ModifiedUnitedHealthcarePolicy CS123LA.R

Transcatheter Procedures for Heart Valve Conditions (for Louisiana Only)

Medical policy governing coverage and medical necessity criteria for transcatheter heart valve procedures (aortic, mitral, pulmonary, tricuspid) for members in Louisiana. Applies to providers and facilities performing or requesting authorization for these procedures.

Policy Summary

PayerUnitedHealthcare

PolicyTranscatheter Procedures for Heart Valve Conditions (for Louisiana Only)

Policy CodePolicy CS123LA.R

Change TypeMaterial clinical coverage additions and documentation clarifications

Effective Date01/01/2026

Next Review DateN/A

Key ActionObtain prior authorization and provide medical records documenting that the member meets device-specific clinical criteria and GDMT where required.

SourceLink

POLICY UPDATE CHANGES

Transcatheter edge-to-edge repair of the tricuspid heart valve is proven and medically necessary when used according to FDA labeled indications, contraindications, warnings, and precautions and the individual meets specified clinical criteria.

Replaced language indicating 'transcatheter tricuspid heart valve repair, reconstruction, or replacement is unproven and not medically necessary' with 'transcatheter tricuspid heart valve reconstruction or replacement is unproven and not medically necessary'.

The patient's medical record must contain documentation that fully supports the medical necessity for the requested services, including relevant history, exam, and diagnostic results.

01/01/2026effective / last review date

1material clinical change added

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.

3key documentation items

II–IVNYHA symptom classes referenced

≥8%PROM high-risk threshold

Coverage Criteria for Transcatheter Valve Procedures

Evidence summaries (informational)

Grouping of evidence summaries informing coverage positions for transcatheter valve procedures (informational). Consolidated summaries are provided by valve type and procedure.

Aortic Valve — TAVR and ViV: Multiple randomized controlled trials and large registries demonstrate that transcatheter aortic valve replacement (TAVR) provides effective symptomatic relief and survival outcomes comparable to or better than surgical aortic valve replacement (SAVR) in selected patient populations across surgical risk strata up to mid-term follow-up. Meta-analyses (e.g., Siontis et al., 2019) showed lower all-cause mortality and stroke up to two years for TAVR versus SAVR in pooled analyses, though TAVR has higher rates of pacemaker implantation and vascular complications. ViV procedures for failed aortic bioprostheses have observational evidence supporting safety and short- to mid-term effectiveness in high- or prohibitive-risk patients; comparative observational studies suggest lower perioperative morbidity versus redo SAVR but randomized data are lacking and hemodynamic outcomes (post-procedure gradients, patient–prosthesis mismatch) can be inferior in some subgroups.

Mitral Valve — TEER, TMVR, and Annuloplasty: Transcatheter edge-to-edge repair (TEER) for mitral regurgitation (e.g., MitraClip) is supported by high-quality randomized evidence in selected populations: the COAPT trial demonstrated reductions in heart failure hospitalization and all-cause mortality versus guideline-directed medical therapy in patients with symptomatic, severe secondary MR despite optimized therapy. TEER is therefore evidence-supported in guideline-concordant indications. In contrast, transcatheter mitral valve replacement (TMVR) and many percutaneous annuloplasty approaches (e.g., Carillon) have substantially more limited evidence: available studies are mainly single-arm registries or small comparative observational analyses with short follow-up, heterogeneous patient selection, and substantial attrition. Systematic reviews and technology assessments conclude that TMVR and percutaneous annuloplasty show promising hemodynamic and symptomatic improvements in select patients but lack robust randomized comparative data and long-term durability evidence; thus their effectiveness remains uncertain for broad adoption.

Pulmonary Valve — TPVR and Related Devices: Single-arm pivotal trials and large registry analyses support transcatheter pulmonary valve replacement (TPVR) for appropriately selected patients with right ventricular outflow tract dysfunction, with high procedural success and favorable short- and mid-term hemodynamic and functional outcomes. Device-specific prospective studies (e.g., SAPIEN/Alterra, Harmony, Melody) show acceptable safety and improved functional class, but long-term durability and comparative effectiveness versus surgery continue to be monitored. Systematic reviews and registry data generally find TPVR comparable to surgical conduit/valve replacement for many outcomes, while noting potential increases in infective endocarditis risk in some series and the need for longer follow-up.

Tricuspid Valve — T-TEER, TTVR, CAVI, and ViV: Evidence for transcatheter edge-to-edge tricuspid repair (T-TEER) has evolved from randomized and randomized-augmented pivotal trials (e.g., TRILUMINATE) and prospective registries showing improvements in TR severity, quality of life measures, and reductions in heart-failure hospitalization in selected symptomatic patients. Transcatheter tricuspid valve replacement (TTVR) devices (e.g., EVOQUE) have emerging RCT and registry data showing symptomatic and functional benefit but signal concerning early adverse events (bleeding, early mortality) in some datasets; longer-term and comparative evidence is limited. Caval valve implantation (CAVI) and ViV for non-aortic valves have small, heterogeneous studies with short follow-up; while procedural success and symptomatic improvement are reported, evidence is insufficient to establish long-term safety and efficacy for routine use.

Cerebral Embolic Protection (CEP): Randomized trials and meta-analyses evaluating CEP devices (notably the Sentinel system) report reductions in surrogate MRI lesion volume and inconsistent impacts on clinical stroke endpoints. A large pragmatic RCT (Kapadia et al., 2022) did not show a statistically significant reduction in periprocedural stroke; pooled analyses including observational data suggest potential benefit but are limited by bias. Technology assessments conclude that CEP placement is generally safe but the evidence remains inconclusive regarding clinically meaningful stroke reduction, and routine use is not uniformly supported.

Evidence Limitations and Generalizability: Across transcatheter valve therapies, key limitations in the evidence base include: reliance on single-arm or observational studies for many newer devices and indications, short duration of follow-up for durability assessment, heterogeneity of patient selection and procedural techniques, and limited randomized head-to-head comparisons for newer valve systems or procedures. Many favorable outcomes derive from specialized, high-volume centers and experienced operators, potentially limiting generalizability to broader practice settings. Systematic reviews and independent technology assessments (ECRI, Hayes) frequently note these evidence gaps and call for larger randomized trials and longer follow-up.

Coding and FDA Device Listings

Listed Proprietary/Category III and other CPT®-like codesCPT

0345T	Transcatheter mitral valve repair percutaneous approach via the coronary sinus.
0483T	Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; percutaneous approach, including transseptal puncture, when performed.
0484T	Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; transthoracic exposure (e.g., thoracotomy, transapical).
0543T	Transapical mitral valve repair, including transthoracic echocardiography, when performed, with placement of artificial chordae tendineae.
0544T	Transcatheter mitral valve annulus reconstruction, with implantation of adjustable annulus reconstruction device, percutaneous approach including transseptal puncture.
0545T	Transcatheter tricuspid valve annulus reconstruction with implantation of adjustable annulus reconstruction device, percutaneous approach.
0569T	Transcatheter tricuspid valve repair, percutaneous approach; initial prosthesis.
0570T	Transcatheter tricuspid valve repair, percutaneous approach; each additional prosthesis during same session (List separately in addition to code for primary procedure).
0646T	Transcatheter tricuspid valve implantation (TTVI)/replacement with prosthetic valve, percutaneous approach, including right heart catheterization, temporary pacemaker insertion, and selective right ventricular or right atrial angiography, when performed.
0805T	Transcatheter superior and inferior vena cava prosthetic valve implantation (i.e., caval valve implantation [CAVI]); percutaneous femoral vein approach.

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Covered/Referenced CPT CodesCPT

33361	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach.
33362	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach.
33363	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach.
33364	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach.
33365	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (e.g., median sternotomy, mediastinotomy).
33366	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (e.g., left thoracotomy).
33367	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation (List separately).
33368	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with open peripheral arterial and venous cannulation (List separately).
33369	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with central arterial and venous cannulation (List separately).
33370	Transcatheter placement and subsequent removal of cerebral embolic protection device(s), including arterial access, catheterization, imaging, and radiological supervision and interpretation, percutaneous (List separately).

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Codes referenced: none listed in this document segmentmixed

No codes listed

Referenced FDA PMA/Product Codes and entriesmixed

P130021	PMA entry listing Evolut FX/PRO/R
P190023	PMA entry listing Navitor
P140031	PMA entry listing SAPIEN 3 series
P100009	PMA entry listing MitraClip
P220003	PMA entry listing PASCAL
P200046	PMA entry listing Harmony
P140017	PMA entry listing Melody
P200015	PMA entry listing SAPIEN 3 (pulmonary) and SAPIEN 3 with Alterra
P230013	PMA entry listing EVOQUE
P230007	PMA entry listing TriClip

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Products possibly without full FDA approvalmixedExperimental

unapproved_products_list

Cardioband; Carillon Mitral Contour System; Harpoon; Intrepid; NeoChord; Tiara; TricValve; TriGUARD 3

Aortic stenosis hemodynamic criteria — thresholds

Mean aortic valve gradient≥ 40 mmHg

Peak aortic jet velocity≥ 4.0 m/s

Aortic valve area≤ 1.0 cm2

Pulmonary stenosis threshold

Mean RVOT gradient (pulmonary stenosis)≥ 35 mmHg

Indication contextApplies for pulmonary stenosis or RVOT dysfunction when considered for TPVR per FDA-labeled indications

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior authorization required for transcatheter valve procedures

Prior authorization is recommended for transcatheter valve procedures to ensure clinical criteria, facility/heart team requirements, and device-specific considerations are documented prior to approval. Requests should include evidence of indication, prior therapies attempted, surgical risk assessment, multidisciplinary heart team concurrence, and that the procedure will be performed at a center meeting Comprehensive Valve Center / heart team standards.

Include heart team documentation and center volume/experience consistent with CMS/STS/ACC recommendations
Document that FDA-labeled indications, contraindications, warnings, and precautions are met
Provide surgical risk scores (e.g., STS PROM, PROM) and shared decision-making notes

Prior Authorization

TMVR prior authorization recommendation — document alternatives and evidence limits

For transcatheter mitral valve replacement (TMVR), prior authorization is recommended with detailed documentation because high-quality comparative and long-term evidence is limited. Requests should explain why guideline-supported alternatives (including TEER/repair and optimal GDMT) are unsuitable, summarize available comparative data, and acknowledge evidence uncertainty.

Background and Rationale

Transcatheter valve procedures offer minimally invasive alternatives to surgical repair or replacement across aortic, mitral, pulmonary, and tricuspid valve disease. Coverage and medical necessity are determined by specific hemodynamic thresholds, symptom status, surgical risk assessment, and multidisciplinary heart‑team recommendations; device‑specific FDA labeling and the quality of clinical evidence also inform coverage decisions.

Key Definitions and Clinical Terms

NYHA Classification definition

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

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

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

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

PROM (STS Predicted Risk of Mortality) definition

PROM (STS Predicted Risk of Mortality)Predictor of 30-day mortality after cardiac procedures used to estimate surgical risk

Policy Revision History and Summary of Changes

2026-01-01material_changeLatest

Added coverage rationale making transcatheter edge-to-edge repair of the tricuspid valve proven and medically necessary when used per FDA labeled indications and the patient meets specified clinical criteria (symptomatic severe TR; ≥30 days GDMT; NYHA II+; PASP <70 mmHg; intermediate or greater surgical risk determined by local heart team).

2026-01-01operational_note

Added language that medical records documentation may be required to assess whether the member meets clinical criteria and that providing documentation does not guarantee coverage; specified required documentation elements and that records must be legible and available upon request.

Policy Summary

PayerUnitedHealthcare

PolicyTranscatheter Procedures for Heart Valve Conditions (for Louisiana Only)

Policy CodePolicy CS123LA.R

Change TypeMaterial clinical coverage additions and documentation clarifications

Effective Date01/01/2026

Next Review DateN/A

Key ActionObtain prior authorization and provide medical records documenting that the member meets device-specific clinical criteria and GDMT where required.

SourceLink

On This Page

Associated conditionMay be accompanied by moderate or greater pulmonary regurgitation as an indication

Mitral regurgitation severity threshold

Mitral regurgitation gradeModerate-to-severe or severe MR (grade ≥ 3)

Primary MR symptom requirementSymptomatic NYHA class III or IV for primary (degenerative) MR per criteria

Secondary MR contextApplies to secondary (functional) MR when criteria include LVEF and GDMT as noted in policy

Primary effectiveness endpoint (COAPT)

Primary effectiveness endpoint (COAPT)All hospitalizations for heart failure within 24 months

Trial populationPatients with heart failure and moderate-to-severe or severe secondary MR despite maximal GDMT

Primary safety endpoint (COAPT)Freedom from device-related complications at 12 months

Pulmonary valve primary endpoint (Alterra SAPIEN 3)

Primary endpoint (Alterra SAPIEN 3)Composite valve dysfunction at 6 months: RVOT/pulmonary valve reintervention, ≥ moderate pulmonary regurgitation, or mean RVOT/pulmonary valve gradient ≥ 35 mmHg

Trial follow-upOutcomes reported through 2 years with majority mild or less PR at 2 years in cohort

Device contextEvaluated in patients with moderate or greater pulmonary regurgitation per FDA-labeled indications

Stable guideline-directed medical therapy duration

Stable guideline-directed medical therapy duration≥ 30 days

Applicable indicationsRequired prior to consideration for transcatheter edge-to-edge tricuspid repair and for functional MR interventions per policy guidance

DocumentationMedical records should document duration and stability of GDMT when submitted for review

Pulmonary artery systolic pressure threshold

Pulmonary artery systolic pressure (PASP) threshold< 70 mmHg

ContextRequired for transcatheter edge-to-edge tricuspid repair eligibility (policy criterion)

AssessmentPASP should be documented by appropriate testing in the medical record for authorization/review

Document failure, contraindication, or unsuitability of guideline-directed medical therapy and cardiac resynchronization therapy when indicated
Document why repair or TEER are not appropriate (anatomic, prior procedures, risk profile)
Include discussion of evidence limitations and rationale for selecting TMVR

Note

Evidence-informed prior authorization summary

Evidence-informed prior authorization summary: authorize when clinical criteria are met and robust evidence supports benefit (e.g., TAVR, transcatheter TEER for labeled indications, tricuspid TEER per FDA labeling). For technologies with limited, short-term, or observational evidence (TMVR, percutaneous annuloplasty/Carillon, CAVI, some TTVR systems, and many ViV data sources), require detailed justification and note that long-term safety/efficacy is uncertain. FDA approval alone does not guarantee coverage.

Differentiate devices with RCT-supported benefit (e.g., MitraClip/TEER, selected TAVR indications) versus those with limited evidence
Require documentation of prior therapies attempted and symptom status for observational-device requests
Inform providers that insufficient long-term evidence may lead to denial or requests for additional information

Documentation Required

Verify device FDA status before authorization

Before authorization, providers should verify and cite the FDA approval status of the specific device requested (include PMA, 510(k), or De Novo references and product code where applicable). Authorization may be contingent on device regulatory status and labeled indications.

Search FDA PMA/510(k)/De Novo databases and include Product Code (e.g., NPT, NPU, NPV, NPW, PUM) and PMA/clearance identifiers
Note that FDA approval alone is informational and not sufficient for coverage determination

Note

Prior authorization reference — CMS NCD and professional guidance

Prior authorization reference: CMS National Coverage Determination (NCD) for TAVR (20.32) and professional society guidance (ACC/STS/SCAI/AATS) should be considered when reviewing TAVR and other transcatheter valve requests. Providers should reference applicable CMS/registry volume requirements when submitting requests.

Cite CMS NCD 20.32 for TAVR when applicable
Provide registry participation or volume evidence (e.g., TVT Registry) if requested

Note

Policy updates — no new prior authorization codes in this section

Policy updates: administrative updates were made to Description of Services, Clinical Evidence, FDA, and References; no new prior authorization codes were added in the revisions referenced in this section. Previous policy version CS123LA.Q is archived.

01/01/2026: content and documentation clarifications; no new PA codes added
Archived prior version: CS123LA.Q

Note

Prior authorization not addressed in this section

Some subsections of the policy do not address prior authorization explicitly. In those areas, absence of an authorization statement does not imply automatic coverage; medical records and clinical criteria still apply. Providers should assume prior authorization may be required per payer procedures even if not enumerated in the excerpt.

Review payer-specific prior authorization lists and provider portals for required PA codes
Lack of explicit PA language in a subsection is not a replacement for standard PA workflows

Note

Prior authorization not specified in this section

Certain policy excerpts do not specify prior authorization requirements. Providers must follow contractual and payer operational rules; when in doubt, submit a prior authorization request with supporting documentation to avoid retrospective denials.

No explicit PA requirements in some revision-history excerpts — check payer portal for operational PA codes
When authorization is unknown, submit PA with full documentation to reduce denial risk

Denial Risk

Documentation insufficiency may trigger denial

Insufficient documentation may trigger a denial. The patient's medical record must fully support medical necessity including history, physical exam, diagnostic test results, device/access planning, and heart team rationale. Documentation must be legible, maintained in the record, and available upon request.

Medical records may be requested for review and do not guarantee coverage
Lack of required elements (e.g., GDMT attempts, surgical risk, imaging, heart team decision) increases denial risk

Denial Risk

TMVR evidence limitations — may affect authorization

TMVR evidence limitations: the clinical literature lacks high-quality long-term comparative studies; most data are observational with short follow-up and high attrition. Authorization reviewers should expect requests for additional justification and may deny if clinical alternatives were not attempted or adequately documented.

Hayes and systematic reviews conclude insufficient evidence to draw firm conclusions on TMVR effectiveness
Comparative registry analyses suggest no mortality benefit vs standard care and possible higher early mortality vs TEER

Denial Risk

Safety-related concern — document device generation and mitigation

Safety-related concern: procedures with safety signals (e.g., high device dislocation rates in CAVI TRICAVAL trial) should be carefully justified; studies stopped early for safety may lead to denial unless clear mitigating rationale and newer device/safety data are provided.

TRICAVAL stopped due to unexpectedly high valve dislocation rate — document device generation and mitigation strategies
Report procedural complications and follow-up outcomes when requesting CAVI or similar devices

Denial Risk

CAVI evidence limitation — limited long-term safety/efficacy data

Caval Valve Implantation (CAVI) evidence limitation: evidence is limited by small, short-term studies and mixed device systems; reviewers may deny requests lacking robust justification or newer prospective data demonstrating safety and durability.

Meta-analyses report short median follow-up (61–350 days) and multiple device types pooled
TRICAVAL RCT showed no superior functional outcome and high dislocation rate prompting early stoppage

Denial Risk

Cerebral protection RCT outcome — large RCT did not show reduced stroke

Cerebral protection RCT outcome: a large randomized trial (Sentinel CEP) did not demonstrate a reduction in periprocedural stroke; routine use of CEP devices for TAVR without clear indication may not be supported for coverage based on current RCT evidence.

Kapadia et al. (2022) RCT: no significant difference in stroke within 72 hours (2.3% vs 2.9%; p=0.30)
Smaller trials using DW-MRI surrogate endpoints also did not show consistent clinical benefit

Note

Imaging surrogate endpoint limitations — do not substitute for clinical outcomes

Imaging surrogate endpoint limitations: claims relying solely on surrogate imaging outcomes (e.g., DW‑MRI lesion volume reductions) are insufficient for demonstrating clinical benefit. Authorization decisions should prioritize patient‑centered clinical outcomes (stroke, mortality, functional status) and robust RCT evidence.

DW‑MRI lesion volume reductions were not consistently linked to clinical stroke reduction in RCTs
Larger studies with clinical endpoints are preferred for coverage decisions

Note

No authorization requirements are specified in some excerpts

No authorization requirements are specified in some excerpts — when policy text omits explicit PA rules, operational payer systems or contractual agreements determine PA needs. Providers should check the payer's PA lists and submit documentation accordingly.

Absence of explicit PA language in a revision-history excerpt does not remove payer PA procedures
Confirm PA requirements via payer portal or provider relations

Denial Risk

Documentation requirement may trigger denial

Documentation requirement may trigger denial: failure to provide requested medical records or incomplete records during review may result in denial. Provide complete records promptly when requested during PA review.

Medical records must be legible, maintained, and made available upon request
Incomplete or missing documentation commonly leads to denials or requests for additional information

Denial Risk

Medical records documentation risk — include heart team and therapy history

Medical records documentation risk: reviewers will assess history, exam, diagnostics, imaging, device/access planning, and heart team notes. Missing elements (e.g., lack of documented GDMT for functional MR/TR, absent surgical risk assessment) increase the likelihood of denial.

For TEER (MitraClip/PASCAL): document persistent symptoms despite optimized GDMT
For TMVR: include indication, prior therapies, surgical risk, informed consent noting evidence uncertainty

Denial Risk

Documentation-related denial risk — procedural and consent details required

Documentation-related denial risk: absence of required documentation (history, exam, diagnostics) or failure to justify device selection and procedural necessity may result in denial. Always include device model, approach, valve size, procedural plan, and informed consent elements when applicable.

Record procedural details: valve type, approach, valve size, anticipated access site and backup plans
Provide informed consent documentation that discusses risks, benefits, and alternative therapies

Note

No explicit authorization or denial triggers in some excerpts

No explicit authorization or denial triggers are listed in some policy excerpts; reviewers should apply the clinical criteria and evidence summaries in the policy plus payer operational rules. Lack of explicit triggers does not preclude denials for missing medical necessity documentation.

Apply clinical criteria and evidence assessments even when the excerpt lacks explicit PA/denial language
Anticipate requests for records to substantiate medical necessity

Documentation Required

Medical records required for review

Medical records required for review: benefit coverage is determined by applicable laws and contractual requirements. Medical records may be requested and must fully support medical necessity including history, exam, diagnostic test results, and evidence of prior therapies; providing these reduces the risk of denial.

Ensure records document GDMT duration (e.g., ≥30 days for tricuspid TEER), imaging results, and heart team assessment
Maintain legible records and make them available upon request

Documentation Required

Documentation for TEER (MitraClip) — GDMT and symptomatic status required

Documentation for TEER (MitraClip/PASCAL): include evidence the patient remained symptomatic despite maximal GDMT, NYHA class, MR grade (≥3+), heart team recommendation, surgical risk assessment, and prior optimization steps taken.

COAPT-like criteria and documentation improve authorization likelihood: symptomatic despite GDMT, MR grade, and heart team management
Provide GDMT regimen, duration, and any CRT use when indicated

Documentation Required

Documentation for TMVR — indication, prior therapies, risk, and evidence uncertainty

Documentation for TMVR: include indication (primary/secondary MR or bioprosthetic failure), documentation that less invasive/guideline-recommended options were considered or tried, surgical risk scores, imaging supporting anatomy, device sizing/approach, and an explicit discussion of limited long-term evidence.

Include TMViV/TMViR/TMViMAC specifics when applicable (prior valve type, ring, calcification details)
Provide procedural planning details (valve type, approach, size) and follow-up plan

Documentation Required

TRICAVAL trial endpoints and follow-up — include functional and safety data

TRICAVAL trial endpoints and follow-up: when requesting CAVI, include trial-relevant endpoints and follow-up measures (6-minute walk, NYHA class, NT-proBNP, right heart function) if available. Note the TRICAVAL trial was stopped early for safety (valve dislocations) and did not show superior functional outcomes vs medical therapy.

Provide functional testing and biomarker data when available to support clinical benefit claims
Document device generation and any improvements addressing TRICAVAL safety concerns

Documentation Required

Imaging and neurocognitive documentation — include clinical correlation

Imaging and neurocognitive documentation: for cerebral protection and procedures with neurologic risk, include baseline and follow-up neurocognitive testing and brain MRI results when relevant. Imaging-only surrogate improvements (e.g., DW‑MRI lesion volume) are insufficient for coverage without correlated clinical benefit.

Report baseline and follow-up DW‑MRI and neurocognitive assessments where performed
Provide clinical stroke or cognitive outcome data to support device use

Documentation Required

NICE governance and consent expectations — document governance and informed consent

NICE governance and consent expectations: procedures with limited evidence (e.g., some ViV, TMVR, CAVI, cerebral protection) should follow special arrangements for clinical governance, informed consent, audit, or research as recommended by NICE. Document governance, consent discussions, and audit arrangements when relevant.

Include evidence of clinical governance arrangements and informed consent that notes uncertainty of long-term outcomes
Reference NICE IPG recommendations when applicable to support governance arrangements

Note

References include guideline and technology assessments — cite supporting evidence

References inform documentation expectations but are not explicit authorization rules. Reviewers may require citation of relevant guidelines, RCTs, registries, and FDA databases as part of the PA review.

Cite pertinent RCTs (e.g., COAPT, TRILUMINATE, SENTINEL) and major registry data when submitting PA
Provide references to supporting evidence included in the request

Documentation Required

Required supporting documentation — history, exam, diagnostics, and heart team notes

Required supporting documentation: include relevant medical history, physical exam, diagnostic test results, imaging, surgical risk assessment, heart team notes, device details, prior therapy attempts, and informed consent. Failure to supply these may lead to denial.

Essential elements: history, exam, imaging (echo/CT), risk scores, GDMT documentation, heart team decision, procedural plan
Make documentation legible, maintained in the medical record, and available upon request

Note

Documentation updates referenced in Summary and Revision History

Documentation updates referenced in the summary and revision history clarify medical records expectations and added definitions (e.g., Symptomatic Severe Tricuspid Regurgitation). These administrative changes do not by themselves create new PA codes but emphasize documentation rigor.

Policy updates emphasize medical records requirements and defined terminology
Providers should align documentation to updated definitions and requirements

Note

Section consists of repeated 'Summary of Changes' — confirm latest effective policy

Notes indicate the source section contains repeated summary elements and administrative revisions; providers should rely on the most current effective policy date and payer portal for operational PA rules.

Section contains repeated 'Summary of Changes' entries — use latest effective date (2026-01-01) for determinations
Operational PA code lists are maintained separately in payer systems

Step Therapy

Step therapy and medical therapy requirements — document GDMT and CRT when indicated

TMVR step therapy consideration and step therapy before TEER: while the policy emphasizes attempting guideline-supported medical therapy (GDMT and CRT when indicated) prior to considering TMVR or tricuspid/mitral TEER, no formal payer step therapy rules are specified in these excerpts. Document attempted therapies and reasons for intolerance or failure.

Document duration and components of GDMT and any CRT trial (e.g., stable ≥30 days for tricuspid TEER)
If no formal step therapy rule is present, provide clear justification for proceeding to device-based therapy

Note

Preference for repair before replacement and ViV vs redo SAVR sequencing

Preference for repair before replacement when appropriate: policy favors less invasive/guideline-recommended repair options (e.g., TEER) before replacement in suitable patients. For ViV versus redo SAVR sequencing, document consideration of redo SAVR for low surgical risk patients and rationale for choosing ViV where applicable.

Document surgical candidacy assessment and heart team discussion comparing SAVR, TAVR, ViV, and repair options
When choosing ViV or transcatheter replacement, provide rationale if redo SAVR is not pursued (e.g., high surgical risk)

Policy useUsed to define high or prohibitive surgical risk (eg, PROM ≥ 8% for ViV aortic indications)

Source referenceSociety of Thoracic Surgeons (STS) PROM score as cited in policy

Shared Decision-Making (SDM) definition

Shared Decision-Making (SDM)Process by which physicians and patients choose the treatment option that best reflects clinical evidence and the individual's values and preferences

Policy contextSDM is required between interventional cardiologist and cardiothoracic surgeon for TAVR candidates per policy

DocumentationEngagement in SDM should be documented in the medical record when seeking authorization

Mitral regurgitation (MR) definition

Mitral regurgitation (MR)Failure of the mitral valve to close properly allowing backward blood flow from the left ventricle to the left atrium; can be primary (degenerative) or secondary (functional)

Clinical consequenceUntreated moderate to severe MR can lead to congestive heart failure and may require repair or replacement

Intervention typesIncludes surgical repair/replacement and transcatheter options (TEER, TMVR) depending on anatomy and risk

Low-gradient (LG) severe aortic stenosis definition

Low-gradient (LG) severe aortic stenosisSevere aortic stenosis with low transvalvular gradients including classical low-flow, paradoxical low-flow, and normal-flow LG subtypes

Clinical implicationLG severe AS may require case-by-case expert evaluation as thresholds may be not met despite severe disease

EvidenceMeta-analyses show both SAVR and TAVR reduce mortality versus conservative therapy in LG subtypes

Valve-in-valve definition

Valve-in-valve (ViV)Transcatheter implantation of a replacement valve within a previously implanted, degenerated bioprosthetic valve

IndicationProven for aortic ViV in individuals at high/prohibitive surgical risk (PROM ≥ 8%) per policy

ConsiderationViV may be preferred in high-risk patients; redo SAVR may offer superior hemodynamics in low-risk patients

Transcatheter edge-to-edge repair (TEER) definition

Transcatheter edge-to-edge repair (TEER)Percutaneous leaflet approximation (eg, MitraClip, PASCAL) to reduce MR; randomized data (COAPT, CLASP IID) demonstrate benefit in selected patients

Primary effectiveness (COAPT)Reduction in heart-failure hospitalizations and improved survival in COAPT population

Use caseIndicated for selected primary and secondary MR patients per detailed policy criteria

Transcatheter mitral valve replacement (TMVR) definition

Transcatheter mitral valve replacement (TMVR)Catheter-delivered implantation of a mitral valve prosthesis; current evidence is mainly registries and observational studies with variable outcomes

Evidence limitationInsufficient high-quality comparative evidence for long-term efficacy; TMVR considered investigational in many contexts

DocumentationPrior authorization should document indication, prior therapies, and surgical risk when TMVR is requested

Percutaneous annuloplasty (Carillon) definition

Percutaneous annuloplasty (Carillon)Coronary sinus–based mitral annular reduction device intended to reduce functional MR; evidence includes small RCTs and observational studies

Evidence statusLimited quality evidence with high attrition; comparative effectiveness versus TEER or surgery unclear

Coverage implicationMay be investigational or require enrollment in clinical study and detailed justification

Transcatheter pulmonary valve implantation (TPVI) definition

Transcatheter pulmonary valve implantation (TPVI)Catheter-based replacement of pulmonary valve (eg, SAPIEN, Harmony) for RVOT conduit/valve dysfunction or pulmonary regurgitation

Typical indicationsModerate or greater pulmonary regurgitation and/or pulmonary stenosis meeting RVOT gradient thresholds

OutcomesProcedural success ≈96% with favorable short- to mid-term durability; long-term durability under continued study

Prestenting definition

PrestentingPlacement of a stent before valve implantation in the RVOT to improve outcomes and reduce stent fracture risk

Clinical impactWidespread adoption of prestenting has improved long-term outcomes in TPVI cohorts

Associated risksConduit rupture and coronary complications are recognized procedural risks

T-TEER definition

T-TEERTranscatheter tricuspid edge-to-edge repair (eg, TriClip) — leaflet approximation technique to reduce TR and improve functional status

EvidenceRCTs and observational data show reduction in TR severity and improvements in NYHA class and quality of life

PreferenceMay be preferred when anatomy is suitable and repair is feasible prior to considering replacement

TMViV/TMViR/TMViMAC definitions

Transcatheter mitral valve-in-valve/repair variants (TMViV/TMViR/TMViMAC)Transcatheter mitral valve replacement inside a degenerated mitral bioprosthesis (TMViV), inside a failed annuloplasty ring (TMViR), or in the setting of mitral annular calcification (TMViMAC)

Clinical noteThese approaches are feasible in high-risk patients but carry procedural complexity and potential complications (eg, LVOT obstruction)

DocumentationProcedural details (valve type, approach, size, gradients) should be reported for TMVR procedures

Cerebral Embolic Protection (CEP) / Sentinel device definition

Cerebral Embolic Protection (CEP) / Sentinel deviceA filter/embolus capture device deployed during transfemoral TAVR intended to reduce embolic material reaching the brain

Surrogate endpoint contextDW‑MRI lesion volume/number has been used as a surrogate endpoint in trials but clinical stroke reduction not consistently demonstrated

Policy stanceLarge RCT did not show significant reduction in periprocedural stroke; routine use remains of uncertain clinical benefit

Cerebral embolic protection definition (DW-MRI surrogate context)

Cerebral embolic protection (DW‑MRI surrogate context)Devices intended to capture embolic debris to reduce new cerebral ischemic lesions detected on diffusion-weighted MRI; trials have shown reductions in lesion volume/number but clinical endpoints unmet

Evidence limitationsSmall sample sizes and incomplete DW‑MRI follow-up limit interpretation of surrogate imaging benefits

Clinical implicationClaims relying solely on DW‑MRI lesion reduction may not demonstrate clinical stroke or cognitive benefit

Comprehensive Valve Center / Heart team definition

Comprehensive Valve Center / Heart teamA multidisciplinary team/institution meeting guideline-recommended expertise and volume criteria to perform transcatheter valve therapies and make individualized treatment decisions

Team compositionIncludes cardiac surgery, interventional cardiology, echocardiology, heart failure specialists, and appropriate ICU support

Policy useProcedures recommended to be performed at centers meeting CMS/STS/ACC volume and governance expectations

ViV TAVR — NICE position summary

ViV TAVR — NICE position summaryNICE supports ViV TAVR for aortic bioprosthetic dysfunction with governance arrangements; long-term evidence mainly from earlier-generation devices

Use conditionsShould be performed with clinical governance, consent, and audit or research per NICE guidance

Evidence noteTechnology is evolving and longer-term data are needed

NYHA shorthand reference

NYHA (shorthand)New York Heart Association functional classes I–IV describing limitation of physical activity due to heart failure symptoms

Common usagePolicy references NYHA II–IV as symptomatic thresholds across valve indications

DocumentationNYHA class should be recorded in medical record for authorization

Symptomatic Severe Tricuspid Regurgitation — new definition

Symptomatic Severe Tricuspid Regurgitation — hemodynamic criteriaValve hemodynamics may include central jet ≥ 50%, vena contracta ≥ 0.7 cm, ERO ≥ 0.40 cm2, regurgitant volume ≥ 45 mL, hepatic vein systolic flow reversal

Clinical featuresSymptoms include fatigue, abdominal bloating, peripheral edema, elevated venous pressure and dyspnea on exertion (Stage D)

Policy implicationRequired for eligibility for transcatheter edge-to-edge tricuspid repair per policy criteria

Symptomatic Severe Tricuspid Regurgitation — repeated/expanded

Symptomatic Severe Tricuspid Regurgitation — added definitionPolicy added formal definition describing hemodynamic, chamber dilation, and symptomatic criteria consistent with ACC/AHA guidelines

Documentation expectationDocumentation of TR severity and related hemodynamics should be included in medical record for review

RelevanceUsed to determine eligibility for T-TEER versus investigational replacement procedures

Symptomatic Severe Tricuspid Regurgitation — additional occurrence

Symptomatic Severe Tricuspid Regurgitation — additional occurrenceDefinition text appears multiple times in policy history confirming addition to definitions section

ElementsIncludes hemodynamic criteria, chamber dilation, and symptom descriptors (eg, edema, ascites)

Policy effectEnables coverage criteria specifying symptomatic severe TR as an entry criterion for T‑TEER

2026-01-01administrative_update

Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect current information.

2026-01-01administrative_archive

Archived previous policy version CS123LA.Q.

2026-01-01summary_updates

Summary of Changes entries updated to note updates to Description of Services, Clinical Evidence, FDA, and References and other supporting information across multiple revision entries.

2026-01-01administrative_placeholders

Document contains repeated Summary of Changes placeholders and supporting-information lines in the policy history; multiple archival notes and placeholders recorded in revision history.