CurrentKaiser PermanentePolicy N/A

Transcatheter mitral valve repair (MitraClip / TMVR) — Clinical Review Criteria

Clinical review criteria governing medical necessity and authorization for transcatheter mitral valve repair (including MitraClip/TEER) for Kaiser Foundation Health Plan of Washington members; applies to providers requesting coverage. Affects Medicare and non‑Medicare members as described.

Policy Summary

PayerKaiser Permanente

PolicyTranscatheter mitral valve repair (MitraClip / TMVR) — Clinical Review Criteria

Policy CodePolicy N/A

Change TypeCriteria expandedthresholds specified

Effective DateJun 1, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with the FDA‑approved device name and the last 6 months of clinical notes to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Criteria were expanded to include symptomatic secondary (functional) mitral regurgitation for patients with heart failure despite maximally tolerated guideline-directed medical therapy.

High surgical risk thresholds for prohibitive risk were specified numerically (logistic EuroSCORE >= 20% or STS predicted mortality >= 12%).

MitraClipnamed device with PMA approval

>=20%Logistic EuroSCORE threshold

>=12%STS predicted mortality threshold

3 codesexample procedure codes listed

01/05/2021policy adoption approval

Medical Necessity and Coverage Rules

Medical necessity criteria

Covered when ALL of the following are met for non‑Medicare members (primary MR) or when the listed criteria for secondary MR are met:

Primary (degenerative) MR - prohibitive surgical risk: Symptomatic primary (degenerative) mitral regurgitation (MR grade 3+ or 4+) AND patient determined to be at prohibitive risk for open mitral valve repair surgery by a heart team (including a cardiac surgeon and cardiologist) AND existing comorbidities would not preclude expected benefit from reduction of MR.prohibitive risk = logistic EuroSCORE >= 20% OR STS predicted mortality >= 12%

Device must be FDA-approved (eg, MitraClip).

Secondary (functional) MR in heart failure: Heart failure patients with symptomatic moderate-to-severe (grade 3+) or severe (grade 4+) secondary (functional) MR despite maximally tolerated guideline-directed medical therapy AND cardiac resynchronization therapy if appropriate; symptoms corresponding to NYHA class II, III, or ambulatory IV.NYHA II-IV; echocardiographic grade 3+ or 4+

Policy Summary

PayerKaiser Permanente

PolicyTranscatheter mitral valve repair (MitraClip / TMVR) — Clinical Review Criteria

Policy CodePolicy N/A

Change TypeCriteria expandedthresholds specified

Effective DateJun 1, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with the FDA‑approved device name and the last 6 months of clinical notes to support medical necessity.

SourceLink

On This Page

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Billing Codes and Risk Thresholds

Covered CPT / HCPCS CodesmixedCovered

0345T	Transcatheter mitral valve repair percutaneous approach via the coronary sinus.
33418	Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; initial prosthesis.
33419	Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; additional prosthesis(es) during same session (List separately in addition to code for primary procedure)

inv-06: Logistic EuroSCORE

Logistic EuroSCORE threshold>= 20%

ContextDocumented presence of a logistic EuroSCORE of 20% or greater as criteria for prohibitive surgical risk

Applies toNon‑Medicare members considered for transcatheter mitral valve repair when prohibitive surgical risk is claimed

inv-07: STS predicted mortality risk

STS predicted mortality risk threshold>= 12%

ContextDocumented presence of a Society for Thoracic Surgeons predicted mortality risk of 12% or greater as alternate criteria for prohibitive surgical risk

Usage noteUsed as an alternate numeric threshold to define prohibitive risk for open mitral valve repair surgery

Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Submit a prior authorization request before scheduling transcatheter mitral valve repair to confirm coverage and medical necessity.

Use Pre-authorization Code Check to verify requirements for specific CPT/HCPCS codes
Include planned FDA‑approved device name in request

Step Therapy

Therapy Optimization Requirement

Therapy optimization required for secondary MR. Coverage for transcatheter mitral valve repair for symptomatic secondary (functional) mitral regurgitation requires persistent symptoms despite maximally tolerated guideline‑directed medical therapy (GDMT) and cardiac resynchronization therapy when appropriate.

Document stable maximal doses of GDMT and duration of optimization
Document use and appropriateness of cardiac resynchronization therapy (if applicable)
Confirm NYHA class II–IV ambulatory symptoms and echocardiographic grade 3+ or 4+ MR

Documentation Required

Required Documentation

Required documentation to support medical necessity. Include complete clinical evidence with the authorization request to expedite review.

Name of the FDA‑approved device to be used
Last 6 months of clinical notes from the requesting provider and/or specialist
Documentation of NYHA functional class and echocardiography confirming MR grade (3+ or 4+)
For secondary MR: records showing maximally tolerated GDMT details and any cardiac resynchronization therapy (if given)
Risk assessment scores when applicable (e.g., logistic EuroSCORE, STS predicted mortality risk)

Denial Risk

Insufficient Documentation / Denial Risk

Insufficient documentation may lead to denial. Failure to provide the required clinical information prevents demonstration of medical necessity and may result in claim denial or delay.

Missing device name, recent clinical notes, echocardiogram results, or GDMT optimization details increases denial risk
Incomplete risk scoring (EuroSCORE or STS) for primary MR cases may prevent approval

Definitions and Device Information

inv-13: MitraClip (MitraClip CDS)

Device nameMitraClip Clip Delivery System (MitraClip CDS)

ApprovalFDA approval via PMA on October 24, 2013

IndicationPercutaneous reduction of significant symptomatic mitral regurgitation due to primary (degenerative) MR in patients at prohibitive surgical risk

Device descriptionSystem consists of implant catheters and a permanent MitraClip implant that attaches to mitral valve leaflets to create a double‑orifice and reduce MR

inv-14: Prohibitive surgical risk

DefinitionProhibitive surgical risk = logistic EuroSCORE >= 20% OR STS predicted mortality >= 12%

DeterminationRisk must be determined by a heart team including a cardiac surgeon and a cardiologist experienced in mitral valve disease

Related requirementExisting comorbidities should not preclude expected benefit from MR reduction

OpenPayer

Transcatheter mitral valve repair (MitraClip / TMVR) — Clinical Review Criteria

Medical Necessity and Coverage Rules

Billing Codes and Risk Thresholds

Authorization, Documentation, and Operational Requirements

Clinical Background

Definitions and Device Information