CMS Covers T-TEER for Tricuspid Regurgitation Under NCD 381 — What Billing Teams Need to Know
The Centers for Medicare & Medicaid Services has issued a modified coverage determination under NCD 381 that establishes national Medicare coverage for transcatheter edge-to-edge repair for tricuspid valve regurgitation (T-TEER). Effective March 12, 2026, CMS covers T-TEER under a Coverage with Evidence Development (CED) framework — meaning coverage is real, but it comes with strict enrollment, physician, and study participation requirements that your billing and credentialing teams must understand before submitting a single claim.
| Field | Detail |
|---|---|
| Payer | CMS (Medicare) |
| Policy | Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER) |
| Policy Code | NCD 381 |
| Change Type | Modified |
| Effective Date | 2026-03-12 |
| Impact Level | High |
| Specialties Affected | Interventional Cardiology, Cardiac Surgery, Heart Failure Cardiology, Interventional Echocardiography |
| Key Action | Confirm your facility is enrolled in a CMS-approved CED study before scheduling T-TEER procedures for Medicare patients. |
What CMS NCD 381 Now Covers for T-TEER
Tricuspid regurgitation (TR) is a condition in which the tricuspid valve fails to close properly, causing blood to leak backward into the right atrium. T-TEER is a catheter-based repair technique that clips the valve leaflets together to reduce regurgitation without open surgery. Until this NCD, Medicare coverage for T-TEER was inconsistent across the country. NCD 381 changes that — but it doesn't open the door unconditionally.
CMS covers T-TEER under Coverage with Evidence Development, which is the agency's mechanism for extending coverage to procedures that show clinical promise but require additional long-term outcomes data. This is not experimental or investigational status — patients can receive the procedure and Medicare will pay — but both the facility and the care team must meet defined criteria and services must be furnished within a CMS-approved CED study.
The benefit categories under NCD 381 are Inpatient Hospital Services and Physicians' Services.
CMS T-TEER Coverage Criteria: Patient, Physician, and Study Requirements
This is where the operational complexity lives. Coverage is only triggered when all three criteria categories are satisfied simultaneously.
Patient Criteria (NCD 381 Section B.1)
Medicare will cover T-TEER only for patients who meet all of the following:
| # | Covered Indication |
|---|---|
| 1 | Symptomatic tricuspid regurgitation that persists despite optimal medical therapy (OMT) |
| 2 | Tricuspid valve repair has been deemed appropriate by a multidisciplinary heart team |
"Symptomatic" and "optimal medical therapy" are not defined further in the NCD summary, which means documentation of OMT failure and symptom burden will be critical for demonstrating medical necessity. Expect payer reviewers — and auditors — to look closely at chart documentation here.
Physician and Heart Team Criteria (NCD 381 Section B.2)
The patient must be under the care of a qualifying heart team both preoperatively and postoperatively. At minimum, the team must include:
| # | Covered Indication |
|---|---|
| 1 | A cardiac surgeon |
| 2 | An interventional cardiologist |
| 3 | A cardiologist with training and experience in heart failure management |
| 4 | An interventional echocardiographer |
All four specialists must have documented experience in the care and treatment of TR specifically. This isn't a checkbox — if you can't document each team member's relevant experience, you're at risk for a claim denial or a post-payment audit finding.
CED Study Criteria (NCD 381 Section B.3)
Every T-TEER procedure billed to Medicare must be furnished within the context of a CMS-approved CED study. The study protocol must:
| # | Covered Indication |
|---|---|
| 1 | Track primary outcomes of all-cause mortality, hospitalizations, or a composite through a minimum of 24 months |
| 2 | Include an active comparator arm |
| 3 | Include a care management plan documenting each heart team member's role |
| 4 | Be registered with ClinicalTrials.gov with a complete, final protocol |
| 5 | Be conducted by sponsors and investigators with the resources to complete it successfully |
The study must also be designed to support subgroup analyses across a detailed list of clinically important variables, including:
| # | Covered Indication |
|---|---|
| 1 | Left ventricular ejection fraction (by guideline-defined subgroups) |
| 2 | Previous tricuspid surgery or intervention |
| 3 | Severe aortic or mitral stenosis or regurgitation |
| 4 | Chronic kidney disease |
| 5 | Indwelling cardiac implantable electronic devices (CIEDs) |
| 6 | Greater than mild right ventricular dysfunction |
| 7 | Hepatic dysfunction |
| 8 | Grade of post-repair residual TR |
This level of subgroup granularity tells you CMS is serious about generating real-world evidence. Facilities that are sloppy about data collection will not only jeopardize future coverage — they may jeopardize reimbursement for procedures already performed.
Non-Coverage Situations Under NCD 381
While the NCD establishes covered indications, coverage does not apply when:
- The patient has not failed optimal medical therapy
- The procedure is not performed under a CMS-approved CED study
- The heart team composition does not meet the four-specialty minimum
- The procedure is not performed according to an FDA market-authorized indication
Facilities performing T-TEER outside of an approved study, or without the complete heart team on record, should expect denials on medical necessity or coverage grounds.
| 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 381 does not list specific CPT or HCPCS codes at this time. Billing teams should monitor the CMS Medicare Coverage Database and the National Coverage Determinations Manual for associated procedure codes as they are published. Work with your coding team to identify the appropriate Category III or Category I CPT codes for transcatheter tricuspid valve repair as CMS updates associated billing guidance.
Related ICD-10 Diagnosis Codes to Watch:
| Code | Description |
|---|---|
| I07.1 | Tricuspid insufficiency (regurgitation) |
| I07.8 | Other tricuspid valve diseases |
| I07.9 | Tricuspid valve disease, unspecified |
Note: These ICD-10 codes reflect standard clinical coding for TR and are not explicitly enumerated in NCD 381. Confirm with your coding team prior to claim submission.
What Your Billing Team Should Do
| # | Action Item |
|---|---|
| 1 | Immediately confirm CED study eligibility. Before scheduling any Medicare patient for T-TEER after March 12, 2026, verify that your facility is enrolled in — or affiliated with — a CMS-approved CED study. Without this, there is no coverage, period. Contact your research or compliance department now if this hasn't been confirmed. |
| 2 | Audit your heart team documentation process. All 4 required specialists must be documented in the medical record, along with their experience in TR care and treatment. Build a checklist into your pre-procedure workflow so this documentation is captured before the case — not reconstructed after a denial. |
| 3 | Update your medical necessity documentation templates. The coverage criteria require evidence that the patient has symptomatic TR despite optimal medical therapy. Work with your clinical documentation improvement (CDI) team to create physician note templates that explicitly address OMT history and symptom burden in language aligned with CMS criteria. |
| 4 | Watch for CPT/HCPCS code assignments. NCD 381 does not currently enumerate specific procedure codes. Set an alert for CMS updates to the Medicare Coverage Database and confirm with your coding team which codes — likely in the transcatheter valve repair family — will map to this NCD when coverage becomes active. |
| 5 | Review your credentialing records for interventional echocardiographers. This is the specialty most likely to be missing from existing heart team rosters. If your facility doesn't have a credentialed interventional echocardiographer with documented TR experience, start that credentialing process now — it won't happen overnight. |
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