate versus delayed implantation. The policy therefore notes that early device implantation following MI lacks proven mortality benefit and implies a recommended waiting period of about 40 days after MI before considering ICD placement for primary prevention.

Within the cited reference material there are reviews and safety analyses but no additional explicit statements labeling procedures or indications as not medically necessary; the document’s disposition of investigational versus covered uses is presented elsewhere in the policy text rather than in these reference chunks.

Coding — CPT, HCPCS, and Diagnosis Codes

Covered CPT Codes (informational list)CPT

33216	Insertion of transvenous electrode; single chamber permanent pacemaker or single-chamber pacing cardioverter-defibrillator
33217	Dual chamber permanent pacemaker or dual chamber pacing cardioverter-defibrillator
33249	Insertion or replacement of permanent pacing cardioverter-defibrillator system with transvenous lead(s) single or dual chamber
33270	Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming
33271	Insertion of subcutaneous implantable defibrillator electrode

HCPCS CodesHCPCS

C1721	Cardioverter-defibrillator, dual chamber (implantable)
C1722	Cardioverter-defibrillator, single chamber (implantable)
C1882	Cardioverter-defibrillator, other than single or dual chamber (implantable)

ICD-10-CM Diagnosis Codes considered medically necessary when submitted with CPT/HCPCS aboveICD-10

D86.85	Sarcoid myocarditis
D86.89	Sarcoidosis of other sites
I25.5	Ischemic cardiomyopathy
I25.6	Silent myocardial ischemia
I25.89	Other forms of chronic ischemic heart disease
I25.9	Chronic ischemic heart disease, unspecified
I42.1	Obstructive hypertrophic cardiomyopathy
I42.2	Other hypertrophic cardiomyopathy
I42.0	Dilated cardiomyopathy
I42.5	Other restrictive cardiomyopathy

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Investigational CPT/HCPCS codesmixedExperimental

No codes listed

Investigational/Category III CPT Codes for substernal/extravascular ICD proceduresCPTNot Covered

0571T	Insertion or replacement of implantable cardioverter-defibrillator system with substernal electrode(s), including imaging guidance and electrophysiological evaluation
0572T	Insertion of substernal implantable defibrillator electrode
0573T
0574T	Repositioning of previously implanted substernal implantable defibrillator-pacing electrode
0580T	Removal of substernal implantable defibrillator pulse generator only
0614T	Removal and replacement of substernal implantable defibrillator pulse generator

Relevant ICD-10-CM diagnosis codesICD-10

D86.85	Sarcoid myocarditis
D86.89	Sarcoidosis of other sites
I25.5	Ischemic cardiomyopathy
I25.6	Silent myocardial ischemia
I25.89	Other forms of chronic ischemic heart disease
I25.9	Chronic ischemic heart disease, unspecified
I42.1	Obstructive hypertrophic cardiomyopathy
I42.2	Other hypertrophic cardiomyopathy
I42.0	Dilated cardiomyopathy
I42.5	Other restrictive cardiomyopathy

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No CPT/HCPCS/ICD codes in reference listmixed

No codes listed

Left ventricular ejection fraction (LVEF) thresholds by ischemic vs non-ischemic and NYHA class

Ischemic cardiomyopathy — post-MI, NYHA anyLVEF ≤ 30% when history of myocardial infarction is at least 40 days before ICD treatment

Ischemic cardiomyopathy — NYHA II–IIILVEF ≤ 35% when NYHA Class II or III symptoms and history of myocardial infarction at least 40 days before ICD treatment

Non‑ischemic dilated cardiomyopathy (NIDCM)LVEF ≤ 35% after reversible causes excluded and response to optimal medical therapy adequately determined

Post-MI delay for early ICD — ~40 days recommendation

Post‑MI waiting period

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required for Inpatient Procedures

For services described in this policy, precertification/preauthorization is required for all products when the procedure is performed inpatient.

Applies to inpatient ICD implantation and related inpatient procedures described in this policy.

Prior Authorization

Outpatient Prior Authorization May Be Required

Prior authorization requirements for outpatient procedures vary by product. For some Commercial products outpatient prior authorization may be required — verify product-specific rules before scheduling. For Commercial PPO and Indemnity products, outpatient prior authorization is not required.

Check the member's plan and product-specific prior authorization rules for outpatient ICD procedures.

Background and Clinical Context

Automatic implantable cardioverter‑defibrillators (ICDs) are supported for both primary and secondary prevention of sudden cardiac death in defined populations. Evidence from multiple randomized controlled trials and systematic reviews supports transvenous ICDs (T‑ICD) for primary prevention in ischemic cardiomyopathy with reduced LVEF and for secondary prevention in patients resuscitated from cardiac arrest or with symptomatic sustained ventricular tachycardia/ventricular fibrillation after reversible causes are excluded. Subcutaneous ICDs (S‑ICD) are an alternative when pacing is not required and when transvenous access is contraindicated; extravascular ICDs (E‑ICD) are currently considered investigational because available studies are nonrandomized and insufficient to establish improved net health outcomes.

Definitions

Primary prevention

DefinitionImplantation of an ICD in patients at high risk of sudden cardiac death who have not experienced a prior life‑threatening ventricular arrhythmic event

ExamplesIschemic cardiomyopathy with reduced LVEF meeting thresholds; nonischemic dilated cardiomyopathy after medical optimization; high‑risk hypertrophic cardiomyopathy

PurposePrimary prevention ICDs are intended to reduce the risk of sudden cardiac death by treating malignant ventricular arrhythmias should they occur

Secondary prevention

DefinitionUse of an ICD in individuals with a history of a life‑threatening ventricular arrhythmic event (eg, sustained ventricular tachyarrhythmia) after reversible causes have been excluded

ContextSecondary prevention ICDs treat patients who survived sudden cardiac arrest or have symptomatic, sustained VT/VF

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyImplantable Cardioverter Defibrillators (ICD) including subcutaneous and extravascular systems — Coverage and Prior Authorization

Policy CodePolicy 070

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrecertification/preauthorization is required for inpatient procedures described in this policy.

SourceLink

On This Page

Individuals with CPVT who experience cardiac arrest or recurrent syncope/ polymorphic bidirectional VT despite maximally tolerated beta‑blockers, flecainide, or left cardiac sympathetic denervation

Inherited ion channelopathies and cardiac sarcoid: Small cohort studies and guideline‑based recommendations support T‑ICD use in inherited ion channelopathies and cardiac sarcoid for primary prevention when medical therapy is optimized or high risk is present

ICD implantation should be deferred until at least 40 days after myocardial infarction before considering for primary prevention

ReasoningRandomized trials did not demonstrate a mortality benefit for immediate versus delayed implantation within this early post‑MI period

ApplicationApplies to ischemic cardiomyopathy primary prevention indications requiring history of MI ≥40 days before ICD treatment

Denial Risk

Investigational Device/Procedure Denial Risk

Some CPT Category III codes and other investigationally designated procedures (for example substernal ICD procedures listed with temporary or Category III CPT codes) are considered investigational for Commercial members and may be denied. Providers should be aware that investigational device or procedure designations can trigger claim denials for Commercial coverage.

Examples: substernal ICD insertion/replacement/removal CPT Category III codes (e.g., 0571T–0614T) may be considered investigational for Commercial members unless otherwise covered by contract.
If a device/procedure is designated investigational, obtain medical necessity documentation and consider pre-submission discussion with the payer; denial remains possible.

Billing Rule

Provider Billing Guidance

Providers should report all services using the most up-to-date industry-standard procedure (CPT/HCPCS), revenue, and diagnosis (ICD-10-CM) codes, including applicable modifiers. Inclusion of a code in policy lists is informational and does not guarantee coverage — verify member contract benefits.

Report CPT codes such as 33216, 33217, 33249, 33270, 33271 and Category III codes 0571T–0614T where applicable.
Report HCPCS device codes (e.g., C1721, C1722, C1882) and the pertinent ICD-10 diagnosis codes when submitting claims.

Documentation Required

Required Coding Documentation

Required coding documentation: when applicable, document and submit the relevant diagnosis codes that justify medical necessity (ICD-10-CM codes listed in the policy), the CPT/HCPCS procedure codes performed, and any applicable modifiers. Ensure coding supports the medical necessity criteria referenced in this policy.

Document ICD-10-CM diagnoses such as I42.0 (Dilated cardiomyopathy), I42.1/I42.2 (Hypertrophic cardiomyopathy), D86.85 (Sarcoid myocarditis), I46.x (Cardiac arrest), I47.x–I49.x (Ventricular arrhythmias), Q24.8 (congenital malformations), and others as appropriate.
Include CPT/HCPCS codes for the specific device/procedure and any modifier(s) to reflect bilateral, staged, or related circumstances.

Note

Documentation / Submission Requirements

No additional documentation or specific prior submission forms are specified in this policy section beyond standard prior authorization and medical record requirements. Follow usual payer submission processes and include clinical records that support the request.

Submit clinical notes, imaging, prior treatment documentation, and device-specific information as requested by the payer during preauthorization review.

Documentation Required

Optimization of Medical Therapy / Exclusion of Reversible Causes

Optimization of medical therapy and exclusion of reversible causes must be documented prior to ICD placement for indications where applicable. Providers should document that reversible causes of arrhythmia (e.g., electrolyte abnormalities, acute ischemia, drug toxicity) have been identified and treated and that guideline-directed medical therapy has been optimized.

For primary prevention in nonischemic dilated cardiomyopathy and other applicable diagnoses, document that reversible causes were excluded and that the response to optimal medical therapy was adequately determined.
If immunosuppression is indicated (eg, cardiac sarcoid with active inflammation), document adequate trial and response when relevant to LVEF-based indications.

Documentation Required

Document Prior Medical Therapy for Primary Prevention

When an ICD is being considered for primary prevention, providers should document prior guideline-directed medical therapy and relevant timelines (for example, prior myocardial infarction ≥40 days prior to consideration, period of optimal medical therapy), and any prior device or procedural therapies attempted.

Document NYHA functional class, left ventricular ejection fraction values, timing of prior MI (if applicable), and trials of evidence-based heart failure therapies.
Include prior medication lists, dosing/optimization notes, and any prior electrophysiologic evaluations.

EvidenceMultiple RCTs show mortality reduction (~25%) for secondary prevention compared with medical therapy

S-ICD (subcutaneous ICD)

DefinitionA totally subcutaneous implantable cardioverter‑defibrillator that does not use transvenous leads and delivers shocks through subcutaneous tissue to avoid venous lead complications

IndicationsOption for patients who need ICD therapy but have no indication for antibradycardia pacing and either have contraindication to transvenous leads or need to preserve vascular access

Clinical rationaleDesigned to reduce lead‑related complications associated with transvenous systems

T-ICD (transvenous ICD)

DefinitionA transvenous implantable cardioverter‑defibrillator with a subcutaneously implanted generator and transvenous leads threaded into the endocardium for sensing and therapy delivery

Use caseStandard approach for primary and secondary prevention where pacing/antitachycardia pacing may be required

Evidence baseMultiple well‑conducted RCTs and systematic reviews support T‑ICD mortality benefit in ischemic cardiomyopathy

Subcutaneous ICD (S-ICD) trial/registry context

Trial/registry contextS‑ICD systems have been evaluated in IDE studies and major registries/trials including the IDE pooled analysis, EFFORTLESS, and UNTOUCHED

Key outcomes studiedSafety and efficacy, inappropriate shock rates, and lead‑related complication rates have been primary endpoints in these studies

Regulatory statusS‑ICD devices have received FDA approval and have an evidence base from randomized and registry data supporting use in selected patients

Extravascular ICD (EV-ICD) trial/reg registry context

Trial/registry contextExtravascular ICD systems have been evaluated in pivotal studies (eg, N Engl J Med 2022) and longer‑term follow‑up reports, but available evidence is limited and largely nonrandomized

Coverage stanceUse of an extravascular ICD is considered investigational due to insufficient evidence to determine improvement in net health outcome

Evidence notePivotal and follow‑up studies exist, but current data are insufficient for routine coverage decisions