Blue Cross Blue Shield MA CRT Coverage Update

Coverage and Investigational Criteria for Cardiac Resynchronization Therapy

inv-01: NYHA III–IV Initial CRT Coverage

Covered when ALL of the following are met for NYHA Class III or IV:

NYHA III or IV: New York Heart Association (NYHA) Class III or IV

LVEF: Left ventricular ejection fraction ≤ 35%≤ 35%

Rhythm: Sinus rhythm

Medical therapy: Patients treated with guideline-directed medical therapy per 2022 AHA/ACC/HFSA guidanceper 2022 AHA/ACC/HFSA guidelines

Conduction abnormality: Either left bundle branch block (LBBB) OR QRS duration ≥ 150 msQRS ≥ 150 ms

Multiple RCT subgroup analyses show benefit mainly restricted to LBBB or QRS ≥150 ms

inv-02: NYHA II Initial CRT Coverage

Covered when ALL of the following are met for NYHA Class II:

NYHA II: New York Heart Association (NYHA) Class II

LVEF: Left ventricular ejection fraction ≤ 30%≤ 30%

Rhythm: Sinus rhythm

Medical therapy: Patients treated with guideline-directed medical therapy per 2022 AHA/ACC/HFSA guidanceper 2022 AHA/ACC/HFSA guidelines

inv-03: CRT as Alternative to Right Ventricular Pacemaker

Covered as alternative to right ventricular pacing when ALL of the following are met:

NYHA class: New York Heart Association (NYHA) class I, II, III, or IV heart failure

LVEF: Left ventricular ejection fraction ≤ 50%≤ 50%

High percentage pacing: Presence of atrioventricular (AV) block with requirement for a high percentage of ventricular pacing

Defined as third-degree AV block, or second-degree AV block, or a PR interval ≥ 300 ms when paced at 100 bpm

Medical therapy: Patients treated with guideline-directed medical therapy per 2022 AHA/ACC/HFSA guidance

inv-04: Investigational / Not Medically Necessary Technologies

Not covered / Investigational when ANY of the following apply:

NYHA I: CRT (with or without ICD) is considered investigational for patients with NYHA class I who do not meet coverage criteria

Few class I patients included in RCTs; evidence insufficient

Atrial fibrillation: CRT (with or without ICD) is considered investigational for patients with atrial fibrillation who do not meet coverage criteria

Small RCTs and registry data are mixed; overall evidence insufficient

Triple-site pacing: Triple-site (triventricular) CRT using an additional pacing lead is investigational

Small trials with methodological limitations and higher radiation and reintervention rates

Intrathoracic fluid sensor:

inv-05: NYHA class III–IV heart failure

Covered when ALL of the following are met:

NYHA III or IV: Patient has NYHA class III or IV heart failure

Supported by RCTs and systematic reviews showing reduced mortality and improved functional status

LVEF: Left ventricular ejection fraction (LVEF) ≤ 35%≤35%

Conduction abnormality: Patient is in sinus rhythm, treated with guideline-directed medical therapy, and has either left bundle branch block (LBBB) or QRS interval ≥ 150 msQRS ≥150 ms

Benefit mainly restricted to LBBB or QRS ≥150 ms

inv-06: NYHA class II heart failure

Covered with criteria (evidence mixed):

NYHA II: Patient has NYHA class II heart failure

At least 4 RCTs; mortality benefit inconsistent across trials

LVEF: Left ventricular ejection fraction (LVEF) ≤ 30%≤30%

Conduction abnormality: Patient is in sinus rhythm, treated with guideline-directed medical therapy, and has either left bundle branch block (LBBB) or QRS interval ≥ 150 msQRS ≥150 ms

Subgroup analyses show benefit mainly in LBBB or QRS ≥150 ms

inv-07: NYHA class I heart failure

Not established as covered based on available evidence:

NYHA I: Patient has NYHA class I heart failure

Evidence insufficient; small subgroup data with wide confidence intervals and potential for harm

inv-08: Patients with AV nodal block or requiring ventricular pacing

Covered when replacing expected frequent RV pacing or in presence of AV block with some LV dysfunction:

AV block with requirement for high ventricular pacing: Patients with AV nodal block requiring a high percentage of ventricular pacing and left ventricular dysfunction or meeting study criteria

Large RCT demonstrated reductions in heart-failure hospitalizations when CRT used instead of RV pacing

No LV dysfunction but pacing required: Patients who require ventricular pacing but have no LV dysfunction

Small RCTs suggest improved cardiac function but were underpowered for clinical outcomes; evidence limited

inv-09: Atrial fibrillation

Coverage stance: evidence insufficient or mixed

HF with AF: Patients with heart failure and atrial fibrillation who receive CRT (with or without defibrillator)

Small RCTs and registry data are mixed; overall evidence insufficient to determine net health benefit

inv-10: Triple-site CRT and CRT with remote fluid monitoring

Not established / investigational

Triple-site CRT has small RCTs with methodological limitations and is associated with higher radiation exposure and more additional procedures post-implantation

Evidence insufficient to determine net health benefit; larger high-quality RCTs needed

Remote fluid monitoring + CRT: CRT combined with remote intrathoracic fluid monitoring has not shown improved outcomes in RCTs

Three RCTs reported no improvement in outcomes; investigational

The policy lists several technologies related to cardiac resynchronization that are considered investigational and therefore not covered. Specifically, triple-site (triventricular) CRT using an additional pacing lead and an intrathoracic fluid monitoring sensor as a component of a biventricular pacemaker are designated investigational. Evidence summarized in the policy notes small, methodologically limited trials for triple-site CRT and lack of demonstrated improvement in outcomes with remote fluid monitoring, supporting the investigational stance for these approaches.

The policy explicitly states that cardiac resynchronization therapy with wireless left ventricular endocardial pacing is considered investigational. This investigational designation is reflected in the listed CPT codes (0861T–0863T) and HCPCS code (C1740) and was added to the policy effective 10/1/2018 as described in the policy history.

Within the referenced sections, there are no additional explicit coverage exclusions beyond the investigational technologies named elsewhere in the policy. The references section and policy text do not list separate exclusion statements beyond the investigational designations already described.

The policy specifies that biventricular pacemakers (with or without an ICD) are considered investigational when used to treat patients with NYHA class I heart failure who do not meet the coverage criteria. The policy also applies the investigational designation to patients with atrial fibrillation who do not meet the coverage criteria.

For patients with NYHA class I heart failure, the policy concludes that evidence is insufficient to establish benefit and thus CRT is not established as medically necessary. Similarly, the policy identifies that triple-site CRT and combinations of CRT with remote fluid monitoring lack adequate high-quality evidence (small RCTs, inconsistent outcomes, and additional procedural burden), and are therefore considered investigational or not established as medically necessary.

The policy text does not include any explicit statements labeled as Not Medically Necessary (NMN) beyond the investigational determinations described elsewhere. No separate NMN listings are provided in the cited reference sections.

Coding and Billing Codes Relevant to CRT

Covered CPT CodesCPTCovered

33224	Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, with attachment to previously placed pacemaker or pacing cardioverter-defibrillator pulse generator (including revision of pocket, removal, insertion, and/or replacement of existing generator).
33225	Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of pacing cardioverter-defibrillator or pacemaker pulse generator (including upgrade to dual chamber system and pocket revision) (List separately in addition to code for primary procedure).

Investigational CPT CodesCPTExperimental

0861T	Removal of pulse generator for wireless cardiac stimulator for left ventricular pacing; both components (battery and transmitter).
0862T	Relocation of pulse generator for wireless cardiac stimulator for left ventricular pacing, including device interrogation and programming; battery component only.
0863T	Relocation of pulse generator for wireless cardiac stimulator for left ventricular pacing, including device interrogation and programming; transmitter component only.

Investigational HCPCS CodesHCPCSExperimental

C1740

Leadless electrode, transmitter, battery (all implantable), for sequential left ventricular pacing.

ICD-10-PCS Procedure Codes (selected)ICD-10

02H40JZ	Insertion of Pacemaker Lead into Coronary Vein, Open Approach
02H43JZ	Insertion of Pacemaker Lead into Coronary Vein, Percutaneous Approach
02H43KZ	Insertion of Defibrillator Lead into Coronary Vein, Percutaneous Approach
02H43MZ	Insertion of Cardiac Lead into Coronary Vein, Percutaneous Approach
02H44JZ	Insertion of Pacemaker Lead into Coronary Vein, Percutaneous Endoscopic Approach
02H60JZ	Insertion of Pacemaker Lead into Right Atrium, Open Approach
02H63JZ	Insertion of Pacemaker Lead into Right Atrium, Percutaneous Approach
02HK3JZ	Insertion of Pacemaker Lead into Right Ventricle, Percutaneous Approach
0JH607Z	Insertion of Cardiac Resynchronization Pacemaker Pulse Generator into Chest Subcutaneous Tissue and Fascia, Open Approach
0JH609Z	Insertion of Cardiac Resynchronization Defibrillator Pulse Generator into Chest Subcutaneous Tissue and Fascia, Open Approach

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Covered ICD-10 Diagnosis CodesICD-10Covered

I50.20	Unspecified systolic (congestive) heart failure
I50.21	Acute systolic (congestive) heart failure
I50.22	Chronic systolic (congestive) heart failure
I50.23	Acute on chronic systolic (congestive) heart failure
I50.9	Heart failure, unspecified

Left ventricular ejection fraction (LVEF) thresholds

ThresholdLeft ventricular ejection fraction ≤ 35% for NYHA Class III–IV

Alternate threshold (NYHA II)Left ventricular ejection fraction ≤ 30% for NYHA Class II

Alternative indicationLVEF ≤ 50% when there is a requirement for a high percentage of ventricular pacing (alternative to RV pacemaker)

QRS duration

Primary QRS thresholdQRS duration ≥ 150 ms

Trial-associated criterion

Preauthorization, Documentation, and Billing Actions for Providers

Prior Authorization

Prior Authorization Required for Inpatient; Outpatient Generally Not Required

Precertification/preauthorization is required when the procedure is performed inpatient for all products. Outpatient prior authorization is generally not required for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO Blue SM, or Medicare PPO Blue SM as indicated in the policy; providers should verify member-specific benefits at time of service.

Inpatient: precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient: prior authorization is not required for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO Blue SM, and Medicare PPO Blue SM (verify member contract).

Billing Rule

Coding and Reporting Guidance / Prior Authorization — Coding Clarified

Clinical Background on Cardiac Resynchronization Therapy

Cardiac resynchronization therapy (CRT) is a device-based pacing strategy that delivers synchronized stimulation to the left and right ventricles to resynchronize ventricular contraction. CRT is intended to improve hemodynamics, symptoms, functional status, and, in selected populations, survival—particularly in patients with ventricular conduction delay such as left bundle branch block or a prolonged QRS duration. The policy bases coverage on symptomatic class (primarily NYHA III–IV), left ventricular ejection fraction thresholds, rhythm, and conduction criteria, and labels several alternative techniques (for example, triple-site CRT and wireless LV endocardial pacing) as investigational due to insufficient or mixed evidence.

Key Definitions and Clinical Terms

Atrioventricular block with high percentage ventricular pacing

DefinitionAtrioventricular block with requirement for high percentage ventricular pacing is present when there is third‑degree AV block

Alternate criteriaOr when there is second‑degree AV block or a PR interval ≥ 300 ms when paced at 100 beats per minute

ImplicationThis definition is used to identify patients who may receive CRT as an alternative to right ventricular pacing

Cardiac resynchronization therapy (CRT)

DefinitionSynchronized pacing of the left and right ventricles via an implanted device to coordinate ventricular contraction and improve cardiac pumping function and LVEF

MechanismDevice paces both ventricles to treat heart failure with dyssynchronous ventricular contractions

OpenPayer

Cardiac Resynchronization Therapy (CRT) — Biventricular Pacemakers / CRT Coverage Criteria

Coverage and Investigational Criteria for Cardiac Resynchronization Therapy

Coding and Billing Codes Relevant to CRT

Preauthorization, Documentation, and Billing Actions for Providers

Clinical Background on Cardiac Resynchronization Therapy

Key Definitions and Clinical Terms