TL;DR: The Centers for Medicare & Medicaid Services modified NCD 379, establishing national Coverage with Evidence Development (CED) for Transcatheter Tricuspid Valve Replacement (TTVR), effective January 9, 2026. Here's what changes for billing teams.
This is a new national coverage determination under NCD 379 in the CMS Medicare system. TTVR is now covered under Medicare — but only when strict patient, physician, and study criteria are met. The policy does not list specific CPT or HCPCS codes, which creates immediate documentation and claim submission challenges your billing team needs to prepare for now.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Transcatheter Tricuspid Valve Replacement (TTVR) |
| Policy Code | NCD 379 |
| Change Type | Modified |
| Effective Date | January 9, 2026 |
| Impact Level | High |
| Specialties Affected | Interventional cardiology, cardiac surgery, heart failure cardiology, electrophysiology, cardiac imaging, interventional echocardiography |
| Key Action | Confirm your facility is enrolled in or linked to a CMS-approved CED study before billing TTVR under Medicare |
CMS TTVR Coverage Criteria and Medical Necessity Requirements 2026
CMS TTVR coverage policy under NCD 379 covers TTVR only under Coverage with Evidence Development. That means coverage is conditional — not open-ended. If the clinical encounter doesn't tie to a CMS-approved CED study, Medicare will not pay. Full stop.
Three layers of medical necessity criteria apply. A patient must meet all three before your facility can bill TTVR under Medicare. Miss any one of them and you're looking at a claim denial.
Patient Criteria
The patient must have symptomatic tricuspid regurgitation (TR) that persists despite optimal medical therapy (OMT). A heart team — not a single physician — must determine that tricuspid valve replacement is appropriate. "Symptomatic" and "despite OMT" are both documentation requirements, not just clinical context. Your medical records must reflect both explicitly.
Physician Criteria
The heart team requirement is specific and demanding. CMS requires, at minimum, all six of the following specialists:
| # | Covered Indication |
|---|---|
| 1 | Cardiac surgeon |
| 2 | Interventional cardiologist |
| 3 | Cardiologist with training and experience in heart failure management |
| 4 | Electrophysiologist |
| 5 | Multi-modality imaging specialists |
| 6 | Interventional echocardiographer |
Every one of these specialists must have documented experience in caring for and treating tricuspid regurgitation. This isn't a checkbox exercise. CMS will look for documentation showing each role was actively involved in the care plan. Build that documentation into your pre-procedure workflow now, before the January 9, 2026 effective date passes.
CED Study Criteria
This is where TTVR billing gets complex. The procedure must be furnished within the context of a CMS-approved CED study. The study must use an active comparator — not just observational data. It must track primary outcomes including all-cause mortality, hospitalizations, or a composite of both, through a minimum of 24 months.
If your facility isn't currently enrolled in or affiliated with a qualifying CED study, you have no pathway to reimbursement under Medicare for TTVR. Prior authorization alone won't unlock coverage here. The CED enrollment is the prerequisite, not a formality.
Talk to your compliance officer and clinical research team before billing a single TTVR claim under NCD 379.
CMS TTVR Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Symptomatic tricuspid regurgitation (TR) despite optimal medical therapy, with heart team approval | Covered | Not specified in NCD 379 | Must be furnished within a CMS-approved CED study; all patient, physician, and study criteria must be met |
| TTVR outside a CMS-approved CED study | Not Covered | N/A | No CED enrollment = no Medicare coverage regardless of clinical indication |
| TTVR without a qualifying heart team (all six specialists) | Not Covered | N/A | Incomplete heart team disqualifies the claim under medical necessity criteria |
| TTVR for patients who have not tried optimal medical therapy | Not Covered | N/A | OMT failure is a required patient criterion |
| TTVR not furnished under an FDA market-authorized indication | Not Covered | N/A | FDA authorization is a threshold requirement, not optional |
CMS TTVR Billing Guidelines and Action Items 2026
TTVR billing under NCD 379 is not plug-and-play. The absence of specific CPT or HCPCS codes in the policy creates real ambiguity. Here's what your billing team should do now.
| # | Action Item |
|---|---|
| 1 | Confirm CED study enrollment before January 9, 2026. If your facility has already performed TTVR procedures or plans to, confirm in writing that you are enrolled in or contracted with a CMS-approved CED study. No study affiliation means no Medicare coverage under this policy. |
| 2 | Build a documentation checklist that mirrors the six-specialist heart team requirement. Every TTVR claim should be backed by records showing all six required specialists — cardiac surgeon, interventional cardiologist, heart failure cardiologist, electrophysiologist, multi-modality imaging specialist, and interventional echocardiographer — were involved in the care plan. Document their specific roles and TR-related experience. |
| 3 | Work with your coding team and MAC to determine the correct procedure codes. NCD 379 does not list specific CPT or HCPCS codes. Contact your Medicare Administrative Contractor directly for guidance on how to code TTVR claims under this policy. Don't assume legacy structural heart procedure codes will apply without confirmation. |
| 4 | Document "symptomatic TR despite OMT" explicitly in the medical record. Vague clinical language will not satisfy medical necessity review. The record must show the patient had symptoms, what optimal medical therapy was tried, and why the heart team determined TTVR was appropriate. |
| 5 | Establish a prior authorization and pre-claim review process now. Even though this policy is framed as a CED coverage policy rather than a traditional prior authorization policy, payers and MACs may require pre-submission review. Treat every TTVR case as high-scrutiny from day one. If you're unsure how your MAC will handle claims under NCD 379, call them before you submit. |
| 6 | Track subgroup documentation requirements. The CED study criteria require design sufficient for subgroup analyses across age, sex, race and ethnicity, left ventricular ejection fraction, prior tricuspid surgery or intervention, severe aortic or mitral stenosis or regurgitation, chronic kidney disease, and indwelling cardiac implantable electronic devices. Your clinical documentation needs to capture these data points for every TTVR patient — not just for research purposes, but because gaps could trigger medical necessity audits later. |
| 7 | Review your billing guidelines with your compliance officer before submitting any TTVR claims. This policy has layers — FDA authorization, CED study compliance, AHRQ scientific standards — that interact in ways that could create unexpected claim denial exposure. Don't let your billing team learn the rules the hard way on a high-cost cardiac procedure. |
| 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 |
CPT, HCPCS, and ICD-10 Codes for TTVR Under NCD 379
A Note on Code Availability
NCD 379 does not specify CPT, HCPCS Level II, or ICD-10-CM codes. This is unusual for a national coverage determination and creates a real operational gap for billing teams.
The absence of codes in the published policy is not a minor technicality. For a high-cost inpatient cardiac procedure, submitting without confirmed codes is a claim denial risk. This pattern has appeared before with emerging structural heart procedures — the coverage policy arrives before the code infrastructure catches up.
What to Do Instead
Contact your Medicare Administrative Contractor and ask specifically which procedure codes they expect for TTVR claims under NCD 379. Get the answer in writing. Also check the CMS Medicare Coverage Database directly at cms.gov for any transmittals or change requests linked to NCD 379 that may include coding instructions.
For diagnosis coding, tricuspid regurgitation maps to ICD-10-CM — but the specific codes applicable under NCD 379 are not listed in the policy. Work with your clinical documentation team to ensure the primary TR diagnosis and any comorbidities (chronic kidney disease, cardiac implantable electronic devices, prior tricuspid surgery) are captured accurately. These comorbidities appear explicitly in the CED subgroup analysis requirements, which signals CMS will be looking at them.
Watch for a CMS transmittal or Claims Processing Manual update that adds coding details to this policy. Set a calendar reminder to recheck the NCD 379 entry in the Medicare Coverage Database in February 2026.
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