CurrentCapital BluecrossPolicy MP 1.153

Transcatheter Mitral Valve Procedures

Covers medical necessity and investigational indications for transcatheter mitral valve repair and replacement (including valve-in-valve) using FDA‑approved devices for patients with primary or secondary mitral regurgitation; applies to certain Capital Blue Cross products and programs.

Policy Summary

PayerCapital Bluecross

PolicyTranscatheter Mitral Valve Procedures

Policy CodePolicy MP 1.153

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document FDA‑approved device use, MR severity, surgical risk scores, and maximally tolerated guideline-directed medical therapy when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2distinct medically necessary indications

ALLmitral valve-in-valve criteria required

STS ≥12%prohibitive risk threshold

STS ≥8%high surgical risk threshold

Grade 3+

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echocardiographic MR severity

0484Tinvestigational codes

Coverage Criteria for Transcatheter Mitral Valve Procedures

Medically Necessary Indications

Covered when ALL of the following are met for specific indications:

Transcatheter mitral valve repair for primary MR (prohibitive surgical risk): Patient has symptomatic, primary (degenerative) mitral regurgitation AND is considered at prohibitive risk for open mitral valve surgery; the procedure uses a device approved by the U.S. Food and Drug Administration for mitral valve repair.Prohibitive risk defined by STS predicted mortality >= 12% and/or logistic EuroSCORE >= 20%

Heart Team determination required; see Policy Guidelines for risk thresholds.

Transcatheter mitral valve repair for secondary MR (heart failure): Patient has heart failure with moderate-to-severe or severe symptomatic secondary (functional) mitral regurgitation despite maximally tolerated guideline-directed medical therapy.Echocardiographic MR grade 3+ or 4+; NYHA class II–IVa where applicable

Device must be FDA‑approved for mitral valve repair and patient selection should reflect trial populations showing benefit.

Transcatheter mitral valve replacement (valve-in-valve) for failed bioprosthesis: Individual has a failed (stenosed, insufficient, or combined) prior surgical bioprosthetic mitral valve AND the Heart Team determines the individual is either not an operable candidate for open surgery or is an operable candidate but at high risk for open surgery; the procedure uses an FDA‑approved device for valve-in-valve implantation.Failed bioprosthetic valve (stenosed, insufficient, or combined); high operative risk defined as predicted surgical mortality >= 8% (STS) or other comorbidities per Heart Team

Valve‑in‑valve statement and criteria were added to policy history; registry evidence supports symptomatic and QOL improvements in selected patients.

Investigational

Not covered (investigational) in the absence of sufficient evidence:

Investigational indications: Transcatheter mitral valve repair in all other situations not specified as medically necessary; transcatheter mitral valve implantation/replacement in all other situations not specified as medically necessary; transcatheter mitral valve annulus reconstruction.N/A

These situations are considered investigational due to insufficient evidence to support improvement in health outcomes.

Coverage by device and indication

Coverage stance varies by device and indication; evidence supports some devices/indications but is insufficient for others.

FDA‑approved edge-to-edge devices for prohibitive surgical risk primary MR: MitraClip is FDA‑approved for significant symptomatic primary (degenerative) MR in patients at prohibitive surgical risk; PASCAL is FDA‑approved for significant primary MR in patients at prohibitive surgical risk.FDA approval

Evidence includes noninferiority RCTs and registry data demonstrating procedural success and short‑term effectiveness.

MitraClip for symptomatic secondary (functional) MR after maximally tolerated medical therapy: MitraClip has an FDA indication for treatment of symptomatic secondary MR in selected heart failure patients who remain symptomatic despite optimal medical therapy (including CRT where appropriate); randomized trials showed benefit in selected populations.Failure of maximally tolerated guideline‑directed medical therapy

Patient selection should mirror trial inclusion criteria; benefits depend on appropriate selection.

Valve-in-valve medical necessity

Coverage stance references and historical actions

Valve-in-valve medical necessity note: Transcatheter mitral valve replacement of a degenerated bioprosthetic valve (valve‑in‑valve) with an FDA‑approved device may be considered medically necessary when the specified criteria for a failed bioprosthesis and Heart Team determination of inoperability or high surgical risk are met.Failed bioprosthetic valve (stenosed, insufficient, or combined)

Policy history documents addition of the valve‑in‑valve statement (06/18/2021) and registry evidence (e.g., SAPIEN 3) demonstrating clinically meaningful symptomatic and quality‑of‑life improvements.

Transcatheter mitral valve procedures that do not meet the specific criteria outlined in this policy are considered investigational. The policy identifies narrowly defined medically necessary indications (transcatheter mitral valve repair for symptomatic primary MR in patients at prohibitive surgical risk; transcatheter mitral valve repair for symptomatic secondary MR despite maximally tolerated guideline-directed medical therapy; and transcatheter mitral valve replacement valve-in-valve for failed bioprosthetic valves when Heart Team criteria are met). Procedures performed outside those indicated circumstances are not supported by sufficient evidence and are therefore investigational.

The following procedure codes are listed as investigational and not covered by this policy: 0484T and 0544T.

Within the document sections cited here there are no additional explicit exclusions beyond the investigational determinations and the defined medically necessary indications; exclusions and detailed applicability may be addressed elsewhere in the full policy and history.

Any transcatheter mitral valve repair, implantation/replacement, or annulus reconstruction performed outside the policy’s stated medically necessary indications — including non‑valve‑in‑valve transcatheter mitral valve replacements and repairs that do not meet the primary or secondary MR criteria — is considered investigational and therefore not covered.

Evidence is insufficient to support TMVR as an alternative to surgery in patients who are surgical candidates. A randomized trial found MitraClip reduced MR less often and less completely than surgical repair and had a higher rate of subsequent surgery, and observational data show mixed long‑term outcomes; for many replacement and repair devices other than MitraClip/PASCAL the evidence (including randomized and nonrandomized studies and feasibility data) does not yet establish benefit. Therefore use of TMVR in surgical candidates or for indications beyond those with demonstrated benefit is considered investigational.

This excerpt of the policy does not contain an explicit separate section titled 'not medically necessary' beyond the investigational statements; the full policy (including policy history and other sections) is the authoritative source for additional 'not medically necessary' language and specific exclusions.

Coding and Code Status

Investigational; therefore, not covered: Procedure CodesCPTNot Covered

0484T	Procedure code listed as Investigational; therefore, not covered
0544T	Procedure code listed as Investigational; therefore, not covered

Covered when medically necessary: Procedure and Diagnosis CodesmixedCovered

33418	Procedure code listed as Covered when medically necessary
33419	Procedure code listed as Covered when medically necessary
0345T	Procedure code listed as Covered when medically necessary
0483T	Procedure code listed as Covered when medically necessary
I05.1	Rheumatic mitral insufficiency
I05.2	Rheumatic mitral stenosis with insufficiency
I05.8	Other rheumatic mitral valve diseases
I05.9	Rheumatic mitral valve disease, unspecified
I08.0	Rheumatic disorders of both mitral and aortic valves
I08.1	Rheumatic disorders of both mitral and tricuspid valves

1–10 of 15

1/2

Procedure code actions in policy historyCPT

0483T	procedure code added to policy
0484T	procedure code moved into this policy historically
I348	deleted code (removed from policy)

STS Predicted Mortality Risk — Example thresholds

STS predicted mortality risk (prohibitive)>= 12% predicted 30-day surgical mortality

STS predicted mortality risk (high operative risk example)>= 8% predicted 30-day surgical mortality (used to define high risk for open surgery)

Context for useUsed by Heart Team as part of surgical risk assessment to determine prohibitive or high operative risk

Logistic EuroSCORE — Prohibitive threshold

Logistic EuroSCORE (prohibitive)>= 20% predicted surgical mortality

Context for useListed as an alternative risk calculator to help define prohibitive surgical risk

Provider Responsibilities, Prior Authorization, and Documentation

Prior Authorization

Program/Product applicability and Prior Authorization

This policy applies only to certain programs and products administered by Capital Blue Cross. Providers must verify program/product applicability and whether prior authorization (PA) is required for the member’s specific health benefit plan before scheduling services.

Applicable programs and product variations may impose different PA rules (e.g., FEP PPO follows the FEP Medical Policy Manual).
Contact Capital Blue Cross or review the member’s benefit plan for program-specific PA requirements.

Documentation Required

Clinical criteria confirmation

Prior authorization requests must confirm that the transcatheter device is FDA‑approved for the intended mitral valve indication and that the member meets the clinical criteria in the policy (e.g., documented moderate-to-severe or severe MR by echocardiography and appropriate NYHA class).

Background and Clinical Context

Mitral regurgitation (MR) is a valvular disorder in which the mitral valve fails to close properly, producing volume overload of the left ventricle, progressive remodeling, and symptoms of heart failure. MR is commonly classified as primary (degenerative) — due to structural valve abnormalities such as leaflet prolapse or flail — or secondary (functional) — caused by left ventricular dilatation from ischemic or dilated cardiomyopathy with structurally normal leaflets. When feasible, surgical mitral valve repair is the standard treatment; transcatheter approaches are targeted to patients who are inoperable or at high/prohibitive surgical risk or to treat failed bioprosthetic valves (valve‑in‑valve).

Definitions and Device Terminology

Primary (Degenerative) MR — Definition summary

DefinitionPrimary (degenerative) MR is caused by a primary structural abnormality of the mitral valve (eg, leaflet prolapse or flail) resulting in valve leakage

Typical managementMost cases are surgically corrected (mitral valve repair is preferred when feasible)

Coverage contextTranscatheter repair may be considered when patients are determined by a Heart Team to be at prohibitive surgical risk

Secondary (Functional) MR — Definition summary

DefinitionSecondary (functional) MR results from left ventricular dilation (ischemic or dilated cardiomyopathy) with structurally normal mitral leaflets

Primary treatment focusOptimization of left ventricular function with guideline-directed medical therapy (medical management) is the primary treatment strategy

Policy Summary

PayerCapital Bluecross

PolicyTranscatheter Mitral Valve Procedures

Policy CodePolicy MP 1.153

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document FDA‑approved device use, MR severity, surgical risk scores, and maximally tolerated guideline-directed medical therapy when requesting coverage.

SourceLink

On This Page

Devices other than MitraClip/PASCAL (annuloplasty, other repair, transcatheter replacement): Evidence is insufficient to determine effects on health outcomes for many other repair devices (direct and indirect annuloplasty) and for several transcatheter replacement devices in broader indications.Varying by device; many remain investigational

Some registry data (e.g., SAPIEN 3 valve‑in‑valve) show symptomatic and QOL improvement for degenerated bioprostheses, but randomized evidence for many devices is lacking.

Role in policyOne of the criteria Heart Team may use to consider a patient prohibitive risk for open mitral valve surgery

MR Severity by Echocardiography — Relevant grades

Echocardiographic MR severity for coverage considerationGrade 3+ (moderate-to-severe) or 4+ (severe) MR confirmed by echocardiography

Associated clinical requirementSymptoms and NYHA functional class II–IVa despite maximally tolerated guideline-directed medical therapy when applicable

Documentation noteMR grade must be demonstrated on echocardiography per policy guidelines

Policy Review Cadence — Consensus reviews and updates

Consensus review cadencePolicy underwent multiple consensus reviews and updates between 2020 and 2025

Notable history entries06/09/2020 consensus review; 06/18/2021 minor review adding valve-in-valve statement; subsequent reviews 2022–2024; retirement review 01/24/2025

Implication for usersReferences, regulatory status, and coding were reviewed and updated at these intervals

Include documentation of MR severity (e.g., grade 3+ or 4+ by echocardiography).

Include NYHA functional class and supporting clinical assessment.

If device use is investigational or off‑label for the indication, state that it is not covered unless explicit justification and plan-level approval are obtained.

Prior Authorization

Preauthorization per benefit plan

Providers should consult the member’s benefit plan or contact Capital Blue Cross to determine whether preauthorization is required and obtain any required authorizations prior to performing transcatheter mitral procedures.

A medical policy does not guarantee benefits — coverage is determined by the member’s health benefit plan language.
If preauthorization is required by the benefit plan, obtain and document the PA prior to the procedure.

Billing Rule

Procedure code prior authorization guidance

Prior authorization and claims submission must use current, valid procedure and diagnosis codes. Providers should supply the specific procedure codes being requested for authorization and verify coding updates.

The coding list in the policy may not be all‑inclusive and is subject to change.
Provide current procedure codes when requesting PA; using removed or deleted codes may result in denial.
If procedure codes have recently changed or been deleted, confirm appropriate replacement codes with Capital Blue Cross prior to claim submission.

Denial Risk

Procedures not meeting medically necessary indications

Procedures that do not meet the policy’s medically necessary indications (for example, off‑label uses or indications listed as investigational) are not covered under this policy and will be denied unless an alternative benefit justification is documented and approved by the plan.

Transcatheter mitral procedures indicated as investigational in the policy are not covered.
Provide clinical rationale and obtain plan approval if proposing treatment outside the policy indications.

Note

Benefit plan governs coverage

The existence of this medical policy does not guarantee coverage. Benefit determinations are governed by the terms of the member’s health benefit plan.

Members and providers should consult the applicable benefit plan or contact Capital Blue Cross for benefit information.
Different product lines and benefit designs may have unique coverage rules and preauthorization requirements.

Denial Risk

Coding-related denial risk

Using outdated, removed, or deleted procedure codes or failing to provide accurate coding may trigger claim denials. Verify code validity at the time of authorization and claim submission.

Code I348 (deleted) and any other removed codes should not be used; replacement codes must be used.
Provide timely updates if submitting claims with codes that have changed since the PA was issued.

Documentation Required

Documentation should demonstrate MR severity and clinical status

Documentation submitted for prior authorization and claims should clearly demonstrate the severity of mitral regurgitation and relevant clinical status.

Echocardiography reports documenting MR grade (e.g., 3+ or 4+).
NYHA functional class and clinical context (II–IVa) with symptoms despite therapy.
Heart Team evaluations and rationale for transcatheter approach vs surgical options.

Note

Coding and coverage note

Coding information in this policy is provided for reference and may not be comprehensive. Inclusion of a code here does not guarantee coverage; coverage depends on member-specific benefits and plan rules.

Review the policy coding section as a guide but confirm plan coverage for listed codes.
Not all covered services are eligible for separate reimbursement; consult benefit plan details.

Documentation Required

Documentation and coding alignment

Providers must align documentation with coding and policy requirements when requesting authorization or submitting claims. Supply all relevant clinical records and the exact procedure codes to facilitate accurate PA decisions and claims processing.

Include operative reports, procedural intent, device model/labeling (to show FDA approval for indication), and preprocedure imaging.
If codes or documentation change after PA issuance, notify the plan and obtain updated authorization if required.

Documentation Required

Requires documentation of maximally tolerated guideline-directed medical therapy

Prior to consideration for transcatheter mitral valve repair (TMVR) for secondary MR, documentation must show that the member received maximally tolerated guideline‑directed medical therapy.

Document trials of guideline-directed therapies for heart failure with reduced ejection fraction: ACEi/ARB/ARNI, beta‑blocker, mineralocorticoid receptor antagonist, and diuretics as appropriate.
Document use of cardiac resynchronization therapy (CRT) when indicated and that medications are at maximally tolerated doses or contraindicated.
State duration and response to medical therapy and rationale for proceeding to TMVR if inadequate response is documented.

TMVR considerationTranscatheter repair (eg, MitraClip) is for symptomatic patients who remain symptomatic despite maximally tolerated GDMT

Primary (Degenerative) MR — Device approvals and indication context

Devices with FDA approvals notedMitraClip and PASCAL have FDA approvals for significant symptomatic primary (degenerative) MR in patients at prohibitive surgical risk

Indication contextMitraClip additionally has an FDA indication for symptomatic secondary MR in selected heart failure patients despite optimal medical therapy; PASCAL shown noninferior to MitraClip in trials

Evidence summaryApprovals supported by RCTs, registries, and postmarketing data demonstrating procedural success and short-term effectiveness in selected populations

Secondary (Functional) MR — MitraClip FDA indication

FDA indication for MitraClip in secondary MRMitraClip approved for treatment of symptomatic secondary (functional) MR in heart failure patients despite optimal medical therapy

Evidence basisRandomized trials and observational studies demonstrated benefit in selected patients, including reduced mortality and HF hospitalization in a larger trial

Prerequisite therapyPatient should have failed maximally tolerated guideline-directed medical therapy prior to consideration

Edge-to-Edge Repair (MitraClip, PASCAL) — Definition

Technique definitionEdge-to-edge repair is a transcatheter technique that approximates mitral valve leaflets to reduce regurgitation

DevicesCommercial edge-to-edge devices include MitraClip and PASCAL (transcatheter clip/implant systems)

Device class and intentMinimally invasive transcatheter approach intended as an alternative to surgery for patients at prohibitive or high surgical risk

Transcatheter Mitral Valve Replacement of a Degenerated Bioprosthetic Valve — Definition (Valve-in-Valve)

Definition (valve-in-valve)Transcatheter mitral valve replacement of a degenerated surgical bioprosthetic mitral valve (valve-in-valve)

Coverage noteValve-in-valve with an FDA-approved device may be considered medically necessary when specified criteria are met

Policy historyStatement adding valve-in-valve consideration was added in 06/18/2021 policy update