UnitedHealthcare Transcatheter Valve Policy Update

Coverage Criteria for Transcatheter Valve Procedures

Aortic

Referential note for aortic transcatheter replacement:

Aortic TAVR referral: For transcatheter aortic heart valve replacement, refer to the Indiana Health Coverage Programs Provider Reference Module: Surgical Services.

Policy defers to Indiana Health Coverage Programs for TAVR medical necessity criteria.

Mitral

Mitral coverage stance and operational requirement:

Mitral TEER: Transcatheter edge-to-edge repair of the mitral heart valve is proven and medically necessary under certain circumstances; medical necessity clinical coverage criteria are those in InterQual CP: Procedures, Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).

Providers must use InterQual criteria for TEER determinations.

Other transcatheter mitral repair/reconstruction: Transcatheter mitral heart valve repair (e.g., annuloplasty), and transcatheter mitral heart valve reconstruction or replacement, except as addressed by InterQual for TEER, are unproven and not medically necessary due to insufficient evidence of efficacy.

Includes transcatheter mitral heart valve reconstruction or replacement deemed unproven and not medically necessary.

Pulmonary

Pulmonary valve coverage when device labeling and clinical criteria are met:

Pulmonary TCVR indications: Transcatheter pulmonary valve replacement and related devices are proven and medically necessary when used according to FDA labeled indications, contraindications, warnings, and precautions in individuals with right ventricular outflow tract (RVOT) dysfunction and clinical indications for intervention (e.g., pulmonary stenosis with a mean RVOT gradient >= 35 mmHg, or moderate or greater pulmonary regurgitation).mean RVOT gradient >= 35 mmHg

Must follow FDA labeling.

Tricuspid and Other Devices

Tricuspid and other device coverage positions:

Tricuspid transcatheter procedures: Transcatheter tricuspid heart valve repair, reconstruction, or replacement is unproven and not medically necessary due to insufficient evidence of efficacy.

Includes devices for CAVI (caval valve implantation) — listed as unproven in Other Devices and Procedures.

Other unproven procedures/devices: Valve-in-valve replacement within a failed bioprosthesis for mitral, pulmonary, or tricuspid valves; cerebral protection devices; and transcatheter superior and inferior vena cava prosthetic valve implantation (CAVI) are unproven and not medically necessary due to insufficient evidence of efficacy.

Enumerated as unproven in policy.

TMVR (evidence)

Summary conclusion on evidence for catheter-delivered mitral valve prostheses:

TMVR evidence conclusion: There is insufficient quality evidence demonstrating long-term efficacy of catheter-delivered mitral valve prostheses; available studies are limited by noncomparative designs, high attrition, short follow-up, and mixed comparative findings versus TEER or guideline-directed medical therapy.

CHOICE-MI and other registry data report technical success but also substantial mortality and study limitations.

Transcatheter Mitral Valve Replacement (TMVR)

Evidence and comparative findings for TMVR:

TMVR evidence summary: Insufficient high-quality evidence demonstrating long-term efficacy of TMVR; observational registries report MR reduction and symptomatic improvement but show mixed mortality and higher early adverse events in some comparisons to TEER or standard care.

Studies include CHOICE-MI registry and observational comparative analyses with limitations including nonrandomized design, attrition, and short follow-up.

Percutaneous Annuloplasty (Carillon)

Percutaneous (coronary sinus) annuloplasty (Carillon) evidence summary:

Carillon evidence summary: Evidence is limited in quality and quantity; randomized sham-controlled REDUCE-FMR showed reductions in regurgitant volume and left ventricular volumes at 12 months but was not powered for clinical endpoints, and other studies are small or nonrandomized with high attrition. Comparative data to surgery or TEER are lacking.

Further large multicenter RCTs are needed to validate clinical benefit and place in therapy.

Other Minimally Invasive Mitral Valve Repair Devices

Early-stage mitral repair devices — evidence limitations:

Early mitral devices: Several minimally invasive mitral valve repair devices (e.g., Harpoon, Cardioband, NeoChord) report promising early results but are supported mainly by small case series and single-arm registries; larger prospective studies with long-term follow-up are required to establish clinical role and safety.

Device-specific issues (e.g., anchor disengagement) and lack of randomized data limit current evidence.

Transcatheter Pulmonary Valve Replacement (PPVI/TPVR)

Overview of transcatheter pulmonary valve replacement evidence:

PPVI outcomes: Multiple trials and registries (Melody, SAPIEN, Harmony, Alterra-supported SAPIEN 3) report high procedural success and favorable short- to mid-term hemodynamic and clinical outcomes; concerns remain about long-term durability, infective endocarditis risk, and stent fracture in some cohorts.

Registry and systematic review data show procedural success ~96% with generally comparable outcomes to surgery in selected patients, but long-term comparative data are limited.

Transcatheter Tricuspid Valve Repair and Replacement (TTVR)

Evidence summary for transcatheter tricuspid interventions:

TTVR evidence summary: Evidence for transcatheter tricuspid valve replacement is limited; RCT and registry data show improvements in symptoms, quality of life, and marked TR reduction in selected high‑risk patients but raise early safety concerns (e.g., bleeding, early mortality) and are limited by short follow-up and open-label designs.

Longer-term RCT data and comparisons to repair and medical therapy are needed; results may not generalize beyond specialized centers.

Device-based transcatheter tricuspid interventions (TTVR, T-TEER)

Trial-based conditions supporting coverage for device-based transcatheter tricuspid interventions:

Patient clinical status: Patient has symptomatic moderate-to-severe or greater tricuspid regurgitation despite optimal medical therapy.symptomatic moderate or greater TR

Supported by TRISCEND and TRILUMINATE populations

Surgical risk/anatomy: Patient is high surgical risk or inoperable and has tricuspid valve anatomy suitable for the selected transcatheter procedure.high surgical risk / anatomy suitable

Consistent with inclusion criteria of TriClip and EVOQUE studies

Setting and expertise: Procedure performed in centers with appropriate experience in transcatheter valve interventions.specialized centers

Cerebral embolic protection — evidence summary

Cerebral embolic protection — evidence and guidance summary (no explicit policy criteria stated):

Evidence: Randomized trials have not consistently met primary efficacy endpoints (reduction in DW‑MRI lesion volume) and are limited by small sample sizes and incomplete imaging follow-up; meta-analyses including observational data suggest possible reductions in 30‑day stroke and mortality but findings are driven largely by nonrandomized studies.

Includes SENTINEL, MISTRAL‑C, CLEAN‑TAVI and pooled analyses.

Imaging endpoints: Some trials show reduced number and volume of new ischemic lesions with embolic protection devices, but clinical stroke and mortality benefits are not consistently demonstrated.

CLEAN‑TAVI and meta‑analyses report lower lesion counts/volumes but not consistent clinical benefit.

Guidance stance: Health‑technology guidance (NICE) states cerebral protection during TAVR raises no major safety concerns but has inconclusive evidence for stroke prevention and should be used only with special arrangements for clinical governance, consent, audit or research.

NICE IPG 2019b.

Guideline and HTA–informed coverage considerations

Guideline and HTA–informed coverage considerations:

Aortic TAVI: TAVI is clinically effective for symptomatic aortic stenosis in patients at intermediate or low surgical risk per NICE; evidence on valve durability beyond 6–7 years is limited.durability evidence 6-7 years

NICE recommendation supports use in these groups.

Mitral interventions: Transcatheter edge‑to‑edge repair is recommended by NICE for selected adults with severe primary mitral regurgitation when surgery is unsuitable and for severe secondary mitral regurgitation in symptomatic heart failure patients when surgery is unsuitable and medical management optimized; some transcatheter mitral procedures (e.g., transapical mitral valve‑in‑ring) should be used only with special governance, consent and audit arrangements.suitability for procedure

NICE guidance limits some mitral transcatheter procedures to special arrangements.

Tricuspid interventions:

Transcatheter mitral heart valve reconstruction or replacement (including annuloplasty and other percutaneous reconstructive approaches) is identified in this policy as unproven and not medically necessary when used outside the specific exceptions addressed by InterQual for transcatheter mitral edge‑to‑edge repair (TEER). The policy explicitly directs clinicians to the referenced InterQual criteria for determinations of medical necessity for TEER; other mitral reconstruction or replacement techniques lack sufficient evidence of efficacy and are not supported as routine therapy.

The policy states that certain procedures lack sufficient high‑quality evidence to support routine use. Specifically, transcatheter mitral valve replacement (TMVR) and coronary‑sinus–based percutaneous annuloplasty (e.g., Carillon) are considered investigational or not medically necessary for routine replacement of established surgical or transcatheter alternatives due to limited comparative data, high attrition, short follow‑up, and study design limitations. Requests for these procedures should include clear clinical justification and may be considered only in the context of clinical trials or registries.

Evidence is currently insufficient to support the routine use of several other transcatheter valve approaches across broader populations. This includes transcatheter tricuspid valve replacement (TTVR), caval valve implantation (CAVI), and some valve‑in‑valve (ViV) procedures when performed outside selected high‑risk or inoperable cohorts or prospective clinical studies. Available trials and registries report symptomatic and hemodynamic improvements in select populations but are limited by short follow‑up, small sample sizes, and safety signals (for example, higher rates of severe bleeding or pacemaker implantation with some TTVR systems), which preclude generalized coverage as standard‑of‑care.

The policy does not list explicit blanket exclusions for cerebral embolic protection devices inserted during TAVR; however, it characterizes the overall evidence as inconclusive and emphasizes that routine clinical benefit has not been established. Use of these devices should be considered in light of available evidence, governance arrangements, and plan‑specific requirements rather than assumed coverage.

A number of named transcatheter products are noted in the policy as potentially lacking full FDA approval. Examples listed include devices such as Cardioband, Harpoon, Intrepid, NeoChord, Tendyne, TricValve, and Tiara. Such products may be restricted, limited, or excluded pending regulatory status, and coverage determinations should reference current FDA approvals and this policy's applicable coding guidance.

Transcatheter mitral valve repair approaches other than TEER (for example, annuloplasty‑type reconstructions) are described as unproven and not medically necessary in this policy except where InterQual criteria apply. The policy explicitly replaces prior blanket language by operationalizing exceptions through reference to InterQual for TEER determinations; providers should document compliance with InterQual where TEER is proposed and otherwise expect noncoverage for alternative transcatheter mitral repair/reconstruction modalities.

The policy enumerates the categories of transcatheter mitral, tricuspid, and related procedures and devices it addresses. Items called out in the document include transcatheter mitral valve replacement (TMVR), transcatheter mitral repair modalities (including annuloplasty and other reconstructive devices), transcatheter edge‑to‑edge repair (TEER), valve‑in‑valve procedures for failed bioprostheses, transcatheter tricuspid repair and replacement (T-TEER, TTVR), transcatheter pulmonary valve implantation (TPVI/PPVI), Caval Valve Implantation (CAVI), and cerebral embolic protection devices. Coverage expectations vary by device class and depend on the strength of evidence, FDA labeling, and referenced clinical criteria.

Given the limited and mixed quality of available data, TMVR and coronary‑sinus based annuloplasty (Carillon) are considered investigational in this policy. The TMVR evidence base is composed largely of nonrandomized registries and small comparative analyses with short follow‑up and substantial attrition; percutaneous annuloplasty studies similarly suffer from small size, loss to follow‑up, and lack of robust comparative effectiveness data. Accordingly, routine coverage is not supported outside of well‑documented research or registry participation.

The policy summarizes cerebral embolic protection evidence as mixed and inconclusive. Randomized trials have not consistently demonstrated clinical stroke reduction, and meta‑analyses that suggest imaging or surrogate benefits are limited by small sample sizes, incomplete imaging follow‑up, and reliance on observational data. NICE and other guidance note no major safety concerns but recommend use only within special arrangements for clinical governance, consent, audit, or research given the uncertain efficacy for stroke prevention.

Across randomized trials and meta‑analyses, evidence remains insufficient to conclude that embolic protection devices definitively reduce overt clinical stroke or all‑cause mortality after TAVR. While some studies show reductions in diffusion‑weighted MRI lesion counts or volumes, these surrogate imaging endpoints have not translated consistently into demonstrated clinical outcome benefits; further adequately powered RCTs with clinical endpoints are needed.

Historically, the policy characterized transcatheter mitral annuloplasty and other mitral reconstruction techniques as unproven and not medically necessary. The current version retains that characterization but has been updated to reference InterQual criteria for TEER rather than applying a blanket exclusion; the net position remains that non‑TEER transcatheter mitral repairs lack sufficient evidence for routine coverage.

Consistent with the policy's revision history, transcatheter mitral annuloplasty and other non‑TEER mitral repair procedures are stated as unproven and not medically necessary except where coverage is determined via referenced InterQual criteria for TEER. Providers should follow the InterQual guidance when seeking authorization for edge‑to‑edge mitral repair; other mitral repair/reconstruction requests should include evidence of trial or registry participation and robust justification if coverage is sought.

Applicable Procedure, Device, and Product Codes

Transcatheter mitral/tricuspid related CPT codesCPT

0345T	Transcatheter mitral valve repair percutaneous approach via the coronary sinus.
0483T	Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; percutaneous approach, including transseptal puncture, when performed.
0484T	Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; transthoracic exposure (e.g., thoracotomy, transapical).
0543T	Transapical mitral valve repair, including transthoracic echocardiography, when performed, with placement of artificial chordae tendineae.
0544T	Transcatheter mitral valve annulus reconstruction, with implantation of adjustable annulus reconstruction device, percutaneous approach including transseptal puncture.
0545T	Transcatheter tricuspid valve annulus reconstruction with implantation of adjustable annulus reconstruction device, percutaneous approach.
0569T	Transcatheter tricuspid valve repair, percutaneous approach; initial prosthesis.
0570T	Transcatheter tricuspid valve repair, percutaneous approach; each additional prosthesis during same session (List separately in addition to code for primary procedure).
0646T	Transcatheter tricuspid valve implantation (TTVI)/replacement with prosthetic valve, percutaneous approach, including right heart catheterization, temporary pacemaker insertion, and selective right ventricular or right atrial angiography, when performed.

Additional transcatheter/cerebral protection and pulmonary/aortic CPT codesCPT

0805T	Transcatheter superior and inferior vena cava prosthetic valve implantation (CAVI); percutaneous femoral vein approach.
0806T	Transcatheter superior and inferior vena cava prosthetic valve implantation (CAVI); open femoral vein approach.
33361	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach.
33362	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach.
33363	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach.
33364	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach.
33365	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (e.g., median sternotomy, mediastinotomy).
33366	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (left thoracotomy).
33367	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation.
33368	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with open peripheral arterial and venous cannulation.

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No explicit codes in this sectionmixed

No codes listed

Aortic devices (PMA/Product listings)mixed

Evolut FX	Medtronic transcatheter aortic valve prosthesis listed as PMA product (Product Code NPT).
Evolut R	Medtronic transcatheter aortic valve prosthesis listed as PMA product (Product Code NPT).
Evolut PRO	Medtronic transcatheter aortic valve prosthesis listed as PMA product (Product Code NPT).
Navitor	Abbott transcatheter aortic valve prosthesis.
SAPIEN 3 Ultra RESILIA	Edwards Lifesciences transcatheter aortic valve prosthesis.
SAPIEN 3	Edwards Lifesciences transcatheter aortic valve prosthesis.
SAPIEN 3 Ultra	Edwards Lifesciences transcatheter aortic valve prosthesis.

Mitral repair devicesmixed

MitraClip	Abbott transcatheter mitral valve repair device.
PASCAL	Edwards Lifesciences transcatheter mitral valve repair device.

Pulmonary devicesmixed

Harmony	Medtronic transcatheter pulmonary valve prosthesis.
Melody	Medtronic transcatheter pulmonary valve prosthesis.
SAPIEN 3	Edwards Lifesciences transcatheter pulmonary valve (also listed under aortic).
SAPIEN 3 with Alterra Adaptive Prestent	Edwards Lifesciences system for pulmonary position.

Tricuspid devicesmixed

EVOQUE	Edwards Lifesciences transcatheter tricuspid valve prosthesis.
TriClip	Abbott transcatheter tricuspid valve repair device.

Cerebral protection devicesmixed

SENTINEL

Boston Scientific cerebral embolic protection device (Product Code PUM).

Additional / possibly non-approved productsmixed

CardiAQ	Additional product; status noted under 'Additional Products'.
Cardioband	Product possibly without full FDA approval.
Harpoon	Product possibly without full FDA approval.
Mitral Contour System	Product possibly without full FDA approval.
Intrepid	Medtronic product; may not have full FDA approval.
NeoChord	Product possibly without full FDA approval.
Tendyne	Abbott product; may not have full FDA approval.
TricValve	Product possibly without full FDA approval.
Tiara	Neovasc product; may not have full FDA approval.

Removed CPT CodesCPTNot Covered

33999

CPT code 33999 (removed from applicable codes list)

Mean RVOT gradient — clinical threshold/value

Mean RVOT gradient threshold>= 35 mmHg

Clinical contextUsed to indicate intervention for pulmonary stenosis in patients with RVOT dysfunction

AlignmentThreshold specified in pulmonary coverage criteria referencing FDA-labeled indications

Valve durability evidence horizon — no evidence beyond 6-7 years (NICE)

Evidence horizon for TAVI durability

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization and Code Management

Prior authorization and code management: Providers must reference the most up-to-date prior authorization and notification requirements for UnitedHealthcare Community Plan of Indiana. Codes listed in the policy are provided for reference only; inclusion does not imply coverage, guarantee payment, or imply authorization. Note: codes labeled with an asterisk (*) in this policy were not managed for medical necessity review for the state of Indiana at the time this policy became effective — providers must still verify current prior authorization lists and procedures before submitting requests.

Reference current Indiana prior authorization list at UnitedHealthcare Community Plan of Indiana
Code listing is not authorization or guarantee of payment
Asterisked (*) codes were not managed for medical necessity review in Indiana when policy became effective — verify current status

Prior Authorization

Prior Authorization for Investigational / Limited‑Evidence Devices

Prior authorization for investigational/limited-evidence devices: For devices or procedures characterized as investigational or with limited evidence (for example, many TMVR devices in current literature), prior authorization requests should include detailed clinical documentation supporting the indication, prior treatments attempted, and outcomes. If a procedure is being done in the context of an approved clinical trial or registry, documentation of trial or registry enrollment should be submitted.

Background and Clinical Context

Transcatheter valve procedures provide minimally invasive alternatives to conventional open surgical repair or replacement by delivering bioprosthetic valves or repair devices via catheter‑based access, thereby avoiding cardiopulmonary bypass and sternotomy in appropriate patients. These techniques are applied to aortic, mitral, pulmonary, and tricuspid valve disease, with device selection, access route, and clinical indications varying by valve and patient anatomy; the strength of evidence and long‑term durability differ across device classes.

Definitions and Abbreviations

NYHA classification — definitions of I–IV

NYHA class INo limitation of physical activity; ordinary activity does not cause undue symptoms

NYHA class IISlight limitation of physical activity; comfortable at rest; ordinary activity causes fatigue, palpitation, dyspnea, or angina

NYHA class IIIMarked limitation of physical activity; comfortable at rest; less than ordinary activity causes symptoms

NYHA class IVUnable to carry on any physical activity without discomfort; symptoms present at rest

PROM (Predicted Risk of Mortality) — STS PROM score definition

DefinitionSociety of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) score estimating 30-day mortality after cardiac procedures

Policy Changes and Revision History

2025-07-01title_changeLatest

Policy title changed from 'Transcatheter Heart Valve Procedures (for Indiana Only) Coverage Rationale' to 'Transcatheter Procedures for Heart Valve Conditions (for Indiana Only)'.

2025-07-01criteria_operationalization

Policy language updated to reference InterQual criteria for exceptions to transcatheter mitral heart valve repair (e.g., annuloplasty) rather than a blanket noncoverage statement.

2025-07-01