CurrentHealthPartnersPolicy N/A

Transcatheter Tricuspid Valve Replacement (TTVR)

Governs coverage of transcatheter tricuspid valve replacement (TTVR) for treatment of symptomatic tricuspid regurgitation (TR) for HealthPartners members, aligning with the CMS National Coverage Determination when furnished within a CMS‑approved Coverage with Evidence Development (CED) study.

Policy Summary

PayerHealthPartners

PolicyTranscatheter Tricuspid Valve Replacement (TTVR)

Policy CodePolicy N/A

Change TypeNCD issued (Coverage with Evidence Development)

Effective DateN/A

Next Review DateN/A

Key ActionObtain authorization and confirm patient enrollment in a CMS‑approved CED study before providing TTVR.

SourceLink

POLICY UPDATE CHANGES

CMS established an NCD to cover TTVR for symptomatic TR under Coverage with Evidence Development when furnished according to an FDA market-authorized indication within a CMS-approved CED study.

1NCD referenced

CEDCoverage pathway

CMS-approved studyEnrollment required

NCD 310.1Alternate pathway

Coverage Criteria for Transcatheter Tricuspid Valve Replacement (TTVR)

Coverage under CMS NCD with CED

Covered when ALL of the following are met

Primary coverage condition: TTVR is furnished for treatment of symptomatic tricuspid regurgitation (TR) AND the procedure is performed according to an FDA market-authorized indication AND the patient is enrolled in a CMS-approved Coverage with Evidence Development (CED) study

Coverage may alternatively be provided via NCD 310.1 (Clinical Trial Policy) or an IDE study per the NCD.

Coverage for transcatheter tricuspid valve replacement (TTVR) does not extend to procedures furnished outside of a CMS‑approved Coverage with Evidence Development (CED) study unless the service is covered under NCD 310.1 (Clinical Trial Policy) or is provided as part of an Investigational Device Exemption (IDE) study. This follows the CMS National Coverage Determination that limits routine coverage to TTVR performed within an approved CED study or through the alternate pathways noted above.

TTVR is not eligible for routine coverage when performed outside of an approved CMS‑CED study, outside coverage under NCD 310.1, or outside an IDE study. Per the CMS NCD, enrollment in a qualifying study or coverage under the Clinical Trial Policy/IDE pathway is required for coverage consideration.

Coding and Billing

Policy Summary

PayerHealthPartners

PolicyTranscatheter Tricuspid Valve Replacement (TTVR)

Policy CodePolicy N/A

Change TypeNCD issued (Coverage with Evidence Development)

Effective DateN/A

Next Review DateN/A

Key ActionObtain authorization and confirm patient enrollment in a CMS‑approved CED study before providing TTVR.

SourceLink

On This Page

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Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Requires CMS‑Approved Study Enrollment

Prior authorization is required. Authorization will only be granted when the provider documents that the patient is enrolled in a CMS‑approved Coverage with Evidence Development (CED) study (or in the alternative pathways described below). The provider must obtain authorization prior to the procedure and confirm study enrollment in the authorization documentation.

Enrollment in a CMS‑approved CED study is mandatory for coverage under the NCD.
Prior authorization must include documentation of CMS‑approved study enrollment.

Documentation Required

Provider Documentation Requirement

Providers must ensure study enrollment is clearly documented in the medical record and in any authorization or claim submission. Failure to document enrollment in an approved study may result in denial of coverage.

Document study name, CMS approval status, and patient enrollment identifier in the record.
Include study enrollment documentation with the prior authorization request and retain copies in the medical record.

Note

Required Study Enrollment and FDA‑Authorized Indication

Coverage is contingent on the patient being both enrolled in a CMS‑approved CED study and that the TTVR is furnished consistent with an FDA market‑authorized indication. If the device/procedure is provided outside an FDA‑authorized indication, coverage is limited to enrollment in an applicable IDE or to coverage under NCD 310.1 (Clinical Trial Policy) when criteria are met.

TTVR must be furnished according to an FDA market‑authorized indication to qualify under the CED pathway.
If not within an FDA indication, coverage may still be possible via an IDE study or NCD 310.1 (Clinical Trial Policy).

Denial Risk

Coverage Contingent on Study Enrollment

Coverage under this NCD is limited to individuals enrolled in a CMS‑approved CED study; alternatively, coverage may be available through NCD 310.1 (Clinical Trial Policy) or an Investigational Device Exemption (IDE) study when applicable. Providers should confirm which pathway applies before scheduling and billing.

Coverage pathways: CMS‑approved CED study (preferred), NCD 310.1 (Clinical Trial Policy), or IDE study.
Verify pathway and document appropriate study enrollment or trial identifiers on prior authorization and claims.

Definitions

CED — Coverage with Evidence Development (definition and requirements)

DefinitionCoverage with Evidence Development (CED): a CMS coverage pathway requiring that items/services be furnished within approved clinical studies to qualify for coverage.

Coverage requirementTTVR is covered under CED only when furnished according to an FDA market-authorized indication within a CMS-approved CED study.

Alternate coverageNothing in the NCD prevents coverage through NCD 310.1 (Clinical Trial Policy) or an IDE study as alternative pathways.

Impact on local determinationsPrior MAC local coverage determinations or plan discretion are supplanted for covered cases meeting the NCD CED requirements.

Action for providersEnsure patient enrollment in a CMS-approved CED study and document FDA market-authorized indication to support coverage under CED.

NCD 310.1 — CMS Clinical Trial Policy (alternate coverage pathway)

DefinitionNCD 310.1 (Clinical Trial Policy): CMS policy permitting coverage when services are furnished in qualifying clinical trials.

Relation to TTVR NCDThe TTVR NCD states that coverage through CED does not prevent coverage via NCD 310.1 for eligible clinical trials.

Alternate pathway useProviders may seek coverage for TTVR through NCD 310.1 when the procedure is provided within a qualifying clinical trial instead of a CMS-approved CED study.

Documentation implicationWhen pursuing NCD 310.1 coverage, document trial eligibility and adherence to trial protocols to support coverage determinations.

OpenPayer

Transcatheter Tricuspid Valve Replacement (TTVR)

Coverage Criteria for Transcatheter Tricuspid Valve Replacement (TTVR)

Coding and Billing

Provider Actions and Authorization Requirements

Background

Definitions