CurrentHealthPartnersPolicy CAG-00468N

Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER)

Governance of coverage for T-TEER for symptomatic tricuspid regurgitation, describing when HealthPartners will cover the procedure for Medicare enrollees in accordance with the CMS National Coverage Determination and related study requirements.

Policy Summary

PayerHealthPartners

PolicyTranscatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER)

Policy CodePolicy CAG-00468N

Change TypeAdoption of CMS NCD (CED) coverage

Effective DateJul 2, 2025

Next Review DateN/A

Key ActionObtain prior authorization confirming the patient is Medicare, has symptomatic TR, the device use matches the FDA market-authorized indication, and the procedure will occur within a CMS-approved CED study.

SourceLink

POLICY UPDATE CHANGES

CMS established an NCD to cover T-TEER for symptomatic TR under Coverage with Evidence Development (CED) when furnished per FDA market-authorized indication and within a CMS-approved CED study.

2025-07-02Effective

1NCD referenced

MedicarePayer population

Coverage Criteria for T-TEER

Coverage under CMS NCD (CED)

Covered when ALL of the following are met:

CMS NCD coverage conditions: Patient is a Medicare beneficiary with symptomatic tricuspid regurgitation AND T-TEER is furnished according to a Food and Drug Administration (FDA) market-authorized indication AND the procedure is performed within a CMS-approved Coverage with Evidence Development (CED) study

Coverage may alternatively be provided under NCD 310.1 (Clinical Trial Policy) or an Investigational Device Exemption (IDE) study when applicable.

T-TEER is not covered for patients treated outside of a CMS-approved Coverage with Evidence Development (CED) study. The CMS NCD states that T-TEER is covered for Medicare patients with symptomatic tricuspid regurgitation only when the procedure is furnished according to an FDA market-authorized indication and within a CMS-approved CED study; procedures performed outside such a study are explicitly not covered.

Any T-TEER performed for patients who do not meet the CMS NCD criteria is not covered under this NCD. Specifically, coverage is limited to Medicare beneficiaries with symptomatic tricuspid regurgitation when the device is used consistent with its FDA market-authorized indication and the procedure is performed within a CMS-approved CED study; procedures that do not match these conditions (including those not within a CMS-approved CED study) are excluded from coverage under the NCD. The NCD does not preclude alternate coverage pathways such as NCD 310.1 (Clinical Trial Policy) or an IDE study when applicable.

Policy Summary

PayerHealthPartners

PolicyTranscatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER)

Policy CodePolicy CAG-00468N

Change TypeAdoption of CMS NCD (CED) coverage

Effective DateJul 2, 2025

Next Review DateN/A

SourceLink

On This Page

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Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required per the CMS National Coverage Determination (NCD) for transcatheter edge-to-edge repair (T-TEER). Providers must confirm the procedure will be performed in accordance with the CMS NCD and within a CMS‑approved Coverage with Evidence Development (CED) study when applicable.

Effective date: 2025-07-02
T-TEER covered only when furnished per FDA market‑authorized indication and within a CMS‑approved CED study
T-TEER not covered for patients outside a CMS‑approved study

Note

Provider Responsibilities

Providers must ensure patient selection and treatment planning follow the CMS NCD/CED requirements. Confirm enrollment/participation in the CMS‑approved CED study before scheduling the procedure and document study participation in the medical record and claim submission.

Verify patient meets CMS NCD eligibility (symptomatic TR and Medicare beneficiary)
Document participation in the CMS‑approved CED study or alternative CMS‑approved coverage pathway (e.g., Clinical Trial NCD 310.1 or IDE study)
Include study identifiers and investigator/site information in clinical documentation

Documentation Required

Documentation Required for Coverage

Medical records and submitted documentation must demonstrate that the patient is a Medicare beneficiary, has symptomatic tricuspid regurgitation (TR), and that T-TEER is furnished per CMS NCD/CED and FDA market‑authorized indication. Documentation should support medical necessity and compliance with all CED data collection and reporting requirements.

Evidence of Medicare beneficiary status (e.g., Medicare ID)
Clinical documentation of symptomatic TR and prior therapies/trial of medical management as applicable
Documentation confirming FDA market‑authorized device indication for the procedure
Proof of enrollment or participation in the CMS‑approved CED study, including study ID and required data elements
Operative note and device implant details showing procedure performed per protocol

Denial Risk

Coverage Limited to CMS‑Approved CED Studies

Coverage is limited to patients treated within a CMS‑approved CED study (or alternative CMS‑approved pathways such as NCD 310.1 or an IDE study). T-TEER performed outside a CMS‑approved CED study is not covered by Medicare and may be denied; providers and facilities may be financially responsible for non‑covered services.

T-TEER not covered outside a CMS‑approved study — claims may be denied and providers may bear cost responsibility
If performed outside a CED study, identify whether another CMS pathway applies (e.g., Clinical Trial NCD 310.1 or IDE) before billing Medicare
Ensure reporting and data submission obligations of the CED study are met to maintain coverage eligibility

Definitions

Coverage with Evidence Development (CED)

DefinitionCoverage with Evidence Development (CED): A CMS approach providing coverage for services contingent on their being furnished in the context of approved clinical studies that collect additional evidence.

Key requirementT-TEER is covered only when furnished within a CMS‑approved CED study as specified in the NCD.

PurposeCollect additional evidence on effectiveness and safety while allowing conditional Medicare coverage.

AlternativesCoverage may instead be available under NCD 310.1 (Clinical Trial Policy) or an Investigational Device Exemption (IDE) study when applicable.

FDA market‑authorized indication

DefinitionFDA market‑authorized indication: Use of the device consistent with indications for which the device has received market authorization from the U.S. Food and Drug Administration.

Key requirementT-TEER must be furnished according to an FDA market‑authorized indication to meet the NCD coverage conditions.

Relation to coverageMeeting the FDA market‑authorized indication is one of the required conditions for Medicare coverage of T‑TEER under the CED NCD.

Documentation implicationProvider documentation must demonstrate device use aligns with the FDA market‑authorized indication for the patient to qualify for coverage under the NCD.

OpenPayer

Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER)

Coverage Criteria for T-TEER

Codes and Coding Notes

Provider Requirements and Documentation

Background

Definitions