CurrentBaylor Scott & White Health PlanPolicy 204

Transcatheter Valve Replacement or Repair

Defines medical necessity, prior authorization, and coding guidance for transcatheter aortic, mitral and pulmonary valve replacement or repair for Baylor Scott & White Health Plan members.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyTranscatheter Valve Replacement or Repair

Policy CodePolicy 204

Change TypeCriteria added and InterQual specified

Effective Date06/01/2026

Next Review Date04/23/2027

Key ActionObtain prior authorization and confirm medical necessity criteria are met before scheduling transcatheter valve procedures.

SourceLink

POLICY UPDATE CHANGES

Updated criteria for TPVI (transcatheter pulmonary valve implantation).

Added InterQual as source for medical necessity for TMVR.

Removed statement that 'Medicare NCD or LCD specific InterQual criteria may be used when available.'

TAVR, TPVI, TMVRservices covered by policy

Prior authorization requiredauthorization requirement

Version 9.0policy version

06/01/2026effective date

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TAVR (Transcatheter Aortic Valve Replacement)

Covered when ALL of the following are met:

TAVR medical necessity: Member has symptomatic aortic valve stenosis and meets device FDA-approved indications or, for Commercial plans, InterQual criteria; for Medicare plans, evaluate against NCD 20.32 and applicable facility/registry requirements.

TAVR is considered experimental, investigational and/or unproven for other indications.

TPVI (Transcatheter Pulmonary Valve Implantation)

Covered when ALL of the following are met:

TPVI medical necessity: Member has prior repair of congenital heart disease with right ventricular outflow tract (RVOT) dysfunction and one of: moderate/severe pulmonary regurgitation OR moderate/severe right ventricular to pulmonary artery (RV-PA) stenosis; and target anatomy includes a surgical RVOT conduit, native RVOT, RVOT with transannular patching, or a bioprosthetic pulmonary valve.

TPVI is considered experimental, investigational and/or unproven for all other indications.

TMVR (Transcatheter Mitral Valve Repair)

Covered when ALL of the following are met:

TMVR medical necessity: Patient has symptomatic mitral regurgitation and is considered high risk for traditional open‑heart mitral valve surgery; the device is FDA‑approved for the indication. For Commercial plans use InterQual; for Medicare lines of business, evaluate against NCD 20.33 and applicable facility/registry requirements.

Transcatheter mitral valve implantation/replacement (TMVI) is considered experimental, investigational and/or unproven for all indications.

This policy defines medical necessity and prior authorization requirements for transcatheter valve procedures including TAVR (transcatheter aortic valve replacement), TPVI (transcatheter pulmonary valve implantation), and TMVR (transcatheter mitral valve repair). Prior authorization is required for these procedures; providers must review the member's Evidence of Coverage or Summary Plan Description and confirm the applicable medical necessity criteria and any plan-specific coverage details before scheduling services. For Medicare and Medicaid lines, applicable NCD/LCD or state Medicaid manuals apply and must be followed when available.

Transcatheter mitral valve implantation/replacement (TMVI) is considered experimental, investigational and/or unproven for all indications and is therefore not medically necessary under this policy. TMVI devices and procedures that do not have FDA approval for the intended indication are not covered.

Procedure and Diagnosis Coding

Covered CPT CodesCPTCovered

33361	TAVR with prosthetic valve; percutaneous femoral artery approach
33362	TAVR with prosthetic valve; open femoral artery approach
33363	TAVR with prosthetic valve; open axillary artery approach
33364	TAVR with prosthetic valve; open iliac artery approach
33365	TAVR with prosthetic valve; transaortic approach (eg, median sternotomy, mediastinotomy)
33366	TAVR with prosthetic valve; transapical exposure (eg, left thoracotomy)
33418	Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; initial prosthesis
33477	Transcatheter pulmonary valve implantation, percutaneous approach, including pre-stenting of the valve delivery site
0345T	Transcatheter mitral valve repair percutaneous approach via the coronary sinus (MitraClip)

Not Covered CPT CodesCPTNot Covered

0483T	Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; percutaneous
0484T	Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; transthoracic

Potentially applicable ICD-10 CodesICD-10

I06.0	Rheumatic aortic stenosis
I08.0	Rheumatic disorders of both mitral and aortic valves
I34.0 - I34.9	Mitral valve disorders (symptomatic degenerative mitral regurgitation)
I35.0 - I35.9	Nonrheumatic aortic valve disorders (stenosis)
T82.01x	Breakdown (mechanical) of heart valve prosthesis (degenerated bioprosthetic aortic valve)
T82.03x	Leakage of heart valve prosthesis (degenerated bioprosthetic aortic valve)
T82.857	Stenosis of cardiac prosthetic devices, implants and grafts (degenerated bioprosthetic aortic valve)
I05.x	Rheumatic mitral valve disease
Q23.2 - Q23.8	Congenital mitral valve disease
Z95.2	Presence of prosthetic heart valve

TPVI eligibility — key elements

Clinical indicationsMember has prior repair of congenital heart disease with right ventricular outflow tract (RVOT) dysfunction AND one of: moderate or severe pulmonary regurgitation (PR) OR moderate or severe right ventricular–to–pulmonary artery (RV‑PA) stenosis.

Anatomic substrate requiredTarget anatomy must include one of: surgical RVOT conduit, native RVOT, RVOT with transannular patching, or bioprosthetic pulmonary valve.

Coverage stance for other usesTPVI is considered experimental, investigational and/or unproven for all other indications (not covered).

Related procedural contextApplies to percutaneous transcatheter pulmonary valve implantation for patients meeting above clinical and anatomic criteria.

Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required for all transcatheter valve procedures (TAVR, TPVI, TMVR) prior to scheduling or performing the service. Lack of prior authorization may result in claim denial or delayed payment.

Applies to TAVR, TPVI, TMVR and related transcatheter valve procedures.
Providers should obtain authorization using the payer's established prior authorization process and include heart team assessment documentation when applicable.

Documentation Required

Review Member Evidence of Coverage / Plan Documents

Providers must review the member's Evidence of Coverage (EOC) or Summary Plan Description (SPD) to confirm benefit coverage, member-specific limitations, and any plan exclusions prior to initiating authorization or treatment. For Medicare members, providers must also confirm applicable NCDs/LCDs and Medicare-specific requirements.

Reference the member's EOC/SPD for benefit determinations and any cost-sharing or coverage limits.
For Medicare: verify NCD 20.32 (TAVR) and NCD 20.33 (TMVR) or relevant LCDs; follow Medicare facility/registry requirements as applicable.

Step Therapy

Step Therapy Not Applicable

There are no step therapy or other pre-authorization sequencing requirements beyond demonstrating medical necessity and an appropriate multidisciplinary heart team assessment for TMVR candidates.

No step therapy protocols apply for transcatheter mitral valve repair beyond the documented clinical criteria and heart team evaluation.
Standard medical necessity review applies; do not require prior trials of alternate therapies as a formal step-therapy pathway.

Denial Risk

Denial Risk — Authorization and Documentation

Failure to obtain prior authorization when required may lead to denial of coverage or payment. Ensure submitted documentation clearly supports medical necessity, heart team recommendations, and alignment with the plan's coverage criteria.

Include operative/ procedure reports, diagnostic imaging, heart team notes, and prior treatment history as part of the authorization request.
Confirm any device-specific FDA indication and member eligibility per the plan before scheduling.

Clinical Background and Rationale

Aortic stenosis is the most commonly acquired valvular heart disease. Surgical aortic valve replacement remains the standard treatment, but less invasive transcatheter approaches such as TAVR/TAVI provide an alternative for patients who are at prohibitive or high surgical risk. For members with symptomatic aortic stenosis, TAVR may be considered medically necessary when performed with FDA‑approved devices and indications; for Commercial plans InterQual criteria are used and for Medicare plans NCD 20.32 and applicable facility/registry requirements should be applied.

Transcatheter pulmonary valve implantation (TPVI) addresses right ventricular outflow tract (RVOT) dysfunction in patients with prior congenital heart disease repair. TPVI may be considered medically necessary when the member has prior repair of congenital heart disease with RVOT dysfunction and one of the following: moderate/severe pulmonary regurgitation or moderate/severe right ventricular–to–pulmonary artery stenosis, and target anatomy suitable for TPVI (surgical RVOT conduit, native RVOT, RVOT with transannular patching, or bioprosthetic pulmonary valve).

Transcatheter mitral valve repair (TMVR), such as edge‑to‑edge leaflet repair (e.g., MitraClip), is used to reduce mitral regurgitation in symptomatic patients who are high risk for traditional open surgical repair; multidisciplinary heart team evaluation is recommended for candidate selection. For Commercial plans, InterQual criteria are used to determine medical necessity; for Medicare lines, NCD 20.33 and any facility/registry requirements should be followed.

Procedure Definitions and Terms

TAVR/TAVI definition

DefinitionTranscatheter aortic valve implantation/replacement (TAVR/TAVI): percutaneous placement of a prosthetic aortic valve that repairs the valve without removing the native, damaged valve by wedging a replacement valve into the aortic valve position.

Clinical roleLess invasive alternative to surgical aortic valve replacement for patients with severe symptomatic aortic stenosis who are at prohibitive or high surgical risk.

Procedure noteNot intended to replace surgical care for most patients; evaluate against device FDA indications and applicable payer/Medicare coverage rules.

TMVR definition and context

DefinitionTranscatheter mitral valve repair (TMVR): edge‑to‑edge leaflet repair (e.g., MitraClip) that clips together a portion of the mitral valve leaflets to reduce mitral regurgitation.

FDA‑approved deviceAbbott’s MitraClip is currently the only FDA‑approved TMVR device referenced in this policy (approved for moderate‑severe or severe primary MR).

Candidate evaluationMultidisciplinary heart team evaluation is recommended for TMVR candidates; use InterQual for Commercial lines and NCD 20.33 for Medicare lines where applicable.

TPVI definition

DefinitionTranscatheter pulmonary valve implantation (TPVI): percutaneous implantation of a pulmonary valve for patients with prior congenital heart disease repair and RVOT dysfunction (meeting specified clinical and anatomic criteria).

Indications summaryUsed to treat RVOT dysfunction manifesting as moderate/severe pulmonary regurgitation or moderate/severe RV‑PA stenosis in appropriate anatomy (conduit, native RVOT, transannular patch, or bioprosthetic pulmonary valve).

Coverage limitationTPVI is considered experimental, investigational and/or unproven for all indications not meeting the listed criteria.

Policy Changes and Review Dates

2012-11-29policy_created

Policy created after TAC review (new policy).

2015-10-22coverage_added

TMVR coverage was added to the policy.

2018-09-25criteria_added

Criteria for pulmonary valve (TPVI) were added to the policy.

2024-06-10formatting_update

Formatting changes and added hyperlinks to CMS and TMPPM resources; note sections updated to align with CMS requirements and business entity changes.

2025-08-11administrative_revision

Removed statement that 'Medicare NCD or LCD specific InterQual criteria may be used when available.' (administrative).

2026-04-23material_revision

Updated criteria for TPVI and added InterQual as the source for medical necessity for TMVR; Medicare hyperlinks and references updated.

2026-06-01effective_dateLatest

Policy effective date reflecting the current version and incorporated revisions effective 06/01/2026.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyTranscatheter Valve Replacement or Repair

Policy CodePolicy 204

Change TypeCriteria added and InterQual specified

Effective Date06/01/2026

Next Review Date04/23/2027

Key ActionObtain prior authorization and confirm medical necessity criteria are met before scheduling transcatheter valve procedures.

SourceLink

On This Page

OpenPayer

Transcatheter Valve Replacement or Repair

Medical Necessity Criteria for Transcatheter Valve Procedures

Procedure and Diagnosis Coding

Authorization, Documentation, and Provider Responsibilities

Clinical Background and Rationale

Procedure Definitions and Terms

Policy Changes and Review Dates