Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER) — NCD 381 | CMS Coverage Update

TL;DR: The Centers for Medicare & Medicaid Services modified NCD 381 to establish national coverage for Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER), effective January 9, 2026 — but only under Coverage with Evidence Development (CED). Here's what billing teams need to know before submitting claims.

CMS T-TEER coverage policy under NCD 381 Medicare is now active, but coverage is conditional. The Centers for Medicare & Medicaid Services covers T-TEER only when performed within a CMS-approved CED study and only when strict patient, physician, and study criteria are met. The policy does not list specific CPT or HCPCS codes, which creates an immediate documentation burden for T-TEER billing teams working with this procedure.

Quick-Reference Table

CMS T-TEER Coverage Criteria and Medical Necessity Requirements 2026

NCD 381 is the National Coverage Determination governing Medicare coverage of T-TEER for symptomatic tricuspid regurgitation. Coverage exists, but it comes with a hard gate: every claim must trace back to a CMS-approved CED study.

Patient-Level Medical Necessity

The coverage policy sets a clear floor for patient eligibility. The patient must have symptomatic tricuspid regurgitation (TR) that persists despite optimal medical therapy (OMT). The heart team — not just the operating physician — must determine that tricuspid valve repair is appropriate.

"Symptomatic" and "despite OMT" are not decorative qualifiers here. They are medical necessity criteria that must be documented in the medical record before the procedure. If your documentation doesn't show OMT was tried and failed, expect a claim denial.

Heart Team Requirement

CMS doesn't just want a cardiologist involved. The policy requires a full, multi-disciplinary heart team with all four of the following members:

All four must have experience specifically in the care and treatment of TR. This isn't a checkbox — CMS's CED study protocols must include a care management plan that documents the experience and role of each heart team member. Missing any one of these specialists from the team disqualifies the case from coverage.

CED Study Enrollment Is Not Optional

This is the coverage policy's central requirement, and it's the one most likely to trip up billing teams. T-TEER is covered only when furnished within a CMS-approved CED study. The procedure is FDA market-authorized, but FDA authorization alone doesn't open the Medicare reimbursement door here. CED enrollment does.

If your facility is not enrolled in a CMS-approved CED study, Medicare will not cover T-TEER services — full stop. Check your CED study status before the January 9, 2026 effective date if you're planning to bill for this procedure.

Prior Authorization and CED Study Design

NCD 381 does not mention a formal prior authorization process in the traditional sense. Instead, the CED study framework serves as the de facto authorization mechanism. Your CED study protocol must be CMS-approved and must meet detailed scientific standards set by the Agency for Healthcare Research and Quality (AHRQ).

The study design requirements are specific and demanding. CED studies must include primary outcomes of all-cause mortality, hospitalizations, or a composite of these — tracked through a minimum of 24 months. An active comparator is required. The study must be designed to support subgroup analyses across more than 10 clinically defined patient groups, including patients with chronic kidney disease, hepatic dysfunction, right ventricular dysfunction greater than mild, and indwelling cardiac implantable electronic devices.

These requirements matter to billing teams because they affect which patients can be enrolled and therefore which T-TEER procedures are billable to Medicare.

Coverage Indications at a Glance

CMS T-TEER Billing Guidelines and Action Items 2026

The real risk with NCD 381 isn't the procedure itself — it's the layered eligibility structure that must be verified before a single claim goes out. Here's what to do.

1. Confirm CED study enrollment before billing any T-TEER services.

Your facility must be operating within a CMS-approved CED study. Contact your cardiovascular service line director or research office to confirm active enrollment status. If your facility is not enrolled, Medicare will not reimburse T-TEER claims regardless of the clinical indication. Do this before January 9, 2026.

2. Build a pre-procedure documentation checklist that covers all three coverage gates.

You need documented evidence of: (a) symptomatic TR with OMT failure, (b) heart team review and approval with all four required specialties, and (c) patient enrollment in the CED study. All three must be in the medical record before claim submission. A claim that passes two out of three fails.

3. Work with your compliance officer to map your CED study protocol to NCD 381's billing guidelines.

The CED study framework has specific scientific requirements — AHRQ standards, 24-month follow-up outcomes, active comparator design, and more. Your billing team doesn't need to know the clinical science, but they do need to know how the study protocol maps to patient eligibility. Talk to your compliance officer about building a coverage verification workflow tied to study enrollment status.

4. Track the "no specific codes listed" problem now.

NCD 381 does not list specific CPT or HCPCS codes. That creates real ambiguity for T-TEER billing. Your billing team needs to identify the codes currently being used for this procedure at your facility and determine how CMS expects them to be reported under the CED framework. Reach out to your Medicare Administrative Contractor (MAC) for guidance on the appropriate code set before submitting claims.

5. Set up 24-month outcome tracking for enrolled patients.

CMS's CED requirements aren't just about getting coverage — they require ongoing data collection on primary outcomes (all-cause mortality, hospitalizations) through at least 24 months. If your facility manages billing across the care continuum, coordinate with your clinical research team to flag CED patients in your revenue cycle system. This supports both compliance and continued coverage eligibility.

6. Prepare for subgroup documentation requirements.

The CED study design must support subgroup analyses across more than 10 patient categories. For billing teams, this means patient records need to capture clinical variables like left ventricular ejection fraction, chronic kidney disease status, history of tricuspid surgery, and severity of right ventricular dysfunction. These are not just clinical data points — they're coverage eligibility variables. Work with your coders and clinical documentation improvement (CDI) team to capture them consistently.

CPT, HCPCS, and ICD-10 Codes for T-TEER Under NCD 381

The policy does not list specific CPT, HCPCS, or ICD-10 codes. This is a real gap that will cause T-TEER billing problems at the claim level.

CMS's NCD 381 establishes coverage criteria and CED requirements without specifying the procedure codes that trigger that coverage. Until CMS or your MAC publishes associated billing instructions, your team is operating without a defined code set.

What to do: Contact your Medicare Administrative Contractor directly and ask for guidance on how to bill T-TEER services under NCD 381 CED coverage. Get that guidance in writing. Also monitor the CMS Medicare Coverage Database for any associated Local Coverage Determinations (LCDs) or billing articles that may publish alongside or after the NCD's effective date.

Do not assume that codes used for mitral valve edge-to-edge repair (like those associated with MitraClip procedures) automatically apply here. Tricuspid valve repair has distinct anatomy and a distinct regulatory history. Using the wrong codes on T-TEER claims risks denial or, worse, a compliance exposure. If you're unsure which codes apply at your facility, loop in your billing consultant before the January 9, 2026 effective date.