ModifiedUnitedHealthcarePolicy CS123IN.11

Transcatheter Procedures for Heart Valve Conditions (for Indiana Only)

Medical policy governing coverage and medical necessity for transcatheter heart valve procedures in the state of Indiana, including aortic, mitral, pulmonary, and tricuspid transcatheter interventions and related devices.

Policy Summary

PayerUnitedHealthcare

PolicyTranscatheter Procedures for Heart Valve Conditions (for Indiana Only)

Policy CodePolicy CS123IN.11

Change TypeCoverage criteria revised — material changes

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with clinical documentation showing symptomatic severe TR, ≥30 days stable GDMT, NYHA II+, PASP <70 mmHg, and local heart team surgical risk determination.

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'.

Medical records documentation language was added specifying that benefit coverage is subject to federal, state, contractual requirements and that documentation may be required to assess criteria but does not guarantee coverage.

Transcatheter edge-to-edge repair of the tricuspid heart valve is proven and medically necessary when used according to FDA labeled indications 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 language that only reconstruction or replacement is unproven and not medically necessary.

Added requirement that medical records documentation may be required to assess whether the member meets clinical criteria and that the patient's medical record must fully support medical necessity.

Added definition of 'Symptomatic Severe Tricuspid Regurgitation'.

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4heart valves addressed

Indianapolicy application state

96.2%procedural success rate (pulmonary meta)

1newly covered procedure

5required criteria items (tricuspid TEER)

Coverage Criteria for Transcatheter Heart Valve Procedures

Aortic (referral to state module)

For transcatheter aortic valve replacement, refer to state-specific surgical services guidance:

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

policy directs to IHCP surgical services reference

Mitral

Mitral valve coverage decisions distinguish TEER (per InterQual) from other transcatheter mitral procedures:

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

See InterQual criteria referenced in policy

Other mitral transcatheter procedures: Transcatheter mitral heart valve repair (e.g., annuloplasty), transcatheter mitral heart valve reconstruction or replacement are unproven and not medically necessary due to insufficient evidence of efficacy.

Policy explicitly states unproven/not medically necessary

Pulmonary

Pulmonary transcatheter valve replacement is covered when device labeling and trial-defined hemodynamic/clinical indications are met:

Pulmonary transcatheter valve replacement: Transcatheter pulmonary heart valve replacement and related devices are proven and medically necessary when used according to FDA labeled indications, contraindications, warnings, and precautions and in individuals with right ventricular outflow tract (RVOT) dysfunction with either moderate or greater pulmonary regurgitation and/or pulmonary stenosis with mean RVOT gradient ≥ 35 mmHg.mean RVOT gradient >= 35 mmHg

Also requires adherence to FDA labeled indications/contraindications/warnings/precautions

Tricuspid

Tricuspid edge-to-edge repair is covered when ALL listed clinical criteria are satisfied; reconstruction/replacement remains unproven:

Tricuspid TEER

Symptomatic severe TR: Symptomatic Severe Tricuspid Regurgitation (TR)
GDMT: Receiving stable (>= 30 days) guideline-directed medical therapy (GDMT) for heart failure>= 30 days
Symptoms: Symptomatic NYHA class II or greaterNYHA >= II

Other unproven procedures/devices

Procedures and devices explicitly identified as unproven and not medically necessary due to insufficient evidence:

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

Listed as not medically necessary

Transcatheter pulmonary valve implantation — illustrative coverage criteria

Illustrative pulmonary implant coverage criteria — all conditions must be met (examples derived from pivotal studies):

Indication: Clinical indication such as moderate or greater pulmonary regurgitation and/or RVOT conduit obstruction or failed bioprosthetic pulmonary valve consistent with trial inclusion criteria.

Based on trial populations (e.g., Alterra, COMPASSION S3)

Hemodynamic criteria: Measured hemodynamic evidence consistent with device trial definitions (e.g., mean RVOT/pulmonary valve gradient >= 35–40 mmHg or ≥ moderate regurgitation).mean RVOT gradient >= 35–40 mmHg or >= moderate regurgitation

Studies used composite endpoints including gradient thresholds to define valve dysfunction.

Anatomic/technical suitability: Anatomic compatibility for the chosen device (conduit or native/surgically repaired RVOT suitable for device), with prestenting when indicated.

Prestenting performed in ~53% in COMPASSION S3 and influences success.

Transcatheter mitral valve replacement (TMVR) — illustrative coverage criteria

TMVR coverage is conditional and generally limited to high-risk or anatomically suitable patients; all conditions below should be met:

Surgical risk: Patient is inoperable or at prohibitive/high surgical risk for conventional mitral valve surgery as reflected in trial/registry cohorts.

Most TMVR evidence comes from high-risk or compassionate-use cohorts.

Anatomic suitability: Anatomic features appropriate for the specific TMVR device (e.g., severe mitral annular calcification for balloon-expandable valves or other device-specific requirements).

Device-specific access routes and anatomy determined candidacy in reported series.

Shared decision-making/registry enrollment: Shared decision-making and consideration of enrollment in prospective registries or informed-consent processes acknowledging limited long-term comparative data.

Hayes and other reviews note insufficient evidence; registry participation is common in published reports.

Coverage considerations and evidence summary

Evidence-based considerations that inform coverage determinations (summarized):

Pulmonary valve considerations: Single-arm and registry studies demonstrate high procedural success and short-term valve function for Melody/Harmony/SAPIEN devices but raise concerns about long-term durability, stent fracture, and endocarditis; patient selection and center experience are important.

See Melody and Harmony/SAPIEN series for outcomes and predictors of dysfunction.

TTVR considerations: Randomized (TRISCEND II) and registry data show clinical improvements with some TTVR devices but also early safety concerns; evidence insufficient to confirm long-term net benefit.

Consider bleeding and early mortality signals and need for longer follow-up.

T-TEER considerations: Randomized TRILUMINATE data and observational studies show reduced TR severity and improved quality of life and functional status up to two years; impact on mortality remains uncertain.

T-TEER may be preferred for symptomatic severe TR in patients at elevated surgical risk with suitable anatomy.

Transcatheter mitral valve procedures (ViV/ViR/TMViMAC)

Valve-in-valve, valve-in-ring, and TMViMAC procedures may be reasonable in selected high-risk patients when ALL listed conditions are met:

Patient selection and setting: Patient is severely symptomatic with bioprosthetic valve dysfunction or severe MR and is at high or prohibitive surgical risk; procedure to be performed at a Comprehensive Valve Center.

Based on ACC/STS statements and registry practice.

Procedure-specific documentation: Transcatheter mitral ViV, ViR, or TMViMAC performed with appropriate procedural documentation (indication, imaging, valve sizing, technical success, peri-procedural complications) and heart team evaluation.

Supported by observational studies reporting high technical success but limited long-term data.

Cerebral embolic protection during TAVR

Cerebral embolic protection (CEP) devices during TAVR — evidence is mixed and routine use is not consistently supported:

Clinical evidence summary: Randomized and observational studies yield inconsistent effects of CEP on clinical stroke endpoints; a large RCT (Kapadia et al.) found no statistically significant reduction in stroke within 72 hours (2.3% vs 2.9%), though confidence intervals do not exclude possible benefit.

See Kapadia et al. and meta-analyses summarizing mixed findings.

Implication for coverage: Routine use of CEP devices for all TAVR patients is not clearly supported by current randomized evidence; coverage may be investigational or restricted pending higher-quality RCT data or patient-specific justification.

Policy states insufficient quality evidence to demonstrate efficacy for improved stroke/neurologic outcomes.

Guideline-based coverage context

Guideline-based recommendations that contextualize coverage decisions:

Aortic valve selection: Choice between SAVR and TAVI should be based on heart team evaluation of clinical, anatomical, and procedural factors; TAVI is generally recommended for older or higher-risk patients and SAVR for younger low-risk patients as specified in guideline thresholds.age >= 75; STS-PROM/EuroSCORE II thresholds specified

ESC/EACTS and ACC/STS guideline summaries referenced.

Tricuspid interventions: Transcatheter treatment of symptomatic secondary severe tricuspid regurgitation may be considered (IIb) in inoperable patients at specialized heart valve centers.IIb recommendation

Evidence less well established

Valve-in-valve (ViV): Transcatheter ViV implantation in the aortic position and selected mitral/tricuspid ViV procedures may be considered depending on anatomy and high surgical risk; mitral/tricuspid ViV carry IIb recommendations for selected high-risk patients.

Tricuspid edge-to-edge repair (medically necessary when criteria met)

Tricuspid edge-to-edge repair is covered only when ALL of the following clinical criteria are documented and met:

Tricuspid edge-to-edge repair coverage criteria

Severe TR: Symptomatic severe tricuspid regurgitation (TR)
GDMT: Receiving stable (>= 30 days) guideline-directed medical therapy (GDMT) for heart failure>= 30 days
Symptoms: Symptomatic NYHA class II or greaterNYHA >= II

Tricuspid edge-to-edge repair - medically necessary

Coverage for transcatheter edge-to-edge repair is conditional on satisfying all listed requirements:

Tricuspid edge-to-edge repair coverage criteria: 1) FDA labeled indications, contraindications, warnings, and precautions are followed; 2) Symptomatic Severe Tricuspid Regurgitation; 3) Receiving stable (>= 30 days) guideline-directed medical therapy (GDMT) for heart failure; 4) Symptomatic NYHA class II or greater; 5) Pulmonary artery systolic pressure < 70 mmHg; 6) Intermediate or greater surgical risk as determined by local heart team including cardiac surgery, interventional cardiology, echocardiology, and heart failure specialists.see node text

All conditions must be met for coverage.

Transcatheter mitral heart valve repair techniques other than transcatheter edge-to-edge repair (TEER) as addressed by InterQual are considered unproven and not medically necessary because current evidence is insufficient to demonstrate long‑term efficacy. The policy explicitly lists transcatheter mitral annuloplasty and other mitral repair approaches (outside InterQual‑specified TEER indications) as not medically necessary, and similarly states that transcatheter mitral valve reconstruction or replacement is unproven and not medically necessary due to limited supportive data.

Procedures for mitral valve disease that lack high‑quality, long‑term comparative evidence — including many indications for transcatheter mitral valve replacement (TMVR) and coronary sinus annuloplasty — are not supported. The document notes insufficient quality evidence, reliance on noncomparative designs or small studies, and recommends these approaches be considered experimental or used only in research or registry settings until more robust randomized data are available.

Evidence for certain transcatheter tricuspid valve replacement (TTVR) devices and some other novel transcatheter approaches remains limited and inconclusive. Systematic reviews and meta‑analyses of primarily single‑arm studies show feasibility and functional improvements in selected cohorts but lack randomized comparisons and consistent long‑term safety data; therefore these devices/procedures are considered insufficiently proven for routine coverage outside clinical trials or registries.

Transcatheter approaches for mitral valve scenarios such as failed annuloplasty rings and severe mitral annular calcification (MAC) carry specific technical risks — notably a significant risk of left ventricular outflow tract (LVOT) obstruction and potential need for additional valve procedures or surgery. The policy highlights these increased procedural risks and states such higher‑risk scenarios require individualized assessment and may be excluded from routine coverage absent specialized programmatic support and documented heart‑team decision.

The National Institute for Health and Care Excellence (NICE) guidance is cited noting that for aortic regurgitation there is currently no accepted transcatheter intervention. NICE also emphasizes limited evidence on durability for some transcatheter aortic valve uses and recommends use of certain transcatheter procedures only with special arrangements for governance, consent, audit, or research.

Transcatheter tricuspid valve reconstruction or orthotopic replacement (TTVR) is identified as having limited and low‑quality evidence for long‑term safety and efficacy. The policy indicates these reconstruction/replacement approaches are considered unproven and not medically necessary for routine use due to small studies, short follow‑up, and absence of robust RCT data.

Restating the policy position, pooled analyses and early series for transcatheter tricuspid replacement show feasibility but inconsistent mortality and heterogeneity across studies; therefore transcatheter tricuspid reconstruction or replacement remains not medically necessary for routine use outside controlled research or registry settings until stronger evidence is available.

Transcatheter mitral valve repair, reconstruction, or replacement techniques (including valve‑in‑valve, valve‑in‑ring, and procedures for severe MAC) are discussed with nuance: valve‑in‑valve or valve‑in‑ring approaches may be reasonable in selected high‑risk patients, but other transcatheter mitral repair/replacement approaches lack comparative long‑term data. The policy emphasizes the need for detailed procedural documentation, heart‑team evaluation, and consideration of registry enrollment when these approaches are used.

Transcatheter mitral valve replacement (TMVR) without device‑ and patient‑specific supportive evidence is not covered as a general therapy. The policy states TMVR should be reserved for patients matching trial or registry populations (typically high or prohibitive surgical risk and anatomically suitable), and that broader application of TMVR for general mitral disease is not supported given limited comparative data and concerns about longer‑term outcomes.

Some transcatheter tricuspid replacement and caval valve implantation (CAVI) approaches have only limited evidence from small randomized or observational studies showing procedural success and symptomatic benefit, but the available data are insufficient to demonstrate consistent clinical outcome improvement or safety superiority. As a result these approaches are considered investigational or not medically necessary for routine care outside defined protocols.

Routine use of cerebral embolic protection (CEP) devices during TAVR is not clearly supported by randomized evidence. A large RCT (Kapadia et al.) found no statistically significant reduction in stroke within 72 hours (2.3% with CEP vs 2.9% without), and meta‑analyses combine mixed randomized and observational data — therefore CEP devices are characterized as having insufficient high‑quality evidence to justify routine coverage for all TAVR patients.

For patients with mild or moderate tricuspid regurgitation, the evidence base for transcatheter annuloplasty or leaflet repair is inadequate in both quantity and quality. NICE guidance specifically highlights this limitation and recommends that such procedures should not be broadly adopted outside research or special governance arrangements, reflecting the policy position that interventions for less‑than‑severe TR lack sufficient support for routine coverage.

Consistent with the document's exclusions, transcatheter tricuspid heart valve reconstruction or orthotopic replacement is described as not medically necessary given current evidence gaps. The policy reiterates that reconstruction/replacement (distinct from FDA‑labeled edge‑to‑edge repair when criteria are met) remains unproven for routine coverage.

The policy restates that transcatheter tricuspid reconstruction or replacement remains unproven and not medically necessary for general use. This position is aligned with systematic reviews and NICE findings that emphasize limited, heterogeneous evidence and the need for further randomized data before routine coverage can be supported.

Applicable Procedure and Device Codes

Applicable procedure 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.

1–10 of 25

1/3

Document does not list explicit CPT/ICD codes in this segmentmixed

No codes listed

FDA PMA Product Codesmixed

Product Code NPT	FDA PMA product code referenced for transcatheter aortic valve prostheses
Product Code NPU	FDA PMA product code referenced for transcatheter mitral valve prostheses
Product Code NKM	FDA PMA product code referenced for transcatheter mitral valve repair devices
Product Code NPV	FDA PMA product code referenced for transcatheter pulmonary valve prostheses

PMA identifiers and listed devicesmixed

P130021	PMA entry listing Evolut FX / PRO / R (Medtronic)
P190023	PMA entry listing Navitor (Abbott)
P140031	PMA entry listing SAPIEN 3 family (Edwards Lifesciences)
P100009	PMA entry listing MitraClip (Abbott)
P220003	PMA entry listing PASCAL (Edwards Lifesciences)
P200046	PMA entry listing Harmony (Medtronic)
P140017	PMA entry listing Melody (Medtronic)

FDA PMA/Product Codes and device referencesmixed

P200046	PMA reference for Harmony (Medtronic) - pulmonary
P140017	PMA reference for Melody (Medtronic) - pulmonary
P200015	PMA reference for SAPIEN 3 and SAPIEN 3 with Alterra Adaptive Prestent (Edwards Lifesciences)
P230013	PMA reference for EVOQUE (Edwards Lifesciences) - tricuspid
P230007	PMA reference for TriClip (Abbott) - tricuspid repair
PUM	FDA product code for cerebral embolic protection devices

Devices without full FDA approval notedneutralExperimental

List of additional products that may not have full FDA approval (Cardioband; Carillon Mitral Contour System; Harpoon; Intrepid; NeoChord; Tiara; TricValve; TriGUARD 3).

Pulmonary stenosis mean RVOT gradient

Pulmonary stenosis mean RVOT gradient>= 35 mmHg

Valve dysfunction composite gradient threshold

Valve dysfunction composite gradient threshold (study definitions)mean RVOT/pulmonary valve gradient ≥ 35–40 mmHg (varies by study)

RVOT gradient example (Melody series)

Melody series example — pre-/post-implant gradientsMedian peak RVOT gradient 37 mmHg pre-implant and 12 mmHg immediately post-implant

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Note (Indiana)

Prior authorization required for transcatheter valve procedures may be state-dependent. For Indiana, some CPT codes are not managed for medical necessity review; providers must consult UnitedHealthcare Community Plan of Indiana prior authorization and notification lists. Prior authorization requests must clearly document how the patient meets the clinical criteria below and include trial-based indication justification when applicable.

Check Indiana-specific prior authorization lists for codes not managed for medical necessity (see Applicable Codes).
Include justification of trial-based indications (failed/contraindicated prior therapies) when device indications require prior therapy attempts.

Prior Authorization

Prior Authorization — Clinical Requirements

Prior authorization clinical requirements: requests must demonstrate that the member meets all relevant clinical criteria for the specific transcatheter valve procedure, including symptom severity, diagnostic findings, risk assessment, prior therapies, and heart team determination when applicable. Provide device-specific FDA labeled indication status or PMA reference where relevant.

Background and Evidence Context

Background: Transcatheter valve procedures are minimally invasive alternatives to open surgical valve repair or replacement that use catheter‑delivered bioprosthetic valves or repair devices to treat stenosis or regurgitation. These approaches seek to reduce the need for cardiopulmonary bypass and repeat sternotomy, and they are particularly considered for patients at elevated surgical risk or with prior prosthetic valves.

Definitions and Key Terms

NYHA Heart Failure Classification

NYHA Class INo limitation of physical activity; ordinary activity does not cause 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 (Predicted Risk of Mortality) / STS PROM

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

Operational Notes for Providers and Coders

Prior Authorization

Cite device and PMA identifiers with requests

When requesting authorization, reference the device and FDA PMA information (PMA/product codes and device listings) provided in the policy to support device-specific requests.

Billing Rule

Indiana prior‑auth coding impact (billing note)

Codes labeled with an asterisk (*) were not managed for medical necessity review for Indiana at the policy effective date; this affects prior authorization handling and may impact billing—verify the current UnitedHealthcare Community Plan of Indiana prior authorization list.

Policy Revision History

2026-01-01policy_revisionLatest

Policy revised to designate transcatheter edge-to-edge repair of the tricuspid heart valve as proven and medically necessary when FDA-labeled indications are followed and specified clinical criteria are met (symptomatic severe TR; stable GDMT ≥30 days; NYHA II+; PASP <70 mmHg; intermediate or greater surgical risk as determined by local heart team).

2026-01-01documentation_update

Medical records documentation language updated to specify required elements for reviews: documentation may be required to assess clinical criteria but does not guarantee coverage, records must fully support medical necessity, include relevant history, physical exam, and diagnostic results, be legible, maintained in the medical record, and made available upon request.

Policy Summary

PayerUnitedHealthcare

PolicyTranscatheter Procedures for Heart Valve Conditions (for Indiana Only)

Policy CodePolicy CS123IN.11

Change TypeCoverage criteria revised — material changes

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with clinical documentation showing symptomatic severe TR, ≥30 days stable GDMT, NYHA II+, PASP <70 mmHg, and local heart team surgical risk determination.

SourceLink

On This Page

Pulmonary artery systolic pressure < 70 mmHg

Surgical risk: Intermediate or greater risk for surgery as determined by the local heart team which includes board-certified specialists in cardiac surgery, interventional cardiology, echocardiology, and heart failure

Local heart team determination required

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

Policy exclusion for reconstruction/replacement

Patient selection: Appropriate patient selection considering age, prior surgeries, and risk factors (younger age and higher discharge gradients linked to earlier device dysfunction).

Registry data identify younger age and higher discharge gradients as predictors of earlier dysfunction.

CAVI considerations: Small RCTs and observational studies show high procedural success but insufficient evidence of superior functional outcomes and safety concerns (valve dislocations); routine coverage not supported outside investigational settings.

Evidence insufficient for routine coverage outside defined protocols.

Valve-in-valve mitral considerations: Observational meta-analyses suggest ViV TMVR may have lower complication rates and shorter hospital stays versus redo surgical replacement in high-risk patients, but evidence is observational and limited.

May be reasonable in high surgical-risk patients with degenerated mitral bioprostheses when anatomically suitable.

IIb for mitral/tricuspid ViV

Heart team decision important

NICE constraints: NICE recommends special arrangements for clinical governance, consent, audit, or research for certain transcatheter procedures and notes limited evidence for some indications (e.g., aortic regurgitation), which may inform restricted use.special arrangements required for certain procedures

May influence coverage decisions

PASP: Pulmonary artery systolic pressure < 70 mmHgPASP < 70 mmHg

Local heart team determination required

STS score (example cohort)

STS PROM example (single-center TMVR cohort)Mean STS score 9.2% in the reported cohort

Pulmonary artery systolic pressure (PASP) threshold for tricuspid TEER

PASP threshold for tricuspid TEER coveragePulmonary artery systolic pressure < 70 mmHg

Stable guideline-directed medical therapy duration

Required duration of stable GDMT prior to coverage>= 30 days

Document symptomatic status (e.g., NYHA class), echocardiographic and hemodynamic data, and relevant imaging.
Provide evidence of guideline-directed medical therapy (GDMT) and duration where required (e.g., ≥ 30 days stable GDMT for heart failure when applicable).
Include local heart team assessment for high-risk procedures (composition and determination).
Reference device-specific FDA approval / PMA identifier when known.

Prior Authorization

Prior Authorization — Trial-Based Indication Justification

Some device indications require trial-based indication justification. For procedures where less-invasive or medical therapies are the standard first-line approach, prior authorization must document prior trials of therapy, intolerance, contraindication, or failure, and the timeframe of those trials.

Specify prior therapies tried (medical therapy, prior transcatheter repair such as TEER when relevant) and dates and responses.
If a trial was not possible due to contraindication, provide clinical rationale and supporting documentation.

Prior Authorization

Prior Authorization — Valve-in-Valve (ViV) Procedures

Prior authorization for valve-in-valve (ViV) procedures: for ViV TAVR and TMVR, requests must document prosthesis degeneration, symptoms, surgical risk assessment, and that the procedure will be performed at an appropriate Comprehensive Valve Center when indicated.

Document type and age of the failing bioprosthesis, valve gradients, regurgitation severity, and prior surgical history.
Include heart team assessment indicating high or prohibitive surgical risk and rationale.
State intended access route and device planned for ViV procedure.

Prior Authorization

Prior Authorization — Reference Device / PMA Information

Prior authorization should reference device and PMA information for FDA-approved devices. Where relevant, include PMA identifiers or product codes to support device candidacy and coverage review.

Provide PMA ID or product code (e.g., NPT, NPU, NKM) and device model when known (e.g., SAPIEN 3, MitraClip, PASCAL, Evolut series, Melody, Harmony).
If using an investigational or off-label device, clearly state and provide supporting evidence; such use may be considered unproven.

Prior Authorization

Prior Authorization — Confirmation of Criteria

Prior authorization reviewers will confirm that submitted documentation supports all required criteria for the requested procedure. Missing or insufficient information may delay review or result in denial.

Ensure complete medical records, imaging reports, and heart team notes are included with the request.
If continuation or staged procedures are anticipated, include prior authorization rationale and planned sequence.

Prior Authorization

Clinical Selection and Technical Risk Factors

Clinical selection and technical risk factors affect coverage decisions. Prior authorization should document anatomic suitability, risk factors for complications (e.g., risk of coronary compression, LVOT obstruction, conduit size limitations), and technical considerations relevant to device success.

Document imaging-based anatomic assessments (CT, TEE) that support device sizing and feasibility.
Address risks such as coronary compression, stent fracture potential, LVOT obstruction, and conduit suitability.

Denial Risk

Evidence Limitations — Potential Coverage Scrutiny

Evidence limitations may trigger coverage scrutiny. For certain transcatheter interventions (TMVR, percutaneous annuloplasty, some pulmonary devices), the literature has limitations — small sample sizes, short follow-up, noncomparative designs — and this may affect medical necessity determinations.

Expect requests for additional supporting evidence when published data are limited or device use is evolving.
Longer-term outcomes and comparative trial data are often required to establish broad coverage.

Denial Risk

NICE Evidence Limitations — Potential Restriction of Coverage

NICE guidance noting limited quantity or quality of evidence for several transcatheter tricuspid and annuloplasty procedures may influence coverage. Procedures with NICE recommendations for special arrangements (governance, consent, audit or research) should include documentation of such arrangements.

If the procedure has NICE IPG recommending special arrangements, include documentation of clinical governance, consent processes, and plans for audit or research participation where relevant.
Be aware that NICE conclusions about limited evidence may restrict coverage for some indications.

Denial Risk

Documentation and Criteria Gaps — Denial Risk

Documentation and criteria gaps: incomplete clinical records, absent heart team documentation, missing imaging, or lack of evidence of prior therapy trials when required may result in denial or request for additional information.

Provide full clinical history, physical exam findings, imaging (CT/TEE), operative reports, and prior treatment details.
Ensure documentation of GDMT and stabilization period when required (e.g., ≥ 30 days for heart failure patients).

Documentation Required