TL;DR: The Centers for Medicare & Medicaid Services modified NCD 367 governing percutaneous left atrial appendage closure (LAAC) coverage, with an effective date of January 9, 2026. This policy update maintains Coverage with Evidence Development (CED) requirements for LAAC in non-valvular atrial fibrillation (NVAF) patients — but the operator volume thresholds, registry enrollment mandates, and shared decision-making documentation requirements make this one of the most documentation-intensive procedures your billing team will encounter. No specific CPT or HCPCS codes are listed in the current policy document.
The CMS LAAC coverage policy under NCD 367 Medicare applies to inpatient hospital services and physicians' services. If your facility performs LAAC — or is evaluating whether to add it — the compliance burden here is significant, and a claim denial based on registry non-enrollment or incomplete shared decision-making documentation will be hard to reverse on appeal.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Percutaneous Left Atrial Appendage Closure (LAAC) — NCD 367 |
| Policy Code | NCD 367 |
| Change Type | Modified |
| Effective Date | January 9, 2026 |
| Impact Level | High |
| Specialties Affected | Interventional Cardiology, Electrophysiology, Cardiovascular Surgery, Structural Heart Disease Programs |
| Key Action | Confirm your facility's registry enrollment and operator volume documentation are current before billing any LAAC procedure after January 9, 2026 |
CMS LAAC Coverage Criteria and Medical Necessity Requirements 2026
CMS covers percutaneous LAAC for non-valvular atrial fibrillation only through Coverage with Evidence Development. That means coverage is conditional — not automatic. If any single condition fails, the claim fails.
The CMS LAAC coverage policy sets medical necessity through a layered set of patient, physician, and facility criteria. All three layers must be met simultaneously. Miss one layer, and you have a non-covered service regardless of clinical appropriateness.
Patient-Level Medical Necessity Criteria
The patient must meet a stroke-risk threshold. Specifically, CMS requires either a CHADS₂ score ≥ 2 or a CHA₂DS₂-VASc score ≥ 3. These are not interchangeable — document which score applies and what the calculated value is for each patient.
Beyond the risk score, the patient must be suitable for short-term warfarin but unable to take long-term oral anticoagulation. This is the "second-line therapy" requirement, and it's the most commonly misunderstood piece of this coverage policy. LAAC is not covered as a first-line alternative to anticoagulation. If the record doesn't clearly show why long-term oral anticoagulation isn't viable, your medical necessity documentation has a gap.
Before the procedure, the patient must complete a formal shared decision-making interaction. This interaction must involve an independent, non-interventional physician. It must use an evidence-based decision tool specifically addressing oral anticoagulation in NVAF patients. And it must be documented in the medical record. "Documented" here means you need to be able to produce that record on a pre-payment review or audit — not reconstruct it after the fact.
Physician-Level Requirements
CMS sets hard volume thresholds for performing physicians. The operator must have performed at least 25 interventional cardiac procedures involving transeptal puncture through an intact septum before performing LAAC. That's a baseline credential check.
Ongoing, the operator must continue performing at least 25 transeptal puncture procedures over every two-year period — of which at least 12 must be LAAC procedures. This means physician credentialing isn't a one-time event. Your billing team should have a process for verifying that performing physicians remain in compliance with the volume requirement on a rolling basis.
Manufacturer training is also required. The performing physician must have completed training prescribed by the device manufacturer prior to the procedure. Get that certificate on file before the first claim goes out.
Facility-Level Requirements
The procedure must be performed in a hospital with an established structural heart disease (SHD) program, an electrophysiology (EP) program, or both. Community hospitals without these programs cannot bill for LAAC under Medicare. Reimbursement depends on this facility designation being established before the procedure date.
The patient — and the multidisciplinary team (MDT) and the hospital — must be enrolled in a prospective, national, audited registry. The registry must consecutively enroll LAAC patients and track at least eight defined outcomes for each patient for a minimum of four years. Those outcomes include operator-specific complications, device-specific complications (including device thrombosis), adjudicated stroke by type, TIA, systemic embolism, death, and major bleeding by site and severity.
This is where LAAC billing gets genuinely complex. Registry enrollment isn't a billing team task — but the absence of it will kill your claim. Build a workflow that ties procedure scheduling to registry enrollment confirmation, before the service date.
Device Requirements
Only FDA-cleared devices with Premarket Approval (PMA) for the specific indication are covered. The device must be used within its FDA-approved indication. Off-label use of an FDA-approved LAAC device is not covered under this policy — even if the procedure is clinically appropriate.
CMS LAAC Exclusions and Non-Covered Indications
CMS is explicit: LAAC is a second-line therapy. Patients who can tolerate long-term oral anticoagulation are not covered under this policy, regardless of their stroke risk score.
Valvular atrial fibrillation is excluded. This policy covers non-valvular AF only. If a patient has AF secondary to mitral stenosis or a mechanical heart valve, LAAC is not a covered service under NCD 367.
Use of a device without FDA PMA for the specific indication is not covered. This is a harder line than some billing teams realize. FDA clearance for a device doesn't automatically translate to CMS coverage if the clinical indication doesn't match the FDA-approved label.
If the shared decision-making requirement is not met — or not documented — the procedure is non-covered. A claim denial on documentation grounds is especially painful here because the procedure may have been clinically appropriate and technically successful. The paperwork gap is the problem, not the care.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| LAAC for NVAF with CHADS₂ ≥ 2 or CHA₂DS₂-VASc ≥ 3, unable to tolerate long-term OAC | Covered (CED) | Not specified in policy | All patient, physician, facility, and registry criteria must be met |
| LAAC as first-line alternative to oral anticoagulation | Not Covered | — | CMS covers LAAC as second-line therapy only |
| LAAC for valvular atrial fibrillation | Not Covered | — | Policy applies to non-valvular AF only |
| LAAC with non-FDA-approved device or off-label device use | Not Covered | — | Device must have PMA for the specific indication |
| LAAC without documented shared decision-making | Not Covered | — | Independent non-interventional physician must conduct and document SDM |
| LAAC without patient enrollment in approved registry | Not Covered | — | Consecutive enrollment in a prospective, audited national registry is required |
| LAAC by physician not meeting volume thresholds | Not Covered | — | ≥25 transeptal puncture procedures baseline; ≥25/2-year period ongoing, with ≥12 LAAC |
CMS LAAC Billing Guidelines and Action Items 2026
The CED framework makes LAAC billing unusually dependent on pre-procedure workflow. Most claim denials for LAAC don't come from coding errors — they come from missing or incomplete eligibility documentation assembled before the service date.
| # | Action Item |
|---|---|
| 1 | Audit your facility's registry enrollment before January 9, 2026. If your hospital isn't currently enrolled in an approved national LAAC registry, you cannot bill for LAAC under Medicare after the effective date. Contact your SHD or EP program director now. This is not a billing department fix — it requires institutional action. |
| 2 | Build a pre-procedure checklist that captures all three eligibility layers. Patient criteria (CHADS₂ or CHA₂DS₂-VASc score, OAC contraindication rationale, shared decision-making documentation), physician criteria (training certificate, transeptal volume verification, LAAC volume for rolling 2-year period), and facility criteria (SHD/EP program status, registry enrollment confirmation). Every LAAC claim should have this checklist completed and stored before the procedure. |
| 3 | Verify that shared decision-making is documented in the medical record — not just performed. The independent non-interventional physician must use an evidence-based decision tool. "The risks and benefits were discussed" is not sufficient documentation for this requirement. The record needs to show who conducted the SDM, what tool was used, and the conclusion reached regarding oral anticoagulation suitability. |
| 4 | Confirm the device has FDA Premarket Approval for the specific indication. Don't assume FDA clearance equals CMS coverage. Check the device's approved indication against the patient's diagnosis. If there's any ambiguity, loop in your compliance officer before the procedure — not after a denial. |
| 5 | Set up a rolling physician volume tracking process. The 2-year volume requirement (≥25 transeptal procedures, ≥12 LAAC) applies on an ongoing basis. Create a quarterly report for each performing physician showing their procedure counts. If a physician drops below threshold, pause LAAC billing under their NPI until they're back in compliance. |
| 6 | Review your LAAC billing guidelines with your compliance officer before the January 9, 2026 effective date. Given the CED framework, the registry requirements, and the multi-layer credentialing conditions, this is a policy where billing errors carry audit exposure — not just claim denial risk. If you're billing LAAC at significant volume, a pre-effective date compliance review is worth the investment. |
| 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 Percutaneous LAAC Under NCD 367
The current NCD 367 policy document does not list specific CPT or HCPCS codes. This is worth flagging. For LAAC billing, your team will need to verify the applicable procedure codes through your MAC's local guidance or the CMS LAAC registry program documentation.
Common Codes Associated with LAAC Procedures (verify with your MAC)
The policy does not specify codes, but LAAC billing typically involves inpatient hospital facility and physician claims. Contact your Medicare Administrative Contractor for the current applicable procedure codes and any local coverage determination (LCD) guidance that supplements NCD 367 in your region.
No CPT, HCPCS, or ICD-10 Codes Are Listed in This Policy
| Field | Status |
|---|---|
| CPT Codes | Not specified in NCD 367 policy document |
| HCPCS Codes | Not specified in NCD 367 policy document |
| ICD-10-CM Codes | Not specified in NCD 367 policy document |
This is a real limitation for billing teams. The absence of specific codes in the national policy means your MAC is the authoritative source for code-level guidance. Reach out to your MAC's provider relations line and ask specifically about the LAAC CED billing requirements for claims effective January 9, 2026, and beyond.
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