CurrentBluecross IdahoPolicy MP 7.01.44

Implantable Cardioverter Defibrillator (ICD)

Customize your policy alerts

Sign up for Bluecross Idaho Policy MP 7.01.44 alerts

Get alerted when Policy MP 7.01.44 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Medical policy governing medical necessity and investigational indications for transvenous, subcutaneous, and extravascular implantable cardioverter defibrillators for adult and pediatric members of Blue Cross of Idaho.

Policy Summary

PayerBluecross Idaho

PolicyImplantable Cardioverter Defibrillator (ICD)

Policy CodePolicy MP 7.01.44

Change TypeNo material change

Effective DateMay 28, 2026

Last ReviewMay 28, 2026

Next Review DateMay 28, 2026

Key ActionObtain prior authorization to document that the individual meets medical necessity criteria for ICD implantation, including LVEF and NYHA class where applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Adults & PediatricsPopulations addressed

Primary & SecondaryIndication categories

Allowed with criteriaSubcutaneous stance

InvestigationalExtravascular ICD

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentBluecross IdahoPolicy MP 7.01.44

Implantable Cardioverter Defibrillator (ICD)

Customize your policy alerts

Sign up for Bluecross Idaho Policy MP 7.01.44 alerts

Get alerted when Policy MP 7.01.44 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerBluecross Idaho

PolicyImplantable Cardioverter Defibrillator (ICD)

Policy CodePolicy MP 7.01.44

Change TypeNo material change

Effective DateMay 28, 2026

Last ReviewMay 28, 2026

Next Review DateMay 28, 2026

Key ActionObtain prior authorization to document that the individual meets medical necessity criteria for ICD implantation, including LVEF and NYHA class where applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Adults & PediatricsPopulations addressed

Primary & SecondaryIndication categories

Allowed with criteriaSubcutaneous stance

InvestigationalExtravascular ICD

Common LVEF threshold

Coverage Criteria for ICDs

Primary Prevention - Adults

Covered when ANY of the following are met for adults:

Ischemic cardiomyopathy NYHA II-III: Ischemic cardiomyopathy with NYHA functional class II or III, history of myocardial infarction at least 40 days before planned ICD implantation, and left ventricular ejection fraction (LVEF) ≤ 35%.MI ≥40 days; LVEF ≤35%

Ischemic cardiomyopathy NYHA I: Ischemic cardiomyopathy with NYHA functional class I, history of myocardial infarction at least 40 days before planned ICD implantation, and LVEF ≤ 30%.MI ≥40 days; LVEF ≤30%

Nonischemic dilated cardiomyopathy with LVEF ≤ 35% after reversible causes have been excluded and response to optimal medical therapy has been adequately determined.LVEF ≤35%

Exclude reversible causes and assess response to optimal medical therapy

Hypertrophic cardiomyopathy with one or more major risk factors for sudden cardiac death and judged to be at high risk by a physician experienced in HCM care.>=1 major HCM risk factor

Examples of risk factors are listed in the policy guidelines (family history of premature HCM-related SCD, LV wall thickness >30 mm, nonsustained VT runs, prior unexplained syncope).

Cardiac ion channelopathies: Diagnosis of a congenital ion channelopathy (congenital long QT syndrome, Brugada syndrome, short QT syndrome, or catecholaminergic polymorphic VT) and considered high risk for sudden cardiac death per guideline-derived criteria.clinical judgment of high risk

See Policy Guidelines for specific disorder-based indications

Cardiac sarcoid: Diagnosis of cardiac sarcoid and considered to be at high risk for sudden cardiac death (see cardiac sarcoid indications and guidelines).clinical judgment and guideline criteria

See Policy Guidelines section for cardiac sarcoid specifics

Secondary Prevention - Adults

Covered when ALL of the following are met:

Secondary prevention following life-threatening ventricular arrhythmia: History of a life‑threatening clinical event associated with ventricular arrhythmic events (e.g., sustained ventricular tachyarrhythmia or cardiac arrest) AFTER reversible causes (for example, acute ischemia) have been excluded.reversible causes excluded

Investigational / Not Covered

Not covered/considered investigational when ANY of the following apply:

Recent acute MI: Acute myocardial infarction less than 40 days before planned ICD implantation.<40 days

Investigational for primary prevention per policy

NYHA class IV without CRT-D eligibility: NYHA class IV heart failure unless the individual is eligible to receive a combination cardiac resynchronization therapy ICD (CRT‑D) device.NYHA IV

Investigational for primary prevention

Recent revascularization or candidate: Cardiac revascularization (CABG or percutaneous coronary intervention) within the past 3 months or the individual is a candidate for revascularization.<3 months

Pediatric Indications

Covered in pediatric individuals when ANY of the following are met:

Survivors of cardiac arrest due to ventricular tachycardia or ventricular fibrillation after reversible causes have been excluded.reversible causes excluded

Long QT syndrome - arrest or cannot tolerate beta-blockers: Individuals with long QT syndrome who are survivors of sudden cardiac arrest (in combination with beta‑blockers) OR those who cannot take beta‑blockers and for whom cardiac sympathetic denervation or other medications are not appropriate.N/A

Includes consideration of cardiac sympathetic denervation

CPVT refractory to therapy: Catecholaminergic polymorphic ventricular tachycardia (CPVT) with cardiac arrest or recurrent syncope despite maximally tolerated beta‑blockers, flecainide, or cardiac sympathetic denervation.refractory to optimal therapy

Subcutaneous ICD - Coverage Criteria

Subcutaneous ICD is covered when ALL of the following are met:

Contraindication to transvenous ICD: The individual has a contraindication to a transvenous ICD because of one or more of the following: inadequate vascular access; compelling reason to preserve vascular access (e.g., need for chronic dialysis, younger individual with anticipated long‑term ICD need); or prior explant of a transvenous ICD for complication with ongoing need for ICD therapy.>=1 of listed reasons

No pacing indication: There is no indication for antibradycardia pacing.N/A

Arrhythmia not responsive to antitachycardia pacing: The ventricular arrhythmias are not known or anticipated to be responsive to antitachycardia pacing.N/A

Cardiac sarcoid — indications for ICD

Consider ICD placement in individuals with cardiac sarcoid when any of the following indications are present and meaningful survival >1 year is expected:

Primary indications: Spontaneous sustained ventricular arrhythmias, including prior cardiac arrest (secondary prevention).

Derived from HRS/AHA/ACC guideline statements

Reduced LVEF: Left ventricular ejection fraction (LVEF) ≤ 35% despite optimal medical therapy and a period of immunosuppression if active inflammation is present (meaningful survival >1 year required).LVEF ≤35%

From guideline-derived criteria

LVEF >35% with additional risk features: LVEF > 35% AND at least one of the following: syncope or near‑syncope felt to be arrhythmic; evidence of myocardial scar on cardiac MRI or PET; inducible sustained ventricular arrhythmias (>30 seconds of monomorphic VT or polymorphic VT) or clinically relevant ventricular fibrillation.LVEF >35%

Trial-based population criteria (evidence summary)

Trials evaluating ICD primary prevention enrolled populations meeting trial-specific criteria such as:

Ischemic cardiomyopathy trial criteria: Ischemic cardiomyopathy cohorts generally included prior MI (commonly ≥3 weeks to ≥1 month per trial), reduced LVEF thresholds commonly ≤30–35%, and varying NYHA classes (I–III in different trials). Examples: MADIT, MADIT II, MUSTT, SCD‑HeFT.see trial specifics

Most ischemic trials reported mortality benefit except those enrolling in the early post‑MI period

Recent post-MI trial criteria: Trials enrolling individuals in the first few weeks after MI (DINAMIT, IRIS, BEST‑ICD) generally did not show overall mortality benefit.MI in preceding days to weeks per trial

ICD not shown to reduce overall mortality in early post‑MI trials

Nonischemic dilated cardiomyopathy (NICM) trial criteria: Nonischemic DCM trials enrolled patients with reduced LVEF (commonly ≤35%) and varying NYHA classes; trial results (e.g., DANISH) showed reduced sudden cardiac death in some analyses but not always overall mortality benefit.

Trial-based eligibility

Coverage context reflected by trial inclusion criteria (used as basis for coverage decisions in the document):

Primary criteria reflected in trials: Patient has LVEF ≤ 35% AND symptomatic heart failure in the NYHA ranges referenced by trials (commonly II–IV or II–III depending on study).LVEF ≤35%; NYHA class II–IV

Reflects repeated trial inclusion criteria such as SCD‑HeFT, DEFINITE, COMPANION

Trial-based eligibility

Evidence summaries and common trial eligibility elements reported in the excerpt

Common trial eligibility: Left ventricular ejection fraction ≤ 35% AND NYHA functional class II–IV (or II–III in some trials).LVEF ≤35%; NYHA II–IV

Multiple pivotal trials (DEFINITE, SCD‑HeFT, COMPANION) used these thresholds

Device candidacy concepts from referenced trials

Trial-based eligibility concepts cited in document excerpts

ICD/CRT‑D candidate per trials: Patient with LVEF ≤35% AND symptomatic heart failure within trial‑specified NYHA class ranges (examples include NYHA II–III for many ICD trials and NYHA III–IV for CRT‑D trials); ischemic and nonischemic etiologies were evaluated in subgroup analyses.LVEF ≤35%

Different trials used overlapping but not identical NYHA windows

General device coverage (ICD/CRT‑D)

Covered when ALL of the following trial-based characteristics are met (as cited in the document excerpts):

Primary device clinical criteria: LVEF ≤ 35% AND NYHA functional class II–IV (with trial‑specific variations such as II–III in SCD‑HeFT or III–IV in COMPANION) documented in the medical record and treated with guideline‑directed medical therapy as applicable.LVEF ≤35%

Trials cited include SCD‑HeFT, COMPANION, DEFINITE, AMIOVIRT

Trial population indicators

Clinical trial populations and outcomes referenced (not explicit coverage criteria in excerpt)

Trial-based indication summary: Patients with reduced LVEF (commonly ≤35%) and heart failure symptoms across NYHA classes were the populations evaluated for ICD and CRT‑D versus medical therapy or alternative interventions in multiple randomized trials.LVEF ≤35%

Multiple trials (SCD‑HeFT, COMPANION, AMIOVIRT, DEFINITE) referenced

Populations studied in cited randomized trials

Trial enrollment characteristics repeatedly reported in the excerpt (these reflect populations studied):

Common trial enrollment: LVEF thresholds commonly ≤35% (some trials used ≤30%), NYHA class ranges I–IV depending on trial, and inclusion of ischemic and nonischemic cardiomyopathy cohorts; some trials excluded participants with unsustained or sustained VT in certain arms.LVEF ≤35% or ≤30%

Summarizes inclusion criteria across multiple cited trials; not explicit policy coverage criteria.

Evidence enrollment characteristics

Evidence from randomized trials generally enrolled patients meeting ALL of the following characteristics:

Trial enrollment characteristics: LVEF ≤35% in many trials (some used ≤30%), NYHA functional class ranges (commonly II–III for primary prevention ICD trials; III–IV for CRT‑D trials), ischemic and nonischemic etiologies assessed, and some trials included asymptomatic patients with nonsustained VT.see node text

These are trial criteria reported in the excerpt, not payer coverage criteria.

Trial-based indications

Trials cited report benefit for device therapy under these patient characteristics

Typical trial patient characteristics: Patients with LVEF ≤35% AND NYHA class II–III (several trials) or NYHA I–III in select studies, treated with guideline‑directed medical therapy during trial follow‑up.see trials

Multiple trials (SCD‑HeFT, COMPANION, AMIOVIRT, CAT) referenced

Subgroup efficacy

Reported subgroup effects

Nonischemic subgroup: Reported subgroup effects include benefit estimates such as CRT‑D versus medical therapy HR 0.50 in nonischemic cohorts and ICD versus placebo HRs ~0.65–0.77 in mixed trial summaries.HR values as reported

Effect sizes quoted from trials

Trial-derived eligibility summaries

Evidence summaries from randomized trials report device benefit in populations meeting trial inclusion criteria (examples below).

Example SCD‑HeFT style primary-prevention inclusion: LVEF ≤35% AND NYHA class II–III AND treated with guideline‑directed medical therapy (ACE inhibitors and beta‑blockers) — as used in SCD‑HeFT comparisons of ICD versus medical therapy/placebo.LVEF ≤35%; NYHA II–III

Cited repeatedly as a common trial inclusion pattern

Example COMPANION style CRT‑D inclusion: LVEF ≤35% AND NYHA class III–IV in dilated cardiomyopathy cohorts — CRT‑D trials demonstrated benefit in selected groups.LVEF ≤35%; NYHA III–IV

COMPANION trial data summarized in the excerpt

Other trial examples: Some trials required LVEF ≤30% and NYHA II–III (e.g., CAT) or enrolled asymptomatic patients with nonsustained VT; comparisons against amiodarone or control reported survival differences (example reported 1‑year survival ICD 96% vs amiodarone 90%).

Evidence populations (trial summaries)

Evidence summaries and populations described in the document (no explicit stepwise coverage rules in this excerpt).

Trial-based indication summary: Randomized trials enrolled patients with LVEF commonly ≤35% and NYHA class II–III for primary ICD trials or NYHA III–IV for CRT‑D trials; ischemic and nonischemic cardiomyopathy populations were evaluated and compared with medical therapy or placebo with reported mortality/survival outcomes.LVEF ≤35% or ≤30%; NYHA II–IV

This node summarizes trial populations and outcomes; explicit coverage rules are not present in the excerpt.

Evidence trial eligibility patterns

Trials cited generally enrolled patients meeting combinations of the following:

Trial enrollment criteria examples: Patients with LVEF ≤35% OR LVEF ≤30% (in some trials); NYHA class ranges I–IV reported, commonly II–III or III–IV; some trials focused on nonischemic dilated cardiomyopathy subgroups; certain trials excluded unsustained VT or sustained VT for selected cohorts.see thresholds

These are trial inclusion patterns extracted from the excerpt, not explicit policy coverage rules

Trial-based clinical contexts

Clinical trial eligibility patterns reported in the excerpt (indicative clinical contexts where devices were studied):

ICD trials: Trials commonly enrolled patients with LVEF ≤35% AND NYHA class II–III (some cohorts included up to class I–III); most participants were treated with ACE inhibitors and beta‑blockers; both ischemic and nonischemic etiologies were represented.LVEF ≤35%

Supported by SCD‑HeFT and other pivotal trials

CRT‑D trials typically enrolled patients with LVEF ≤35% AND NYHA class III–IV in dilated cardiomyopathy cohorts and compared CRT‑D versus medical therapy.LVEF ≤35%

Supported by COMPANION trial data

Smaller/other trials: Smaller trials enrolled patients with LVEF ≤30% AND NYHA class II–III without prior symptomatic VT/VF in EPS‑guided or control comparisons (e.g., CAT trial).LVEF ≤30%

The policy states that the use of an extravascular implantable cardioverter defibrillator (extravascular ICD) is considered investigational. This investigational designation indicates the device is not recognized as medically necessary under the terms of this policy and coverage for EV‑ICD devices will generally not be provided when that device type is selected.

This policy may not apply uniformly across all lines of business. Certain plans and programs—such as the Federal Employee Program, Medicare Supplement, Medicare Advantage, Medicaid, and some self‑insured groups—may be subject to different rules or benefit exceptions. In addition, Medicare has specific registry/IDE enrollment requirements that can affect reimbursement and referral pathways for ICD implantation.

Randomized trials enrolling patients in the early weeks after myocardial infarction did not consistently show an overall mortality benefit. The document highlights that trials enrolling shortly after MI (for example, DINAMIT, IRIS, and BEST‑ICD in the evidence base) did not demonstrate reduced all‑cause mortality, and other post‑revascularization studies (e.g., CABG Patch) likewise failed to show benefit. These findings support the policy position that ICD implantation in the immediate post‑MI period is not supported by evidence of improved overall survival.

Within the provided excerpt there are no additional explicit exclusion criteria listed beyond the investigational and trial‑based exclusions already noted. The document's coverage discussion focuses on trial populations and eligibility patterns rather than enumerating discrete administrative exclusion rules.

The excerpt does not set out explicit exclusion criteria in operational terms. Instead, it summarizes trial eligibility (e.g., LVEF thresholds, NYHA class) and trial outcomes; no standalone exclusion list (such as life expectancy, active infection, or other administrative exclusion conditions) is provided in these chunks.

No explicit coverage exclusions are stated in the supplied fragments; the content emphasizes trial results and characteristics of populations studied (for example, LVEF thresholds and NYHA class) rather than listing discrete coverage exclusions.

Coding and Key Clinical Thresholds

inv-51: Inducible sustained VT duration — > 30 seconds

Inducible sustained VT duration> 30 seconds

ContextListed as a qualifying arrhythmic finding for ICD consideration in cardiac sarcoid when LVEF >35% with additional risk features

Example phrasing in policy>30 seconds of monomorphic VT or polymorphic VT (inducible sustained ventricular arrhythmias)

inv-52: Expected meaningful survival — greater than 1 year

Expected meaningful survivalgreater than 1 year

Clinical contextRequired for several cardiac sarcoid ICD indications (spontaneous sustained ventricular arrhythmias, reduced LVEF despite therapy, and other risk features)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required to confirm medical necessity

Prior authorization is required to establish that the individual meets medical necessity criteria for ICD implantation (primary or secondary prevention) and to justify the selection of transvenous, subcutaneous, or investigational extravascular devices.

Prior Authorization

Prior authorization may be influenced by Medicare registry/benefit exceptions

Prior authorization decisions may be affected by Medicare registry/IDE enrollment requirements and by benefit-exception rules that vary by line of business; plans may require out-of-network referral when Medicare registry enrollment is necessary.

Prior Authorization

Prior authorization to confirm trial-based indications

Prior authorization is implied for ICD placement to confirm medical necessity based on trial-based clinical eligibility such as LVEF thresholds, timing after MI, and NYHA functional class.

Definitions and Device Types

inv-130: Transvenous ICD — Traditional ICD implanted with transvenous leads; policy statements generally refer to transvenous devices unless specified otherwise.

Transvenous ICDTraditional ICD implanted with transvenous leads; policy statements generally refer to transvenous devices unless specified otherwise.

Clinical descriptionGenerator placed in chest wall with transvenous leads threaded into endocardium to sense rhythms and deliver therapy.

Policy noteUnless specified, the policy applies to transvenous ICDs rather than combination CRT or pacemaker devices.

inv-131: Subcutaneous ICD — ICD system placed subcutaneously without transvenous leads; medically necessary only when specific criteria (vascular access issues, need...).

Subcutaneous ICD (S-ICD)ICD system placed subcutaneously without transvenous leads; medically necessary only when specific criteria (eg, inadequate vascular access, need to preserve vascular access, prior transvenous explant) are met.

Background and Evidence Context

Implantable cardioverter defibrillators (ICDs) are implanted to reduce the risk of sudden cardiac death from life‑threatening ventricular arrhythmias by detecting and terminating ventricular tachycardia or fibrillation. Indications differ between primary prevention (prophylactic implantation in patients at elevated risk, commonly defined in trials by reduced LVEF and certain NYHA functional classes) and secondary prevention (after survivors of ventricular arrhythmia or cardiac arrest). The policy generally refers to transvenous ICDs unless an alternate device (for example, subcutaneous ICD) is specifically addressed, and it designates extravascular ICDs as investigational.

The policy notes that ICD implantation in the immediate period after myocardial infarction did not demonstrate an overall mortality benefit in trials enrolling within weeks after MI. It references randomized controlled trial evidence indicating lack of overall survival advantage for early post‑MI ICD implantation, supporting the policy's investigational stance for such early post‑MI use.

Evidence from randomized trials enrolling patients in the immediate post‑MI period or shortly after revascularization does not support ICD implantation for overall mortality benefit. The policy cites these trials as the basis for treating ICD use in the immediate post‑MI window as not supported by evidence of improved all‑cause survival.

Policy Summary

PayerBluecross Idaho

PolicyImplantable Cardioverter Defibrillator (ICD)

Policy CodePolicy MP 7.01.44

Change TypeNo material change

Effective DateMay 28, 2026

Last ReviewMay 28, 2026

Next Review DateMay 28, 2026

Key ActionObtain prior authorization to document that the individual meets medical necessity criteria for ICD implantation, including LVEF and NYHA class where applicable.

SourceLink

On This Page

Investigational for primary prevention

Limited life expectancy: Noncardiac disease associated with life expectancy less than 1 year.<1 year

Investigational for primary prevention

Extravascular ICD: Use of an extravascular implantable cardioverter defibrillator (EV‑ICD).N/A

Considered investigational

Brugada, HCM, arrhythmogenic cardiomyopathy, nonischemic DCM, congenital heart disease: Pediatric individuals who are survivors of sudden cardiac arrest or have documented spontaneous sustained VT not due to reversible causes; includes symptomatic sustained VT associated with congenital heart disease after appropriate evaluation.documentation of arrest or sustained VT

Policy states investigational for pediatric indications not listed

Each bulleted sub-item qualifies

Pacemaker indication: An indication for permanent pacemaker implantation (concurrent pacing indication).

From guideline-derived criteria

LVEF commonly ≤35%

Age and subgroup effects noted (DANISH)

LVEF ≤30% in some trials

AMIOVIRT and CAT trials referenced

Supported by CAT trial summaries

Policy wordingif meaningful survival of greater than 1 year is expected

inv-53: Left ventricular ejection fraction (LVEF) — 6435%

LVEF threshold≤35%

Use in policyCommon numeric threshold for primary prevention ischemic and nonischemic cardiomyopathy trial inclusion and coverage consideration

Provider documentationDocument LVEF measurement (≤35%) when requesting ICD coverage

inv-54: LVEF threshold — 6435%

LVEF threshold≤35%

Evidence basisRepeated trial inclusion criterion (eg, SCD-HeFT, DEFINITE, COMPANION) uses LVEF ≤35%

ImplicationMany coverage and trial-derived eligibility statements reference LVEF ≤35%

inv-55: Left ventricular ejection fraction — 6435%

LVEF threshold≤35%

Associated NYHA classesOften paired with NYHA class II–IV (or II–III in some trials) for device candidacy

Trial supportUsed across multiple RCTs summarized in the policy as an enrollment threshold

inv-56: LVEF threshold — 6435%

LVEF threshold≤35%

Clinical noteReferenced for both ICD and CRT-D trial populations as a common eligibility cutpoint

DocumentationProviders should supply LVEF (≤35%) when seeking coverage based on trial-based criteria

inv-57: LVEF threshold — 6435%

LVEF threshold≤35%

Trial examplesCited in multiple trials (AMIOVIRT, DEFINITE, SCD‑HeFT) as an inclusion threshold

PopulationApplies to ischemic and nonischemic cohorts in evidence summaries

inv-58: LVEF threshold — 6435%

LVEF threshold≤35%

Alternate threshold notedSome trials (eg, CAT) used a LVEF ≤30% threshold in select cohorts

Reported outcomesTrials using these thresholds reported survival differences (eg, ICD 1‑yr survival ~96% in cited summaries)

inv-59: Left ventricular ejection fraction (LVEF) — 6435% (commonly cited); 6430% (in CAT trial)

LVEF thresholds in trials≤35% (commonly cited); ≤30% in CAT trial

ContextCAT and similar smaller trials used ≤30% for enrollment in some cohorts; most larger RCTs used ≤35%

Implication for coveragePolicy references both ≤35% and trial-specific ≤30% thresholds when summarizing evidence

inv-60: Left ventricular ejection fraction — 6435% (multiple trials); some mentions of 6430%

LVEF threshold≤35% (multiple trials); some mentions of ≤30%

Associated NYHA rangesOften combined with NYHA II–III or II–IV in trial eligibility descriptions

Evidence notePolicy summarizes heterogeneous trial thresholds but emphasizes ≤35% as common criterion

inv-61: LVEF threshold — 6435% (multiple trials)

LVEF threshold≤35% (commonly cited); also ≤30% in some trials

Use in CRT‑D vs ICD contextsLVEF ≤35% used for both ICD and CRT‑D trial populations with differing NYHA classes

Provider actionEnsure LVEF documentation is included to align with trial-derived coverage considerations

inv-62: Left ventricular ejection fraction (LVEF) — 6435% (commonly cited); some trials used 6430%

LVEF threshold≤35% (commonly cited); some trials used ≤30%

Trial variabilityNYHA class ranges and exact LVEF cutpoints varied by study; policy notes the heterogeneity

Evidence summaryMost larger RCTs used ≤35% while select trials (eg, CAT) used ≤30%

inv-63: NYHA functional class — Ranges cited: I–IV depending on trial; common groups: II–III for ICD primary prevention, III–IV for CRT-D trials

NYHA functional class rangesI–IV depending on trial; common groups: II–III for ICD primary prevention, III–IV for CRT‑D trials

Policy examplesPrimary prevention statements reference NYHA II–III for many ICD trials; COMPANION used III–IV for CRT‑D

Documentation tipInclude NYHA class in clinical documentation when requesting coverage

inv-64: Left ventricular ejection fraction (LVEF) — 6435% (commonly cited); also 6430% in some trials

LVEF threshold≤35% (commonly cited); also ≤30% in some trials

Trial notesSeveral trials report inclusion criteria using these thresholds across ischemic and nonischemic cohorts

Clinical implicationPolicy emphasizes LVEF ≤35% as central in trial-derived eligibility summaries

inv-65: NYHA functional class — II–III; III–IV (for CRT‑D in some trials); I–III cited for some cohorts

NYHA functional class typicalII–III; III–IV (for CRT‑D in some trials); I–III cited for some cohorts

Trial contextSCD‑HeFT and DEFINITE commonly enrolled NYHA II–III; COMPANION enrolled NYHA III–IV for CRT‑D

DocumentationRecord NYHA class to support alignment with trial-based criteria for device consideration

inv-66: Left ventricular ejection fraction (LVEF) — 6435% (multiple trials); some trials report 6430%

LVEF threshold summary≤35% (multiple trial criteria); some trials report ≤30%

Evidence variabilityDifferent trials used either ≤35% or ≤30% depending on study design and cohort

Policy emphasisThe policy summarizes trial heterogeneity but reiterates ≤35% as the common threshold

inv-67: NYHA class — Ranges referenced: I to IV, commonly II–III or III–IV depending on trial

NYHA class ranges referencedI to IV, commonly II–III or III–IV depending on trial

Trial examplesSCD‑HeFT, COMPANION, and others used varying NYHA ranges to define enrolled populations

Clinical noteNYHA class often paired with LVEF threshold to determine device candidacy in evidence summaries

inv-68: Left ventricular ejection fraction — 6435% (multiple trials); one trial LVEF 6430%

LVEF threshold≤35% (multiple trials); one trial LVEF ≤30%

Evidence contextPolicy repeatedly cites ≤35% as common across trials; CAT used ≤30%

Provider implicationConfirm which trial threshold is relevant when interpreting evidence for a given patient

Note

No explicit prior-authorization code list in excerpt

The provided document extract does not include an explicit list of CPT/HCPCS codes or a mandatory prior authorization code list for ICD implantation.

Note

Prior authorization not specified in this fragment

This excerpt does not provide an explicit mandatory prior authorization procedure or code list for ICDs; the policy text focuses on clinical indications rather than operational prior authorization steps.

Note

Clinical eligibility referenced; prior authorization steps not listed

The document presents clinical eligibility concepts (e.g., LVEF ≤35%, NYHA class ranges) but does not list explicit prior authorization steps or codes in this section.

Prior Authorization

Prior authorization implied when LVEF and NYHA documented (e.g., ≤35%)

When LVEF ≤35% and NYHA class ranges consistent with cited trials are documented, prior authorization is implied to support ICD/CRT‑D placement based on the evidence summaries presented.

Note

No explicit prior authorization statement in excerpt

No explicit prior authorization code lists or mandatory prior authorization statements are present in these chunks; only clinical trial indications and outcomes are summarized.

Note

Prior authorization not stated in excerpt

Prior authorization requirements are not specified within the provided chunks of the policy.

Note

Prior authorization details not specified here

No explicit prior authorization requirements or code lists are contained in these chunks; the excerpt emphasizes clinical trial-based eligibility concepts rather than operational prior-auth rules.

Note

No prior authorization procedures or affected codes listed

The excerpt does not specify prior authorization procedures or specific CPT/HCPCS codes that require prior authorization within these sections of the policy.

Note

Prior authorization not specified in excerpt

This excerpt contains no explicit prior authorization instructions or a list of affected billing codes; content summarizes clinical trial inclusion criteria and evidence.

Note

No prior authorization requirements listed

The provided text does not state prior authorization requirements or specific billing codes that would be subject to prior authorization in this fragment.

Note

Prior authorization not specified in provided text

No explicit prior authorization rules are present in these excerpts; the document summarizes clinical trial inclusion criteria and outcomes rather than administrative prior-auth processes.

Step Therapy

Ensure optimization of medical therapy and exclude reversible causes

Before considering primary-prevention ICD implantation, reversible causes should be excluded and optimal medical therapy should have been trialed with reassessment of LVEF after therapy as appropriate.

Exclude reversible causes of low LVEF
Reassess LVEF after a trial of optimal medical therapy

Documentation Required

Document prior guideline-based medical management

Document prior medical management in the chart when seeking coverage; guideline-based medical therapy (and steroid therapy for cardiac sarcoid when relevant) is the standard comparator to ICD implantation.

Step Therapy

Consider medical management before device implantation

Consider and document guideline-based medical management (antihypertensives, antiarrhythmics, steroid therapy for cardiac sarcoid) as the comparator or preceding therapy when clinically appropriate.

Note

No step therapy sequence mandated in excerpt

The policy fragment does not describe any formal step therapy pathways or mandated sequencing (e.g., required failed medication trials) before ICD implantation.

Key criteriaNo indication for antibradycardia pacing and arrhythmias not expected to respond to antitachycardia pacing

Regulatory/historyS-ICD approved by FDA (2012) with subsequent device iterations and recalls noted (eg, Emblem recall 2021)

inv-132: Extravascular ICD — Non-transvenous ICD technology placed outside the thoracic vasculature; considered investigational by this policy.

Extravascular ICD (EV‑ICD)Non‑transvenous ICD technology placed outside the thoracic vasculature; considered investigational by this policy

Regulatory noteAurora EV‑ICD received FDA approval in Oct 2023 for selected individuals, but policy maintains investigational stance

Device placementLeads are placed in the anterior mediastinum rather than inside the heart or veins

inv-133: Subcutaneous ICD (S-ICD) — An ICD system that uses a subcutaneous electrode implanted adjacent to the left sternum and does not use transvenous leads, avoiding veno...

S‑ICD descriptionAn ICD system that uses a subcutaneous electrode implanted adjacent to the left sternum and does not use transvenous leads, avoiding venous access and related lead complications.

MechanismElectrodes sense cardiac rhythm and deliver countershocks through subcutaneous tissue

IndicationsApproved for treatment of life‑threatening ventricular tachyarrhythmias in patients without pacing indications

inv-134: Extravascular ICD (EV-ICD) — An ICD with leads placed in the anterior mediastinum (outside the heart and veins); Aurora EV-ICD received FDA approval in 2023 for selec...

EV‑ICD definitionAn ICD with leads placed in the anterior mediastinum (outside the heart and veins); Aurora EV‑ICD received FDA approval in 2023 for selected individuals

Placement detailLeads are extravascular (anterior mediastinum) rather than transvenous

Policy stanceDespite FDA approval of a device, the policy considers extravascular ICD use investigational in general

inv-135: ICD — A device designed to monitor heart rate, recognize VF or VT, and deliver an electric shock to terminate these arrhythmias to reduce the r...

ICD (general)A device designed to monitor heart rate, recognize VF or VT, and deliver an electric shock to terminate these arrhythmias to reduce the risk of sudden death.

ComponentsGenerator implanted in chest wall and leads (transvenous or alternative) that sense and deliver therapy

Therapy typesUsed for primary prevention (prophylactic) and secondary prevention (after life‑threatening arrhythmia)

inv-136: Primary prevention — ICD implantation in individuals at high risk of SCD who have not had prior sustained ventricular arrhythmia or sudden cardiac arrest, typ...

Primary prevention definitionICD implantation in individuals at high risk of sudden cardiac death who have not had prior sustained ventricular arrhythmia or sudden cardiac arrest

Common selection criteriaOften based on LVEF thresholds and NYHA functional class as reflected by trial inclusion

Policy usePrimary prevention indications are enumerated in policy (ischemic and nonischemic cardiomyopathy, HCM, channelopathies, sarcoid)

inv-137: LVEF 6435% — Left ventricular ejection fraction at or below 35%, cited as a threshold for trial inclusion and therapeutic consideration.

LVEF ≤35% thresholdLeft ventricular ejection fraction at or below 35% is repeatedly cited as a threshold for trial inclusion and therapeutic consideration

Evidence basisUsed across multiple RCTs summarized in the policy (eg, SCD‑HeFT, DEFINITE, COMPANION)

Clinical implicationProviders should document LVEF when evaluating ICD candidacy per policy and trial evidence

inv-138: NYHA class — New York Heart Association functional class; classes II–IV and I–III are repeatedly referenced as eligibility strata in trials.

NYHA class termNew York Heart Association functional class; classes II–IV and I–III are repeatedly referenced as eligibility strata in trials

Common pairingNYHA class often reported with LVEF thresholds to define trial cohorts (eg, II–III for ICD primary prevention)

DocumentationNYHA class should be recorded to align with trial-based eligibility statements

inv-153: Primary prevention ICD candidate — Patient with reduced LVEF (commonly ≤35%) and symptomatic heart failure (commonly NYHA class II–III) without recent sustained ventricular...

Primary prevention ICD candidatePatient with reduced LVEF (commonly ≤35%) and symptomatic heart failure (commonly NYHA class II–III) without recent sustained ventricular arrhythmia

Policy examplesIschemic cardiomyopathy with NYHA II–III and LVEF ≤35% (post‑MI ≥40 days) is listed in Primary Prevention criteria

Evidence linkageTrial evidence cited supports benefit in populations meeting these characteristics

inv-154: CRT-D candidate — Patient with reduced LVEF and more advanced heart failure (examples in trials: NYHA class III–IV, especially with nonischemic dilated car...

CRT‑D candidatePatient with reduced LVEF and more advanced heart failure (examples in trials: NYHA class III–IV) who may derive additional benefit from cardiac resynchronization with defibrillation

Trial contextCOMPANION and CRT‑D trials enrolled NYHA III–IV patients with LVEF ≤35%

Policy implicationCRT‑D considerations are presented separately from standalone ICD indications in the evidence summaries