CMS Covers Transcatheter Tricuspid Valve Replacement — But Only Under Strict CED Requirements
The Centers for Medicare & Medicaid Services has issued a modified national coverage determination for transcatheter tricuspid valve replacement (TTVR), effective March 12, 2026. Under NCD 379, CMS will cover TTVR for symptomatic tricuspid regurgitation (TR)—but exclusively under Coverage with Evidence Development (CED), meaning your facility must be enrolled in a CMS-approved clinical study to bill for this service. If your structural heart program is preparing to offer TTVR or has already performed cases, the coverage criteria here are specific, non-negotiable, and require immediate operational preparation.
| Field | Detail |
|---|---|
| Payer | CMS |
| Policy | Transcatheter Tricuspid Valve Replacement (TTVR) |
| Policy Code | NCD 379 |
| Change Type | Modified |
| Effective Date | 2026-03-12 |
| Impact Level | High |
| Specialties Affected | Cardiac surgery, interventional cardiology, heart failure cardiology, electrophysiology, cardiac imaging, interventional echocardiography |
| Key Action | Confirm your facility is enrolled in a CMS-approved CED study before billing any TTVR cases to Medicare. |
What CMS NCD 379 Says About TTVR Coverage
CMS is covering TTVR for the treatment of symptomatic tricuspid regurgitation—but coverage is conditional, not open. The procedure must be furnished in accordance with an FDA market-authorized indication AND within the context of a CMS-approved CED study. Both conditions must be met simultaneously. A case that meets the patient criteria but is performed outside an approved study protocol is not covered under this NCD.
This is a meaningful distinction for revenue cycle teams. CED coverage is not the same as standard Medicare coverage. It means your facility is essentially operating as a research site, and your documentation obligations extend well beyond typical medical necessity standards.
CMS TTVR Coverage Criteria: Patient, Physician, and Study Requirements
Patient Eligibility Under NCD 379
To qualify for Medicare coverage, patients must meet a single core clinical criterion: symptomatic TR that persists despite optimal medical therapy (OMT), with tricuspid valve replacement deemed appropriate by a heart team evaluation. There is no age floor or ejection fraction cutoff specified at the patient-selection level, but the approved CED study must be designed to capture subgroup data across several clinical variables (detailed below).
Documentation of OMT failure and the heart team's determination of appropriateness should be in the medical record before the case is scheduled. Retroactive documentation will not hold up to a Medicare audit.
Heart Team Composition — A Non-Negotiable Physician Criterion
CMS requires that each patient be under the care of a multidisciplinary heart team both preoperatively and postoperatively. The team must include, at minimum:
| # | Covered Indication |
|---|---|
| 1 | Cardiac surgeon |
| 2 | Interventional cardiologist |
| 3 | Cardiologist with training and experience in heart failure management |
| 4 | Electrophysiologist |
| 5 | Multi-modality imaging specialist(s) |
| 6 | Interventional echocardiographer |
Every member of this team must have documented experience specifically in the care and treatment of TR. This is not a general cardiac surgery credential requirement—it is TR-specific. If your team cannot document that experience, the claim is at risk regardless of the procedure's clinical success.
CED Study Requirements — What the Protocol Must Include
The CMS-approved CED study protocol carries a detailed set of scientific and operational requirements. For billing managers, the key takeaways are:
| # | Covered Indication |
|---|---|
| 1 | Primary outcomes must include all-cause mortality, hospitalizations, or a composite of these, tracked through a minimum of 24 months of follow-up. |
| 2 | Composite outcomes must be co-directional—every component must move in the same direction—and each component must be individually reported. |
| 3 | The study must include an active comparator arm. |
| 4 | A care management plan must document the experience and role of each heart team member. |
| 5 | The study must be powered for subgroup analyses across: age, sex, race and ethnicity, practitioner and facility variables, left ventricular ejection fraction (by guideline-defined subgroups), history of previous tricuspid surgery or intervention, presence of severe aortic or mitral stenosis or regurgitation, chronic kidney disease status, and presence of indwelling cardiac implantable electronic devices (CIEDs). |
These subgroup requirements are significant from a documentation standpoint. Your clinical team must be capturing this data systematically—not reconstructing it at the time of billing or audit.
AHRQ Scientific Standards Compliance
CMS explicitly requires that approved CED study protocols adhere to scientific standards identified by the Agency for Healthcare Research and Quality (AHRQ), as outlined in CMS's Coverage with Evidence Development Guidance Document (published August 7, 2024). The protocol must be registered on ClinicalTrials.gov, and a complete final protocol—including the statistical analysis plan—must be delivered to CMS before study initiation. Sponsors and investigators must demonstrate they have the resources and skills to complete the study, with a written milestone plan covering initiation, enrollment progress, interim reporting, and final results.
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
Affected Codes
The policy data for NCD 379 does not list specific CPT or HCPCS codes for TTVR at this time. This is consistent with how CMS handles newly covered procedures under CED—coding guidance typically follows in separate transmittals or Coding Committee decisions after the NCD is finalized.
What this means for your billing team: Do not assume existing transcatheter valve codes (used for TAVR or MitraClip procedures) are crosswalkable to TTVR without explicit CMS coding guidance. Monitor the CMS Medicare Coverage Database and applicable MAC bulletins for HCPCS or Category III CPT code assignments tied to NCD 379.
What Your Billing Team Should Do
| # | Action Item |
|---|---|
| 1 | Verify CED study enrollment before scheduling any Medicare TTVR cases. Contact your structural heart program director now to confirm whether your facility is participating in a CMS-approved CED study. If you are not enrolled, TTVR is non-covered for Medicare patients—full stop. |
| 2 | Build a heart team documentation checklist aligned with NCD 379 physician criteria. Each of the six required specialists must be documented in the record with evidence of TR-specific experience. Create a pre-procedure attestation template that captures this before the case date. |
| 3 | Set up a 24-month follow-up tracking process. CED coverage depends on your facility's ability to contribute primary outcome data through at least 24 months. Coordinate with your clinical research and care management teams to build this follow-up protocol into your patient workflow now—not after cases start accumulating. |
| 4 | Monitor CMS and your MAC for TTVR-specific coding guidance. Since NCD 379 lists no specific codes, assign a team member to watch for coding transmittals tied to this NCD, and flag any TTVR claims for manual review until official coding guidance is published. |
| 5 | Audit patient records for the nine required subgroup data fields. Your CED study data capture must support subgroup analyses by LVEF, CKD status, CIED presence, prior tricuspid intervention, and five additional variables. Run a gap analysis on your current EHR documentation templates against this list before your first case. |
Get the Full Picture
Track this policy across versions, search 1,500+ policies by CPT code, and get real-time alerts when any payer changes coverage.