Currentselect_healthPolicy CCP.1264

Transcatheter pulmonary valve replacement (TPVR)

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Defines medical necessity criteria, contraindications, and device coverage for transcatheter pulmonary valve replacement (e.g., Melody, Harmony, SAPIEN 3 with Alterra) for members with pulmonary valve dysfunction and congenital heart disease.

Policy Summary

Payerselect_health

PolicyTranscatheter pulmonary valve replacement (TPVR)

Policy CodePolicy CCP.1264

Change TypeDevice expansion and criteria restructuring

Effective DateNov 20, 2025

Last ReviewNov 1, 2025

Next Review DateMar 1, 2027

Key ActionObtain prior authorization demonstrating member meets symptomatic or asymptomatic pathway criteria with required hemodynamic and objective findings before TPVR.

SourceLink

POLICY UPDATE CHANGES

Policy transitioned from a Melody-only policy to a device-agnostic transcatheter pulmonary valve replacement policy covering Melody, Harmony, and Edwards Sapien 3 with the Alterra Adaptive Prestent and extended eligibility to native or surgically repaired right ventricular outflow tracts.

Melody, Harmony, SAPIEN 3 + AlterraDevices covered

≥35 mmHgRVOT gradient threshold

RVEDVi ≥160 mL/m²

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Currentselect_healthPolicy CCP.1264

Transcatheter pulmonary valve replacement (TPVR)

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Policy Summary

Payerselect_health

PolicyTranscatheter pulmonary valve replacement (TPVR)

Policy CodePolicy CCP.1264

Change TypeDevice expansion and criteria restructuring

Effective DateNov 20, 2025

Last ReviewNov 1, 2025

Next Review DateMar 1, 2027

Key ActionObtain prior authorization demonstrating member meets symptomatic or asymptomatic pathway criteria with required hemodynamic and objective findings before TPVR.

SourceLink

POLICY UPDATE CHANGES

Melody, Harmony, SAPIEN 3 + AlterraDevices covered

≥35 mmHgRVOT gradient threshold

RVEDVi ≥160 mL/m²

RV dilation thresholds

PR fraction ≥30%Pulmonary regurgitation threshold

2.2/100 PYEndocarditis incidence

Coverage Criteria for Transcatheter Pulmonary Valve Replacement

Symptomatic Intervention

Covered when ALL of the following are met for symptomatic intervention

Symptomatic pathway: Member has symptoms, reduced functional capacity, or arrhythmia attributable to the valve dysfunction

references ACC/AHA, ESC, CCS

Hemodynamic dysfunction - dysfunctional conduit or bioprosthetic valve: Either pulmonary regurgitation moderate or greater OR pulmonary stenosis with mean right ventricular outflow tract gradient ≥35 mmHgPR ≥ moderate; mean gradient ≥35 mmHg

FDA indications for Melody

Hemodynamic dysfunction - native or surgically repaired RVOT: Severe pulmonary regurgitation defined by echocardiography OR pulmonary regurgitant fraction ≥30% by cardiac magnetic resonance imagingPR severe OR regurgitant fraction ≥30%

FDA approvals for Harmony and SAPIEN contexts

Asymptomatic Intervention

Covered when ALL of the following are met for asymptomatic intervention

Severe hemodynamic dysfunction: Member has severe pulmonary regurgitation OR severe pulmonary stenosissevere PR or PS

per guidelines

Objective findings (require at least one): Progressive right ventricular dilation (RVEDVi ≥160 mL/m² OR RVESVi ≥80 mL/m²) OR progressive right ventricular systolic dysfunction (e.g., <45%) OR objective decrease in exercise capacity OR progressive tricuspid regurgitation (≥moderate) OR sustained atrial or ventricular arrhythmias OR (if stenosis primary) right ventricular systolic pressure >60 mmHgsee items

ESC/CCS/ACC guideline-derived thresholds

This policy does not support use of transcatheter pulmonary valve replacement (TPVR) for patients with only mild pulmonary regurgitation or mild pulmonary stenosis when there is no significant hemodynamic compromise. Interventions should be reserved for situations meeting the policy’s defined symptomatic or asymptomatic pathways supported by objective measurements (for example, the hemodynamic and imaging thresholds specified elsewhere in the policy). TPVR is intended for treatment of clinically and physiologically significant pulmonary valve dysfunction (native, surgically repaired, or failing conduit/bioprosthesis) rather than minimal valvular disease.

TPVR is considered not medically necessary for mild regurgitation or stenosis without significant hemodynamic compromise and for asymptomatic pulmonary dysfunction without objective physiologic compromise (for example, normal right ventricular volumes and function and normal exercise capacity). The policy also excludes members with active bacterial endocarditis or other active infection, those unable to tolerate required anticoagulation or antiplatelet therapy, and individuals with known intolerance to device materials (e.g., cobalt‑chromium or Nitinol). These situations are contraindications and will result in denial of TPVR authorization.

Clinical Thresholds and Coding-related Metrics

inv-05: Right ventricular outflow tract mean gradient

ThresholdMean RVOT gradient ≥35 mmHg for dysfunctional conduit or bioprosthetic valve

ContextUsed as a hemodynamic criterion for symptomatic intervention (pulmonary stenosis) per FDA guidance

ApplicabilityReferenced specifically for dysfunctional conduits or failing bioprosthetic pulmonary valves

inv-06: RV end-diastolic volume index (RVEDVi)

ThresholdRV end-diastolic volume index (RVEDVi) ≥160 mL/m²

ContextObjective finding for asymptomatic intervention when progressive RV dilation is present

Provider Requirements, Documentation, and Alternatives

Prior Authorization

Obtain prior authorization demonstrating symptomatic or asymptomatic criteria

Prior authorization is required and must document that the member meets either the symptomatic or asymptomatic intervention criteria in this policy, including the corresponding hemodynamic and objective findings specified for the relevant anatomic substrate (e.g., mean RVOT gradient ≥35 mmHg for dysfunctional conduit/bioprosthesis or severe PR defined by echo or pulmonary regurgitant fraction ≥30% for native/repaired RVOT). Approval for TPVR will be contingent on receipt of this prior authorization demonstrating those criteria are met.

Show member meets symptomatic pathway OR asymptomatic pathway per policy.
Include hemodynamic measurements tied to anatomy (e.g., mean RVOT gradient ≥35 mmHg; PR severe or regurgitant fraction ≥30%; RV volumes or systolic function thresholds when applicable).

Step Therapy

Consider surgical repair or replacement as alternative covered services

When TPVR is not appropriate or not medically necessary, surgical valve repair or surgical valve replacement are listed alternative covered services and may be considered as the next treatment option.

Background and Clinical Context

Congenital heart disease frequently involves abnormalities of the pulmonary valve and right ventricular outflow tract that can progress to clinically significant pulmonary stenosis or regurgitation. When valve dysfunction is minimal and produces no physiological compromise, intervention is not indicated; however, progressive disease may lead to right ventricular dilation, reduced function, exercise limitation, arrhythmia, or infection risk that necessitate valve replacement. Active endocarditis or inability to tolerate anticoagulation/antiplatelet therapy are important clinical exclusions when considering TPVR.

Definitions and Key Terms

inv-16: Transcatheter pulmonary valve replacement (TPVR)

DefinitionTranscatheter pulmonary valve replacement (TPVR) is the minimally invasive implantation of a valve into the right ventricular outflow tract or failing conduit/bioprosthesis to treat pulmonary regurgitation or stenosis.

Examples of devicesMelody Transcatheter Pulmonary Valve (Medtronic), Harmony Transcatheter Pulmonary Valve System (Medtronic), Edwards SAPIEN 3 with Alterra Adaptive Prestent (Edwards Lifesciences)

Clinical roleProvides a minimally invasive alternative to open-heart surgery for eligible anatomies, addressing conduits, bioprostheses, and native/surgically repaired RVOTs

inv-17: Severe pulmonary regurgitation (per policy)

Policy definitionSevere pulmonary regurgitation is defined as severe by echocardiography OR pulmonary regurgitant fraction ≥30% by cardiac magnetic resonance imaging.

Policy Summary

Payerselect_health

PolicyTranscatheter pulmonary valve replacement (TPVR)

Policy CodePolicy CCP.1264

Change TypeDevice expansion and criteria restructuring

Effective DateNov 20, 2025

Last ReviewNov 1, 2025

Next Review DateMar 1, 2027

Key ActionObtain prior authorization demonstrating member meets symptomatic or asymptomatic pathway criteria with required hemodynamic and objective findings before TPVR.

SourceLink

On This Page

ESC/CCS/ACC guideline–derived numeric cutoff cited in policy

inv-07: RV end-systolic volume index (RVESVi)

ThresholdRV end-systolic volume index (RVESVi) ≥80 mL/m²

ContextObjective finding for asymptomatic intervention when progressive RV dilation is present

UseOne of the volumetric criteria that may trigger TPVR consideration in asymptomatic patients

inv-08: Pulmonary regurgitant fraction (CMR)

Policy thresholdPulmonary regurgitant fraction (CMR) ≥30%

Guideline contextESC suggests intervention for regurgitant fraction >30–40%; Canadian guideline uses 25% as significant—policy uses ≥30% as the quantitative cutoff

RoleDefines severe pulmonary regurgitation for native or surgically repaired RVOT in symptomatic pathway when measured by CMR

inv-09: Right ventricular systolic function

Example thresholdRight ventricular systolic function <45% (example threshold for systolic dysfunction)

ContextUsed as an objective finding for asymptomatic intervention indicating progressive RV systolic dysfunction

Guideline referenceCited among objective criteria (Baumgartner, Marelli, Stout) in policy

inv-10: Right ventricular systolic pressure when stenosis is primary indication

ThresholdRight ventricular systolic pressure >60 mmHg when stenosis is the primary indication

ContextListed as the pressure criterion to support intervention when pulmonary stenosis is the dominant lesion

UseOne of the objective findings for asymptomatic intervention per guideline-derived criteria

Surgical valve repair.
Surgical valve replacement (e.g., surgical pulmonary valve replacement).

Documentation Required

Provide required clinical documentation and supporting imaging/hemodynamics

Clinical documentation submitted for prior authorization or claims must demonstrate the indication per the policy thresholds, link symptoms to pulmonary valve dysfunction when applicable, and include supporting imaging and hemodynamic data.

For symptomatic pathway: documentation of symptoms, reduced functional capacity, or arrhythmia attributable to the valve dysfunction and corresponding hemodynamics (e.g., moderate-or-greater PR, mean RVOT gradient ≥35 mmHg, or severe PR by echo/CMR ≥30% as applicable).
For asymptomatic pathway: evidence of severe hemodynamic dysfunction plus at least one objective finding (e.g., RVEDVi ≥160 mL/m², RVESVi ≥80 mL/m², RV systolic dysfunction <45%, decreased exercise capacity, progressive TR ≥ moderate, sustained arrhythmia, or RV systolic pressure >60 mmHg when stenosis is primary).

Denial Risk

Avoid TPVR if contraindications or denial triggers are present

Do not proceed with TPVR when contraindications or denial triggers are present; these conditions will result in denial if documented.

Active bacterial endocarditis or other active infection.
Inability to tolerate anticoagulation or antiplatelet therapy.
Known intolerance to device materials (e.g., cobalt-chromium, Nitinol/titanium or nickel).
Use of TPVR for mild regurgitation or stenosis without significant hemodynamic compromise, or for asymptomatic dysfunction without objective physiologic compromise.

Used to determine eligibility in symptomatic and asymptomatic intervention pathways (native or surgically repaired RVOT)

Guideline contextESC guidance references regurgitant fraction thresholds (30–40%) and CCS notes a 25% cutoff; policy adopts ≥30% as its quantitative standard