Capital Bluecross ICD Coverage Update

Clinical Indications and Medical Necessity

Implantable Defibrillator - Adults: Primary Prevention

ICD may be medically necessary in adults who meet any one of the following primary prevention criteria:

ANY of the following

Ischemic cardiomyopathy with NYHA class II or III symptoms, history of myocardial infarction >= 40 days before ICD treatment, and LVEF <= 35%
MI must be at least 40 days prior to ICD treatment
Ischemic cardiomyopathy with NYHA class I symptoms, history of myocardial infarction >= 40 days before ICD treatment, and LVEF <= 30%
MI must be at least 40 days prior to ICD treatment
Nonischemic dilated cardiomyopathy with LVEF <= 35% after reversible causes excluded and response to optimal medical therapy adequately determined
Hypertrophic cardiomyopathy (HCM) with major risk factor(s)
- Diagnosis of HCM
- ANY of the following
  - History of premature HCM-related sudden death in >=1 first-degree relatives younger than 50 years
  - Left ventricular hypertrophy > 30 mm
  - >=1 runs of non-sustained VT at heart rates >=120 bpm on 24-hour Holter
  - Prior unexplained syncope inconsistent with neurocardiogenic origin
  - Judged high risk for SCD by an experienced HCM physician
Cardiac ion channelopathies at high risk for SCD
- Diagnosis of a channelopathy (e.g., congenital LQTS, Brugada syndrome, Short QT syndrome, CPVT)
- ANY of the following
  - Specific high-risk features as enumerated for each syndrome (see detailed criteria)
Cardiac sarcoid at high risk for SCD
- Diagnosis of cardiac sarcoid and considered high risk for SCD
- ANY of the following
  - Spontaneous sustained ventricular arrhythmias, including prior cardiac arrest
    LVEF <=35% despite optimal medical therapy and immunosuppression if active inflammation
  - LVEF >35% with expected meaningful survival >1 year
    ANY of the following
    Syncope or near-syncope felt to be arrhythmic
    Evidence of myocardial scar by cardiac MRI or PET
Arrhythmogenic right ventricular dysplasia/cardiomyopathy, giant cell myocarditis, or Chagas disease with high risk for SCD
Any one of these cardiomyopathies considered high risk

ANY of the following

Ischemic cardiomyopathy with NYHA class II or III symptoms, history of myocardial infarction >= 40 days before ICD treatment, and LVEF <= 35%
MI must be at least 40 days prior to ICD treatment
Ischemic cardiomyopathy with NYHA class I symptoms, history of myocardial infarction >= 40 days before ICD treatment, and LVEF <= 30%
MI must be at least 40 days prior to ICD treatment

Implantable Defibrillator - Adults: Secondary Prevention

ICD may be medically necessary for secondary prevention when ALL of the following are met:

ALL of the following

History of life-threatening clinical event associated with ventricular arrhythmic events such as sustained VT or VF
Reversible causes (e.g., acute ischemia) have been excluded

ALL of the following

History of life-threatening clinical event associated with ventricular arrhythmic events such as sustained VT or VF
Reversible causes (e.g., acute ischemia) have been excluded

Investigational / Not Medically Necessary - Adults

Use of ICD is considered investigational (not medically necessary) for the following primary prevention groups (insufficient evidence):

ANY of the following

Acute myocardial infarction <40 days before planned ICD
NYHA Class IV congestive heart failure (unless eligible for CRT-D combination device)
Cardiac revascularization (CABG or PTCA/PCI) within past 3 months or candidates for revascularization
Noncardiac disease with life expectancy <1 year

ANY of the following

Implantable Defibrillator - Pediatrics

ICD may be medically necessary in pediatric patients who meet any of the following:

ANY of the following

Survivors of cardiac arrest due to VT or VF after reversible causes excluded
Long QT syndrome: survivors of sudden cardiac arrest (with beta-blockers)
Long QT syndrome: symptomatic when beta-blockers ineffective or not tolerated and denervation/other meds not appropriate
Brugada syndrome (pediatric)
- Survivors of sudden cardiac arrest or documented spontaneous sustained VT

Subcutaneous ICD (S-ICD)

S-ICD may be medically necessary for adult or pediatric individuals with an indication for ICD implantation if ALL of the following are met:

ALL of the following

Have an indication for ICD for primary or secondary prevention (per above)
ANY of the following
- Contraindication to transvenous ICD due to lack of adequate vascular access
- Compelling reason to preserve vascular access (e.g., chronic dialysis, younger patient anticipating long-term ICD therapy)
- History of need for explantation of a transvenous ICD due to complication with ongoing need for ICD therapy

Extravascular ICD

Use of extravascular ICD is considered investigational:

ANY of the following

All indications (insufficient evidence to determine benefit)

ANY of the following

All indications (insufficient evidence to determine benefit)

Wearable Cardioverter Defibrillator (WCD) - Medically Necessary

WCD may be medically necessary for individuals who meet ICD criteria and have at least one of the following:

ANY of the following

Alternative to ICD in individuals with documented contraindication to ICD (e.g., systemic infection, lack of vascular access)
Previously implanted defibrillator requires explantation
ALL of the following
- ANY of the following
  - LVEF <= 35% after recent cardiac events such as recent MI (within 40 days), coronary revascularization within 90 days, or recently diagnosed non-ischemic cardiomyopathy during 3-month period awaiting LV improvement/ICD

Wearable Cardioverter Defibrillator (WCD) - Not Medically Necessary

WCD is considered not medically necessary for any other indications not listed as medically necessary above.

ANY of the following

Any indication not explicitly enumerated as medically necessary

ANY of the following

Any indication not explicitly enumerated as medically necessary

Automatic External Defibrillators (AED) for Home Use

AEDs for home use:

ANY of the following

Considered investigational due to insufficient evidence of benefit for home use

ANY of the following

Considered investigational due to insufficient evidence of benefit for home use

Wearable Cardioverter-Defibrillator (WCD) — Evidence summary and coverage implication

Evidence statements in this section describe situations where WCD is not supported by sufficient evidence and thus not expected to improve outcomes:

ALL of the following

For patients with newly diagnosed nonischemic cardiomyopathy: randomized controlled trial evidence found prophylactic ICD placement did not improve mortality compared with usual care; retrospective WCD registry analyses do not demonstrate improved outcomes. Given lack of evidence that ICD improves outcomes in these trials, WCD is not expected to improve outcomes under the studied conditions.
Policy conclusion: WCD use not supported by evidence in this context.
For patients with peripartum cardiomyopathy: evidence (retrospective registry and small cohort) is insufficient to determine effect of WCD on outcomes; registry showed no shocks over average 124 days while cohort reported 4 appropriate shocks over 133 days.
Insufficient evidence to support benefit of WCD in peripartum cardiomyopathy.
Single-arm studies, manufacturer registry data, and case series do not provide sufficient evidence to determine whether WCD benefits patients compared with usual care.

Coding-based coverage statements (implantable systems)

Policy includes lists of procedure and supply codes that are either covered when medically necessary or not medically necessary.

ANY of the following

ICD with substernal lead placement
Multiple ICD implantation procedure codes, device supply codes, and associated HCPCS/C-codes are listed as covered when medically necessary; see code_groups for full lists.

Extravascular Implantable Cardioverter Defibrillators

Policy statement updated 06/13/2024:

ALL of the following

Extravascular Implantable Cardioverter Defibrillators are considered investigational

ALL of the following

Extravascular Implantable Cardioverter Defibrillators are considered investigational

Wearable Cardioverter-Defibrillators (WCD) — policy-level changes (07/20/2022)

Policy changes effective 07/20/2022 modified prior constraints — current document notes the following policy-level changes:

ALL of the following

Age limit removed for WCD use
Wear time limit removed for WCD use
Time period limit (previously up to 3 months) removed
Heart transplant criteria revised to: awaiting heart transplantation and considered high risk for arrhythmia
Added 'decline ICD placement' as an acceptable criterion for WCD use

ALL of the following

Pediatric Implantable Defibrillator Criteria (summary of change) — 06/13/2024

06/13/2024 Minor Review revised pediatric indications:

ALL of the following

Left ventricular hypertrophy criterion changed to 'Massive left ventricular hypertrophy based on age-specific norms'
Removed abnormal blood pressure response to treadmill exercise from pediatric criteria
Criteria for cardiac ion channelopathies moved into the Policy Statement (from Policy Guidelines)

ALL of the following

Left ventricular hypertrophy criterion changed to 'Massive left ventricular hypertrophy based on age-specific norms'

Procedure, Supply, and Diagnosis Codes

Policy identifiers and regulatory codes citedmixed

MP 1.081	Policy number for Cardioverter-Defibrillators (Implantable and External)
FDA product code: LWS	ICD devices PMA product code
FDA product code: MVK	WCD product code

Not medically necessary (ICD with substernal lead placement)CPT|HCPCSNot Covered

0571T
0572T
0573T
0574T
0575T
0576T
0577T
0578T
0579T
0580T

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1/2

Covered when medically necessary — Implantable device procedure codesCPT|HCPCS|C-codesCovered

33241	Insertion or replacement of transvenous lead, single or dual chamber ICD-related (as listed in policy)
33217
33218
33220
33223
33226
33230
33231
33240
33243

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1/5

Diagnosis codes referenced in policyICD-10

B57.0	Acute Chagas' disease with heart involvement
B57.2	Chagas' disease (chronic) with heart involvement
D86.85	Sarcoid myocarditis
I24.89	Other forms of acute ischemic heart disease
I25.5	Ischemic cardiomyopathy
I40.1	Isolated myocarditis
I42.0	Dilated cardiomyopathy
I42.1	Obstructive hypertrophic cardiomyopathy
I42.2	Other hypertrophic cardiomyopathy
I42.3	Endomyocardial (eosinophilic) disease

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1/11

Policy-specific CPT codes mentioned/added historicallyCPT

0614T	Previously added CPT code (not further defined in this part)
33727	Added 06/29/2023 (procedure code added; description not provided in this part)
0930T	Added 12/11/2024 effective 1/1/2025 (description not provided in this part)
0931T	Added 12/11/2024 effective 1/1/2025 (description not provided in this part)

ICD-10 codes added/modifiedICD-10

I47.20	Added 08/15/2022 (specific descriptor not provided in this part)
I47.29	Added 08/15/2022
Q21.10	Added 08/15/2022
Q21.11	Added 08/15/2022
Q21.13	Added 08/15/2022
Q21.14	Added 08/15/2022
Q21.15	Added 08/15/2022
Q21.16	Added 08/15/2022
Q21.19	Added 08/15/2022
Q21.20	Added 08/15/2022

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1/2

HCPCS / C-codes addedHCPCS

C7537	Added 11/29/2022 (no description in this part)
C7538	Added 11/29/2022
C7539	Added 11/29/2022
C7540	Added 11/29/2022

Documentation, Prior Authorization, and Billing Requirements

Documentation Required

Document reversible causes excluded

Document that reversible causes (for example, acute ischemia) have been evaluated and excluded prior to ICD implantation as part of the clinical record for secondary prevention and other applicable indications.

Documentation Required

Document timing related to recent MI or revascularization

Record dates of recent myocardial infarction and coronary revascularization to confirm waiting periods before primary-prevention ICD placement: at least 40 days after MI and at least 90 days after CABG/PCI (recent revascularization within 3 months is investigational for primary prevention).

Prior Authorization

Policy applicability to product variations

Clinical and Administrative Background

An implantable cardioverter‑defibrillator (ICD) is an implanted device that continuously monitors cardiac rhythm and delivers an electric shock to terminate life‑threatening ventricular arrhythmias (ventricular tachycardia or ventricular fibrillation) to reduce the risk of sudden cardiac death. ICD therapy generally involves a subcutaneously placed pulse generator connected to leads that sense cardiac rhythm and deliver therapy when dangerous arrhythmias are detected. Transvenous ICDs use leads threaded through the venous system into the heart to sense and deliver therapy, while a subcutaneous ICD (S‑ICD) places the sensing and shock electrode subcutaneously adjacent to the sternum and avoids transvenous leads, which may reduce lead‑related complications.

A wearable cardioverter‑defibrillator (WCD) is a temporary external vest‑based system intended to detect and terminate malignant ventricular arrhythmias as a bridge when an implantable device is contraindicated or when the need for a permanent ICD is uncertain. WCDs perform similar monitoring and shock functions externally, and are primarily used as an interim alternative when ICD implantation is contraindicated (for example, active systemic infection or lack of vascular access) or deferred while clinicians manage reversible conditions or reassess left ventricular recovery.

Defined Terms

Definitions

Cardiac arrestSudden cessation of functional circulation (pulselessness).

CardiomyopathyAny disease that affects the heart muscle, diminishing cardiac performance.

First-degree relativeA parent, sibling, or child.

NYHA (New York Heart Association)Classification used to describe heart failure symptoms (Class I–IV definitions provided).

QT intervalPeriod from beginning of QRS complex to end of T wave on EKG; reflects cardiac refractory period (profound prolongation >550 ms noted for LQTS assessment).

Tachyarrhythmia / TachycardiaAny cardiac rhythm disturbance with heart rate >100 beats per minute (tachycardia defined as >100 bpm in an adult).

Clinical Thresholds and Waiting Periods

Key clinical thresholds

Post‑MI waiting period for ICD primary prevention>= 40 days

Post‑CABG/PCI (recent revascularization) waiting period for ICD primary prevention>= 90 days (revascularization within 3 months is investigational for primary prevention)

Left ventricular ejection fraction (LVEF) cutoffs<= 35% (typical primary prevention cutoff); <= 30% for ischemic patients with NYHA Class I

Sustained ventricular tachyarrhythmia duration (secondary prevention / sarcoid criteria)>= 30 seconds (sustained VT) or clinically relevant VF

Holter non‑sustained VT heart rate criterion (HCM major risk feature)>= 120 beats per minute on 24‑hour Holter (one or more runs)

QT interval threshold (LQTS/ profound prolongation)>550 ms noted as profound QT prolongation relevant to risk assessment

Policy Changes and History

06/13/2024Minor Review (clinical)

Minor review revised pediatric ICD indications (including LVH criterion and other pediatric changes) and added that extravascular implantable cardioverter defibrillators are considered investigational; Policy Guidelines, cross-references, background, rationale, and references were updated.

12/11/2024Administrative Update (coding)

Administrative update added CPT codes 0930T and 0931T effective 01/01/2025.

01/24/2025Retirement Review (operational)Latest

Evidence Summary and Coverage Implication Notes

Evidence for use of the WCD in newly diagnosed nonischemic cardiomyopathy is limited. Randomized trial evidence did not show a mortality benefit for prophylactic ICD placement in newly diagnosed nonischemic cardiomyopathy, and retrospective registry analyses of WCD use do not demonstrate improved outcomes compared with usual care; therefore, under the conditions studied, a WCD is not expected to improve outcomes when ICD benefit is unproven.

For peripartum cardiomyopathy, available data are from retrospective registries and small cohorts and are inconsistent: one registry reported no shocks over a mean of 124 days of WCD use while a small cohort observed 4 appropriate shocks over 133 days. These limited, noncomparative data are insufficient to determine whether WCD use improves health outcomes in this population.

More broadly, the comparative evidence base for several WCD indications is weak. Much of the literature consists of single‑arm studies, manufacturer registries, and case series that lack control groups; these study designs do not provide sufficient comparative evidence to conclude that WCDs confer benefit over usual care for many proposed indications. As a result, policy conclusions limit WCD use to specific temporary or high‑risk situations where implantation is contraindicated or deferred and recognize evidence gaps for other applications.

Cardioverter-Defibrillators (Implantable and External)

Clinical Indications and Medical Necessity

Procedure, Supply, and Diagnosis Codes

Documentation, Prior Authorization, and Billing Requirements

Clinical and Administrative Background

Defined Terms

Clinical Thresholds and Waiting Periods

Policy Changes and History

Cross-References

Evidence Summary and Coverage Implication Notes