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UnitedHealthcare Transcatheter Heart Valve Coverage Update | OpenPayer

ModifiedUnitedHealthcarePolicy CS123ID.B

Transcatheter Procedures for Heart Valve Conditions (for Idaho Only)

Policy governs medical necessity and coverage criteria for transcatheter (percutaneous) heart valve procedures (aortic, mitral, pulmonary, tricuspid, and related devices) for the state of Idaho and Idaho Medicaid Plus plans. It specifies indications, required team and center capabilities, and which procedures are considered unproven/not medically necessary.

Policy Summary

PayerUnitedHealthcare

PolicyTranscatheter Procedures for Heart Valve Conditions (for Idaho Only)

Policy CodePolicy CS123ID.B

Change TypeMaterial coverage changes to tricuspid criteriacode list update

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain and submit documentation of medical necessity and prior therapies (including ≥30 days stable guideline-directed medical therapy for tricuspid interventions) when requesting authorization.

SourceLink

POLICY UPDATE CHANGES

Added language that transcatheter edge-to-edge repair of the tricuspid valve is proven and medically necessary when used according to FDA-labeled indications and when the individual meets specified clinical criteria.

Replaced statement that transcatheter tricuspid valve repair, reconstruction, or replacement is unproven with a narrower statement that reconstruction or replacement is unproven and not medically necessary.

Added documentation requirements language describing what medical records may be required to support medical necessity determinations.

Added definition of 'Symptomatic Severe Tricuspid Regurgitation'.

Removed CPT code 33999 from the applicable codes list.

Title changed from 'Transcatheter Heart Valve Procedures (for Idaho Only)' to the current title.

05/01/2026Policy revision date

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.

Coverage Criteria and Evidence Summaries

Aortic — TAVR for native aortic stenosis

Covered when ALL of the following are met:

Aortic TAVR criteria: Diagnosis of severe calcific native aortic valve stenosis as indicated by one of: mean aortic valve gradient ≥ 40 mmHg OR peak aortic jet velocity ≥ 4.0 m/s OR aortic valve area ≤ 1.0 cm2; Individual is symptomatic (NYHA class II or greater) with symptoms due to aortic stenosis; An interventional cardiologist and an experienced cardiothoracic surgeon have determined the procedure is appropriate; Individual has engaged in a Shared Decision-Making conversation with an interventional cardiologist and an experienced cardiothoracic surgeon; Procedure is performed in a center that meets the following: on-site heart valve surgery and interventional cardiology programs; post-procedure intensive care unit with personnel experienced in managing individuals who have undergone open-heart valve procedures; and volume requirements consistent with CMS/STS/ACC TVT Registrysee node text

Follow FDA labeled indications, contraindications, warnings, and precautions.

Aortic — Valve-in-valve (ViV) in failed bioprosthetic aortic valve

Covered when ALL of the following are met:

Aortic ViV criteria: Valve‑in‑valve (ViV) transcatheter replacement within a failed surgical bioprosthetic aortic valve for individuals at high or prohibitive surgical risk defined as Predicted Risk of Mortality (PROM) score ≥ 8%; Procedure performed according to FDA labeled indications, contraindications, warnings, and precautions; Care performed at a Comprehensive Valve Center with heart team evaluation considering anatomic features of the prosthesis and patient-specific surgical risk.PROM ≥ 8%

ViV evidence from observational and registry studies supports feasibility in high-risk patients but randomized data are lacking; consider device‑ and anatomy‑specific issues (e.g., post‑TAVR gradients).

Mitral — Transcatheter edge-to-edge repair (primary/degenerative MR)

Covered when ALL of the following are met:

Primary MR edge-to-edge criteria: Moderate-to-severe or severe primary (degenerative) mitral regurgitation (MR grade ≥ 3); Symptomatic NYHA class III or IV; Prohibitive surgical risk defined by either PROM ≥ 8% if valve replacement is likely OR PROM ≥ 6% if valve repair is likely OR predicted risk of death or major morbidity at 1 year > 50%; Care directed by a multidisciplinary heart team including a heart failure specialist, interventional cardiologist, and cardiothoracic surgeon experienced in mitral valve disease; Procedure performed according to FDA labeled indications, contraindications, warnings, and precautions.MR grade ≥ 3; PROM thresholds as above

Randomized and registry data (CLASP IID, COAPT) support TEER in selected patients when anatomy and prior therapy criteria are met.

Mitral — Transcatheter edge-to-edge repair (secondary/functional MR)

Covered when ALL of the following are met:

Secondary MR edge-to-edge criteria: Moderate-to-severe or severe secondary (functional) MR (grade ≥ 3) with left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%; Symptomatic NYHA class II–IV (ambulatory); Optimal evidence-based management including guideline‑directed medical therapy and cardiac resynchronization therapy as indicated has been optimized; High surgical risk (PROM ≥ 8%); Care directed by a multidisciplinary heart team including a heart failure specialist, interventional cardiologist, and cardiothoracic surgeon experienced in mitral valve disease; Procedure performed according to FDA labeled indications, contraindications, warnings, and precautions.LVEF 20–50%; MR grade ≥ 3; PROM ≥ 8%

COAPT trial criteria inform patient selection for secondary MR TEER; ensure documented optimization of GDMT prior to intervention.

Pulmonary — Transcatheter pulmonary valve replacement

Covered when ALL of the following are met:

Pulmonary valve indications: Right ventricular outflow tract (RVOT) dysfunction presenting as moderate or greater pulmonary regurgitation AND/OR pulmonary stenosis with mean RVOT gradient ≥ 35 mmHg; Procedure performed according to FDA labeled indications, contraindications, warnings, and precautions; Care performed at centers experienced in transcatheter pulmonary valve implantation with appropriate technical expertise (including prestenting where indicated).RVOT mean gradient ≥ 35 mmHg

Published single-arm trials and systematic reviews report high procedural success and improved hemodynamics; long-term durability varies by device.

Tricuspid — Transcatheter edge-to-edge repair

Covered when ALL of the following are met:

Tricuspid edge-to-edge criteria: Symptomatic severe tricuspid regurgitation; Receiving stable (≥ 30 days) guideline-directed medical therapy (GDMT) for heart failure; Symptomatic NYHA class II or greater; Pulmonary artery systolic pressure (PASP) < 70 mmHg; Intermediate or greater surgical risk as determined by the local heart team which includes board-certified specialists in cardiac surgery, interventional cardiology, echocardiology, and heart failure; Procedure performed according to FDA labeled indications, contraindications, warnings, and precautions.PASP < 70 mmHg; GDMT ≥ 30 days

TRILUMINATE and other trials support T-TEER effectiveness in selected patients; documentation of GDMT and heart‑team determination is required.

Transcatheter Mitral Valve Replacement (TMVR) — evidence considerations

Evidence-based stance and criteria context for TMVR and mitral interventions

TMVR evidence-based considerations: TMVR currently has limited high-quality comparative evidence for long-term efficacy; available registry data report high technical success and marked reductions in MR at discharge but variable and sometimes substantial mortality at longer follow-up; observational comparative studies suggest no clear mortality benefit and possible higher early mortality versus TEER or GDMT in some cohorts.

Decision-making should favor established alternatives (e.g., TEER, optimized GDMT) where appropriate and require heart‑team evaluation and documentation of rationale if TMVR is considered.

Transcatheter Aortic Valve Replacement (TAVR) — evidence summary

TAVR evidence summary across risk strata

TAVR comparative outcomes: Multiple randomized trials and meta-analyses across high, intermediate, and low surgical risk populations demonstrate that TAVR reduces or is noninferior to SAVR for mortality in many groups, with tradeoffs: lower bleeding and acute kidney injury but higher vascular complications and higher need for permanent pacemaker implantation; device- and approach-specific outcomes vary and registry data report high procedural success (≈91%–99%) and favorable short-term survival in many cohorts.

Selection should be individualized by the heart team considering patient age, anatomy, and long-term durability considerations.

Coverage-relevant evidence syntheses

Summary of evidence-based coverage-relevant findings from this document portion:

TEER (MitraClip/PASCAL) evidence: Randomized trials (COAPT, CLASP IID) and registries support safety and effectiveness of TEER in selected patients with severe MR, demonstrating reductions in heart-failure hospitalizations and mortality in appropriately selected secondary MR (COAPT) and noninferiority between PASCAL and MitraClip (CLASP IID).

Applicable when trial eligibility and GDMT optimization criteria are met.

TMVR evidence: Current evidence for TMVR is limited and largely observational with variable technical success and substantial adverse event rates in some cohorts; comparative studies suggest higher early mortality versus TEER and uncertain long-term benefit versus guideline‑directed medical therapy.

Requires cautious consideration and heart-team justification if used.

Percutaneous annuloplasty (Carillon): Trials (REDUCE‑FMR) and meta-analyses show reductions in MR grade and some functional improvements versus medical therapy, but limitations (small trials, attrition, limited comparisons) make evidence insufficient to establish broad effectiveness compared with other transcatheter or surgical approaches.

Evidence summaries (no single unified coverage criterion)

Evidence-based coverage considerations reflect device- and indication-specific findings; where RCT data exist, outcomes are mixed and longer follow-up is required.

TTVR evidence summary: Randomized data (TRISCEND II) show TTVR (EVOQUE) reduces TR severity and improves quality of life and functional measures at 1 year but is associated with higher rates of early adverse events including severe bleeding and new pacemaker implantation; registries report symptomatic and hemodynamic improvements in selected high‑risk cohorts.

Longer-term safety and comparative effectiveness data remain limited.

T-TEER evidence summary: Randomized TRILUMINATE and single-arm studies of TriClip demonstrate durable reduction in TR severity and improved quality of life and NYHA class, with reductions in heart‑failure hospitalizations in some analyses; mortality benefit is not established.

Transcatheter pulmonary valve summary: Systematic reviews and single-arm trials report high procedural success and improved gradients and regurgitation, with device‑specific risks such as conduit rupture, stent fracture, endocarditis, and variable long-term durability.

Aortic ViV (evidence for coverage consideration)

Evidence summary relevant to coverage decisions for valve-in-valve procedures:

Aortic ViV evidence summary: Observational and registry data demonstrate ViV TAVR is feasible in failed surgical aortic bioprostheses and in high‑risk/inoperable patients is associated with similar or lower short‑term mortality and lower rates of bleeding and stroke versus redo SAVR, but may have higher transvalvular gradients and more paravalvular leak; randomized trials are lacking and surgical repair may offer superior hemodynamics in low‑risk patients.

Consider anatomy (small surgical bioprosthesis) and device selection when evaluating ViV candidacy.

Mitral valve-in-valve / valve-in-ring / MAC (evidence for coverage consideration)

Evidence summary relevant to coverage decisions for mitral ViV/ViR/TMVR:

Mitral ViV/TMVR evidence summary: Systematic reviews and observational series report high technical success and acceptable short‑term survival for TMViV in high‑risk patients with degenerated mitral bioprostheses; valve‑in‑ring and TMViMAC cases have higher complication rates (e.g., LVOT obstruction) and long‑term randomized data are lacking.

TMViV/TMViR/TMViMAC remain options in selected high‑risk patients with heart‑team evaluation and informed consent regarding limited long‑term evidence.

Caval valve implantation

Caval valve implantation (CAVI):

CAVI evidence summary: Randomized TRICAVAL trial (n=28) showed no superior functional outcome versus optimal medical therapy and was stopped early for safety due to an unexpectedly high rate of valve dislocations; evidence is insufficient to support routine use.

Safety concerns and small sample limit conclusions; CAVI may be considered investigational.

Cerebral embolic protection

Cerebral embolic protection during TAVR:

CEP evidence summary: Randomized evidence including a large RCT of the Sentinel device (Kapadia et al., 2022; n=3,000) did not demonstrate a statistically significant reduction in periprocedural stroke; smaller RCTs (e.g., CLEAN‑TAVI) and meta‑analyses show reductions in MRI surrogate endpoints (number and volume of new ischemic lesions) but inconsistent effects on clinical stroke or mortality; overall evidence is mixed and device‑specific, with ongoing trials evaluating clinical benefit.

NICE recommends special arrangements for governance and audit if used; observational meta‑analyses may show benefit but are susceptible to bias.

Guideline-based reasonable use / candidate selection

Guideline recommendations and reasonable-use statements from ACC/AHA and ESC:

Aortic TAVR selection: Choice between surgical and transcatheter aortic valve intervention should be made by the heart team based on clinical, anatomical, and procedural factors with shared decision‑making; TAVR may be considered in older or higher‑risk patients and in selected bicuspid cases when performed at a Comprehensive Valve Center.see guideline details

Mitral TEER: TEER is reasonable for primary severe MR in high/prohibitive surgical risk patients if anatomy is favorable and life expectancy ≥ 1 year; for secondary MR, TEER is reasonable in patients with LVEF 20–50%, LVESD ≤ 70 mm, and PASP ≤ 70 mmHg who remain symptomatic despite optimal therapy.LVEF 20–50%, LVESD ≤70 mm, PASP ≤70 mmHg

Tricuspid interventions: Transcatheter treatment for symptomatic secondary severe tricuspid regurgitation may be considered (ESC IIb) in inoperable patients at experienced heart valve centers; evidence is less established than for aortic and mitral interventions.

Cerebral protection — evidence summary

Clinical trial and meta-analysis findings on cerebral protection during TAVR:

CLEAN-TAVI findings: In a randomized trial (CLEAN‑TAVI; n=100), cerebral protection reduced the number and volume of new ischemic cerebral lesions on MRI (median new lesions 4.00 vs 10.00; lesion volume 242 mm3 vs 527 mm3) though clinical outcome effects remain uncertain.MRI lesion count/volume differences

Meta-analysis findings: A systematic review/meta-analysis of four RCTs (n=252) found embolic protection associated with lower total lesion volume and fewer new ischemic lesions but no significant reduction in overt stroke or all‑cause mortality; results are hypothesis‑generating due to study limitations.n=252 across 4 RCTs

NICE position on cerebral protection: NICE states efficacy for preventing TAVR‑related stroke is inconclusive and recommends use only with special arrangements for governance, consent, and audit or research.

Tricuspid edge-to-edge repair (Covered with criteria)

Covered when ALL of the following are met

Tricuspid edge-to-edge repair coverage criteria: 1) Symptomatic severe tricuspid regurgitation; 2) Receiving stable (≥ 30 days) guideline‑directed medical therapy (GDMT) for heart failure; 3) Symptomatic NYHA class II or greater; 4) Pulmonary artery systolic pressure < 70 mmHg; 5) Intermediate or greater surgical risk as determined by the local heart team including board‑certified cardiac surgery, interventional cardiology, echocardiology, and heart failure specialists; Procedure performed according to FDA labeled indications, contraindications, warnings, and precautions.

Documentation of GDMT, heart‑team determination, and symptomatic status should be available for authorization review; meeting criteria does not guarantee coverage per benefit terms.

Transcatheter tricuspid reconstruction or replacement (Not medically necessary)

Transcatheter tricuspid reconstruction/replacement: Transcatheter tricuspid heart valve reconstruction or replacement is unproven and not medically necessary due to insufficient evidence of efficacy and safety; this stance is distinct from edge‑to‑edge repair which may be covered when criteria are met.

Procedures classified as reconstruction or replacement should not be authorized as medically necessary under this policy.

The policy identifies a set of transcatheter heart valve devices and procedures that are considered unproven and not medically necessary due to insufficient evidence of efficacy. Examples called out include cerebral embolic protection devices (e.g., Sentinel™), valve‑in‑valve (ViV) replacement within a failed bioprosthesis for mitral, pulmonary, or tricuspid valves, and transcatheter superior and inferior vena cava prosthetic valve implantation (CAVI).

The evidence base for transcatheter mitral valve replacement (TMVR) is limited and of insufficient quality to establish long‑term effectiveness and safety. Most data are noncomparative registries with high attrition and short follow‑up; comparative observational studies raise concerns about higher early mortality versus alternatives and no consistent mortality benefit versus guideline‑directed medical therapy. Because of this substantial uncertainty, TMVR may be excluded or restricted where less‑proven interventions cannot be justified without additional high‑quality comparative data.

There is insufficient evidence to support broad coverage of TMVR and coronary sinus annuloplasty (e.g., Carillon) as replacements for established therapies. Available trials and meta‑analyses are limited by small size, loss to follow‑up, and lack of randomized comparisons to standard surgical or transcatheter alternatives; these limitations prevent concluding that these novel approaches provide equivalent or superior long‑term clinical benefit.

Some procedures may not be attempted or may be contraindicated in patients with specific anatomic or procedural risks. For transcatheter pulmonary valve implantation, for example, implantation was not attempted in a subset of patients because of risk of coronary artery compression or other protocol contraindications. Cases with such risks require alternative management and documentation of contraindications when considering transcatheter approaches.

Caval valve implantation (CAVI) is associated with safety concerns and limited evidence of functional benefit. The randomized TRICAVAL trial was stopped early for safety because of a high rate of valve dislocations and did not demonstrate superior functional outcomes versus optimal medical therapy. Given these safety signals and limited data, CAVI may be excluded from routine coverage.

Per NICE guidance, there is currently no accepted transcatheter intervention for aortic regurgitation. Transcatheter pulmonary valve replacement has demonstrated favorable short‑ to mid‑term outcomes in selected populations but is variably addressed in guideline documents; use and coverage should follow device labeling, available evidence, and guideline recommendations.

FDA clearance or approval status is provided for informational purposes only and does not, by itself, establish coverage. The policy explicitly states that FDA approval alone is not a basis for coverage.

Transcatheter tricuspid heart valve reconstruction or replacement is considered unproven and not medically necessary because of insufficient evidence of efficacy. By contrast, transcatheter edge‑to‑edge repair (T‑TEER) of the tricuspid valve is supported and covered when the individual meets the specified clinical criteria and FDA‑labeled indications.

Transcatheter mitral valve repair techniques other than edge‑to‑edge repair (for which specific criteria are defined) — including percutaneous annuloplasty and other mitral reconstruction approaches — remain unproven and not medically necessary in the absence of stronger comparative evidence. TMVR and other reconstruction/replacement approaches lack robust randomized data and therefore are generally not covered except where explicit criteria or evidence support use.

Overall, TMVR lacks sufficient high‑quality comparative evidence demonstrating durable long‑term efficacy and safety. Registry data show high technical success and MR reduction in many series but also report substantial mortality at follow‑up and inconsistent comparative results versus TEER or guideline‑directed medical therapy. Given these limitations, TMVR may be considered not medically necessary for most patients until higher‑quality comparative data establish net clinical benefit.

Given current evidence limitations — including nonrandomized designs, attrition, and variable long‑term outcomes — use of TMVR outside of defined investigational protocols or well‑documented cases with compelling rationale is likely to be considered not medically necessary. Coverage decisions should consider whether established alternatives (TEER, GDMT, or surgery) were considered and whether sufficient documentation justifies the transcatheter replacement approach.

Evidence for CAVI and some valve‑in‑valve (ViV) procedures for non‑aortic valves is limited and heterogeneous. Small studies with short follow‑up, heterogeneous devices, and safety events (including valve dislocations) mean long‑term efficacy and safety are not established; such procedures may be considered experimental or investigational in the absence of stronger data.

CAVI lacks sufficient evidence of benefit — the TRICAVAL randomized trial was stopped for safety concerns related to valve dislocations — and routine use of cerebral embolic protection devices during TAVR is not supported by consistent RCT evidence for clinical stroke reduction. Both CAVI and routine cerebral embolic protection are therefore not supported for routine coverage based on current evidence.

NICE and other guideline assessments note limitations in the evidence for some transcatheter indications, including concerns about durability of TAVR valves beyond 6–7 years and inadequate evidence for certain valve positions or patient subgroups. These guideline observations underscore the need for continued long‑term surveillance and selective use of some transcatheter interventions.

Reiterating the policy distinction: transcatheter tricuspid edge‑to‑edge repair is supported and covered when the member meets the stated clinical criteria and FDA‑labeled indications; however, transcatheter tricuspid heart valve reconstruction or replacement remains unproven and is considered not medically necessary.

Applicable Procedure and Regulatory Codes

Applicable CPT and Category III Codes (group 1)CPT

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.

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Applicable CPT Codes (group 2)CPT

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 (e.g., left thoracotomy).
33367	TAVR with cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation (List separately).
33368	TAVR with cardiopulmonary bypass support with open peripheral arterial and venous cannulation (List separately).
33369	TAVR with cardiopulmonary bypass support with central arterial and venous cannulation (List separately).
33370	Transcatheter placement and subsequent removal of cerebral embolic protection device(s), percutaneous (List separately).
33418	Transcatheter mitral valve repair, percutaneous approach; initial prosthesis.

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Applicable Codes (group 3 / pulmonary and unlisted)mixed

33364-33370	Additional TAVR approaches and related supporting procedure codes as listed.
33477	Transcatheter pulmonary valve implantation, percutaneous approach, including pre-stenting of the valve delivery site, when performed.
93799	Unlisted cardiovascular service or procedure.

Regulatory identifiersmixed

Product Code NPT

FDA PMA product code for transcatheter aortic valve prostheses

Removed CPT CodesCPT

33999

CPT code removed from Applicable Codes

Clinical thresholds and scores

Severe aortic stenosis diagnostic thresholdsMean aortic valve gradient ≥ 40 mmHg OR peak aortic jet velocity ≥ 4.0 m/s OR aortic valve area ≤ 1.0 cm2

PROM threshold for high/prohibitive surgical riskPredicted Risk of Mortality (PROM) score ≥ 8%

PROM threshold referenced for mitral repair vs replacementPROM ≥ 8% for likely replacement; PROM ≥ 6% for likely repair

Symptom class referencedNYHA class II–IV (symptomatic individuals eligible for many transcatheter procedures)

Pulmonary RVOT hemodynamic thresholdMean RVOT gradient ≥ 35 mmHg for transcatheter pulmonary valve intervention

Provider Requirements, Prior Authorization, and Documentation

Note

Provider action: None specified

No specific provider action items (e.g., operational authorization codes or unique procedural prior authorization lists) are specified in this section. FDA approval alone is informational and is not determinative for coverage decisions.

Documentation Required

Documentation requirements

Medical record documentation must fully support the medical necessity for requested transcatheter valve procedures. Documentation should include relevant history, physical examination, diagnostic test results (e.g., echocardiography, hemodynamic measurements), risk scores (e.g., STS PROM), heart team determination, and evidence of shared decision-making. Documentation must be legible, maintained in the patient’s record, and provided upon request. Lack of sufficient documentation may result in denial or noncoverage.

Include baseline severity (valve-specific grades, gradients, valve area, LVEF where applicable).
Record prior interventions, contraindications, and reasons for device selection.
Document multidisciplinary heart team deliberation and shared decision-making with the patient.

Background and Rationale

Background: Transcatheter valve procedures provide minimally invasive alternatives to surgical valve repair or replacement for aortic, mitral, pulmonary, and tricuspid valve disease. They deliver bioprosthetic valves or perform percutaneous repair without cardiopulmonary bypass via approaches tailored to the target valve. While randomized trials support TAVR and edge‑to‑edge repair in specific indications, many newer transcatheter reconstructions, replacements, and adjunctive devices have limited comparative evidence; this policy delineates which procedures are proven and which remain unproven or investigational.

Definitions and Abbreviations

NYHA — New York Heart Association classification

DefinitionNew York Heart Association (NYHA) classification: I–IV grading of functional capacity in heart failure.

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

NYHA III–IV (actionable)Marked limitation or symptoms at rest; policy references NYHA III–IV (mitral primary) and NYHA II–IV (secondary/other valves) for eligibility.

PROM — Predicted Risk of Mortality (STS PROM)

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

PROM ≥ 8%Used to define high or prohibitive surgical risk (e.g., ViV TAVR, many mitral/tricuspid indications).