ModifiedCignaPolicy 0469

Nonpharmacological treatments for atrial fibrillation (ablation and LAA closure)

Defines medical necessity, investigational status, and coding guidance for catheter ablation, percutaneous and surgical left atrial appendage (LAA) closure, and surgical maze procedures for atrial fibrillation for Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyNonpharmacological treatments for atrial fibrillation (ablation and LAA closure)

Policy CodePolicy 0469

Change TypeFocused review — revised and added policy statements

Effective DateMay 15, 2025

Next Review DateOct 15, 2025

Key ActionSubmit prior authorization when requesting percutaneous or surgical LAA procedures and document CHA2DS2-VASc score and contraindication to long-term anticoagulation as applicable.

SourceLink

POLICY UPDATE CHANGES

Revised policy statement for cardiac catheter ablation.

Revised policy statements for surgical ablation (surgical Maze or modified Maze procedure).

Revised policy statements for percutaneous transcatheter closure of the left atrial appendage (LAA).

Added policy statement for repeat cardiac catheter ablation.

Added policy statement for active esophageal cooling device.

Title changed from 'Nonpharmacological Treatments for Atrial Fibrillation'.

93656/93657Catheter ablation codes

33340Percutaneous LAA code

CHA2DS2-VASc ≥2Stroke risk threshold

≤40%

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>5 mmPeridevice leak concern

Coverage Criteria

inv-01: Catheter Ablation - Medically Necessary Indications

Cardiac catheter ablation with pulmonary vein isolation (CPT 93656, 93657) is considered medically necessary when ANY of the following are met:

Catheter ablation indications: 1) Symptomatic atrial fibrillation (paroxysmal or persistent) AND antiarrhythmic drugs have been ineffective, contraindicated, not tolerated, or not preferred; 2) Symptomatic atrial fibrillation associated with heart failure and reduced ejection fraction (HFrEF) with left ventricular ejection fraction ≤ 40%; 3) Athlete (high‑volume endurance athleticism defined as >45 MET‑hours/week) who develops atrial fibrillation with or without symptoms; 4) Individual with or without symptoms who has pulmonary hypertension with pulmonary vascular disease and atrial fibrillation.

Repeat cardiac catheter ablation is medically necessary for recurrent symptomatic atrial fibrillation (ACC Class I).

inv-02: Catheter Ablation - Not Medically Necessary

When considered not medically necessary:

Not medically necessary: Cardiac catheter ablation for any other indication including asymptomatic atrial fibrillation (except as discussed for select asymptomatic patients in professional society guidance) is considered not medically necessary.

Vein of Marshall alcohol ablation (VOM ethanol infusion) (CPT 93799) is considered not medically necessary; use of an active esophageal cooling device during ablation (HCPCS C1889) is considered experimental/investigational/unproven.

inv-03: Percutaneous Transcatheter LAA Closure - Medically Necessary Criteria

Percutaneous transcatheter closure of the left atrial appendage (CPT 33340) with an FDA‑approved device is medically necessary when ALL of the following are met:

Percutaneous LAA closure criteria: 1) Nonvalvular atrial fibrillation; 2) CHA2DS2‑VASc score ≥ 2 indicating moderate to high stroke risk; 3) Contraindication to long‑term oral anticoagulation due to a nonreversible cause (examples: untreatable arteriovenous malformation, recurrent duodenal ulcer, recurrent falls with untreatable cause).CHA2DS2‑VASc >=2

Percutaneous LAA closure for any other indication (including hypertrophic cardiomyopathy) is considered not medically necessary.

inv-04: Surgical LAA Closure

Surgical closure/excision of the left atrial appendage is considered medically necessary when performed in conjunction with other cardiac surgical procedures:

Surgical LAA closure criteria: Surgical closure of the left atrial appendage (CPT 33268) using an FDA‑approved device performed in conjunction with other cardiac surgery for prevention of stroke is medically necessary.

Closure not performed with open cardiac surgery (CPT 33267, 33269) is considered not medically necessary; closure of a peridevice leak (CPT 33999) is considered experimental/investigational/unproven.

inv-05: Surgical Maze Procedures

Coverage stance for surgical ablation (Maze):

Maze with cardiac surgery: Surgical Maze or modified Maze with cardiopulmonary bypass (CPT 33256, 33257, 33259) is medically necessary when performed in an individual with AF who is undergoing cardiac surgery. Surgical Maze without cardiopulmonary bypass (CPT 33258) is medically necessary when the individual with AF is undergoing cardiac surgery.

Endoscopic Maze as part of a hybrid convergent procedure without concomitant cardiac surgery (CPT 33254, 33255, 33265, 33266) is considered experimental/investigational/unproven. Documentation of entrance/exit block and lesion completeness is beneficial.

inv-06: Covered indications and contexts

Covered when guideline-based criteria are met and patient selection aligns with professional society recommendations:

Catheter ablation for AF: Catheter ablation (CPT 93656/93657) is reasonable/beneficial for symptomatic AF to improve symptoms and quality of life; particularly reasonable after prior ablation failure or after failure/intolerance of antiarrhythmic drugs; in selected patients with HFrEF catheter ablation can improve symptoms, QOL, ventricular function, and outcomes.

Supported by ACC/AHA and HFSA guidance.

Vein of Marshall infusion: Addition of Vein of Marshall (VOM) ethanol infusion showed increased freedom from AF/AT at 6 and 12 months in the VENUS RCT but overall evidence is limited; VOM infusion remains under evaluation and may be considered investigational.

Evidence limited; CPT 93799 considered not medically necessary in policy.

Percutaneous LAA occlusion (pLAAO): pLAAO (CPT 33340) is reasonable for patients with nonvalvular AF, CHA2DS2‑VASc ≥2, and contraindication to long‑term OAC due to a nonreversible cause; may be reasonable in selected high bleeding risk patients after shared decision‑making.

inv-07: Surgical LAA exclusion during cardiac surgery

Covered when ALL of the following are met for surgical LAA exclusion performed during cardiac surgery:

Concomitant cardiac surgery indication: Patient has atrial fibrillation and is undergoing cardiac surgery.

Recommended during first‑time nonemergent cardiac surgery, especially mitral procedures.

Stroke risk: CHA2DS2‑VASc score ≥ 2 (or equivalent stroke risk).CHA2DS2‑VASc >=2

Indication for surgical LAA exclusion in addition to anticoagulation.

Surgical outcome expectation: Surgical technique should result in absence of flow across the suture line and an LAA stump < 1 cm as determined by intraoperative transesophageal echocardiography (TEE).stump <1 cm

Intraoperative TEE recommended to confirm adequacy of exclusion.

inv-08: LAAO for patients with high ICH risk or contraindication to OAC

Covered/considered when ALL of the following are met for patients with high bleeding or intracranial hemorrhage (ICH) risk or contraindication to oral anticoagulation:

High ICH risk: Patient has atrial fibrillation and a condition associated with high risk of recurrent intracranial hemorrhage (e.g., cerebral amyloid angiopathy).

Anticoagulation‑sparing strategies such as LAAO may be considered (Class IIb).

Anticoagulation contraindication: Patient is not a candidate for long‑term oral anticoagulation due to a nonreversible contraindication or unacceptable bleeding risk.

SCAI/HRS and ACC guidance support consideration of LAAC in selected high‑risk patients.

inv-09: Stand-alone procedures

Stand‑alone surgical LAA exclusion or stand‑alone surgical ablation — evidence and coverage stance:

Stand-alone LAA exclusion: Stand‑alone surgical LAA exclusion is under evaluation; current evidence is primarily small observational studies and short‑term series and is insufficient to establish long‑term efficacy — randomized trials are needed.

Described as investigational/limited evidence.

Stand-alone surgical ablation: Stand‑alone surgical ablation may be reasonable in selected symptomatic patients refractory to antiarrhythmic drugs or prior catheter ablation; Cox‑Maze procedures at high‑volume centers report strong outcomes but evidence is heterogeneous; epicardial‑only or atypical lesion sets remain exploratory.

Stand‑alone or hybrid approaches should be considered after documenting prior therapy and rationale; evidence limitations noted.

inv-10: Surgical/hybrid ablation guideline recommendations

Guideline-aligned recommendations summarized (European Heart Rhythm Association/Heart Rhythm Society, 2024):

Concomitant surgical AF ablation is beneficial in patients with paroxysmal or persistent AF undergoing left atrial open cardiac surgery regardless of prior antiarrhythmic drug failure or intolerance; biatrial Cox maze or at minimum PVI plus left atrial posterior wall isolation is recommended.

Advice TO DO; supported by meta‑analyses and RAND evidence.

Concomitant surgical ablation in closed cardiac surgery: Concomitant surgical ablation is beneficial in patients intolerant or refractory to antiarrhythmic therapy undergoing closed (non‑left atrial open) cardiac surgery.

Advice TO DO; supported by meta‑analyses.

Stand‑alone surgical or hybrid ablation is reasonable in symptomatic persistent AF after prior unsuccessful catheter ablation or intolerance/refractory to antiarrhythmic drugs after weighing risks and benefits.

May be reasonable for paroxysmal AF after failed catheter ablation; evidence graded as Area of Uncertainty for some indications.

inv-11: Randomized trial evidence

Randomized trial evidence summaries informing coverage considerations:

CEASE-AF: Hybrid epicardial–endocardial ablation (HA) demonstrated higher freedom from AF at 12 months versus catheter ablation (71.6% vs 39.2%; p<0.001); major complication rates were similar (7.8% vs 5.8%).

Study limitations include staged procedures, LAA management differences, and limited follow‑up.

HARTCAP-AF: Small single‑center RCTs (eg, HARTCAP‑AF) reported higher freedom from recurrent tachyarrhythmia with hybrid approaches, but generalizability is limited by size and design; some hybrid arms included concomitant LAA closure.

Interpret with caution due to trial limitations.

CONVERGE/Hybrid Convergent: Hybrid Convergent improved AF outcomes and AF burden reduction versus catheter ablation in persistent/LSPAF with acceptable safety profile; limitations include unequal randomization and short follow‑up.

Supports consideration of hybrid approaches in selected patients.

inv-12: Registry and surgical series

Observational and registry evidence relevant to surgical (Cox‑Maze) outcomes:

STS database outcomes: Registry data (STS Adult Cardiac Surgery Database) report overall 30‑day operative mortality of 0.74% for surgical ablation procedures with higher complication rates in on‑CPB versus off‑CPB groups; stroke and renal failure rates were higher in on‑CPB group.

Data reflect large registry experience but include heterogeneous procedures (2005–2010).

Single‑center Cox‑Maze series: High long‑term freedom from atrial tachyarrhythmias reported in selected single‑center series (eg, freedom ~94% at 1 year and 79% at 10 years in some cohorts), but studies are retrospective and lack comparators.

Outcomes often from high‑volume specialized centers; generalizability limited.

inv-13: Esophageal cooling device coverage considerations

Active esophageal cooling device stance and evidence:

FDA classification: ensoETM received FDA De Novo Class II classification as a temperature regulation device intended to reduce ablation‑related esophageal injury during cardiac ablation procedures; device maintains water temperature between 4°C and 42°C in a closed‑loop system.

Device description and regulatory status per FDA De Novo determination.

Evidence on AEF reduction: Retrospective multicenter analysis across 30 hospitals (14,224 patients) reported 0 atrioesophageal fistulas after adoption of ensoETM versus 16 AEFs (0.146%) in pre‑adoption cohorts (P<0.0001); study limited by retrospective design and nonstandardized data collection.

Promising observational signal but insufficient randomized evidence for routine adoption.

inv-14: Active Esophageal Cooling — Coverage Determination

Policy coverage stance for active esophageal cooling during AF ablation:

Experimental/Investigational: Use of an active esophageal cooling device during cardiac catheter ablation is considered Experimental/Investigational/Unproven.

Policy identifies device coding as HCPCS C1889 and concludes evidence insufficient for routine use despite FDA De Novo classification and limited trial data.

inv-15: Catheter Ablation with PVI — Coverage Determination

Catheter ablation with pulmonary vein isolation is considered medically necessary when applicable policy criteria are met:

Medically necessary: Cardiac catheter ablation with pulmonary vein isolation (report with CPT 93656 and CPT 93657 as applicable) is medically necessary when the policy criteria are met. Repeat ablation is medically necessary for recurrent symptomatic AF.

Providers should report procedures with the covered CPT codes and document prior therapies and indications.

inv-16: Revised/Added Policy Statements

Policy statements updated or added:

Cardiac catheter ablation: Policy statement for cardiac catheter ablation was revised.

See full policy for specific clinical criteria and revised language.

Surgical ablation (Maze/modified Maze): Policy statements for surgical ablation were revised.

See full policy for detailed indications and exclusion criteria.

Percutaneous transcatheter LAA closure: Policy statements were revised for percutaneous transcatheter closure of the left atrial appendage.

See full policy for device‑specific and patient‑selection criteria.

Repeat cardiac catheter ablation: Policy statement for repeat cardiac catheter ablation was added.

Percutaneous left atrial appendage occlusion (pLAAO) and catheter ablation coverage is tightly linked to established indications. Percutaneous LAA closure (CPT 33340) is covered only for prevention of stroke in individuals with nonvalvular atrial fibrillation who have a CHA2DS2‑VASc ≥2 and a documented contraindication to long‑term oral anticoagulation due to a nonreversible cause; other indications are considered not medically necessary. Cardiac catheter ablation with pulmonary vein isolation (CPT 93656, 93657) is medically necessary for symptomatic AF when antiarrhythmic drugs are ineffective, contraindicated, not tolerated or not preferred, and for selected other indications (eg, HFrEF ≤40%, athletes with high‑volume endurance activity, PH with pulmonary vascular disease).

Current evidence and guideline statements indicate that the benefit of surgically excluding the left atrial appendage when anticoagulation is discontinued is uncertain. Professional guidance characterizes surgical LAA exclusion performed in the absence of continued anticoagulation as a Class IIb recommendation with uncertain net benefit, and available data do not support routine use of surgical exclusion as a substitute for long‑term anticoagulation.

Stand‑alone surgical LAA exclusion (open or thoracoscopic procedures not performed during other cardiac surgery) is supported primarily by small observational series and retrospective reports with limited follow‑up. Because high‑quality randomized data and long‑term outcome evidence are lacking, stand‑alone surgical LAA exclusion is considered to have insufficient evidence to establish efficacy for stroke prevention and remains investigational.

Epicardial‑only ablation approaches and atypical epicardial lesion sets remain exploratory. Although hybrid and convergent techniques have shown promising results in selected trials, epicardial ablation strategies without robust randomized trial evidence are considered investigational until further high‑quality data clarify safety, lesion set efficacy, and patient selection.

Active esophageal cooling devices (eg, ensoETM) have received an FDA De Novo classification and have been evaluated in retrospective series and a small randomized trial; however, the policy classifies the use of an active esophageal cooling device during cardiac catheter ablation as Experimental/Investigational/Unproven (HCPCS C1889) because evidence is insufficient to support routine coverage.

Surgical exclusion or excision of the left atrial appendage (CPT 33268) is considered medically necessary when performed in conjunction with other cardiac surgical procedures. By contrast, open or thoracoscopic LAA exclusion performed without concomitant open cardiac surgery (CPT 33267, 33269) is considered Not Medically Necessary due to limited evidence and guideline recommendations.

The policy was updated during focused and annual reviews with multiple revisions. Notably, earlier policy statement criteria for surgical closure of the left atrial appendage were removed as part of the 3/15/2024 annual review; subsequent focused reviews revised statements for catheter ablation, surgical ablation, and percutaneous LAA closure and added statements for repeat catheter ablation and active esophageal cooling. Refer to the full policy for the complete, current criteria and revision history.

Catheter ablation for indications other than those explicitly listed as medically necessary is considered Not Medically Necessary. This includes routine ablation for asymptomatic atrial fibrillation except in select asymptomatic patients addressed by professional society guidance; repeat ablation for recurrent symptomatic AF is an exception and is considered medically necessary when meeting guideline criteria.

Vein of Marshall (VOM) ethanol infusion has been evaluated in randomized and nonrandomized studies, including the VENUS randomized trial (n=343), which reported improved freedom from AF/AT at 6 and 12 months when VOM ethanol infusion was added to catheter ablation. Despite these findings, the overall evidence base is limited, comprised of a single RCT with adjunctive benefits and multiple observational reports; further large, diverse, long‑term studies are needed before routine adoption.

As noted for surgical LAA exclusion, available guidance indicates uncertainty about the protective benefit of surgical LAA exclusion if anticoagulation is not continued. The policy reiterates that surgical LAA exclusion should not be considered a substitute for ongoing anticoagulation when anticoagulation would otherwise be indicated, given the lack of definitive evidence supporting equivalent stroke risk reduction without anticoagulation.

Stand‑alone Maze or modified Maze procedures performed without concomitant cardiac surgery have heterogeneous supporting data, variable lesion sets and energy sources, and inconsistent outcome definitions across studies. Because of these limitations and the absence of well‑designed controlled trials with long‑term outcomes, stand‑alone surgical Maze procedures are considered to have insufficient evidence to define a standard role and remain investigational.

Open or thoracoscopic left atrial appendage exclusion performed without concomitant open cardiac surgery (CPT 33267, 33269) is considered Not Medically Necessary. When LAA exclusion is indicated, coverage is limited to procedures performed in conjunction with other cardiac surgical procedures (eg, CPT 33268) per policy guidance.

Closure of a peridevice leak after LAA occlusion (reported with unlisted cardiac procedure CPT 33999) is considered Experimental/Investigational/Unproven. The clinical consequences of peridevice leaks are uncertain, and proposed closure techniques lack evidence showing improved clinical outcomes compared with medical management or observation.

This document does not list every condition categorized as Not Medically Necessary within the extracted chunks. For a comprehensive listing of procedures and circumstances deemed Not Medically Necessary or Experimental/Investigational, reviewers should consult the full policy text and coding sections.

Coding Guidance

Covered CPT Codes - Catheter AblationCPTCovered

93656	Comprehensive electrophysiologic evaluation including transseptal catheterizations with intracardiac catheter ablation of atrial fibrillation by pulmonary vein isolation
93657	Additional linear or focal intracardiac catheter ablation of the left or right atrium for treatment of atrial fibrillation remaining after completion of pulmonary vein isolation (listed separately in addition to code for primary procedure)

Covered CPT Codes - Percutaneous LAA ClosureCPTCovered

33340

Percutaneous transcatheter closure of the left atrial appendage with endocardial implant

Surgical LAA Closure CodesCPT

33268	Exclusion of left atrial appendage, open, performed at the time of other sternotomy or thoracotomy procedure(s), any method
33267	Exclusion of left atrial appendage, open, any method
33269	Exclusion of left atrial appendage, thoracoscopic, any method
33999	Unlisted procedure, cardiac (used to report closure of a peridevice leak)

Surgical Maze CodesCPT

33256	Surgical Maze procedure with cardiopulmonary bypass
33257	Surgical Maze procedure with cardiopulmonary bypass (additional variant)
33259	Surgical Maze procedure with cardiopulmonary bypass (additional variant)
33258	Surgical Maze or modified Maze procedure without cardiopulmonary bypass
33254	Endoscopic Maze as part of hybrid convergent procedure (listed as experimental/investigational)
33255	Endoscopic Maze as part of hybrid convergent procedure (listed as experimental/investigational)
33265	Endoscopic Maze as part of hybrid convergent procedure (listed as experimental/investigational)
33266	Endoscopic Maze as part of hybrid convergent procedure (listed as experimental/investigational)

Not Covered / Experimental CodesCPTNot Covered

93799

Unlisted cardiovascular service or procedure (used here for Vein of Marshall alcohol ablation / VOM ethanol infusion)

Experimental HCPCSHCPCSExperimental

C1889

Implantable/insertable device, not otherwise classified (active esophageal cooling device)

Catheter ablation CPT codesCPTCovered

93656	Comprehensive electrophysiologic evaluation including transseptal catheterizations with intracardiac catheter ablation of atrial fibrillation by pulmonary vein isolation
93657	Additional linear or focal intracardiac catheter ablation of the left or right atrium for treatment of atrial fibrillation remaining after completion of pulmonary vein isolation

Vein of Marshall procedure codeCPTExperimental

93799

Unlisted cardiovascular procedure (used to reference Vein of Marshall ethanol infusion)

Percutaneous LAA closure codesCPTCovered

33340

Percutaneous transcatheter closure of the left atrial appendage with endocardial implant

Surgical LAA exclusion codesCPTCovered

33268

Surgical closure/exclusion of the left atrial appendage performed in conjunction with other cardiac surgical procedures

Cardiac Surgery - LAA Exclusion/ExcisionCPTCovered

33268

Exclusion of left atrial appendage, open, performed at the time of other sternotomy or thoracotomy procedure(s), any method

Surgical Ablation (performed without cardiopulmonary bypass)CPTCovered

33254	Surgical ablation — CPT code included in group (endoscopic/hybrid convergent contexts)
33255	Surgical ablation — CPT code included in group (endoscopic/hybrid convergent contexts)
33265	Surgical ablation — CPT code included in group (endoscopic/hybrid convergent contexts)
33266	Surgical ablation — CPT code included in group (endoscopic/hybrid convergent contexts)

Peridevice Leak ClosureCPTExperimental

33999

Unlisted procedure, cardiac (used to report closure of a peridevice leak after LAA occlusion)

Surgical ablation CPT codesCPT

33254	Surgical ablation performed without cardiopulmonary bypass (listed)
33255	Surgical ablation performed without cardiopulmonary bypass (listed)
33265	Surgical ablation performed without cardiopulmonary bypass (listed)
33266	Surgical ablation performed without cardiopulmonary bypass (listed)

Active esophageal cooling deviceHCPCS

C1889

Active esophageal cooling device — temperature regulation device for esophageal protection during cardiac ablation (FDA De Novo referenced)

Covered CPT Codes for PV isolationCPTCovered

93656	Comprehensive electrophysiologic evaluation including transseptal catheterizations with intracardiac catheter ablation of atrial fibrillation by pulmonary vein isolation
93657	Additional linear or focal intracardiac catheter ablation of the left or right atrium for treatment of atrial fibrillation remaining after completion of pulmonary vein isolation

Experimental/Investigational Device CodeHCPCSExperimental

C1889

Implantable/insertable device, not otherwise classified (active esophageal cooling) — considered Experimental/Investigational/Unproven when used during cardiac catheter ablation

Surgical LAA closure codes and stanceCPT

33268	Exclusion of left atrial appendage, open, performed at the time of other sternotomy or thoracotomy procedure(s) — considered medically necessary when performed with other cardiac surgery
33267	Exclusion of left atrial appendage, open, any method — considered not medically necessary when performed without concomitant open cardiac surgical procedure
33269	Exclusion of left atrial appendage, thoracoscopic, any method — considered not medically necessary when performed without concomitant open cardiac surgical procedure

Percutaneous LAA closure CPTCPTCovered

33340

Percutaneous transcatheter closure of the left atrial appendage with endocardial implant

Unlisted cardiac surgery proceduresCPTExperimental

33999

Unlisted procedure, cardiac (used to report closure of a peridevice leak after LAA occlusion)

Device regulatory numbers referencedmixed

P130013	PMA - Watchman Left Atrial Appendage Closure Device
P200049	PMA - Amplatzer Amulet Left Atrial Appendage Occluder
K220305	510(k) - Syntheon Left Atrial Appendage Exclusion System
K093679	510(k) - AtriClip LAA Exclusion System
DEN230021	De Novo - ensoETM (esophageal cooling)
P230017	PMA - PulseSelect Pulsed Field Ablation (PFA) system
P230030	PMA - FARAPULSE Pulsed Field Ablation System

CHA2DS2-VASc threshold for pLAAO — percutaneous LAA closure

CHA2DS2-VASc threshold for pLAAOCHA2DS2-VASc score ≥2 (moderate-to-high stroke risk) required for percutaneous LAA closure candidacy

Indication contextNonvalvular atrial fibrillation with contraindication to long-term oral anticoagulation

Device requirement

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization and documentation expectations

When coverage depends on meeting policy criteria, prior authorization is required and providers must submit clinical documentation for review. Coverage determinations consider plan terms, applicable laws/regulations, relevant collateral materials, and the specific clinical facts of the case.

Prior authorization required when coverage depends on meeting policy criteria.
Claims submitted without covered codes under the applicable policy will be denied as not covered.

Prior Authorization

Prior authorization for LAA procedures

Percutaneous left atrial appendage occlusion (pLAAO, CPT 33340) and surgical LAA exclusion (CPT 33268) require prior authorization and will be authorized when guideline-based indications are met (eg, AF with CHA2DS2-VASc ≥2 and contraindication to long‑term anticoagulation or other guideline criteria). Providers should document stroke risk score, reason anticoagulation is not suitable, life expectancy, and expected benefit.

Authorize pLAAO (CPT 33340) when ACC/AHA guideline indications are met (eg CHA2DS2‑VASc ≥2 and contraindication to long‑term OAC).

Background

Atrial fibrillation is the most common sustained cardiac arrhythmia and is associated with increased risks of stroke, heart failure, and mortality. Management priorities include stroke risk assessment and prevention, symptom and rhythm control when appropriate, and strategies to reduce AF burden and related complications; nonpharmacological options such as catheter ablation and left atrial appendage closure are considered within this clinical context.

Definitions

Paroxysmal AF — definition

Definition — Paroxysmal AFIntermittent atrial fibrillation that terminates within ≤7 days of onset

Clinical notePatients with persistent AF who convert to paroxysmal with therapy remain defined as persistent to reflect original pattern

RelevanceUsed to classify AF type for procedural indications and eligibility

Persistent AF — definition

Definition — Persistent AFContinuous atrial fibrillation that sustains for >7 days and requires intervention

Classification notePatients who become paroxysmal after therapy should still be defined as persistent based on original pattern

Revision History

2025-05-15Focused reviewLatest

Revised policy statement for cardiac catheter ablation; revised policy statements for surgical ablation (surgical Maze or modified Maze procedure).

2025-03-15Focused review

Revised policy statements for percutaneous transcatheter closure of the left atrial appendage (LAA).

2024-10-15Annual review

Policy Summary

PayerCigna

PolicyNonpharmacological treatments for atrial fibrillation (ablation and LAA closure)

Policy CodePolicy 0469

Change TypeFocused review — revised and added policy statements

Effective DateMay 15, 2025

Next Review DateOct 15, 2025

Key ActionSubmit prior authorization when requesting percutaneous or surgical LAA procedures and document CHA2DS2-VASc score and contraindication to long-term anticoagulation as applicable.

SourceLink

On This Page

See professional society statements (SCAI/HRS, ACC).

Surgical LAA exclusion during cardiac surgery: In patients with AF undergoing cardiac surgery with CHA2DS2‑VASc ≥2 (or equivalent stroke risk), surgical LAA exclusion in addition to continued anticoagulation is indicated; technique should result in absence of flow across suture line and stump <1 cm as confirmed by intraoperative TEE.CHA2DS2‑VASc ≥2; stump <1 cm

Class I recommendation per guideline summaries.

Procedural documentation: Documentation of entrance/exit block across pulmonary veins and completeness of lesion lines is beneficial during surgical AF ablation.

Advice TO DO; supports procedural quality and assessment.

Refer to policy for timing and documentation requirements for repeat procedures.

Active esophageal cooling device: Policy statement for active esophageal cooling device was added.

Refer to policy for device coding and the Experimental/Investigational stance.

Procedure performed with an FDA‑approved transcatheter LAA occlusion device (CPT 33340)

Left ventricular ejection fraction threshold for HFrEF consideration

EF threshold for HFrEF considerationLeft ventricular ejection fraction ≤40% cited as HFrEF criterion for catheter ablation consideration

Clinical contextSymptomatic atrial fibrillation associated with heart failure and reduced ejection fraction

Therapy sequencing noteAblation may be reasonable in selected HFrEF patients to improve symptoms, QOL, and ventricular function

PFA indication duration restriction (PulseSelect)

PFA indication duration restriction (PulseSelect)Indication limits treatment of persistent atrial fibrillation to episode duration less than 1 year for PulseSelect PFA system

Device approval datePulseSelect™ PFA received FDA PMA approval 12/13/2023 (P230017)

Use caseIndicated for drug‑refractory, recurrent, symptomatic paroxysmal or specified persistent AF when used with the PulseSelect system

CHA2DS2-VASc score threshold for surgical LAA exclusion

CHA2DS2-VASc threshold for surgical LAA exclusionCHA2DS2-VASc score ≥2 (or equivalent stroke risk) indicated for surgical LAA exclusion during cardiac surgery

Concomitant procedure requirementSurgical LAA exclusion indicated when performed in patients with AF who are undergoing cardiac surgery

Adjunct to anticoagulationSurgical exclusion is indicated in addition to continued anticoagulation to reduce stroke/systemic embolism

Recommended maximum LAA stump size after surgical exclusion

Recommended maximum LAA stump size after surgical exclusionLAA stump < 1 cm as determined by intraoperative transesophageal echocardiography

Imaging verificationIntraoperative TEE recommended to confirm absence of flow across the suture line and stump <1 cm

RationaleStump <1 cm recommended to ensure effective exclusion per guideline/consensus statements

Peridevice leak size threshold (FDA guidance)

Peridevice leak size threshold (FDA)FDA guidance: continue or restart anticoagulation if peridevice leak > 5 mm; leak ≤ 5 mm may allow anticoagulation cessation at physician discretion

Assessment timingTEE with color Doppler at 45 days and 12 months recommended to assess device seal and measure residual leak

Clinical uncertaintyClinical impact and management of peridevice leaks not fully understood; efforts should minimize leaks at implantation

Minimum life expectancy for LAAC candidacy (per SCAI/HRS)

Minimum life expectancy for LAAC candidacy (SCAI/HRS)> 1 year minimum life expectancy and adequate quality of life expected to benefit from LAAC

Appropriate patient selectionRecommended for patients with high thromboembolic risk not suited for long‑term oral anticoagulation

Routine practice noteRoutine closure of iatrogenic atrial septal defects associated with LAAC is not recommended

Left atrial diameter enrollment criterion in CEASE-AF

Left atrial diameter enrollment criterion in CEASE-AFLeft atrial diameter > 4.0 cm was an enrollment criterion for CEASE-AF in persistent/LSPAF patients

Population includedCEASE-AF enrolled symptomatic, drug‑refractory persistent AF patients aged 18–75 with LAD >4.0 cm or symptomatic LSPAF

Trial contextHybrid epicardial–endocardial ablation vs catheter ablation study assessing freedom from AF at 12 months

Policy review dates and focused reviews

Most recent focused review datesFocused reviews noted: 5/15/2025 and 3/15/2025

Recent annual review datesAnnual reviews recorded: 10/15/2024, 3/15/2024, 12/15/2023

Policy changes summaryRevisions included updated statements for catheter ablation, surgical ablation, percutaneous LAA closure; added statements for repeat ablation and active esophageal cooling device

Authorize surgical LAA exclusion (CPT 33268) when performed in patients with AF undergoing cardiac surgery with CHA2DS2‑VASc ≥2 per guideline recommendations.

Prior Authorization

Prior authorization recommended for concomitant procedures

Prior authorization is recommended for concomitant procedures performed at the time of cardiac surgery. Surgical LAA exclusion (CPT 33268) performed concomitantly in patients with AF and CHA2DS2‑VASc ≥2 should be reviewed and documented to support coverage.

Recommend prior authorization for concomitant surgical procedures (including surgical LAA exclusion) to document indication and intraoperative imaging.
Concomitant surgical AF ablation is beneficial in patients undergoing left atrial open cardiac surgery; document prior AAD therapy and rationale when applicable.

Prior Authorization

Prior authorization for revised procedures

Policy revisions (including addition of repeat cardiac catheter ablation and active esophageal cooling device policy statements) have prior authorization implications. Ensure prior authorization submissions reference the updated policy statements and include required supporting documentation.

Repeat cardiac catheter ablation (codes 93656/93657) is included in the policy—prior authorization required with documentation of recurrent symptomatic AF.
Active esophageal cooling device (HCPCS C1889) is considered experimental/investigational — prior authorization submissions should note investigational status and supporting rationale if requested.

Denial Risk

Coding-based claim denial risk

Claims submitted without covered or appropriate codes per this policy are subject to denial as not covered. Use the most appropriate procedure and device codes as of the date of service.

Claims lacking covered codes under this policy will be denied as not covered.
When reporting PVI procedures, use CPT 93656 (and CPT 93657 as applicable) per policy coding guidance.

Note

Stand‑alone surgical ablation: evidence limitations

Evidence for stand‑alone surgical ablation (surgical Maze or modified Maze when NOT performed concomitantly with cardiac surgery) is limited and heterogeneous. Coverage reviewers should note the inconsistent outcomes, variable lesion sets and energy sources, and lack of standardized success definitions when evaluating requests for stand‑alone surgical ablation.

Stand‑alone surgical ablation: limited evidence, heterogeneous populations, and inconsistent outcomes — randomized controlled trials with larger populations and long‑term follow-up are needed.
Concomitant surgical ablation has stronger evidence; document indication and prior therapies when requesting stand‑alone procedures.

Documentation Required

Imaging and peridevice leak documentation

Imaging documentation is required to support coverage decisions for surgical LAA exclusion and device-based LAA procedures. Intraoperative transesophageal echocardiography (TEE) should confirm absence of flow across the suture line and stump <1 cm after surgical exclusion. For device-based procedures, document post‑implant imaging and any peridevice leak measurements.

Intraoperative TEE recommended to confirm stump <1 cm and absence of flow after surgical LAA exclusion.
For Watchman/Watchman FLX and Amulet devices, document 45‑day and 12‑month imaging per FDA guidance and report any peridevice leak size; leaks >5 mm may require continuation or restart of anticoagulation.

Billing Rule

Coding and procedural reporting for catheter ablation and adjunct devices

When reporting catheter ablation with pulmonary vein isolation, report CPT 93656 for the primary procedure and CPT 93657 for additional linear or focal left/right atrial ablation as applicable. For repeat ablation, document recurrent symptomatic AF and prior procedure details. If an active esophageal cooling device is used, note the device and HCPCS code C1889, understanding it is considered experimental/investigational.

Report CPT 93656 for comprehensive PVI procedures; report 93657 in addition when additional ablation performed.
Document repeat ablation indications when reporting repeat PVI.
Document use of active esophageal cooling (HCPCS C1889) if used; coverage status is experimental/investigational.

Note

Therapy sequencing for catheter ablation

Therapy sequencing: Catheter ablation is considered after antiarrhythmic drugs (AADs) have been ineffective, contraindicated, not tolerated, or not desired. For select patients (eg symptomatic AF with HFrEF ≤40% or athletes), ablation may be appropriate earlier. Provide documentation of prior AAD trials or rationale for earlier ablation.

Ablation considered after AAD failure/intolerance/contraindication or patient preference.
For HFrEF (≤40%) or high‑volume endurance athletes, ablation may be appropriate per guideline-based indications.

Note

Therapeutic sequencing for LAA management in AF

Therapeutic sequencing for AF: When considering LAA exclusion or pLAAO in patients at high risk of intracranial hemorrhage or bleeding, anticoagulation‑sparing strategies may be considered. For pLAAO, document CHA2DS2‑VASc score, bleeding risk, and reason long‑term OAC is unsuitable.

In patients with AF and high ICH risk, anticoagulation‑sparing strategies (eg LAAO) may be considered—document rationale and alternatives.
For pLAAO, include CHA2DS2‑VASc score ≥2 and contraindication or high bleeding risk to support the request.

Documentation Required

Required prior therapy and clinical documentation

Prior therapy documentation must be provided with authorization requests. Include AF type (paroxysmal/persistent/long‑standing), prior antiarrhythmic drug therapy (agents, duration, response, intolerance), anticoagulation status and history, prior ablation or surgical procedures, imaging findings, and symptom burden.

Required clinical details: AF type, prior AAD therapy and reason for discontinuation, anticoagulation history and contraindications, prior ablation/surgical history, symptom severity.
For repeat procedures or hybrid approaches, provide documentation of prior interventions and outcomes.

Step Therapy

Active esophageal cooling: evidence vs step therapy

No step therapy or specific step‑limit is specified for the active esophageal cooling device; randomized trial evidence (eg IMPACT trial) showed reduced mucosal injury but overall evidence is insufficient for routine coverage—device remains experimental/investigational.

No step therapy specified for ensoETM; evidence from randomized trials is limited and insufficient for routine coverage.
Active esophageal cooling (HCPCS C1889) considered E/I/U at this time; document any rationale when requested for case review.

Note

Focused and annual review — provider action

Focused and annual policy reviews updated statements for catheter ablation, surgical ablation, and pLAAO; providers should reference the updated policy statements and supply documentation aligned with the revised criteria when submitting prior authorization requests.

Revision dates: focused review 5/15/2025 (catheter and surgical ablation revisions), focused review 3/15/2025 (pLAAO revisions), annual reviews noted in policy history.
Providers must reference the current policy effective date and the revised statements when preparing authorization requests.

Persistent AF duration informs procedure selection and device indications

Long-standing persistent AF — definition

Definition — Long-standing persistent AFAtrial fibrillation continuous for >12 months in duration

Trial relevanceOften used as an inclusion criterion in trials of hybrid or convergent ablation

Clinical implicationLong-standing persistent AF may require more extensive lesion sets (eg, Cox maze) for durable rhythm control

Permanent AF — definition

Definition — Permanent AFWhen patient and clinician decide to stop further attempts to restore or maintain sinus rhythm

Therapeutic implicationRepresents a treatment decision rather than intrinsic pathophysiology; affects candidacy for rhythm-control procedures

Documentation noteClassification should be explicit in clinical records supporting procedural requests

VOM ethanol infusion — definition/key term

VOM ethanol infusion — definition/key termVein of Marshall (VOM) ethanol infusion: infusion of ethanol into the vein of Marshall during AF ablation to alter atrial substrate and improve freedom from AF

Evidence statusEvaluated in RCTs (eg, VENUS) and observational studies but considered investigational/limited evidence in this policy

Coding noteOften reported with unlisted CPT code 93799 in documentation and claims

pLAAO — definition (percutaneous LAA occlusion)

pLAAO — definitionPercutaneous left atrial appendage occlusion: transcatheter endocardial or epicardial approaches to mechanically exclude the LAA to prevent thromboembolism

Primary indicationUsed for stroke prevention in nonvalvular AF patients with CHA2DS2-VASc ≥2 who have contraindication to long‑term OAC

Representative CPT codeCPT 33340 for percutaneous transcatheter LAA closure

CHA2DS2-VASc — stroke risk scoring system definition

CHA2DS2-VASc — definitionStroke risk scoring system: congestive heart failure, hypertension, age ≥75 (2 points), diabetes, prior stroke/TIA/thromboembolism (2 points), vascular disease, age 65–74, sex category

Use caseScore used to stratify stroke risk and determine candidacy for LAA closure (threshold ≥2) and surgical exclusion decisions

Clinical noteReferenced throughout policy for procedural indications and guideline recommendations

Peridevice leak (PDL) — definition and clinical impact note

Peridevice leak (PDL) — definitionResidual flow around an implanted LAAC device; clinical impact is uncertain and management varies based on leak size

Management thresholdFDA uses 5 mm threshold to guide anticoagulation decisions (continue/restart if >5 mm)

Policy noteEfforts should be made to minimize PDLs at implantation; follow-up imaging recommended to quantify leaks

Cox maze — definition and context

Cox maze — definitionA biatrial surgical lesion set intended to eliminate atrial fibrillation (Cox maze procedure)

Outcome contextFull biatrial Cox maze associated with strong longitudinal evidence of efficacy in selected high‑volume centers

Clinical implicationOften performed concomitantly with other cardiac surgery; can improve long‑term freedom from AF

Active esophageal cooling device (HCPCS C1889) — definition/description

Active esophageal cooling device (HCPCS C1889) — definition/descriptionA closed-loop esophageal temperature regulation device (eg, ensoETM) placed in the esophagus to control temperature during cardiac ablation and provide gastric decompression/suctioning

FDA statusensoETM granted FDA De Novo Class II classification (DEN230021) as a temperature regulation device for esophageal protection

Coding noteDevice billed using HCPCS C1889; policy classifies its use during ablation as Experimental/Investigational/Unproven

Active esophageal cooling (ensoETM) — device description

Active esophageal cooling (ensoETM) — device descriptionA silicone tube through which distilled water is pumped in a closed-loop irrigation system connected to a console; maintains water at operator‑selected temperatures (4°C–42°C) and includes gastric aspiration lumen

Intended effectsIntended to reduce the likelihood of ablation‑related esophageal injury and provide gastric decompression/suctioning

Operational detailClosed‑loop system: no water enters the GI tract; temperature is thermostat‑controlled via a mobile console

Atrioesophageal fistula (AEF) — definition and significance

Atrioesophageal fistula (AEF) — definitionA rare but life‑threatening connection between the left atrium and esophagus that can occur after esophageal thermal injury from catheter ablation

Clinical significanceAEF is a serious complication the esophageal cooling devices aim to reduce; observational data suggest reduced AEF rates after adoption of ensoETM but evidence limited by retrospective design

MonitoringEndoscopic and clinical surveillance used in trials assessing esophageal injury; adoption requires careful evaluation of safety evidence

Hybrid convergent ablation — definition and trial context

Hybrid convergent ablation — definitionCombined epicardial and endocardial ablation approach (hybrid epicardial–endocardial) studied in CONVERGE and CEASE‑AF trials

Trial contextCEASE‑AF and CONVERGE enrolled patients with persistent/LSPAF and evaluated hybrid vs catheter ablation effectiveness and safety

Clinical roleMay improve freedom from AF in persistent/LSPAF but has longer procedures and variable complication rates; patient selection important

LAA closure — definition: percutaneous or surgical methods and device examples

LAA closure — definitionLeft atrial appendage closure: percutaneous or surgical occlusion/exclusion of the LAA using devices such as Watchman, Amplatzer Amulet, or AtriClip to prevent thromboembolism

ApproachesIncludes endocardial transcatheter devices (eg, Watchman, Amplatzer Amulet) and surgical/extracardiac clips (eg, AtriClip) placed during cardiac surgery or thoracoscopically

Primary goalPhysical elimination or exclusion of the LAA to reduce risk of stroke in selected patients with AF who are not candidates for long‑term anticoagulation

Revised policy statements for surgical ablation (surgical Maze or modified Maze procedure).

2024-03-15Annual review

Title changed from 'Nonpharmacological Treatments for Atrial Fibrillation'; added policy statements for repeat cardiac catheter ablation and active esophageal cooling device; revised policy statements for cardiac catheter ablation, percutaneous transcatheter LAA closure, and surgical ablation.

2023-12-15Annual review

Added policy statement for transcatheter ablation for atrial fibrillation and heart failure; removed prior policy statement criteria for surgical closure of the left atrial appendage.

Material changes in the recent review cycle include revisions to policy statements for cardiac catheter ablation, surgical ablation (Maze/modified Maze), and percutaneous transcatheter LAA closure. The review also added policy statements for repeat cardiac catheter ablation and for active esophageal cooling devices. These changes are summarized in the policy revision history and should be used when preparing prior authorization requests and clinical documentation.