Transcatheter Valve Replacement or Repair
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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.
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.'
Medical Necessity Criteria for Transcatheter Valve Procedures
TAVR (Transcatheter Aortic Valve Replacement)
Covered when ALL of the following are met:
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 is considered experimental, investigational and/or unproven for all other indications.
TMVR (Transcatheter Mitral Valve Repair)
Covered when ALL of the following are met:
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
| 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) |
| 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 |
Authorization, Documentation, and Provider Responsibilities
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.
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 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 — 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
Policy Changes and Review Dates
Policy created after TAC review (new policy).
TMVR coverage was added to the policy.
Criteria for pulmonary valve (TPVI) were added to the policy.
Formatting changes and added hyperlinks to CMS and TMPPM resources; note sections updated to align with CMS requirements and business entity changes.
Removed statement that 'Medicare NCD or LCD specific InterQual criteria may be used when available.' (administrative).
Updated criteria for TPVI and added InterQual as the source for medical necessity for TMVR; Medicare hyperlinks and references updated.
Policy effective date reflecting the current version and incorporated revisions effective 06/01/2026.
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