CurrentHealthPartnersPolicy CAG-00438R

Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R)

Defines Medicare national coverage changes for transcatheter edge-to-edge repair (TEER) of the mitral valve, expanding coverage to selected beneficiaries with functional mitral regurgitation (FMR) and maintaining coverage for degenerative mitral regurgitation (DMR) under Coverage with Evidence Development (CED); also specifies exclusions and modifications to evaluation, facility, heart team, and volume requirements.

Policy Summary

PayerHealthPartners

PolicyTranscatheter Mitral Valve Repair (TMVR) (CAG-00438R)

Policy CodePolicy CAG-00438R

Change TypeRenamed; Coverage expanded; Requirements modified

Effective DateJan 19, 2021

Next Review Date

Key ActionPerform TEER for covered DMR and FMR patients only as part of a CMS‑approved clinical trial under Coverage with Evidence Development and ensure enrollment and compliance with CED and CMS evaluation/facility/team/volume requirements.

POLICY UPDATE CHANGES

NCD renamed to Transcatheter Edge-to-Edge Repair (TEER) for mitral valve regurgitation.

Coverage expanded to include Medicare beneficiaries with moderate-to-severe or severe functional mitral regurgitation (FMR) under select conditions.

Coverage of TEER for degenerative mitral regurgitation (DMR) maintained under CED and FDA‑approved indications.

Modified requirements for patient evaluation, facility infrastructure, heart team composition, and procedural volume.

TEER is non-covered in patients with untreated severe aortic stenosis.

2Covered Indications (DMR, FMR)

1Coverage Mechanism (CED)

Exclusion: Untreated severe AS

Coverage Summary

Scope: Transcatheter Edge-to-Edge Repair (TEER) — Medicare national coverage changes for transcatheter edge-to-edge repair of the mitral valve, expanding coverage to selected beneficiaries with functional mitral regurgitation (FMR) while maintaining coverage for degenerative mitral regurgitation (DMR) under Coverage with Evidence Development (CED).

Policy status: CURRENT; Policy number: CAG-00438R; Effective date: January 19, 2021.

Key Items

Covered Indications2

Definitive Exclusion1

Coverage Mechanism1

Coverage Stancemixed

StatusCURRENT

Medical-Necessity Criteria

Coverage for Degenerative Mitral Regurgitation (DMR)

Covered when ALL of the following are met:

DMR criteria: Patient has significant symptomatic degenerative mitral regurgitation (DMR)
FDA indication: Procedure (TEER) is performed according to an FDA‑approved indication
CED requirement: TEER is performed as part of a clinical trial under Coverage with Evidence Development (CED)

Coverage for Functional Mitral Regurgitation (FMR)

Covered when ALL of the following are met:

Required Provider Actions & Billing Impact

Prior Authorization

Coverage contingent on clinical trial / CED enrollment

Providers must perform TEER for covered DMR and FMR patients as part of a CMS‑approved clinical trial under Coverage with Evidence Development (CED) and ensure patient enrollment and ongoing compliance with the CED requirements.

Documentation Required

Meet CMS evaluation and facility/team/volume requirements

Providers and facilities must document that the CMS‑specified patient evaluation criteria are satisfied and that facility infrastructure, appropriate heart team composition, and the procedural volume requirements (as modified by CMS) are met to qualify for coverage.

Coding

No specific codes listed in documentmixed

No codes listed

Background

Background: CMS renamed the National Coverage Determination to Transcatheter Edge-to-Edge Repair (TEER) to more specifically identify the covered procedure, broadened coverage to include selected Medicare beneficiaries with moderate-to-severe or severe functional mitral regurgitation (FMR) under conditions intended to address evidence gaps and optimize outcomes, and retained coverage of TEER for degenerative mitral regurgitation (DMR) per FDA‑approved indications under Coverage with Evidence Development (CED).

CMS also modified program requirements — updating patient evaluation processes, facility infrastructure expectations, heart team composition, and procedural volume requirements — to facilitate access while ensuring quality; and clarified that TEER is non-covered for patients with untreated severe aortic stenosis.

Definitions

CEDCoverage with Evidence Development — coverage contingent on participation in CMS‑approved clinical studies or registries

DMRDegenerative mitral regurgitation

FMRFunctional mitral regurgitation

Medicare Determinations

Name	Number	Type	Effective Date
Transcatheter Mitral Valve Repair / Transcatheter Edge-to-Edge Repair (TEER)	20.33 (CAG-00438R)	NCD	2021-01-19

Revision History

2021-01-19renamed

NCD renamed to Transcatheter Edge-to-Edge Repair (TEER) for mitral valve regurgitation.

2021-01-19coverage_expansion

Coverage expanded to include Medicare beneficiaries with moderate-to-severe or severe functional mitral regurgitation (FMR) under select conditions and Coverage with Evidence Development (CED) to address evidence gaps and optimize outcomes.

2021-01-19coverage_maintained

Coverage of TEER for degenerative mitral regurgitation (DMR) maintained under Coverage with Evidence Development (CED) in accordance with FDA‑approved indications.

Policy Summary

PayerHealthPartners

PolicyTranscatheter Mitral Valve Repair (TMVR) (CAG-00438R)

Policy CodePolicy CAG-00438R

Change TypeRenamed; Coverage expanded; Requirements modified

Effective DateJan 19, 2021

Next Review Date

On This Page

FMR criteria: Patient has moderate-to-severe or severe functional mitral regurgitation (FMR)
Applicable clinical criteria (as defined in final decision memo) are met
CED requirement: Procedure (TEER) is performed as part of a clinical trial (CED)

Non-Coverage / Exclusions

Untreated severe aortic stenosis exclusion: TEER is not covered for beneficiaries with untreated severe aortic stenosis

Facility, Team, and Procedural Requirements

Coverage requires adherence to specified evaluation, infrastructure, team composition, and volume requirements:

Patient evaluation requirements as specified by CMS must be satisfied
Facility infrastructure requirements as specified by CMS must be met
Heart team composition: Appropriate heart team composition requirements as specified by CMS must be met
Procedural volume requirements (as modified by CMS) must be met

Denial Risk

Non-coverage for untreated severe aortic stenosis

TEER is non‑covered for beneficiaries with untreated severe aortic stenosis; claims for TEER in such patients are not covered and are subject to denial.

2021-01-19requirements_modified

Modified requirements for patient evaluation, facility infrastructure, heart team composition, and procedural volume to facilitate access and ensure quality.

2021-01-19non_coverage_clarified

TEER is non-covered for beneficiaries with untreated severe aortic stenosis.