Transcatheter Procedures for Heart Valve Conditions
Medical policy governing when transcatheter heart valve procedures (aortic, mitral, pulmonary, tricuspid, and related devices) are considered medically necessary or not for UnitedHealthcare Commercial and Individual Exchange plans and the clinical criteria and program requirements that apply.
Policy Summary
PayerUnitedHealthcare
PolicyTranscatheter Procedures for Heart Valve Conditions
Policy CodePolicy 2026T0557EE
Change TypeTemplate Update
Effective DateJan 1, 2026
Next Review Date
Key ActionObtain prior authorization with documentation of symptomatic status, surgical risk (PROM) and required clinical records to support medical necessity.
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Coverage Criteria and Evidence Considerations
Transcatheter aortic valve replacement (TAVR)
Covered when ALL of the following are met:
Diagnosis criteria: Diagnosis of severe calcific native aortic valve stenosis as indicated by mean aortic valve gradient ≥ 40 mmHg OR peak aortic jet velocity ≥ 4.0 m/s OR aortic valve area ≤ 1.0 cm2.Mean gradient ≥ 40 mmHg OR Peak velocity ≥ 4.0 m/s OR AVA ≤ 1.0 cm2
Per FDA labeled indications and policy requirements.
Symptoms: Individual is symptomatic (New York Heart Association [NYHA] class II or greater) and symptoms are due to aortic valve stenosis.NYHA ≥ II
Heart team assessment: An interventional cardiologist and an experienced cardiothoracic surgeon have determined the procedure is appropriate and the individual has engaged in a shared decision-making conversation with them.
Facility requirements: Procedure is performed in a center meeting on-site heart valve surgery and interventional cardiology programs, post-procedure ICU with personnel experienced in managing valve procedure patients, and CMS-consistent volume requirements.See CMS volume requirements
Refer to CMS NCD and STS/ACC TVT Registry for specific volume criteria.
Aortic valve-in-valve (ViV) replacement
Covered when ALL of the following are met:
Indication: Transcatheter valve‑in‑valve (ViV) replacement within a failed bioprosthetic aortic valve for individuals at high or prohibitive surgical risk.Predicted Risk of Mortality (PROM) ≥ 8%
When performed according to FDA labeled indications, contraindications, warnings, and precautions.
Regulatory: Procedure performed according to FDA labeled indications, contraindications, warnings, and precautions.
Document device and FDA labeling compliance.
Transcatheter edge-to-edge mitral valve repair
Covered when ALL of the following are met:
Clinical indication groups: Primary (degenerative) MR OR Secondary (functional) MR with specified criteria.
Details below.
Primary MR criteria: Moderate-to-severe or severe MR (grade ≥ 3) AND symptomatic NYHA class III or IV AND prohibitive surgical risk defined by PROM ≥ 8% if likely replacement OR PROM ≥ 6% if likely repair OR predicted risk of death/major morbidity at 1 year > 50% AND care directed by a multidisciplinary heart team including heart failure specialist, interventional cardiologist, and cardiothoracic surgeon experienced in mitral disease.MR ≥ grade 3; NYHA III–IV; PROM thresholds as noted
Per FDA labeled indications and COAPT/EVEREST evidence contexts.
Secondary MR criteria: Moderate-to-severe or severe MR (grade ≥ 3) with left ventricular ejection fraction between 20% and 50% AND symptomatic NYHA class II–IV AND optimal evidence‑based management (including pharmacologic therapy and CRT when indicated) AND high surgical risk (PROM ≥ 8%) AND care directed by a multidisciplinary heart team including heart failure specialist, interventional cardiologist, and cardiothoracic surgeon experienced in mitral disease.
Not medically necessary: Transcatheter mitral annuloplasty, mitral valve reconstruction, or transcatheter mitral valve replacement (TMVR) are unproven and not medically necessary due to insufficient evidence of long‑term efficacy, except where specific coverage statements indicate otherwise.
Documented as investigational/unproven in current evidence base.
Transcatheter pulmonary valve replacement
Covered when ALL of the following are met:
Indications: Right ventricular outflow tract (RVOT) dysfunction with moderate or greater pulmonary regurgitation and/or pulmonary stenosis with mean RVOT gradient ≥ 35 mmHg.Mean RVOT gradient ≥ 35 mmHg or moderate+ regurgitation
Procedure and device use should follow FDA labeled indications and precautions (e.g., Alterra/SAPIEN 3 studies).
Transcatheter tricuspid edge-to-edge repair
Covered when ALL of the following are met:
Severity and symptoms: Symptomatic severe tricuspid regurgitation (TR) and symptomatic NYHA class II or greater.Severe TR; NYHA ≥ II
Medical therapy: Receiving stable (≥ 30 days) guideline‑directed medical therapy (GDMT) for heart failure prior to intervention.≥ 30 days GDMT
Unproven/not medically necessary: The following are considered unproven and not medically necessary due to insufficient evidence of efficacy: cerebral embolic protection devices (e.g., Sentinel) for routine use, valve‑in‑valve replacement within failed bioprostheses for mitral, pulmonary, or tricuspid valves, transcatheter superior and inferior vena cava prosthetic valve implantation (CAVI), and other listed early‑stage devices/procedures.
See Benefit Considerations and evidence summaries for exceptions and research contexts.
Clinical evidence overview
Evidence summaries and outcomes across surgical risk groups (no explicit coverage decision logic present in this segment):
Evidence summary: Randomized trials and meta-analyses show TAVR reduces mortality versus conservative therapy in inoperable patients and demonstrates similar or improved outcomes compared with SAVR across high, intermediate, and selected low‑risk patients up to available follow‑up; device‑specific differences in complications (permanent pacemaker, vascular complications) are noted.
See referenced RCTs and registries for device- and risk‑specific outcomes.
Evidence-informed coverage considerations
Coverage decisions should reflect trial populations, device-specific outcomes, and strength of evidence; consider the following selection logic drawn from reported studies:
TAVR (high/prohibitive surgical risk aortic stenosis): Patient has severe symptomatic aortic stenosis AND is at high or prohibitive surgical risk and anticipated benefit outweighs increased early risks (eg, stroke, vascular complications).
Supported by PARTNER Cohort B and RCT meta-analyses showing mortality benefit in inoperable/high‑risk patients; consider device‑specific complication profiles.
TEER for secondary MR: Patient has moderate‑to‑severe or severe secondary MR, remains symptomatic despite optimal guideline‑directed medical therapy, and meets anatomical and clinical selection criteria similar to the COAPT trial enrollment.
COAPT demonstrated reduced heart‑failure hospitalizations and mortality in appropriately selected patients; MITRA‑FR did not, underscoring selection importance.
TMVR: Consider TMVR primarily in clinical trial settings or selected patients unsuitable for other options after multidisciplinary evaluation due to limited comparative effectiveness evidence and safety concerns.
Consider coverage for transcatheter tricuspid and pulmonary valve procedures in patients who meet device-specific trial-like criteria:
TTVR trial‑like candidate: Severe, symptomatic tricuspid regurgitation despite optimal medical therapy; judged inoperable or high surgical risk by heart team; anatomy suitable for device; informed consent about early increased risks (eg, severe bleeding, pacemaker) and potential quality‑of‑life benefits.
Based on TRISCEND II and registry populations.
T‑TEER (TriClip) candidate: Symptomatic moderate‑or‑greater TR despite optimal medical therapy, anatomy suitable for edge‑to‑edge repair, and considered high or prohibitive surgical risk; document baseline NYHA class and KCCQ as applicable.
Based on TRILUMINATE randomized and single‑arm studies.
Pulmonary valve transcatheter replacement candidate: Dysfunctional RVOT conduits or surgical pulmonary valves with moderate or greater pulmonary regurgitation or RVOT obstruction may be considered when anatomy is appropriate and coronary compression risk has been evaluated.
Based on COMPASSION S3, Alterra, Melody/registry data.
Evidence summaries relevant to coverage
Summary of evidence-based findings relevant to coverage decisions:
T‑TEER (TRILUMINATE): Randomized trial (n=350) showed T‑TEER reduced TR severity and improved KCCQ scores and NYHA class but did not reduce death or heart‑failure hospitalization; safety profile acceptable with few major adverse events at 30 days.
Benefit driven by quality‑of‑life endpoints; lack of masking may bias results.
CAVI: Meta‑analyses and small studies show procedural success and symptomatic improvements but are limited by small sizes, short follow‑up, heterogenous devices, and safety signals (valve dislocation); evidence insufficient for routine coverage.
Valve‑in‑Valve (ViV) procedures: Observational studies and registries suggest ViV TMVR and ViV for other positions can be feasible with favorable short‑term outcomes in high‑risk patients; comparative data versus redo surgery show trade‑offs and evidence is largely observational.
Long‑term efficacy evidence is limited.
Guideline-informed indications
Society guideline recommendations (may inform coverage decisions):
Aortic valve guidelines: Choice of prosthetic valve should be based on shared decision‑making accounting for patient values, anticoagulation implications, and reintervention risk; TAVR may be considered as alternative to SAVR in selected bicuspid aortic valve patients when performed at a Comprehensive Valve Center.
Mitral valve — primary MR: In severely symptomatic patients (NYHA III–IV) with primary severe MR and high or prohibitive surgical risk, transcatheter edge‑to‑edge repair is reasonable if anatomy is favorable and life expectancy ≥ 1 year.
Mitral valve — secondary MR: In chronic severe secondary MR with LVEF <50% and persistent symptoms despite guideline‑directed therapy, transcatheter edge‑to‑edge repair is reasonable for appropriate anatomy with LVEF 20–50%, LVESD ≤ 70 mm, and PASP ≤ 70 mmHg.LVEF 20–50%; LVESD ≤70 mm; PASP ≤70 mmHg
NICE-sourced usage and limitations
NICE-based coverage considerations and limits:
TAVI/TAVR usage: NICE states TAVI is clinically effective for symptomatic aortic stenosis in intermediate or low surgical risk patients; transcatheter interventions are currently indicated only for symptomatic aortic stenosis.
NICE (2021).
Aortic regurgitation: NICE reports there is no currently accepted transcatheter intervention for aortic regurgitation.
Valve durability caution: NICE notes limited evidence for TAVI valve durability beyond 6–7 years and possible leaflet deterioration related to crimping; consider durability concerns in coverage decisions.6–7 years
Procedures requiring special arrangements:
Valve-in-valve (ViV) replacement within a failed surgical bioprosthesis for the mitral, pulmonary, or tricuspid positions is considered unproven and not medically necessary due to insufficient quality evidence demonstrating long-term safety and efficacy. Observational series and registry data for non-aortic ViV procedures are limited by noncomparative designs and short follow-up, and the policy references specific exclusions for these valve positions. For members with life‑threatening illnesses or serious rare diseases, consult the member-specific benefit plan for potential exceptions under defined Benefit Considerations.
Transcatheter mitral and transcatheter tricuspid heart valve reconstruction or replacement (TMVR/TTVR) are described in this policy as unproven and not medically necessary except where specific, device‑labeled indications and high‑quality evidence support use. The document states that transcatheter mitral heart valve reconstruction or replacement is unproven because existing studies are limited by noncomparative designs, high attrition, or short follow-up; similarly, transcatheter tricuspid valve reconstruction/replacement lacks sufficient evidence of efficacy and long‑term outcomes.
Some member benefit plans may permit coverage of experimental, investigational, or unproven treatments under narrowly defined conditions (for example, life‑threatening illnesses or serious rare diseases). The policy advises that the member‑specific benefit plan document must be consulted to determine whether an otherwise unproven service may be covered under those plan provisions.
Transcatheter mitral valve replacement (TMVR) for routine treatment of mitral valve disease is exclusionary for broad coverage in this policy. The policy notes insufficient high‑quality comparative evidence and limited long‑term efficacy data for TMVR outside of clinical trials or carefully selected cases; therefore TMVR is considered unproven and not medically necessary for general use.
Devices and techniques identified as early‑stage or supported only by small case series (for example Harpoon, early Cardioband reports, early Harmony feasibility studies) are described as requiring larger prospective studies with long‑term follow‑up before routine coverage can be recommended. These early‑stage mitral and pulmonary valve technologies remain unproven for routine clinical use due to limited evidence on durability and comparative effectiveness.
Procedures lacking sufficient quality evidence demonstrating long‑term safety and efficacy — including caval valve implantation (CAVI) and valve‑in‑valve (ViV) procedures for some non‑aortic valves — are described as unproven and not medically necessary. The policy highlights small sample sizes, short follow‑up, heterogeneous devices, and safety concerns (for example valve dislocation in some CAVI series) as reasons these interventions are not established.
The National Institute for Health and Care Excellence (NICE) guidance cited in the policy notes that there is currently no accepted transcatheter intervention for aortic regurgitation and raises durability concerns for transcatheter valves, with limited evidence beyond about 6–7 years. NICE also recommends that some procedures with limited evidence be used only with special arrangements for governance, consent, and audit or research.
The policy clarifies that contemporary transcatheter interventions are indicated primarily for symptomatic aortic stenosis and that, outside of device‑specific labeled indications, there is no accepted transcatheter intervention for conditions such as native aortic regurgitation. Coverage decisions should align with device labeling, guideline recommendations, and available evidence.
Devices listed under the policy's 'Additional Products' section (for example, Cardioband, Carillon, Harpoon, NeoChord, TricValve, TriGUARD 3, Intrepid, Tiara) are identified as may not have full FDA approval. Use of these products may fall outside standard approved device use and could prompt additional payer review, prior authorization requirements, or exclusion depending on the member's benefit plan and applicable coverage rules.
Transcatheter mitral annuloplasty and other transcatheter mitral valve repair approaches, except where specifically addressed as covered interventions (for example edge‑to‑edge repair when criteria are met), are considered unproven and not medically necessary because evidence of comparative clinical benefit and long‑term outcomes is insufficient.
Routine use of other early‑stage minimally invasive mitral repair devices (for example Harpoon, early iterations of Cardioband, NeoChord outside trial settings) is not considered medically necessary pending larger, randomized or well‑controlled prospective studies with longer follow‑up to establish durability and comparative benefit.
Procedures employing newer minimally invasive mitral devices and other early‑stage valve repair systems lack sufficient high‑quality long‑term evidence for routine coverage. The policy emphasizes the need for larger multicenter randomized trials and extended follow‑up before these technologies can be considered established therapy.
Routine use of cerebral embolic protection devices during TAVR is not established to improve clinically evident stroke or 30‑day mortality based on current randomized controlled trials and meta‑analyses. Large RCTs have not shown a statistically significant reduction in periprocedural stroke, and pooled analyses provide mixed results; therefore routine coverage of CEP devices is considered unproven.
Randomized trials and meta‑analyses have not consistently demonstrated significant reductions in clinically evident stroke or 30‑day mortality with cerebral embolic protection during TAVR. While some imaging‑based endpoints (smaller lesion volumes) and observational data suggest potential benefit, the evidence to date is inconclusive for routine clinical benefit in reducing stroke or death.
The policy states that procedures for which the evidence of efficacy is limited in quality should generally be used only within research settings or with special governance arrangements. Such procedures may be considered investigational or not medically necessary for routine coverage unless accompanied by documentation of clinical governance, informed consent acknowledging limited evidence, and participation in audit or approved research.
Procedure, Device, and Diagnostic Codes
Listed Transcatheter Valve/Therapy CPT Category III and related codes (partial)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.
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.
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).
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Aortic device PMA product codemixed
Product Code NPT
FDA PMA product code for transcatheter aortic valve prostheses
Mitral device PMA product codesmixed
Product Code NPU
FDA PMA product code for transcatheter mitral valve prostheses
Product Code NKM
FDA PMA product code for transcatheter mitral valve repair devices
Pulmonary device PMA product codemixed
Product Code NPV
FDA PMA product code for transcatheter pulmonary valve prostheses
Tricuspid device PMA product codesmixed
Product Code NPW
FDA PMA product code for transcatheter tricuspid valve prostheses
Product Code NPS
FDA PMA product code for transcatheter tricuspid valve repair devices
Severe aortic stenosis diagnostic thresholds
Mean aortic valve gradient≥ 40 mmHg
Peak aortic jet velocity≥ 4.0 m/s
Aortic valve area≤ 1.0 cm2
PROM surgical risk thresholds
PROM for replacement candidatesPredicted Risk of Mortality (PROM) ≥ 8%
PROM for likely repair candidates
Prior Authorization, Documentation, and Operational Requirements
Documentation Required
Consult member benefit for coverage
Consult the member-specific benefit plan document to determine coverage and any limitations or exceptions. This medical policy is for UnitedHealthcare standard plans and does not guarantee coverage — in the event of any conflict, the member-specific benefit plan governs. Check for applicable federal or state mandates before applying this policy.
Member-specific benefit documents may allow coverage of experimental/investigational services in limited circumstances — verify plan language.
When in doubt for Medicare Advantage members, reference applicable Medicare NCDs/LCDs; absent Medicare guidance MAOs may apply objective evidence-based rationale.
Prior Authorization
Prior authorization and plan applicability
Prior authorization is generally required for transcatheter valve procedures per UnitedHealthcare plan administration. Providers should initiate prior authorization before scheduling procedures and confirm plan applicability (Commercial, Individual Exchange, Medicare Advantage where applicable).
Background and Scope
Transcatheter valve procedures provide a percutaneous, minimally invasive alternative to open‑heart surgical valve repair or replacement. They deliver bioprosthetic valves or use leaflet approximation or annuloplasty devices via catheter access to treat stenosis or regurgitation, and are intended to reduce procedural morbidity associated with surgical approaches in appropriately selected patients.
Definitions and Acronyms
NYHA classification
NYHA class INo limitation of physical activity
NYHA class IISlight limitation of physical activity
NYHA class IIIMarked limitation of physical activity
NYHA class IVSymptoms at rest; unable to carry on any physical activity without discomfort
PROM (STS PROM)
DefinitionPredicted Risk of Mortality (PROM) is the Society of Thoracic Surgeons (STS) PROM score predicting 30-day mortality after cardiac procedures
Use in policy
Policy Changes and Revision History
01/01/2026Template UpdateLatest
Template update to the medical policy document (non-material).
Policy Summary
PayerUnitedHealthcare
PolicyTranscatheter Procedures for Heart Valve Conditions
Policy CodePolicy 2026T0557EE
Change TypeTemplate Update
Effective DateJan 1, 2026
Next Review Date
Key ActionObtain prior authorization with documentation of symptomatic status, surgical risk (PROM) and required clinical records to support medical necessity.
Aligns with COAPT enrollment and guideline-recommended selection.
Intermediate or greater surgical risk as determined by the local multidisciplinary heart team including cardiac surgery, interventional cardiology, echocardiography, and heart failure specialists.
Intermediate+ surgical risk
Observational registries report technical success but variable short‑term mortality and device‑related complications.
Percutaneous annuloplasty (Carillon): Consider when patient has functional MR despite optimized medical therapy and when device use aligns with trial indications; acknowledge limited evidence for mortality benefit.
REDUCE‑FMR met echocardiographic endpoints but was not powered for clinical endpoints; larger trials are needed.
Other early‑stage mitral devices: Devices such as Harpoon, NeoChord, and early Cardioband iterations should be used in research settings or with careful case selection given limited long‑term comparative data.
Evidence limited to small series and short follow‑up.
Transcatheter pulmonary valve interventions: Consider for patients with clinically significant pulmonary valve disease consistent with device‑specific trial indications; mid‑term results show favorable hemodynamics and durability through 1–2 years in selected cohorts.
Alterra and Harmony pivotal studies report favorable short‑ to mid‑term outcomes.
TMVR: Observational series and registry data report high technical success and acceptable short‑term outcomes in selected high‑risk patients, but lack randomized comparative data and longer‑term follow‑up.
Specific subgroups (ViV, ViR, ViMAC) have differing complication profiles.
Cerebral Embolic Protection: A large RCT (n=3,000) of the Sentinel device did not demonstrate a significant reduction in periprocedural stroke; meta‑analyses show mixed results and routine benefit remains unproven.
Evidence inconclusive for routine use; results device‑specific.
ViV aortic: For symptomatic patients with bioprosthetic aortic valve stenosis at high or prohibitive surgical risk, transcatheter ViV is reasonable when performed at a Comprehensive Valve Center.
Tricuspid: Transcatheter treatment of symptomatic secondary severe TR has a IIb guideline recommendation and may be considered in inoperable patients at specialized centers; evidence is less well established.
NICE recommends that procedures with limited‑quality evidence (eg, transapical TMViV, some ViV procedures, cerebral protection device use) be used only with special arrangements for clinical governance, consent, audit, or research.
Context of usePROM is the STS Predicted Risk of Mortality used to define prohibitive/high surgical risk in valve candidates
Pulmonary RVOT gradient threshold
Mean RVOT gradient≥ 35 mmHg
Indication contextApplied for pulmonary stenosis or RVOT obstruction when considering transcatheter pulmonary valve replacement
Other qualifying findingModerate or greater pulmonary regurgitation may also indicate candidacy (per device labeling)
Prior authorization expectations apply to listed transcatheter valve procedure codes and devices.
Failure to obtain prior authorization or provide required documentation may result in denial or delayed payment.
Prior Authorization
Clinical-entry prior authorization
Prior authorization requests must document that the patient meets the clinical-entry criteria appropriate to the valve and device being requested (for example, severity of valvular disease, symptomatic status, and eligibility measures described in policy sections for mitral, tricuspid, aortic, pulmonary indications).
Document objective measures of severity (e.g., MR/TR grade ≥3, aortic valve gradients/area, LVEF values) and symptomatic class (NYHA).
For mitral and tricuspid indications, show that care is directed by a multidisciplinary heart team including a heart failure specialist, interventional cardiologist and cardiothoracic surgeon as applicable.
Documentation Required
Prior authorization: documentation of candidacy and risk
Prior authorization must include documentation of the member's candidacy and procedural risk. Evidence of increased or prohibitive surgical risk, prior optimization of guideline-directed medical therapy, and functional status should be provided.
Surgical risk estimates (e.g., STS/PROM scores) and the rationale for deeming surgical repair/replacement prohibitive or high risk.
For secondary MR and tricuspid disease, document prior optimal GDMT and cardiac resynchronization therapy when indicated.
Document prior attempts and responses to medical therapy when device therapy is considered (T-TEER, TMVR, etc.).
Prior Authorization
Prior authorization for transcatheter valve procedures
Because evidence is evolving for many transcatheter valve procedures, prior authorization should include procedure-specific supporting documentation (diagnostic imaging, quantitative echocardiographic measures, prior procedures, and procedural access route). Provide trial data or rationale when requesting newer or less-established interventions.
Include echocardiographic measures (e.g., regurgitant volume, effective regurgitant orifice, valve gradients) and imaging that supports anatomic feasibility.
Transcatheter valve procedures should generally be performed at Comprehensive Valve Centers with multidisciplinary heart teams. Prior authorization may require documentation that the performing center meets guideline-recommended institutional and operator requirements.
Document the center's experience and program structure (Comprehensive Valve Center designation, multidisciplinary heart team composition).
Reference ACC/STS/SCAI/AATS recommendations for program requirements where requested.
Documentation Required
Confirm and document FDA PMA device status
Confirm and document the FDA Premarket Approval (PMA) status of the specific device to be used. Include device name, manufacturer, and PMA identifier or FDA database link in the prior-authorization submission.
Search the FDA PMA database (Product Code NPT for aortic devices, NPS for tricuspid devices) and include the PMA link or PMA ID.
Prior authorization likely required for non-FDA-approved devices
When devices or products noted in policy as possibly lacking full FDA approval are planned (e.g., Cardioband, Carillon, Harpoon, Intrepid, NeoChord, Tiara, TricValve, TriGUARD 3), prior authorization is likely required and may trigger intensified review or denial if the request lacks supporting evidence or plan coverage for investigational devices.
If requesting coverage for devices without full FDA approval, include clinical rationale, supporting literature, and any applicable investigational protocols or enrollment in approved registries.
Verify whether the member's plan permits coverage of investigational/experimental services under specific benefit terms.
Documentation Required
Documentation may be required for review
Medical records and supporting documentation may be required to assess whether the member meets clinical criteria. Lack of sufficient documentation may result in denial or a request for additional information.
Include relevant clinical notes, imaging reports, operative history, and prior authorization forms.
Retain and submit documentation of prior medical therapy optimization, risk scores, and heart-team discussions.
Documentation Required
Benefit plan limitations
Benefit plan limitations may restrict coverage of experimental, investigational, or unproven treatments. Providers must consult the member-specific benefit plan to determine whether such services are excluded or conditionally covered.
Some benefit documents may allow investigational therapies for life-threatening illnesses under narrow conditions — document applicability.
If the member-specific plan excludes experimental treatments, prior authorization is unlikely to be approved.
Denial Risk
Risk of denial for high-risk TMVR cases
High-risk transcatheter mitral valve replacement (TMVR) cases — including compassionate-use series or small registries that report high procedural mortality or major adverse events — carry an elevated risk of prior-authorization denial unless robust supporting documentation and justification are provided.
Provide detailed risk/benefit rationale for TMVR in high-risk patients, including alternative options and why conventional surgery is not feasible.
Cases with limited supporting evidence (small series, compassionate use) should include center experience and governance oversight.
Denial Risk
Contraindication risk
Contraindications and procedural exclusion criteria (e.g., risk of coronary artery compression for pulmonary valve procedures, anatomic contraindications) must be documented. Requests for procedures contraindicated by clinical or protocol criteria may be denied.
Document pre-procedure imaging and assessments demonstrating absence of contraindications (or rationale if attempting to proceed despite elevated risk).
If coronary compression or other contraindications are present, provide the mitigation plan or alternative treatment justification.
Denial Risk
Evidence insufficiency / safety concerns
Evidence insufficiency and safety concerns noted in the literature (short-term follow-up, small sample sizes, device dislocations, early safety signals) should be addressed in the prior-authorization submission. Interventions with limited or evolving evidence have higher denial risk unless appropriate governance, consent, and audit/research arrangements are documented.
For procedures with noted safety concerns (e.g., CAVI valve dislocations), include safety monitoring plans and justification for individual patient use.
Attach pertinent literature, registry data, and any institutional oversight approvals or IRB/research documentation if applicable.
Denial Risk
Evidence limitations may affect coverage
Evidence limitations (for example, lack of long-term valve durability data beyond 6–7 years, small or observational studies for some valve types) may affect coverage decisions. Submit available long-term data and justify clinical necessity when long-term outcomes are uncertain.
If device durability data are limited, include expected follow-up plan and reintervention contingency.
When randomized trial data exist, include trial identifiers and key outcome measures to support effectiveness claims.
Denial Risk
Governance/Research requirement may trigger denial risk
Procedures or uses that NICE or other authorities recommend only 'with special arrangements' (clinical governance, consent, audit or research) should include documentation of those arrangements; absence of governance or research documentation may trigger denial.
Provide evidence of institutional governance, consent processes, audit plans, and any research/registry enrollment.
If the procedure is being performed under an investigational protocol, include protocol ID and IRB approval.
Denial Risk
Use of devices noted as 'may not have full FDA approval'
When using devices identified as 'may not have full FDA approval' or devices for novel indications, provide full device disclosure, regulatory status, and supporting evidence. Use of such devices without plan allowance for investigational items increases likelihood of denial.
List the device and its regulatory status; if investigational, include the manufacturer documentation and any FDA communications.
If device use is part of a trial, include enrollment/consent information and sponsor documentation.
Documentation Required
Member-specific plan governs
The member-specific benefit plan governs final coverage decisions. This medical policy provides standard-plan interpretation and operational guidance but does not override the member-specific benefit contract.
In case of discrepancies between this policy and the member's plan, follow the member-specific benefit document.
Confirm any plan-level step therapy or coverage exclusions prior to authorization.
Documentation Required
Patient selection and procedural documentation
Include patient selection and procedural documentation that supports clinical appropriateness: objective imaging, hemodynamic measurements, access route, device sizing, anticipated complications, and plans to prevent/manage known device-specific risks (e.g., stent fracture in TPV, LVOT obstruction in TMVR).
Provide procedural plan (device model, size, access route) and intra-procedural contingencies.
Document measures to mitigate known device risks (e.g., strategies to prevent stent fracture or LVOT obstruction).
Documentation Required
Clinical outcomes and functional measures
Prior authorization submissions should include anticipated clinical outcomes and functional measures used to evaluate effectiveness and safety (e.g., NYHA class, KCCQ scores, six-minute walk distance, hospitalization rates). When trial data informed the indication, include key trial endpoints and follow-up intervals.
Provide baseline and expected post-procedure functional measures and planned follow-up intervals.
When neurologic or embolic risk is relevant (for example, TAVR), include imaging and neurologic outcome documentation when available. Studies have used baseline and post-procedure brain MRI to document new ischemic lesions; include such assessments or rationale if performed.
Include cerebral protection device use rationale and supporting imaging if employed.
Document any peri-procedural strokes, transient ischemic attacks, or new neurologic findings with corresponding imaging reports.
Documentation Required
Document clinical governance and consent
For procedures recommended by NICE or other authorities 'only with special arrangements', document institutional clinical governance, informed consent processes, and audit or research oversight in the authorization submission.
Attach evidence of institutional governance review, informed consent forms addressing known uncertainties, and audit/research enrollment details where applicable.
Note
Cites CMS National Coverage Determination (NCD) for TAVR
When applicable, cite and reference the CMS National Coverage Determination (NCD) for TAVR (20.32) and any other applicable Medicare guidance in the prior-authorization submission for Medicare Advantage members. Compliance with NCD/LCD requirements should be shown.
Include NCD/LCD identifiers and show how the case meets stated Medicare requirements.
If MAO-level coverage differs from Medicare NCDs, provide justification based on evidence and plan terms.
Documentation Required
Surgical vs transcatheter approach
Describe why a transcatheter approach is being selected over conventional surgical repair or replacement when both are feasible. Document shared decision-making discussions addressing anticoagulation management, reintervention risk, and patient preferences.
Include documentation of shared decision-making and consideration of SAVR vs TAVR/TMV procedures.
Record patient values and preferences, and the heart team's assessment of anatomical and procedural factors influencing the approach.
Step Therapy
Step: optimize medical therapy first
Document attempts to optimize guideline-directed medical therapy (GDMT) prior to device interventions where applicable (e.g., mitral and tricuspid indications). For T-TEER and other repair strategies, show that medical therapy alone was inadequate or that the patient remained symptomatic despite optimization.
For secondary MR and TR, provide evidence of stable and adequate GDMT (duration, agents, response).
When step therapy is relevant, include timeline and reasons why medical therapy failed or was insufficient.
Step Therapy
Step therapy considerations for T-TEER
For transcatheter edge-to-edge tricuspid repair (T-TEER), prior authorization should document prior optimal medical therapy and specific indications per the trial and device labeling. Demonstrate that noninvasive therapy was attempted and that the heart team supports device therapy.
Provide duration and components of GDMT (>=30 days where specified) and heart-team concurrence.
Include objective TR severity measures and symptomatic status (NYHA) supporting the request.
Step Therapy
Optimize medical therapy before device intervention
When device intervention is considered, document that medical therapy was optimized and that device therapy is likely to provide incremental clinical benefit. Trials often used medical therapy alone as the comparator; show why device therapy is appropriate for the individual.
Attach evidence of maximal tolerated medical therapy and any prior interventions.
If crossover from medical therapy to device occurred in trials, include relevant outcome data to support expected benefit.
Used to define prohibitive/high surgical risk thresholds for valve candidates (eg, PROM ≥ 8%)
ApplicationInforms selection between surgical and transcatheter approaches for high-risk patients
Shared Decision-Making (SDM)
DefinitionShared Decision-Making is a process by which physicians and individuals work together to choose the treatment option that best reflects clinical evidence and the individual’s values and preferences
Policy expectationSDM should occur between interventional cardiologist and cardiothoracic surgeon for TAVR candidates
DocumentationEngagement in an SDM conversation is required in procedural criteria (per policy)
Transcatheter valve procedure
DefinitionCatheter-based approach to manage heart valve disorders without open-heart surgery and cardiopulmonary bypass
Typical devicesIncludes compressed bioprosthetic valves or repair devices delivered via catheter and expanded in situ
Access routesMay use transfemoral, transapical, subaxillary, or transaortic approaches depending on anatomy
Transcatheter leaflet repair (edge-to-edge)
DescriptionPercutaneous clip-based leaflet approximation to reduce regurgitation, requiring transseptal puncture and femoral venous access
MechanismCreates a double orifice by approximating mitral leaflets using a clip delivered via a steerable guide catheter
IndicationsUsed to reduce mitral regurgitation severity in anatomically suitable patients
Transcatheter edge-to-edge repair (TEER)
DefinitionPercutaneous mitral leaflet approximation devices (eg, MitraClip, PASCAL) used to reduce mitral regurgitation; supported by randomized trials in selected patients
Evidence noteCOAPT trial showed reduced heart-failure hospitalizations and mortality versus medical therapy in selected secondary MR patients
Care requirementsProcedure should be directed by a multidisciplinary heart team experienced in mitral disease
Transcatheter mitral valve replacement (TMVR)
DefinitionReplacement of the mitral valve using catheter-delivered prostheses; evidence is primarily from observational registries with variable outcomes
Evidence limitationsExisting studies are noncomparative with short follow-up and report substantial adverse events in some series
Policy stanceTMVR is considered investigational/not medically necessary for routine use outside select settings
Percutaneous annuloplasty (Carillon)
DescriptionCoronary sinus–based device intended to reduce mitral annular dimensions and mitral regurgitation severity (eg, Carillon)
EvidenceRandomized and observational trials show MR reduction and functional improvement but limited high-quality evidence for long-term clinical endpoints
RoleMay be considered in select functional MR patients but larger RCTs are needed to define clinical benefit
TTVR (Transcatheter Tricuspid Valve Replacement)
DefinitionTranscatheter placement of a prosthetic valve in the tricuspid position (eg, EVOQUE) for patients with significant TR who are high risk or inoperable
EvidenceTRISCEND II showed symptomatic and quality-of-life improvements but early safety signals (eg, severe bleeding) warrant longer follow-up
StatusEvidence is evolving; use generally considered in specialized centers and selected patients
DefinitionEdge-to-edge leaflet repair for tricuspid regurgitation using devices such as TriClip, delivered percutaneously
EvidenceRandomized TRILUMINATE and single-arm studies demonstrate reduction in TR severity and improvements in quality-of-life and NYHA class
Clinical useConsider for symptomatic severe TR in anatomically suitable, high-risk patients after heart-team evaluation
T-TEER
RCT evidenceTRILUMINATE pivotal trial randomized participants and showed reduced TR severity and improved KCCQ scores but no mortality benefit at 1 year
SafetyLow major adverse events within 30 days reported in trial (eg, 3 events in T-TEER arm)
RecommendationProcedure best performed at experienced centers with heart-team oversight
CAVI
DefinitionCaval valve implantation places valves in the vena cavae to treat symptoms of severe TR by reducing venous congestion
Evidence concernsStudies are small with short follow-up and some safety signals (eg, valve dislocations) leading to trial stoppage in at least one study
DefinitionValve-in-valve (ViV) is transcatheter implantation of a prosthetic valve within a failing surgical bioprosthetic valve (aortic, mitral, pulmonary, tricuspid)
IndicationsReasonable for aortic ViV in high or prohibitive surgical risk patients when performed at a Comprehensive Valve Center
EvidenceObservational registries show favorable short-term outcomes but long-term comparative evidence is limited
Cerebral embolic protection (CEP)
DefinitionDevices (eg, Sentinel) deployed during TAVR intended to capture embolic debris to reduce periprocedural cerebral ischemia
Evidence summaryLarge RCT (n=3,000) did not show statistically significant reduction in clinical stroke; meta-analyses and smaller trials show mixed results
Policy stanceRoutine use is unproven based on current randomized evidence
Cerebral embolic protection device
DefinitionA catheter-delivered filter or deflection device deployed during TAVR to capture or deflect embolic debris and potentially reduce ischemic brain lesions
Delivery successDevice deployment success rates reported around 94% in pooled studies
Clinical effectMay reduce silent ischemic lesion volume but RCTs have not demonstrated consistent reduction in clinical stroke outcomes
DefinitionTranscatheter Aortic Valve Implantation/Replacement (TAVI/TAVR) is a catheter-based procedure to replace the aortic valve without open-heart surgery
IndicationsProven and medically necessary for symptomatic severe calcific native AS when criteria (eg, gradients/AVA, NYHA symptoms, heart-team assessment) are met
Program requirementsShould be performed at centers meeting CMS/ST S/ACC volume and program criteria