CurrentAetnaPolicy 0610

Cardiac Resynchronization Therapy and Other Pacing/Defibrillator Treatments for Heart Failure

Defines Aetna’s medical necessity, noncoverage, and investigational positions for biventricular pacemakers (CRT), combination CRT-defibrillators, and related pacing therapies for members with heart failure; affects providers submitting prior authorization and claims to Aetna.

Policy Summary

PayerAetna

PolicyCardiac Resynchronization Therapy and Other Pacing/Defibrillator Treatments for Heart Failure

Policy CodePolicy 0610

Change TypeNo material change

Effective DateApr 30, 2002

Next Review DateJun 27, 2024

Key ActionObtain prior authorization and document LVEF, NYHA class, QRS duration/morphology, and at least 3 months of guideline-directed medical therapy before requesting CRT.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

<=35%LVEF ≤35%

>=150 msQRS ≥150 ms

>=130 msQRS ≥130 ms

40 daysPost‑MI wait

3 monthsGDMT duration

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Coverage Criteria

Biventricular pacemaker (CRT) — Pathways A or B (sinus rhythm)

Covered when either A OR B is met (member is in sinus rhythm):

Pathway A or B: Either Pathway A OR Pathway B must be met (member in sinus rhythm)

Pathway A: NYHA class III or IV AND LVEF <= 35% AND QRS duration >= 150 ms AND member is on an optimal pharmacologic regimen for 3 months (maximally titrated as tolerated) AND member is >= 40 days post‑myocardial infarctionLVEF <= 35%; QRS >= 150 ms

All components must be satisfied

Pathway B: NYHA class II–IV AND LVEF <= 35% AND left bundle branch block (LBBB) with QRS duration >= 130 ms AND member is on an optimal pharmacologic regimen for 3 months (maximally titrated as tolerated) AND member is >= 40 days post‑myocardial infarctionLVEF <= 35%; QRS >= 130 ms

All components must be satisfied

Combination resynchronization‑defibrillator (CRT‑D) — additional high‑risk arrhythmia criteria

CRT‑D is covered when CRT criteria are fulfilled AND any of the following arrhythmic risk criteria are met:

Baseline requirement: Patient meets the biventricular pacemaker (CRT) medical necessity criteria (see CRT Pathway A or B)

CRT criteria must be fulfilled

High‑risk arrhythmic criteria (any one suffices): 1) ≥1 episode of cardiac arrest due to ventricular tachyarrhythmias; OR 2) recurrent, poorly tolerated sustained ventricular tachycardia; OR 3) prior myocardial infarction with documented non‑sustained ventricular tachycardia and inducible ventricular tachyarrhythmia; OR 4) prior myocardial infarction and LVEF ≤ 30%LVEF <= 30% (for criterion 4)

Any one of these arrhythmic criteria supports CRT‑D over CRT alone

Not medically necessary

Interventions considered not medically necessary:

Not medically necessary list: Adjunctive CRT in individuals with a left ventricular assist device (LVAD) in place; CRT or CRT‑D for heart failure or ventricular arrhythmias that are reversible or temporary; asynchronous pacing when competitive paced and intrinsic rhythms are likely; unipolar pacing in individuals with an implanted defibrillator/ICD due to risk of unwanted therapy delivery or inhibition.

These interventions are designated not medically necessary

Experimental / Investigational

Procedures considered experimental and investigational (not covered):

Investigational procedures: Biventricular pacemakers for indications not listed as medically necessary (eg, atrial fibrillation, NYHA class I, anti‑bradycardia pacing); wireless left ventricular endocardial pacing for CRT; combination CRT‑D for other non‑specified indications; Galectin‑3 testing to select individuals for CRT; His bundle pacing for CRT; implantable diaphragmatic stimulation (e.g., VisCardia VisONE); other novel/leadless or investigational device procedures not established as effective.

Effectiveness not established; these are investigational and not covered

Guideline-based CRT indications

Guideline-based indications summarized from ACCF/AHA/HRS focused update (2012) incorporated into 2008 device-based therapy guidelines

Non‑LBBB wide QRS (useful): LVEF ≤ 35%, sinus rhythm, non‑LBBB pattern with QRS ≥ 150 ms, NYHA class III or ambulatory IV despite guideline‑directed medical therapy (GDMT) (LOE: A)LVEF ≤ 35%; QRS ≥ 150 ms

(ACCF/AHA/HRS guidance)

LBBB with wide QRS (indicated): LVEF ≤ 35%, sinus rhythm, LBBB with QRS ≥ 150 ms, NYHA class II, III, or ambulatory IV with symptoms on GDMT (LOE: A for III/IV; LOE: B for II)LVEF ≤ 35%; QRS ≥ 150 ms

(ACCF/AHA/HRS guidance)

LBBB with intermediate QRS (useful): LVEF ≤ 35%, sinus rhythm, LBBB with QRS 120–149 ms, NYHA class II, III, or ambulatory IV with symptoms on GDMT (LOE: B)

Evidence summaries

Evidence supporting clinical benefits in specific populations

CRT vs RV pacing: Randomized trials demonstrate biventricular pacing prevents adverse LV remodeling and preserves LVEF compared with right‑ventricular apical pacing in select patients and reduces composite outcomes versus RV pacing in patients with AV block and LV systolic dysfunction.

(Yu et al; Curtis et al)

CRT reduces death/HF hospitalization: RCTs (eg, RAFT) and meta‑analyses show CRT combined with ICD reduces death and heart‑failure hospitalization in appropriately selected NYHA II–III patients with reduced LVEF and wide QRS.

(RAFT and related trials)

Benefits in mild/asymptomatic patients: Trials such as REVERSE and MADIT‑CRT indicate CRT can prevent progression in mildly symptomatic or asymptomatic patients with LBBB and other trial‑specific criteria; these data informed select FDA indications for CRT‑D.

(REVERSE, MADIT‑CRT)

Dyssynchrony imaging considerations

Limitations of echocardiographic dyssynchrony measures

Echocardiographic dyssynchrony limitations: No single echocardiographic measure of mechanical dyssynchrony is recommended to improve CRT patient selection beyond guideline‑validated QRS duration because of modest sensitivity/specificity, lack of large randomized validation trials, conflicting predictive value, and technical limitations.

Echocardiographic dyssynchrony parameters should not be used to deny CRT

Guideline-based CRT indications (summary of recommendations)

Covered when criteria align with guideline recommendations:

Core guideline criteria: LVEF ≤ 35% AND NYHA class II–IV symptoms despite guideline‑directed medical therapy (GDMT)LVEF ≤ 35%

Document duration of GDMT (eg, ≥3 months)

QRS duration and morphology in sinus rhythm: In sinus rhythm, consider: (1) LBBB with QRS ≥150 ms (NYHA II–ambulatory IV); (2) LBBB with QRS 120–149 ms (NYHA II–ambulatory IV; lower strength); (3) non‑LBBB with QRS ≥150 ms (NYHA II or ambulatory IV).QRS durations as stated

Evidence strength varies by subgroup

Atrial fibrillation considerations: CRT may be less effective in atrial fibrillation unless adequate biventricular capture is achieved; AV‑junction ablation can allow comparable benefit to sinus rhythm when necessary.

CRT-D for mild heart failure / primary prevention

Evidence and coverage considerations for patients with mild HF:

Mild HF / primary prevention considerations: In patients with mild heart failure (eg, NYHA I–II) the benefit of CRT‑D varies by QRS duration and morphology; some analyses show reduced composite outcomes, but patients with shorter QRS (eg, ≤134 ms) or non‑LBBB may not benefit and may be harmed. Consider subgroup trial data (eg, MADIT‑CRT) when evaluating implants in mild HF for primary prevention.QRS thresholds and subgroup findings per cited trials

Use trial‑specific criteria to guide decisions in mild HF

Wireless/leadless LV endocardial pacing (LVEP) — coverage stance

Emerging technologies for CRT delivery in patients who cannot receive or respond to conventional CRT:

LV endocardial / wireless pacing candidacy: Patients with failed conventional CRT (inability to place coronary‑sinus LV lead) or non‑responders may be considered for wireless/leadless LV endocardial pacing in specialized centers or clinical trials; early studies demonstrate feasibility and clinical signals but also substantial procedure‑related complication rates.

Reserve for experienced centers; evidence limited and procedures may be investigational depending on specific technique

CRT in patients with continuous-flow LVAD (CF-LVAD)

Coverage consideration for continued CRT after LVAD implantation:

CRT after CF‑LVAD: Observational and pooled analyses have not demonstrated survival, hospitalization, ventricular arrhythmia, or ICD therapy benefit from continuing CRT after continuous‑flow LVAD implantation and have shown increased pulse‑generator replacements; discontinuation of biventricular pacing post‑LVAD may be considered unless specific indications to continue exist.

Evidence is observational; individualize decisions

Use of alternatives when standard CRT not possible

Coverage stance for alternative pacing approaches

Alternatives reserved for failed/infeasible CRT: Conventional transvenous biventricular CRT remains the established therapy for appropriate candidates; alternatives such as His bundle pacing, left bundle branch area pacing (LBBAP), and leadless LV pacing are generally considered when standard CRT is impossible or ineffective.

Document rationale and prior attempts at conventional CRT

Imaging guidance for CRT

Use of imaging to guide LV lead placement

Imaging‑guided LV lead targeting: Cardiac MRI and other imaging modalities (eg, STE, multi‑modality imaging) can identify scar location and latest mechanical activation to guide LV lead placement and may improve selection and response; evidence is variable and limited by small trials and heterogeneity.

Imaging findings (scar, mechanical delay) may support lead targeting but require adequate documentation

Implantable diaphragmatic stimulation

Investigational status of diaphragmatic stimulation (VisONE/PIDS)

PIDS / VisONE evidence limitations: Pacing‑induced diaphragmatic stimulation (PIDS) and VisCardia VisONE have shown hemodynamic or symptomatic signals in small pilot studies but are limited by small sample sizes, short follow‑up, lack of mortality or hospitalization data, and require larger randomized trials; VisONE has FDA breakthrough designation but commercialization and long‑term efficacy/safety remain unestablished.

Currently investigational; not covered outside trials

Leadless cardiac pacing

Leadless pacing developments and limitations

Leadless pacing potential and concerns: Leadless LV pacing, bi‑ventricular endocardial pacing, and leadless left bundle branch pacing are promising alternatives when transvenous leads are problematic but face technical limitations, procedural complexity, battery life and device‑interaction concerns, and limited randomized clinical data; further trials and device development are needed before broad adoption.

Consider investigational status for many leadless/novel systems; reserve for appropriate settings

Galectin‑3 testing to select individuals for cardiac resynchronization therapy (CRT) and implantable diaphragmatic stimulation (VisONE) are explicitly listed as experimental and investigational (not covered). The policy also identifies His‑bundle pacing for CRT as investigational. These technologies lack established effectiveness for routine selection or replacement of guideline‑based CRT approaches and are not covered pending further evidence.

Echocardiographic measures of mechanical dyssynchrony are not validated to replace guideline‑validated criteria and should not be used to deny CRT. Landmark trials prospectively validated selection based on the electrocardiogram (QRS duration and morphology) rather than the many proposed echo dyssynchrony parameters, which show poor reproducibility and limited predictive power in multicenter core‑lab studies. In addition, pooled randomized data in patients with QRS ≤130 ms found no benefit and an increased all‑cause mortality signal with CRT‑D versus ICD alone, supporting reliance on validated QRS‑based thresholds for selection.

Guideline summaries indicate that CRT is not recommended for patients with NYHA class I or II symptoms who have a non‑LBBB conduction pattern with QRS duration <150 ms. This reflects guideline evidence (LOE: B) that benefit is unlikely in non‑LBBB patients with shorter QRS durations and that implantation outside these guideline‑based indications may be inconsistent with evidence supporting CRT.

In patients supported with continuous‑flow left ventricular assist devices (CF‑LVADs), pooled observational studies and a meta‑analysis did not demonstrate a significant benefit of continued CRT on mortality, hospitalizations, ventricular arrhythmia incidence, or ICD therapies, and continued CRT was associated with more pulse‑generator replacements. These findings support individualized reassessment of the need for ongoing biventricular pacing after CF‑LVAD implantation and may justify discontinuing routine CRT continuation absent a clear subgroup benefit.

Current evidence is insufficient to broadly recommend implantable diaphragmatic stimulation or to assert that cardiac magnetic resonance (CMR) guidance is superior to other modalities for LV lead targeting. Small pilot studies of diaphragmatic stimulation (VisONE/PIDS) show proof‑of‑principle signals but are limited by small sample sizes, short follow‑up, lack of mortality/hospitalization data, and methodological limitations. Similarly, meta‑analyses of imaging‑guided lead placement cite heterogeneity, small trial numbers, and variable protocols, limiting confidence in routine adoption of CMR‑guided strategies. Larger, randomized, longer‑term studies are required.

The portions of the document represented by these background, appendix, and reference sections do not specify additional explicit coverage exclusions. They provide supporting clinical context, discussion of emerging technologies, and bibliographic material rather than new, standalone coverage positions.

Clinical Policy Bulletins are intended to assist in administering plan benefits but are not contracts and do not replace specific plan documents or member benefit determinations. Coverage may be limited by plan provisions, certificates, or member‑specific eligibility rules; providers remain responsible for obtaining authorization and documenting medical necessity per the plan’s procedures.

The policy lists several explicit not medically necessary positions, including adjunctive CRT in individuals with a left ventricular assist device and CRT or CRT‑D used for heart failure or ventricular arrhythmias that are reversible or expected to be temporary. Requests for device therapy in those reversible contexts may be denied as not medically necessary.

Meta‑analyses and long‑term subgroup analyses indicate that CRT‑D in patients with systolic heart failure and relatively narrow QRS durations (≤130 ms) provides no heart‑failure mortality benefit and may increase all‑cause mortality compared with ICD alone. Similarly, in patients with mild heart failure without left bundle branch block morphology, CRT‑D did not demonstrate consistent clinical benefit and, in some shorter‑QRS subgroups, was associated with harm. These findings support excluding CRT‑D for narrow‑QRS and certain non‑LBBB mild‑HF populations.

Randomized trial subgroup data in mild heart failure suggest that CRT‑D offers inconsistent benefit in patients without LBBB morphology and may increase risk in shorter‑QRS subgroups; therefore, CRT‑D for mild HF without LBBB should be considered carefully and is not supported as a broad indication. Evaluation should emphasize QRS duration, morphology, and trial subgroup evidence when considering CRT‑D in less symptomatic patients.

Because observational and pooled studies of CF‑LVAD recipients found no clear survival or hospitalization benefit from continued biventricular pacing and an increased need for pulse‑generator replacements, continued CRT after CF‑LVAD implantation may be considered not medically necessary in the absence of evidence identifying subgroups likely to benefit. Decisions should be individualized and documented.

Implantable diaphragmatic stimulation (VisONE) and other novel pacing modalities remain investigational pending larger, longer‑term studies that demonstrate clinical outcome benefit (mortality, hospitalization) and acceptable safety. These technologies are not covered for routine clinical use at this time.

This portion of the document (background, appendix, references) does not state any additional not medically necessary conditions; it provides context on emerging technologies, imaging considerations, and bibliographic references rather than new denial or exclusion rules.

Coding

Biventricular Pacing — CPT codes covered if selection criteria are metCPTCovered

33208	Insertion or replacement of permanent pacemaker with transvenous electrode(s); atrial and ventricular.
33213	Insertion of pacemaker pulse generator only; with existing dual leads.
33214	Upgrade of implanted pacemaker system, conversion of single chamber system to dual chamber system (includes removal of previously placed pulse generator, testing of existing lead, insertion of new lead, insertion of new pulse generator.
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 (eg, for upgrade to dual chamber system) (List separately in addition to code for primary procedure).

Combination Resynchronization‑Defibrillation Devices — CPT codes covered if selection criteria are metCPTCovered

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 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 (eg, for upgrade to dual chamber system) (List separately in addition to code for primary procedure).
33230	Insertion of pacing cardioverter‑defibrillator pulse generator only; with existing dual leads.
33231	Insertion of pacing cardioverter‑defibrillator pulse generator only; with existing multiple leads.
33240	Insertion of pacing cardioverter‑defibrillator pulse generator only; with existing single lead.
33249	Insertion or replacement of permanent pacing cardioverter‑defibrillator system with transvenous lead(s), single or dual chamber.
33262	Removal of pacing cardioverter‑defibrillator pulse generator with replacement of pacing cardioverter‑defibrillator pulse generator; single lead system.
33263	Removal of pacing cardioverter‑defibrillator pulse generator with replacement of pacing cardioverter‑defibrillator pulse generator; with existing dual lead system.
33264	Removal of pacing cardioverter‑defibrillator pulse generator with replacement of pacing cardioverter‑defibrillator pulse generator; with existing multiple lead system.

HCPCS codes covered if selection criteria are metHCPCSCovered

C1779	Lead, pacemaker, transvenous VDD single pass.
C1785	Pacemaker, dual chamber, rate‑responsive (implantable).
C1882	Cardioverter‑defibrillator, other than single or dual chamber (implantable).
C1895	Lead, cardioverter‑defibrillator, endocardial dual coil (implantable).
C1896	Lead, cardioverter‑defibrillator, other than endocardial single or dual coil (implantable).
C1898	Lead, pacemaker, other than transvenous VDD single pass.
C1899	Lead, left pacemaker/cardioverter‑defibrillator combination (implantable).
C1900	Lead, left ventricular coronary venous system.
C2619	Pacemaker, dual chamber, non rate‑responsive (implantable).
C2620	Pacemaker, single chamber, non rate‑responsive (implantable).

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Other CPT codes and codes not covered / investigationalmixed

82777	Galectin‑3.
83520	Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified [galectin-3 test].
0515T	Wireless cardiac stimulation system for left ventricular pacing (CPT codes listed among codes not covered).
0522T	Wireless cardiac stimulation system for left ventricular pacing (CPT codes listed among codes not covered).
0674T	Laparoscopic insertion of new or replacement of permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function, including an implantable pulse generator and diaphragmatic lead(s).
0675T	Laparoscopic insertion of new or replacement of diaphragmatic lead(s), permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function, including connection to an existing pulse generator; first lead.
0676T	Laparoscopic insertion of new or replacement of diaphragmatic lead(s), permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function, including connection to an existing pulse generator; each additional lead (List separately in addition to code for primary procedure).
0677T	Laparoscopic repositioning of diaphragmatic lead(s), permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function, including connection to an existing pulse generator; first repositioned lead.
0678T	Laparoscopic repositioning of diaphragmatic lead(s), permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function, including connection to an existing pulse generator; each additional repositioned lead (List separately in addition to code for primary procedure).
0679T	Laparoscopic removal of diaphragmatic lead(s), permanent implantable synchronized diaphragmatic stimulation system for augmentation of cardiac function.

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ICD‑10 diagnosis codes — covered and not covered per indicationsICD-10

I50.1 - I50.9	Heart failure (covered ICD‑10 codes when selection criteria are met).
I20.0 - I22.9	Acute, subacute, and old myocardial infarction (used for CRT‑D indications).
I24.0 - I25.2	Ischemic heart disease / prior MI (used for CRT‑D indications).
I46.2	Cardiac arrest due to underlying cardiac condition.
I47.1	Supraventricular tachycardia.
I47.20 - I47.29	Ventricular tachycardia.
Z86.74	Personal history of sudden cardiac arrest.
I35.0	Nonrheumatic aortic (valve) stenosis (listed as ICD‑10 code not covered for Galectin‑3 prognostic use).
I42.0	Dilated cardiomyopathy (listed as ICD‑10 code not covered for Galectin‑3).
I48.0	Atrial fibrillation (listed among ICD‑10 codes not covered for CRT indications and for Galectin‑3).

Left ventricular ejection fraction (LVEF) — numeric threshold for eligibility

LVEF thresholdLeft ventricular ejection fraction (LVEF) ≤ 35%

ContextRequired for both Pathway A (NYHA III/IV) and Pathway B (NYHA II–IV) CRT eligibility

DocumentationPrior authorization and chart should document recent LVEF ≤35%

QRS duration — numeric thresholds for different pathways and device indications

Pathway A thresholdQRS duration ≥ 150 msec for NYHA class III or IV (Pathway A)

Pathway B / device indications

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization: device selection and LVAD CRT continuation

Prior authorization may be required by the member's Aetna plan for device selection and for requests involving continued CRT after implantation of a continuous‑flow left ventricular assist device (CF‑LVAD). When submitting prior authorization requests, document the clinical rationale for the chosen device (eg, CRT‑D vs CRT‑P) and explicitly address why continued CRT is indicated or why it should be discontinued after CF‑LVAD, referencing available comparative evidence and patient‑specific factors.

Document rationale for device choice (CRT‑D vs CRT‑P) and cite clinical evidence or patient risk factors.
For CRT continuation after CF‑LVAD, include data on survival, hospitalizations, arrhythmia burden, and plans to minimize generator changes.

Prior Authorization

Prior Authorization Required per Plan

Providers must obtain prior authorization per the enrollee's Aetna plan procedures before performing implantation, upgrade, or investigational device procedures described in this policy. Authorization requirements apply to listed CPT/HCPCS codes where plan rules indicate prior authorization.

Background

Heart failure affects approximately 5 million Americans with about 500,000 new cases per year, and up to half of patients with advanced heart failure have ventricular dyssynchrony. Prolonged QRS duration contributes to impaired cardiac mechanics; cardiac resynchronization therapy (CRT) aims to restore ventricular synchrony and improve hemodynamics. These epidemiologic and pathophysiologic considerations underpin the guideline‑validated, QRS‑based selection approach for CRT.

Definitions

Cardiac resynchronization therapy (CRT) — definition / key concept

DefinitionCardiac resynchronization therapy (CRT) refers to pacing techniques that provide electrical stimulation to both left and right sides of the heart to synchronize atrioventricular and ventricular contractions

PurposeDesigned to restore ventricular synchrony, improve hemodynamics, prevent adverse remodeling, and improve symptoms in selected HF patients

FormsDelivered via biventricular pacing systems, sometimes combined with ICD function (CRT‑ICD) depending on indication

CRT‑ICD (combination resynchronization‑defibrillator) — definition

DefinitionCRT‑ICD is an implantable device that combines biventricular pacing (CRT) with an implantable cardioverter‑defibrillator to both resynchronize ventricles and terminate life‑threatening arrhythmias

Indication context

Policy Summary

PayerAetna

PolicyCardiac Resynchronization Therapy and Other Pacing/Defibrillator Treatments for Heart Failure

Policy CodePolicy 0610

Change TypeNo material change

Effective DateApr 30, 2002

Next Review DateJun 27, 2024

Key ActionObtain prior authorization and document LVEF, NYHA class, QRS duration/morphology, and at least 3 months of guideline-directed medical therapy before requesting CRT.

SourceLink

On This Page

LVEF ≤ 35%; QRS 120–149 ms

(ACCF/AHA/HRS guidance)

Not recommended subgroup: CRT is not recommended for patients with NYHA class I or II symptoms and non‑LBBB pattern with QRS < 150 ms (LOE: B)QRS < 150 ms

(ACCF/AHA/HRS guidance)

Ensure adequate biventricular pacing capture in AF

QRS duration ≥ 130 msec for LBBB in NYHA class II–IV and FDA device labeling

Selection basisQRS duration and morphology (eg, LBBB) are primary selection parameters validated in landmark trials

Time post‑myocardial infarction — minimum waiting period before implantation

Minimum waiting period>= 40 days post‑myocardial infarction before CRT implantation

ApplicabilityRequired component for both Pathway A and Pathway B eligibility criteria

DocumentationPrior authorization should include date of MI and documentation that ≥40 days have elapsed

Duration of optimal pharmacologic therapy — required duration before CRT implantation

Required duration3 months of maximally titrated guideline‑directed pharmacologic therapy as tolerated before CRT implantation

Included agentsMay include ACE inhibitors, ARBs, beta blockers, digoxin, or diuretics unless contraindicated

DocumentationChart / prior authorization should document duration and agents used for GDMT

Follow Aetna plan-specific prior authorization process and submit applicable CPT/HCPCS codes.

Include clinical documentation described below with the prior authorization request.

Denial Risk

Requests for CRT/CRT‑D when HF or ventricular arrhythmias are reversible

Requests for CRT or CRT‑D when heart failure or ventricular arrhythmias are reversible or temporary are generally considered not medically necessary and may be denied. Examples include patients with transient causes of cardiomyopathy or arrhythmias expected to resolve.

Provide documentation that heart failure or arrhythmia is persistent and not reversible prior to approval.
If reversible causes have not been excluded, expect request denial.

Documentation Required

Use Validated Selection Parameters

Use guideline‑validated selection parameters when justifying CRT — specifically LVEF, rhythm (sinus vs atrial fibrillation), QRS duration and morphology (LBBB vs non‑LBBB), and NYHA functional class. Do not rely on unvalidated echocardiographic dyssynchrony measures alone to deny therapy.

QRS duration from ECG is the primary validated electrical selection parameter.
Echocardiographic dyssynchrony parameters should not be used in isolation to withhold CRT.

Documentation Required

Guideline‑Consistent Indications

Ensure device implantation aligns with guideline‑consistent indications: documented LVEF ≤35% (or as specified by guideline subgroup), appropriate QRS duration and morphology, NYHA functional class per criteria, and that the member has received guideline‑directed medical therapy (GDMT) for the recommended timeframe.

Match patient characteristics to guideline criteria (eg, LBBB with QRS ≥150 ms and NYHA II–IV on GDMT).
Requests outside guideline-based indications (eg, NYHA I/II non‑LBBB with QRS <150 ms) may be inconsistent with coverage.

Denial Risk

CRT Continuation after CF‑LVAD May Be Questioned

Continuation of CRT after CF‑LVAD implantation is not routinely supported by current evidence; studies and meta‑analyses have not shown consistent mortality or hospitalization benefits and continuation may increase generator changes. Prior authorization requests to continue CRT post‑LVAD should include specific clinical justification and subgroup rationale.

Include published data and patient‑level factors that support continued CRT use after CF‑LVAD.
If rationale is absent or weak, expect coverage denial or request for additional information.

Denial Risk

Evidence Limitations May Trigger Denial

Requests relying on limited, heterogeneous, or small‑sample evidence (for example, many image‑guided or novel device approaches) may be denied if the submission does not present strong supporting data. Imaging‑oriented LV lead targeting, novel leadless systems, or other experimental approaches require robust evidence to justify deviation from standard CRT.

Provide high‑quality RCT or large observational data when seeking exceptions for image‑guided or novel approaches.
If evidence is inconsistent or insufficient, authorization may be denied.

Note

No Explicit Authorization or Denial Triggers in Background Sections

Some portions of the policy serve as background and do not specify explicit authorization or denial triggers; provider submissions should follow the operational guidelines of the member's plan and include the required clinical documentation described below to facilitate review.

If unsure about prior authorization applicability, contact Aetna plan operations for instructions.
Background sections summarize evidence but are not an authorization checklist by themselves.

Documentation Required

Documentation Should Support NYHA Class, LVEF, QRS, Rhythm, and GDMT

Documentation submitted with prior authorization or claims must support NYHA class, LVEF, QRS duration and morphology, cardiac rhythm, and evidence of guideline‑directed medical therapy (eg, 3 months of maximally tolerated GDMT or ≥40 days post‑MI where specified). Detailed implant and follow‑up data are required for alternative pacing modalities.

Document LVEF (with date and imaging modality), rhythm (sinus vs AF), QRS duration and pattern (LBBB vs non‑LBBB), and current NYHA class.
Include evidence of ≥3 months of maximally tolerated GDMT or appropriate post‑MI timing prior to CRT implantation.

Documentation Required

Required Clinical Data

Required clinical data for review: clear LVEF measurement, NYHA functional class, ECG demonstrating QRS duration and morphology, documentation of rhythm, record of pharmacologic therapy (types, doses, and duration), and prior interventions or reversible causes addressed.

Attach imaging/echo/cardiac MRI reports with numeric LVEF.
Provide medication lists showing class, dose titration, and duration of GDMT.

Documentation Required

HBP Procedural and Follow‑Up Documentation

For His bundle pacing (HBP) procedures and other alternative conduction system pacing approaches, include procedural details and follow‑up parameters: implant success, capture thresholds, pre‑ and post‑implant QRS duration, LVEF, NYHA class, and recorded complications or revisions.

Report acute implant success and chronic capture threshold trends.
Provide functional and imaging follow‑up data (eg, change in QRS, LVEF, NYHA) at ≥3 months.

Documentation Required

Imaging Documentation to Support LV Lead Targeting

When imaging is used to support LV lead targeting or an image‑guided CRT approach, include the imaging modality, specific findings (eg, scar burden/location, latest mechanical activation), and how the imaging results directed lead placement. Cite any concordance between target segment and actual lead location.

Submit CMR, STE, SPECT, CT or multimodality reports used for lead targeting.
Document whether lead placement was concordant with the image‑derived target and resulting clinical response.

Documentation Required

NYHA Class Documentation

Document the member's NYHA functional class with supporting clinical notes that describe symptom burden and activity limitations consistent with the class definitions in the Appendix.

Include clinic visit notes describing symptoms and functional limitations mapping to NYHA I–IV.
If available, include standardized functional assessments or patient‑reported outcomes.

Prior Authorization

Patients Must Have Trialed an Optimal Pharmacologic Regimen

Patients must have trialed an optimal pharmacologic regimen for 3 months (maximally titrated as tolerated) prior to CRT implantation, except where guideline timing (eg, ≥40 days post‑MI) applies. Ensure GDMT has been optimized and documented before considering device therapy.

Document classes of heart failure medications, dosing history, and tolerability during the 3‑month optimization period.
If not met, provide rationale (eg, intolerance, contraindication) and supporting notes.

Documentation Required

Optimize Medical Therapy First

Optimize guideline‑directed medical therapy (GDMT) prior to device therapy. Authorization reviewers will expect evidence that reversible causes have been addressed and that maximal tolerated medical therapy has been attempted.

List medications tried, reasons for discontinuation or dose limitations, and objective measures of adherence or response.
For post‑MI patients, ensure timing thresholds (eg, ≥40 days) are documented.

Note

Economic Justification Considerations

Consider economic justification when selecting device type; cost‑effectiveness analyses show variable incremental cost‑effectiveness ratios (ICERs) for CRT‑D versus ICD alone. Document clinical reasons for selecting higher‑cost device options when relevant to the member's risk profile.

If choosing CRT‑D over CRT‑P, document arrhythmic risk factors that support defibrillator inclusion.
Attach cost or value considerations only when plan requests justification for higher‑cost devices.

Documentation Required

Alternative Pacing Reserved for Failed or Infeasible Conventional CRT

Alternative pacing strategies (His bundle pacing, left bundle branch area pacing, leadless LV pacing) are generally reserved for patients in whom conventional transvenous CRT is infeasible or has failed. When proposing alternative approaches, include prior attempts, reasons conventional CRT is not possible, and comparative outcome data where available.

Describe failed or infeasible conventional CRT procedures (eg, coronary sinus anatomy, lead complications).
Provide evidence supporting the chosen alternative pacing approach and expected benefit.

Step Therapy

No Step Therapy Requirements Provided

No step therapy requirements are specified in this policy section. Follow plan‑specific utilization management rules for any step edits that may be applied outside this policy.

If a plan applies step‑therapy, providers should follow that operational process.
This policy does not establish a drug or device step‑therapy sequence.

Considered for patients with CRT criteria who also meet arrhythmic high‑risk criteria for sudden cardiac death

Regulatory noteFDA‑approved combination CRT‑ICD systems are marketed for select patients with moderate‑to‑severe HF and LVEF ≤35%

QRS-based selection — definition

DefinitionQRS-based selection: patient selection for CRT primarily on QRS duration and morphology (eg, LBBB), the parameter prospectively validated in landmark randomized trials

RationaleElectrocardiogram (QRS) is reproducible and inexpensive compared with unvalidated echocardiographic dyssynchrony measures

ImplicationQRS criteria drive Pathway A/B eligibility and guideline recommendations

Biventricular pacing (CRT) — definition

DefinitionBiventricular pacing (CRT) delivers synchronized pacing to both right and left ventricles to restore mechanical synchrony and improve LV function

Clinical effectShown to prevent adverse LV remodeling and preserve/improve LVEF compared with RV apical pacing in trials

DeliveryTypically achieved with a coronary sinus transvenous LV lead and a right ventricular lead connected to a CRT device

CRT-D / CRT-P — definition distinction between defibrillator-equipped and pacemaker-only devices

CRT‑DCRT device with integrated implantable cardioverter‑defibrillator capability to treat ventricular arrhythmias

CRT‑PCRT device that provides biventricular pacing without defibrillation functionality (pacemaker‑only)

Clinical considerationChoice between CRT‑D and CRT‑P depends on arrhythmic risk factors, guideline indications, and evidence comparing outcomes in specific etiologies

Left ventricular endocardial pacing (LVEP) / WiSE-CRT — definition of endocardial/leadless LV pacing approaches

DefinitionLeft ventricular endocardial pacing (LVEP) / WiSE‑CRT: techniques that deliver LV pacing from the endocardial surface, including wireless systems, used when coronary sinus lead placement is not possible or in non‑responders

Use caseConsidered for patients with failed conventional CRT due to difficult CS anatomy or nonresponse, typically in specialized centers or trials

SafetyFeasible with clinical improvements reported but associated with notable procedure‑related complication rates in early studies

CRT-D — short definition entry

Short definitionCRT‑D: cardiac resynchronization therapy device that includes defibrillation capability to terminate life‑threatening ventricular arrhythmias

RoleProvides both ventricular resynchronization and protection from sudden cardiac death

CRT-P — short definition entry

Short definitionCRT‑P: cardiac resynchronization therapy pacemaker without defibrillator function (pacemaker‑only)

RoleUsed when defibrillation capability is not indicated based on arrhythmic risk assessment

HBP, LBBP, HPSP — physiologic pacing definitions

HBPHis bundle pacing (HBP): physiologic pacing that directly engages the His‑Purkinje conduction system to achieve synchronous ventricular activation

LBBPLeft bundle branch pacing (LBBP): pacing the left bundle branch area to capture conduction system distal to block, with higher success rates and stable thresholds compared with HBP

HPSPHis‑Purkinje system pacing (HPSP): umbrella term for conduction system pacing strategies (HBP, LBBP) aimed at physiologic ventricular activation

NYHA functional classes — definition and mention of 4 classes

DefinitionNYHA functional classes: a four‑tier subjective classification of heart failure status ranging from Class I (no limitation) to Class IV (symptoms at rest)

Classes listedClass I, II, III, and IV

UseNYHA class is required documentation for CRT eligibility assessments

Implantable diaphragmatic stimulation (PIDS/VisONE) — definition

DefinitionImplantable diaphragmatic stimulation (PIDS/VisONE): device‑based therapy that synchronously stimulates the diaphragm to modulate intrathoracic pressures and potentially improve cardiac filling/output

StatusEarly studies show hemodynamic signals; VisCardia's VisONE received FDA breakthrough designation but remains investigational with limited clinical outcome data

Use caseInvestigational; not established as standard HF therapy per guideline/UpToDate summaries

Leadless LV pacing — definition and context

DefinitionLeadless LV pacing: a pacing approach that delivers left ventricular endocardial or left‑bundle‑area stimulation without transvenous LV leads, intended to provide CRT when transvenous leads are problematic

ContextDeveloped as an alternative for patients with venous occlusion, lead infection, difficult CS anatomy, or CRT nonresponse

LimitationsCurrent evidence limited; procedural complexity, device-specific constraints (eg, acoustic window, battery life) and complication rates reported

NYHA functional classes (duplicate entry) — definition

Definition duplicateNYHA functional classes: 4‑tier classification (I–IV) describing functional impairment in HF

Clinical noteDocumented NYHA class is required to determine eligibility under Pathway A or B

ReferenceAppendix includes full class descriptions

Leadless cardiac pacing — definition and evolving status

DefinitionLeadless cardiac pacing: pacing without transvenous leads potentially providing long‑term therapy; technology is evolving and may become more widely used

StatusDescribed as an evolving approach with potential to become a first‑line option if safety and durability improve

ConsiderationCurrent evidence supports use mainly when conventional CRT is infeasible or has failed

CRT — general definition entry (bibliography/tail references)

General CRT definitionCardiac resynchronization therapy (CRT): pacing techniques that alter atrial and ventricular electromechanical asynchrony by stimulating left and right sides of the heart to synchronize contractions

Clinical roleUsed to improve hemodynamics and symptoms in selected HF patients with conduction delay and reduced LVEF

Reference noteSee bibliography for supporting trials and guideline sources

Guideline sources — guideline references included in definitions

Guideline sources listedGuideline references include 2012 ACCF/AHA/HRS focused update incorporated into 2008 device‑based therapy guidelines and ESC pacing/CRT guidelines

Supporting documentsUpToDate reviews and major trials (eg, MADIT‑CRT, RAFT) cited in bibliography

Use in policyPolicy aligns coverage criteria with these guideline recommendations for LVEF, QRS duration/morphology, NYHA class, and GDMT duration