Blue Cross Blue Shield RI Transcatheter Mitral Coverage Update

Coverage Criteria for Transcatheter Mitral Procedures

TEER or TMVR for primary MR

Covered when ALL of the following are met

Primary MR - symptomatic & prohibitive risk: Patient has symptomatic primary (degenerative) mitral regurgitation

Operative risk assessment: Patient is considered at prohibitive risk for open surgical mitral valve repair or replacementSTS predicted mortality risk ≥ 12% and/or logistic EuroSCORE ≥ 20%

Operative risk determination should be based on accepted risk models and clinical judgment

Device regulatory status: Procedure is performed with a device that is approved by the U.S. Food and Drug Administration for mitral valve repair/replacement

Device must be FDA‑approved for mitral valve repair

TEER for secondary MR with heart failure

Covered when ALL of the following are met

Heart failure with symptomatic secondary MR: Patient has heart failure and moderate-to-severe or severe symptomatic secondary (functional) mitral regurgitationEchocardiographic MR grade 3+ or 4+; NYHA class II, III, or IVa

MR severity and symptoms must be confirmed despite stable, maximally tolerated guideline-directed medical therapy

Optimized medical therapy: Patient has received maximally tolerated guideline-directed medical therapy for heart failure (and cardiac resynchronization therapy if appropriate)

Includes ACEi/ARB/ARNI, beta-blocker, mineralocorticoid receptor antagonist, diuretics as indicated per guideline recommendations

Device regulatory status: Procedure is performed with a device that is approved by the U.S. Food and Drug Administration for transcatheter mitral valve repair

Device must be FDA‑approved for this indication

Transcatheter mitral valve-in-valve replacement (TMViVR)

Covered when ALL of the following are met

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

Documented by appropriate imaging and clinical assessment

Symptomatic status: Patient has New York Heart Association (NYHA) class II, III, or IV symptomsNYHA II–IV

Symptoms should be attributable to mitral valve dysfunction

Operability / surgical risk documented: Individual is not an operable candidate for open surgery, or is operable but at intermediate to prohibitive surgical risk, or is at increased surgical risk due to prior anatomy/operationsOperability/surgical risk documented by at least 2 cardiovascular specialists (including a cardiac surgeon)

Covered with criteria / product-specific statements

Coverage stance and medical necessity summaries by product and procedure

Medicare Advantage - TEER: Transcatheter Edge-to-Edge Repair (TEER) with an FDA-approved device may be considered medically necessary for Medicare Advantage members when medical criteria are met or when provided under a CMS‑approved clinical trial as applicable.

BCBSRI follows CMS guidelines; Medicare Advantage policies may differ from Commercial products.

Commercial - TEER: TEER with an FDA-approved device may be considered medically necessary for Commercial product members when the medical criteria in this policy are met.

Prior authorization is recommended for Commercial products.

TMVR general (Medicare Advantage & Commercial): Transcatheter mitral valve replacement with an FDA-approved device may be considered medically necessary when the specific medical criteria in this policy are met; evidence is insufficient to support coverage outside these indications.

Applies to Medicare Advantage Plans and Commercial Products.

Covered with criteria / Evidence summaries

Coverage stance and supporting evidence summaries present in this section:

TMViVR evidence summary - prior bioprosthetic valves: For individuals with dysfunction of a prior bioprosthetic mitral valve who are at intermediate-to-high or prohibitive risk for redo surgical mitral valve replacement, TMViVR using an FDA‑approved device is supported by meta-analyses, comparative retrospective cohort studies, and observational studies showing comparable short-term survival, shorter hospital/ICU stay, and fewer certain complications versus redo surgical replacement; evidence limited by lack of randomized trials.FDA‑approved device

See regulatory evidence summaries for details on study types and outcomes.

TMViVR in intermediate-risk patients - FDA analysis: Use in intermediate surgical risk patients is supported by an FDA analysis combining registry and prospective cohort data that met FDA performance goals for mortality and stroke and demonstrated improvements in functional status and MR severity.Benchmarked against historical surgical standards

FDA analysis met predefined performance goals.

Medicare Advantage plan coverage for transcatheter mitral valve procedures must follow Centers for Medicare and Medicaid Services (CMS) guidelines. BCBSRI follows CMS determinations, and as a result policies for Medicare Advantage members may differ from Commercial products and may reflect CMS national or local coverage determinations.

Procedures described in this policy are covered only when the specified medical criteria are met. When those medical criteria are not met, the procedures (including TEER, TMVR, and TMViVR) are not covered or considered not medically necessary because the evidence is insufficient to determine meaningful effects on health outcomes in other situations.

Randomized trials comparing TMViVR to redo surgical mitral valve replacement (rSMVR) are limited because assigning patients at high or prohibitive surgical risk to repeat open surgery raises ethical concerns. As noted in the evidence review, this ethical limitation means most comparative data are retrospective or observational rather than randomized.

Coverage determinations are governed by the member's subscriber agreement, member certificate, and/or employer agreement, which supersede this medical policy. This policy is informational and does not guarantee payment; providers should verify member-specific benefits and eligibility with the payer or provider call center before proceeding.

When the medical criteria in this policy are not satisfied, transcatheter mitral valve repair or replacement (including TEER and TMVR) may be deemed not medically necessary and therefore not covered. Coverage is limited to the indications and criteria expressly described in the policy.

If a service is determined to be not medically necessary or is a non-covered benefit, the provider may not bill the member unless the member provided written agreement in advance to assume financial responsibility. Providers should obtain prior written member agreement before delivering services expected to be non-covered.

Coding and Definitions Relevant to Procedures

Transcatheter Edge-to-Edge Repair (TEER) CPT codesCPT

33418	TEER procedure code listed
33419	TEER procedure code listed
0345T	TEER emerging technology/procedure code listed

Transcatheter Mitral Valve Replacement (TMVR) CPT codeCPT

0544T

Transcatheter mitral valve replacement (TMVR) code

Transcatheter mitral valve-in-valve replacement (TMViVR) CPT codesCPT

0483T	Transcatheter mitral valve-in-valve replacement code
0484T	Transcatheter mitral valve-in-valve replacement code

TEER CPT CodesCPTCovered

33418	Transcatheter mitral valve repair, percutaneous approach; initial prosthesis
33419	Transcatheter mitral valve repair, percutaneous approach; additional prosthesis(es) during same session (add-on)
0345T	Transcatheter mitral valve repair percutaneous approach via the coronary sinus

TMVR CodesCPTCovered

0544T

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

TMViVR CodesCPTCovered

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

Prohibitive surgical risk thresholds — STS and EuroSCORE

STS predicted mortality≥ 12% (Society for Thoracic Surgeons predicted mortality)

Logistic EuroSCORE≥ 20% (logistic EuroSCORE)

Determination basisProhibitive risk may be determined by presence of either threshold (STS ≥12% and/or logistic EuroSCORE ≥20%).

MR severity by echocardiography — grading and symptomatic threshold

Echocardiographic gradeGrade 3+ (moderate) or 4+ (severe) MR confirmed by echocardiography

Provider Actions, Prior Authorization, and Billing Requirements

Prior Authorization

Prior Authorization Required / Recommended

Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products. Participating providers must obtain prior authorization via the payer's online tool. Failure to obtain required prior authorization for Medicare Advantage members may result in claim denial or noncoverage.

Prior authorization required for Medicare Advantage Plans.
Prior authorization recommended for Commercial Products.
Obtain prior authorization via the payer's online tool for participating providers.

Documentation Required

Confirm Prior Authorization and Verify Benefits

Providers must confirm prior authorization and member benefits prior to scheduling the procedure. Benefits and coverage may vary by contract; verify applicable surgery benefits via the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement and by contacting the provider call center as needed.

Background and Epidemiology

Mitral regurgitation (MR) may be primary—caused by a structural valve abnormality such as leaflet prolapse or flail—or secondary (functional), resulting from left ventricular dilatation with otherwise structurally normal valve leaflets. Transcatheter approaches include Transcatheter Edge-to-Edge Repair (TEER) for leaflet approximation and transcatheter mitral valve replacement (TMVR) techniques, including valve-in-valve implantation for dysfunctional bioprosthetic mitral valves. These less-invasive options are intended principally for patients at increased, intermediate, or prohibitive surgical risk or for those with symptomatic secondary MR despite maximally tolerated guideline-directed medical therapy.

Definitions and Clinical Thresholds

Prohibitive risk for open surgery

STS predicted mortality threshold≥ 12%

Logistic EuroSCORE threshold≥ 20%

InterpretationPresence of either threshold may be used to determine prohibitive risk for open surgery.

Moderate-to-severe or severe secondary MR

Echocardiographic MR gradeGrade 3+ (moderate) or 4+ (severe)

Symptom requirementNYHA class II–IVa (ambulatory) despite stable, maximally tolerated guideline-directed medical therapy

Context

OpenPayer

Transcatheter Mitral Valve Repair or Replacement

Coverage Criteria for Transcatheter Mitral Procedures

Coding and Definitions Relevant to Procedures

Provider Actions, Prior Authorization, and Billing Requirements

Background and Epidemiology

Definitions and Clinical Thresholds