ModifiedUnitedHealthcarePolicy CS123KS.02

Transcatheter Procedures for Heart Valve Conditions (for Kansas Only)

Clinical coverage guidance for transcatheter heart valve procedures (aortic, mitral, pulmonary, tricuspid, and other related devices) applicable to UnitedHealthcare members in Kansas.

Policy Summary

PayerUnitedHealthcare

PolicyTranscatheter Procedures for Heart Valve Conditions (for Kansas Only)

Policy CodePolicy CS123KS.02

Change TypeMaterial and non-material revisions

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document medical necessity per InterQual criteria for TAVR and mitral TEER; include required clinical documentation and local heart team assessment when applicable.

SourceLink

POLICY UPDATE CHANGES

Title changed from 'Transcatheter Heart Valve Procedures (for Kansas Only)' to 'Transcatheter Procedures for Heart Valve Conditions (for Kansas Only)'.

Clarified that transcatheter aortic heart valve replacement is proven and medically necessary for surgical aortic valve replacement in certain circumstances.

Replaced language about mitral transcatheter repair being unproven with language that it is unproven except as addressed in InterQual criteria.

Added criteria indicating transcatheter edge-to-edge repair of the tricuspid valve is proven and medically necessary when used according to FDA labeled indications and specific clinical criteria (symptomatic severe TR, stable GDMT ≥30 days, NYHA class II+, PASP <70 mmHg, intermediate or greater surgical risk determined by a local heart team).

CPT code 33999 was removed from the applicable codes list.

Added statements about documentation requirements and that plan, federal, state, or contractual requirements govern coverage decisions.

Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect most current information and archived previous policy version CS123KS.01.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

valve types addressed

YesInterQual referenced

91-99%TAVR registry success

29.7%TMVR 30-day mortality (some series)

Coverage Criteria for Transcatheter Heart Valve Procedures

Coverage rationale: ViV, TMVR, CAVI, and cerebral protection devices

ViV/TMVR/CAVI/CEP coverage rationale

ALL of the following

Valve-in-valve (ViV) procedures in the aortic position have evolving evidence supporting use in selected patients at high or prohibitive surgical risk; observational and registry data suggest favorable short-term outcomes compared with reoperative surgery, but long-term durability evidence is limited and randomized data are lacking. ViV in non-aortic positions (mitral, pulmonary, tricuspid) has more limited evidence; mitral ViV may be reasonable in select high-risk patients but evidence is primarily observational.
See clinical evidence citations summarized in policy text.
Transcatheter mitral valve replacement (TMVR) demonstrates promising technical success and symptomatic improvement in registries, but randomized comparative evidence is limited and some comparative studies suggest higher early mortality or no mortality benefit versus alternative therapies; therefore long-term efficacy and safety are uncertain.
Hayes and systematic reviews conclude insufficient high-quality evidence.
Caval valve implantation (CAVI) and transcatheter tricuspid valve replacement (TTVR) are investigational for many indications because of limited sample sizes, short follow-up, and safety concerns in randomized or controlled data; while selected registry and single-arm studies report symptomatic and hemodynamic improvements, evidence gaps remain regarding net clinical benefit and durability.
TRICAVAL and other small trials highlight safety/efficacy uncertainties.
Embolic/cerebral protection devices (CEP) used during TAVR reduce radiographic cerebral lesion burden in small randomized trials and meta-analyses but have not conclusively demonstrated reduction in clinically overt stroke or long-term cognitive benefit; evidence remains inconclusive and use should be individualized pending larger RCT data.
Giustino et al. and small RCTs summarized in clinical evidence.
Because evidence strength varies by valve position and device, coverage decisions require alignment with FDA labeling, guideline and society recommendations, and available InterQual or other recognized clinical criteria when applicable, and should emphasize treatment at experienced centers (Comprehensive Valve Centers) for complex transcatheter and ViV procedures.

Guideline-based indications and considerations

ALL of the following

The choice between surgical and transcatheter intervention should be made by the multidisciplinary heart team (cardiac surgery, interventional cardiology, echocardiography, heart failure) using shared decision-making that incorporates patient values, anatomy, comorbidities, and procedural risks.
Refer to ACC, STS, SCAI, AATS consensus statements and guideline recommendations.
Transcatheter aortic valve replacement (TAVR) is supported across a range of surgical risk profiles in appropriately selected patients; SAVR remains preferred in many younger or low-risk patients where long-term durability is a primary concern.
See guideline summary: age, STS-PROM/EuroSCORE II thresholds and heart team discussion.
For patients with failed bioprosthetic aortic valves and high or prohibitive operative risk, transcatheter ViV in the aortic position may be reasonable when performed at a Comprehensive Valve Center. For mitral and tricuspid ViV procedures, guideline recommendations are more conservative (IIb) and these approaches may be considered in selected high-risk patients due to less well-established evidence.
Guideline excerpts on ViV use and recommendation classes.

Cerebral protection devices

Cerebral protection (embolic) devices

ALL of the following

Randomized trials and meta-analyses show CEP devices during TAVR reduce total diffusion-weighted MRI lesion volume and number of new ischemic lesions but have not demonstrated consistent reductions in clinical stroke or mortality. Evidence is limited by small sample sizes, short follow-up, and heterogeneity in endpoints and devices.
Radiographic benefits observed but clinical benefit remains unproven.
Given inconclusive evidence for clinical stroke reduction or long-term cognitive outcomes, CEP devices are considered investigational/optional adjuncts and use should be individualized; documentation of rationale may be required for coverage review.
Larger adequately powered RCTs are needed to establish clinical benefit.

Tricuspid edge-to-edge repair (T-TEER)

Tricuspid edge-to-edge repair (T-TEER) — proven and medically necessary when criteria met

ALL of the following

T-TEER (e.g., TriClip, PASCAL when indicated) is considered proven and medically necessary for symptomatic severe tricuspid regurgitation in patients who meet all of the following clinical criteria:
Criteria below reflect randomized and pivotal trial inclusion and FDA labeling considerations.
Required clinical criteria
- Symptomatic severe tricuspid regurgitation (TR).
- Receiving stable (≥ 30 days) guideline-directed medical therapy (GDMT) for heart failure.
- Symptomatic NYHA class II or greater.

Aortic valve interventions (TAVR)

Aortic — proven in certain circumstances

ALL of the following

Transcatheter aortic valve replacement (TAVR) is proven and medically necessary for treatment of severe, symptomatic aortic stenosis in appropriately selected patients based on surgical risk, anatomy, and shared decision-making by the heart team. Refer to InterQual CP: Procedures, Transcatheter Aortic Valve Replacement (TAVR) for detailed medical necessity criteria used operationally for coverage determinations.
Randomized trial evidence across risk spectra supports TAVR in many patients; consider device labeling and center expertise.
For bicuspid aortic valve (BAV) anatomy, observational and registry data suggest TAVR with contemporary devices may be reasonable in select patients at increased surgical risk when performed at experienced centers; surgery remains first-line for many BAV patients pending further RCT evidence.
Evidence limited to nonrandomized studies — see policy clinical evidence summary.

Mitral valve interventions

Mitral — unproven except per InterQual/TEER

ALL of the following

Transcatheter edge-to-edge mitral repair (TEER, e.g., MitraClip, PASCAL) is proven and medically necessary in certain circumstances; for medical necessity clinical coverage criteria, refer to InterQual CP: Procedures, Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).
COAPT and other randomized data support TEER in selected patients with secondary MR who remain symptomatic on GDMT.
Other transcatheter mitral procedures — including transcatheter mitral valve repair (annuloplasty), transcatheter mitral valve reconstruction, and transcatheter mitral valve replacement (TMVR) — are unproven and not medically necessary except when specifically addressed and supported by InterQual criteria or FDA labeled indications. Evidence for many mitral transcatheter technologies remains limited (small single-arm studies, short follow-up, and lack of randomized comparative data).
Percutaneous annuloplasty, early-stage repair devices, and many TMVR systems require further evidence before routine coverage.

Procedure, Device, and Product Codes

Applicable procedure codesmixed

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.
0805T	Transcatheter superior and inferior vena cava prosthetic valve implantation (i.e., caval valve implantation [CAVI]); percutaneous femoral vein approach.

1–10 of 25

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Procedure and device codes (not specified here)mixed

not specified in excerpt

No explicit CPT/HCPCS/ICD codes listed in this document excerpt.

Procedure and device codes (not specified here)mixed

not specified in excerpt

No explicit CPT/HCPCS/ICD codes listed in this document excerpt.

Procedure/CPT groups referenced in evidencemixed

No codes listed

Aortic valve PMA product codemixed

NPT	FDA PMA product code for transcatheter aortic valve prostheses

Mitral device PMA product codesmixed

NPU	FDA PMA product code for transcatheter mitral valve prostheses
NKM	FDA PMA product code for transcatheter mitral valve repair devices

Device product codes — Aorticmixed

NPT	FDA PMA product code for transcatheter aortic valve prostheses (used to search PMA database as referenced)

Device product codes — Mitralmixed

NPU	FDA PMA product code for transcatheter mitral valve prostheses
NKM	FDA PMA product code for transcatheter mitral valve repair devices

Device product codes — Pulmonarymixed

NPV	FDA PMA product code for transcatheter pulmonary valve prostheses

Device product codes — Tricuspidmixed

NPW	FDA PMA product code for transcatheter tricuspid valve prostheses
NPS	FDA PMA product code for transcatheter tricuspid valve repair devices

Device product codes — Cerebral protectionmixed

PUM	FDA 510(k)/De Novo product code for cerebral embolic protection devices

Removed/Updated CodesCPT

33999

Previously listed CPT code removed from applicable codes

Predicted Risk of Mortality (PROM)

DefinitionPredicted Risk of Mortality (PROM) refers to the Society of Thoracic Surgeons (STS) PROM score predicting 30-day mortality after cardiac procedures.

Threshold for high/prohibitive surgical riskPROM ≥ 8%

Use in policyPROM ≥ 8% used to define high or prohibitive surgical risk for transcatheter aortic valve-in-valve (ViV) eligibility when performed per FDA labeling.

Pulmonary stenosis mean RVOT gradient

Prior Authorization, Documentation, and Verification Steps

Prior Authorization

Prior Authorization Required / InterQual® Criteria

Prior authorization is required or expected for most transcatheter heart valve procedures. Providers should verify prior authorization requirements with UnitedHealthcare and submit requests per payer-specific processes. Use InterQual® criteria where referenced to support medical necessity determinations.

Prior authorization required for many transcatheter valve procedures — confirm with payer.
InterQual®-based medical necessity criteria apply for TAVR and TEER where referenced.

Documentation Required

Verify FDA Approval Status

Providers must confirm and document the FDA approval status of the specific device proposed for the procedure. FDA approval information is provided for reference; there is no implicit authorization or denial rule based solely on FDA status. The provider is responsible for verifying device approval (PMA/PMA supplements, De Novo, or 510(k) as applicable) prior to submission and for noting the approval source in the medical record and prior authorization documentation.

Background and Context

Transcatheter valve procedures provide minimally invasive alternatives to open surgical repair or replacement for aortic, mitral, pulmonary, and tricuspid valve disease. Indications, candidacy, and coverage depend on valve‑specific evidence and regulatory labeling: TAVR and transcatheter pulmonary valve implantation are supported in FDA‑labeled situations; mitral and tricuspid edge‑to‑edge repair have evidence‑based, limited indications (mitral TEER per InterQual; tricuspid TEER per policy criteria); other transcatheter mitral and tricuspid reconstruction or replacement procedures, CAVI, ViV in some positions, and cerebral protection devices lack sufficient high‑quality evidence of long‑term clinical benefit and are generally investigational. The policy emphasizes multidisciplinary heart‑team evaluation, documentation of guideline‑directed medical therapy, and verification of device regulatory status for coverage determinations.

Definitions and Terms

NYHA Classification

Class INo limitation of physical activity; ordinary activity does not cause undue symptoms.

Class IISlight limitation of physical activity; comfortable at rest; ordinary activity causes symptoms.

Class IIIMarked limitation of physical activity; less than ordinary activity causes symptoms.

Class IVUnable to carry on any physical activity without discomfort; symptoms at rest.

PROM (STS PROM)

DefinitionSociety of Thoracic Surgeons Predicted Risk of Mortality (PROM) predicts 30‑day mortality after cardiac procedures.

Common use

Policy Revision History and Updates

2026-01-01Title change and coverage updatesLatest

Title changed to 'Transcatheter Procedures for Heart Valve Conditions (for Kansas Only)' and coverage rationale for aortic TAVR added; language for mitral repair updated to reference InterQual criteria; tricuspid edge-to-edge repair criteria and related multidisciplinary team and GDMT requirements were added.

2026-01-01Code update

CPT code 33999 was removed from the applicable codes list.

2026-01-01

Policy Summary

PayerUnitedHealthcare

PolicyTranscatheter Procedures for Heart Valve Conditions (for Kansas Only)

Policy CodePolicy CS123KS.02

Change TypeMaterial and non-material revisions

Effective DateJan 1, 2026

Next Review DateN/A

SourceLink

On This Page

Interventions for RVOT dysfunction (pulmonary position) should follow congenital heart disease and adult valve guidance; transcatheter pulmonary valve replacement or stenting can benefit patients with conduit stenosis or regurgitation and reduced exercise capacity or arrhythmias when anatomy is suitable.

Refer to ACC adult congenital heart disease guidance.

Pulmonary artery systolic pressure < 70 mmHg.

Deemed intermediate or greater surgical risk by the local heart team that includes board-certified specialists in cardiac surgery, interventional cardiology, echocardiography, and heart failure.

T-TEER should be performed at centers with appropriate experience and multidisciplinary teams; documentation of prior optimization of medical therapy and heart team evaluation should be available for authorization and coverage determination.

See TRILUMINATE, TRILUMINATE pivotal, TRILUMINATE extended follow-up and supporting systematic reviews.

MeasureMean right ventricular outflow tract (RVOT) gradient

ThresholdMean RVOT gradient ≥ 35 mmHg

Clinical contextUsed as an indication for transcatheter pulmonary valve implantation in patients with RVOT dysfunction and pulmonary stenosis.

Echocardiographic thresholds used in studies

MR grade endpoints used in trialsReduction to ≤ 2+ or ≤ 1+ reported as trial effectiveness endpoints (eg, CLASP IID, COAPT).

Echocardiographic severity criteriaExamples include effective regurgitant orifice area (EROA) > 20 mm2 or regurgitant volume > 30 mL to define severe secondary MR in trial context.

Documentation recommendationBaseline and follow-up echocardiographic measures (MR grade, regurgitant volume, gradients) should be documented to support medical necessity for mitral interventions.

Small surgical bioprosthesis threshold

DefinitionSmall surgical bioprosthesis refers to a surgical bioprosthesis with internal diameter ≤ 21 mm.

RelevanceSmall surgical bioprosthesis (≤ 21 mm) associated with worse one-year survival after aortic valve-in-valve procedures.

Documentation recommendationRecord original surgical valve size when considering ViV procedures because small valve size influences outcomes and strategy.

Stable guideline-directed medical therapy (GDMT)

DefinitionStable guideline-directed medical therapy (GDMT) means the patient has been receiving optimized GDMT for heart failure for a sustained period.

Policy thresholdStable GDMT defined as ≥ 30 days prior to considering transcatheter tricuspid edge-to-edge repair (T-TEER).

Documentation recommendationProviders should document prior GDMT and symptomatic status when requesting authorization for transcatheter valve procedures, especially T-TEER.

Pulmonary artery systolic pressure

MeasurePulmonary artery systolic pressure (PASP)

Policy thresholdPASP < 70 mmHg required for eligibility for transcatheter edge-to-edge tricuspid repair in this policy.

Use in selectionPASP should be documented as part of heart team assessment when evaluating candidates for T-TEER.

Verify device FDA approval via FDA PMA, De Novo, or 510(k) databases and include reference or PMA ID in documentation.
FDA approval references in the policy are informational; they do not replace benefit determination or medical necessity review.

Prior Authorization

TMVR — Risk Justification Required

For TMVR, provide explicit risk justification when medical records or evidence for the procedure are limited. TMVR currently has limited comparative evidence and may require articulation of why other options (e.g., TEER, surgery, or continued GDMT) are unsuitable for this patient. Include discussion of anatomical factors, surgical risk, contraindications to alternative therapies, and anticipated benefits versus risks.

Explain why surgical or transcatheter alternatives are not appropriate when anatomy or risk favors TMVR.
Document objective measures (STS score, frailty, anatomic constraints) supporting elevated surgical risk and choice of TMVR.

Documentation Required

Optimize Medical Therapy Before Tricuspid Procedures (Including CAVI)

Document guideline-directed medical therapy (GDMT) and optimization of medical therapy prior to some transcatheter procedures. For tricuspid TEER and other tricuspid interventions (including CAVI), ensure and document adequate trials of medical therapy where specified. CAVI should be considered only after optimization of medical therapy and documentation of lack of sufficient clinical response.

Tricuspid TEER: member should be receiving stable (≥ 30 days) GDMT for heart failure before consideration.
CAVI: document prior optimization of medical therapy and rationale for proceeding to CAVI due to insufficient response.

Documentation Required

Required Medical Record Documentation

Medical record documentation must fully support the medical necessity of the requested service. Include relevant history, physical exam findings, diagnostic test results, echocardiographic measures, details of GDMT, and explicit statements of surgical risk and heart team determinations. Lack of sufficient documentation or evidence may result in denial.

Include heart team assessment (cardiac surgery, interventional cardiology, echocardiology, heart failure) for high-risk decisions.
Provide echocardiographic parameters and documentation of prior therapies to support clinical criteria.

Note

No Other Provider Actions Specified

No additional provider actions specified in this section beyond verification of FDA status, documentation of GDMT and risk justification, and confirming prior authorization requirements with the payer.

None specified.

Used to stratify surgical risk and determine candidacy for transcatheter aortic ViV when PROM ≥ 8% denotes high/prohibitive surgical risk.

Reference noteInterQual criteria are referenced in the policy for TAVR and TEER evaluations that incorporate PROM assessments.

Shared Decision-Making (SDM)

DefinitionShared decision-making (SDM) is a collaborative process between clinicians and patients to choose treatments aligned with evidence and patient preferences.

Policy applicationSDM is recommended when selecting between surgical and transcatheter interventions, incorporating guideline recommendations and heart team input.

Documentation adviceDocument SDM discussions in the medical record when seeking authorization for transcatheter valve procedures.

Transcatheter leaflet repair

DefinitionTranscatheter leaflet repair (edge-to-edge) approximates valve leaflets with a clip to reduce regurgitation (eg, MitraClip, PASCAL).

Typical approachProcedure generally requires transseptal puncture and femoral venous access for mitral leaflet repair.

Evidence noteEdge-to-edge leaflet repair is supported by randomized evidence (eg, COAPT, CLASP IID) for selected mitral patients; follow InterQual criteria for coverage.

Transcatheter pulmonary valve implantation

DefinitionTranscatheter pulmonary valve implantation places a stent-mounted bioprosthetic valve in the native or repaired RVOT via percutaneous venous access.

IndicationsUsed for RVOT dysfunction with moderate or greater pulmonary regurgitation and/or pulmonary stenosis meeting device labeling (eg, mean RVOT gradient ≥ 35 mmHg).

Device examplesExamples include Melody, SAPIEN 3, Harmony, and Alterra SAPIEN 3 configurations with device-specific indications and follow-up data.

Valve-in-valve

DefinitionValve-in-valve (ViV) is transcatheter implantation of a new bioprosthetic valve within a previously implanted degenerated surgical bioprosthesis.

Aortic ViV policy useConsidered proven and medically necessary for failed aortic bioprostheses in high/prohibitive surgical risk patients (eg, PROM ≥ 8%) when performed per FDA labeling.

Documentation recommendationDocument original valve type and size (small valve ≤ 21 mm increases risk) and mode of failure (stenosis vs regurgitation) when requesting ViV procedures.

Cerebral embolic protection

DefinitionCerebral embolic protection devices are designed to capture or deflect debris released during TAVR to reduce ischemic brain lesions.

Evidence summaryRCTs and meta-analyses show reduction in lesion volume and fewer new ischemic lesions on imaging but inconsistent effects on clinical stroke and mortality.

Device exampleSentinel (Boston Scientific) is listed in the policy as an available cerebral protection system; regulatory status should be verified via FDA product code PUM.

Transcatheter edge-to-edge mitral valve repair

DefinitionTranscatheter edge-to-edge mitral valve repair uses clip-based leaflet approximation (eg, MitraClip, PASCAL) to reduce MR severity.

Coverage conditionProven and medically necessary in selected patients when InterQual/COAPT-like criteria are met (symptomatic secondary MR despite optimized GDMT).

EvidenceCOAPT RCT demonstrated reduced heart failure hospitalizations and mortality versus medical therapy in appropriately selected patients.

Percutaneous annuloplasty (Carillon)

DefinitionPercutaneous annuloplasty (eg, Carillon) is a coronary sinus–based approach intended to reduce mitral annular dimension for functional MR.

Evidence summaryRandomized and observational trials show reductions in MR severity and some functional improvements, but overall long-term efficacy and comparative data are limited.

Coverage stanceConsidered limited/evidence insufficient for broad coverage; requires strong justification and documentation when proposed.

Transcatheter Mitral Valve Replacement (TMVR)

DefinitionTranscatheter Mitral Valve Replacement (TMVR) is transcatheter implantation of a prosthetic valve into the native mitral position.

Evidence limitationsPublished experience mainly from small registries and compassionate-use series with substantial periprocedural morbidity and limited comparative evidence.

Policy stanceTMVR is considered experimental/insufficient evidence for routine coverage outside specified contexts and trials.

Transcatheter pulmonary valve implantation (TPVI)

DefinitionTranscatheter pulmonary valve implantation (TPVI/TPV) is catheter-based replacement of dysfunctional pulmonary valves or conduits (eg, Melody, SAPIEN, Harmony).

EvidenceSystematic reviews and trials report high procedural success (eg, pooled procedural success ~96.2%) with improved hemodynamics and functional class in appropriate candidates.

Policy requirementUse according to FDA labeled indications and document RVOT dysfunction, degree of regurgitation or stenosis, and hemodynamic measures.

Transcatheter pulmonary valve implantation (TPV)

SynonymTranscatheter pulmonary valve (TPV) implantation—percutaneous placement of valve into RVOT or conduit.

Clinical outcomesTrials report improvements in NYHA class and reductions in gradients with low midterm reintervention and endocarditis rates for selected devices.

Device examplesMelody, SAPIEN 3, Harmony, and SAPIEN 3 with Alterra adaptive prestent are referenced with device-specific evidence.

Transcatheter edge-to-edge tricuspid repair (T-TEER)

DefinitionTranscatheter edge-to-edge tricuspid repair (T-TEER) approximates tricuspid leaflets (eg, TriClip) to reduce TR severity.

EvidenceRandomized evidence (TRILUMINATE) shows symptomatic and quality-of-life benefits and reductions in TR severity up to two years, though mortality benefit is not established.

Coverage criteria notePolicy requires symptomatic severe TR, stable GDMT ≥30 days, NYHA II+, PASP <70 mmHg, and intermediate or greater surgical risk per local heart team for medical necessity.

Transcatheter tricuspid valve replacement (TTVR)

DefinitionTranscatheter tricuspid valve replacement (TTVR) is orthotopic replacement of the tricuspid valve via transcatheter approach (eg, EVOQUE).

Evidence and risksRCT (TRISCEND II) data show marked reductions in TR and functional improvement but increased early severe bleeding and higher new pacemaker rates; longer-term safety uncertain.

Policy stanceTTVR considered investigational or requiring careful case review outside trial settings due to safety and evidence limitations.

Caval valve implantation (CAVI)

DefinitionCaval valve implantation (CAVI) places prosthetic valves in the superior and/or inferior vena cava to treat symptoms of severe TR.

Evidence limitationsRandomized TRICAVAL trial did not show superior functional outcomes versus medical therapy and had safety concerns (high valve dislocation rate); evidence insufficient for routine coverage.

RecommendationConsider CAVI only in clinical trials or highly selected cases with detailed justification and specialty review.

Small surgical bioprosthesis

DefinitionSmall surgical bioprosthesis defined as internal diameter ≤ 21 mm.

ImpactAssociated with worse one-year survival after aortic valve-in-valve procedures and should be documented when planning ViV interventions.

Clinical noteOriginal valve size influences procedural strategy and outcomes; document valve size and mode of failure in authorization requests.

TMViV/TMViR/TMViMAC

DefinitionsTMViV = transcatheter mitral valve-in-valve; TMViR = transcatheter mitral valve-in-ring; TMViMAC = TMV in mitral annular calcification contexts.

Evidence summaryObservational data suggest TMViV/TMViR may be reasonable in high surgical risk patients, but TMViMAC has higher procedural complexity and risks (eg, LVOT obstruction).

Policy stanceRequire detailed documentation and specialty heart team assessment; TMVR approaches generally considered investigational outside defined contexts.

Embolic (cerebral) protection

DefinitionEmbolic (cerebral) protection devices aim to capture/deflect debris during TAVR to reduce cerebral ischemic lesions.

Evidence summaryMeta-analyses show reduced lesion volume and fewer new ischemic lesions on imaging, but no consistent reduction in clinical stroke or mortality—clinical benefit remains unproven.

Device exampleSentinel is cited; verify regulatory status via FDA product code PUM when considering use or documentation.

Valve-in-valve (ViV)

DefinitionValve-in-valve (ViV) is transcatheter implantation of a prosthetic valve within a failing surgical bioprosthesis.

Use casesReasonable for symptomatic patients with failed bioprosthetic aortic valves who are high or prohibitive surgical risk; mitral/tricuspid ViV have IIb guideline recommendations and are considered in select high-risk patients.

DocumentationProvide heart team assessment, original valve size, mode of failure, and justification for transcatheter approach when requesting ViV procedures.

NPT (aortic PMA product code)

Product codeNPT — FDA PMA product code for transcatheter aortic valve prostheses.

UseUse NPT to search FDA PMA database to verify approval status of aortic transcatheter valve prostheses.

ExamplesPolicy lists approved aortic devices (eg, Evolut FX/PRO/R, Navitor, SAPIEN 3 variants) in PMA references.

NPU / NKM (mitral PMA product codes)

Product codesNPU — PMA product code for transcatheter mitral valve prostheses; NKM — PMA product code for transcatheter mitral repair devices.

UseSearch FDA PMA database with NPU/NKM to verify regulatory status of mitral prostheses and repair devices (eg, MitraClip, PASCAL).

ExamplesPolicy references MitraClip and PASCAL under these product code searches.

NPV (pulmonary PMA product code)

Product codeNPV — FDA PMA product code for transcatheter pulmonary valve prostheses.

UseUse NPV to search the FDA PMA database for pulmonary valve devices (eg, Melody, Harmony, SAPIEN 3 with Alterra).

ExamplesPolicy lists Harmony, Melody, SAPIEN 3 and Alterra-associated devices in PMA references.

NPW / NPS (tricuspid PMA product codes)

Product codesNPW — PMA product code for transcatheter tricuspid valve prostheses; NPS — PMA product code for transcatheter tricuspid repair devices.

UseSearch FDA PMA database using NPW/NPS to verify regulatory status of tricuspid valves and repair systems (eg, EVOQUE, TriClip).

ExamplesPolicy references EVOQUE and TriClip under tricuspid PMA product code searches.

PUM (cerebral protection product code)

Product codePUM — FDA De Novo or 510(k) product code for cerebral embolic protection devices.

UseUse PUM to search FDA De Novo/510(k) databases to confirm regulatory status (eg, SENTINEL listed).

Device exampleSENTINEL (Boston Scientific) is specifically named in the policy under cerebral protection devices.

Symptomatic Severe Tricuspid Regurgitation

DefinitionSymptomatic Severe Tricuspid Regurgitation as used in policy references Stage D TR with echocardiographic criteria (eg, central jet ≥ 50%, vena contracta ≥ 0.7 cm, ERO ≥ 0.40 cm2, regurgitant volume ≥ 45 mL) and signs of right atrial/ventricular dilation and symptoms.

Policy relevancePresence of symptomatic severe TR is a required criterion for coverage of transcatheter edge-to-edge tricuspid repair (T-TEER).

DocumentationProviders should include echocardiographic measures and clinical symptoms consistent with Stage D TR in authorization requests.

Documentation and benefit-rule additions

Policy added statements that benefit coverage is determined by federal, state, or contractual requirements and that medical record documentation may be required to support medical necessity.

2026-01-01Section updates and archival

Description of Services, Clinical Evidence, FDA, and References sections were updated to reflect current information and previous policy version CS123KS.01 was archived.