Blue Cross Blue Shield MA Transcatheter Mitral Coverage Update

Coverage Criteria

TMVR for symptomatic primary MR in prohibitive surgical risk

Covered when ALL of the following are met

Indication: Symptomatic primary (degenerative) mitral regurgitation (MR).

Surgical risk: Patient is considered at prohibitive risk for open surgical mitral valve repair or replacement as defined by policy or heart team assessment (eg, STS predicted mortality ≥12% or logistic EuroSCORE ≥20%; FDA high-risk definition noted).Prohibitive surgical risk as defined by policy

Operability and surgical risk should be documented by at least two cardiovascular specialists, including a cardiac surgeon.

Device approval: Use of an FDA‑approved transcatheter mitral valve repair device for the indicated repair procedure.

Examples include devices approved for TEER (eg, MitraClip/PASCAL) when appropriate for primary MR per labeling.

TMVR for symptomatic secondary MR despite guideline-directed therapy

Covered when ALL of the following are met

Indication: Heart failure with symptomatic moderate-to-severe (grade 3+) or severe (grade 4+) secondary (functional) mitral regurgitation.Moderate-to-severe or severe MR (grade 3+ or 4+)

MR severity should be confirmed by echocardiography.

Symptoms: Persistent symptoms consistent with New York Heart Association (NYHA) functional class II, III, or IV despite therapy.NYHA class II–IV

Ambulatory patients should remain symptomatic despite therapy.

Maximally tolerated guideline-directed therapy: Patient has received maximally tolerated guideline-directed medical therapy for heart failure (ACE inhibitor, ARB, or ARNI; beta‑blocker; mineralocorticoid receptor antagonist; diuretics as needed) and cardiac resynchronization therapy when appropriate.

TMViVR for failing surgical bioprosthetic mitral valve

Covered when ALL of the following are met

Bioprosthetic valve failure: Failure of a surgical bioprosthetic mitral valve (stenosis, insufficiency, or combined dysfunction).

Symptoms: New York Heart Association (NYHA) heart failure class II, III, or IV symptoms.NYHA class II–IV

Operability / Surgical risk (one of): One of the following must be documented by at least two cardiovascular specialists (including a cardiac surgeon): (1) patient is not an operable candidate for open surgery; OR (2) patient is an operable candidate but is at intermediate to prohibitive surgical risk for open surgery; OR (3) patient is at increased surgical risk for open surgery due to factors such as prior sternotomy, congenital vascular anomalies, or complex intrathoracic surgical history.

Documentation by ≥2 cardiovascular specialists (including a cardiac surgeon) is required.

Investigational / Not covered indications

Investigational uses: Transcatheter mitral valve procedures and devices not explicitly described as medically necessary in this policy are considered investigational and not covered. This includes procedures/devices without U.S. FDA approval for the specific indication (eg, transcatheter mitral valve annulus reconstruction with adjustable annulus devices and other devices under investigation).

Use of non‑approved devices or indications lacks sufficient evidence to determine improvement in net health outcome.

TMViVR medically necessary criteria

Transcatheter mitral valve-in-valve replacement (TMViVR) with an FDA-approved device is considered medically necessary when ALL of the following are present:

Failed surgical bioprosthesis: Failure (stenosed, insufficient, or combined) of a surgical bioprosthetic mitral valve.

Symptoms: New York Heart Association (NYHA) heart failure class II, III, or IV symptoms.NYHA class II–IV

Operability documentation (one of): One of the following documented by at least two cardiovascular specialists (including a cardiac surgeon): (1) patient is not an operable candidate for open surgery; OR (2) patient is an operable candidate but is at intermediate to prohibitive surgical risk for open surgery; OR (3) patient is at increased surgical risk for open surgery (eg, repeat sternotomy, congenital vascular anomalies, or complex intrathoracic surgical history).

Documentation by ≥2 cardiovascular specialists (including a cardiac surgeon) is required.

TMVR for secondary MR coverage prerequisites

Coverage for transcatheter mitral valve repair (TMVR) using MitraClip for secondary MR requires:

Guideline‑directed medical therapy: Persistent symptomatic secondary MR despite maximally tolerated guideline‑directed medical therapy for heart failure, including ACE inhibitor or ARB or ARNI, beta‑blocker, mineralocorticoid receptor antagonist, and diuretics as needed.

Therapy should be administered in accordance with specialty society guidelines and documented in the record.

Resynchronization when appropriate: Cardiac resynchronization therapy (CRT) has been considered and applied when indicated and appropriate prior to TMVR evaluation.

Document CRT use or rationale if CRT is not appropriate.

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Procedures or devices that are not specifically FDA‑approved for transcatheter mitral valve repair or that remain under investigation are considered investigational and not covered. Examples cited in the evidence base include transcatheter mitral annulus reconstruction techniques and adjustable annuloplasty systems (e.g., devices described in the Carillon, Monarc, AccuCinch, enCorTC/enCorso, and Cardioband programs) whose safety and long‑term efficacy remain under evaluation.

The policy explicitly lists transcatheter annulus reconstruction with implantation of an adjustable annulus reconstruction device (CPT 0544T) among approaches under investigation. Devices and techniques targeting the annulus by direct or indirect annuloplasty are noted in the literature but, unless an FDA indication is documented in this policy, such approaches are treated as investigational.

Use of TMVR devices other than the FDA‑approved transcatheter edge‑to‑edge systems (MitraClip and PASCAL) is considered investigational or insufficient for routine coverage pending stronger evidence of net health benefit. Systematic reviews, randomized and nonrandomized prospective studies, and feasibility series are summarized but judged inadequate to establish consistent improvement in patient‑centered outcomes.

The evidence review highlights that while some devices (including indirect annuloplasty systems) have promising safety signals, additional randomized or longer‑term comparative data are required before routine coverage can be supported for devices beyond MitraClip or PASCAL.

The policy references external guidance (professional society guidelines and the CMS National Coverage Determination for TEER) to inform coverage decisions but does not state additional explicit exclusions beyond investigational uses described elsewhere in the document.

Providers should refer to the cited CMS NCD and specialty society guidance for specific requirements that may affect prior authorization and documentation; absence of a specific exclusion in these reference sections does not imply coverage if the intervention does not meet the policy’s medical‑necessity criteria.

Transcatheter mitral valve repair or replacement performed for indications not listed as medically necessary in this policy is considered investigational. Specifically, TMVR performed outside the delineated situations — symptomatic primary MR in patients at prohibitive surgical risk; symptomatic secondary MR refractory to maximally tolerated guideline‑directed medical therapy; or TMViVR for failing surgical bioprosthetic valves meeting the stated criteria — is not covered.

The policy therefore restricts coverage to the defined medically necessary scenarios and treats other clinical indications or uses of non‑approved devices as investigational until sufficient evidence supports a change in stance.

TMVR with devices other than MitraClip or PASCAL for symptomatic MR is considered investigational when the evidence is insufficient to demonstrate an improvement in net health outcome. The document’s evidence summary notes mixed results across trials and observational studies and emphasizes the need for additional randomized or longer‑term comparative data before these alternatives can be considered medically necessary.

Coverage decisions for newer or alternative TMVR devices will depend on high‑quality evidence showing benefit on survival, functional status, symptom burden, and acceptable procedural morbidity compared with available therapies.

The policy’s evidence summary cites multiple pivotal trials and reviews relevant to transcatheter mitral interventions, including EVEREST, COAPT, MITRA‑FR and other randomized and observational studies. These sources are summarized to convey varied outcomes across devices and patient populations rather than to establish broad not‑medically‑necessary determinations.

While some trials (for example COAPT and subsequent follow‑up publications) support benefit in selected patients, other randomized trials and comparative studies report less definitive or mixed results. The policy therefore relies on the totality of the evidence and guideline recommendations to define the specific medically necessary indications listed elsewhere in the document.

Coding

Covered CPT CodesCPTCovered

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).
0483T	Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; percutaneous approach including transseptal puncture when performed.
0484T	Transcatheter mitral valve implantation/replacement (TMI) with prosthetic valve; transthoracic exposure (eg, thoracotomy, transapical).
0345T

Investigational CPT CodesCPTExperimental

0544T

Transcatheter mitral valve annulus reconstruction; with implantation of adjustable annulus reconstruction device, percutaneous approach including transseptal puncture.

ICD-10-PCS Procedure CodesICD-10

O2RG3JZ	Replacement of Mitral Valve with Synthetic Substitute, Percutaneous Approach.
O2RGAJZ	Replacement of Mitral Valve with Synthetic Substitute, Percutaneous Endoscopic Approach.
02Q63ZZ	Repair Mitral Valve; Percutaneous Approach.
O2QG4ZZ	Repair Mitral Valve, Percutaneous Endoscopic Approach.
02UG3JZ	Supplement Mitral Valve with Synthetic Substitute, Percutaneous Approach.
02UG4JZ	Supplement Mitral Valve with Synthetic Substitute; Percutaneous Endoscopic Approach.

Medically necessary CPT codes (updated)CPTCovered

0483T	CPT code added to medically necessary table (document notes addition).
0484T	CPT code added to medically necessary table (document notes addition).

STS predicted operative risk score — Prohibitive

Prohibitive STS threshold>= 12% predicted mortality (STS predicted operative risk)

FDA high-risk STS thresholdSTS predicted operative risk >= 8% (FDA definition of high risk)

FDA expected mortality criterionExpected mortality for open surgery >= 15% (FDA high-risk definition)

NYHA class

NYHA functional classes includedClass II, III, or IV

Context of requirementRequired for TMViVR medical necessity and for defining moderate-to-severe/severe MR despite therapy

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Precertification/preauthorization is required for all products if the procedure is performed inpatient. For outpatient settings, follow product-specific prior authorization rules; some commercial plans designate these procedures as inpatient-only and thus outpatient prior authorization may not apply.

Preauthorization required for inpatient procedures described in this policy.
For outpatient, confirm product-specific rules (Commercial Managed Care HMO/POS; PPO and Indemnity noted as inpatient-setting procedures).

Documentation Required

Documentation Requirement for Surgical Risk

Documentation must demonstrate that the individual is not an operable candidate for open surgery or is at intermediate to prohibitive surgical risk, as determined and documented by at least two cardiovascular specialists (one of whom must be a cardiac surgeon). If operable but at increased surgical risk (eg, repeat sternotomy, complex intrathoracic history, congenital vascular anomalies), this must also be documented by at least two cardiovascular specialists (including a cardiac surgeon). Acceptable risk scores and criteria (eg, STS, EuroSCORE) may be used to support the assessment.

Background and Evidence Summary

Mitral regurgitation (MR) is a common valvular condition in older adults and is categorized as primary (degenerative) MR or secondary (functional) MR. Primary MR arises from structural abnormalities of the mitral valve apparatus (for example leaflet prolapse or flail) and is often managed surgically when patients are candidates for repair or replacement.

Secondary MR results from left ventricular dilatation or dysfunction (for example ischemic or dilated cardiomyopathy) with structurally normal leaflets and is primarily managed with guideline‑directed medical therapy for heart failure. Transcatheter approaches, including transcatheter edge‑to‑edge repair and valve‑in‑valve replacement, provide less invasive options for patients who are not suitable surgical candidates or who remain symptomatic despite optimal medical therapy.

Definitions

Primary MR

DefinitionMitral regurgitation caused by a primary structural abnormality of the mitral valve (e.g., leaflet prolapse or flail).

Alternate termAlso called degenerative or primary MR involving structural valve abnormality

Typical management implicationOften amenable to surgical correction; transcatheter approaches considered when surgery is high risk

Secondary MR

DefinitionMitral regurgitation due to left ventricular dilatation from ischemic or dilated cardiomyopathy with structurally normal valve leaflets.

Alternate termAlso called functional or secondary MR

OpenPayer

Transcatheter Mitral Valve Repair or Replacement

Coverage Criteria

Coding

Provider Actions and Requirements

Background and Evidence Summary

Definitions