CMS Modifies LAAC Coverage Policy: What Cardiac Billing Teams Need to Know Before March 2026
The Centers for Medicare & Medicaid Services has modified National Coverage Determination (NCD) 367, governing coverage of percutaneous left atrial appendage closure (LAAC) for non-valvular atrial fibrillation. This update carries significant implications for interventional cardiology, electrophysiology, and cardiovascular surgery programs that bill Medicare for LAAC procedures—particularly around registry participation, physician volume requirements, and the shared decision-making documentation CMS now scrutinizes closely.
| Field | Detail |
|---|---|
| Payer | Centers for Medicare & Medicaid Services (CMS) |
| Policy | Percutaneous Left Atrial Appendage Closure (LAAC) |
| Policy Code | NCD 367 |
| Change Type | Modified |
| Effective Date | 2026-03-12 |
| Impact Level | High |
| Specialties Affected | Interventional Cardiology, Electrophysiology, Cardiovascular Surgery, Structural Heart Disease Programs |
| Key Action | Verify that your performing physicians meet updated volume thresholds and that your facility is enrolled in a CMS-approved prospective LAAC registry before submitting claims. |
CMS LAAC Coverage Policy (NCD 367): What Changed and Why It Matters
CMS covers percutaneous LAAC for non-valvular atrial fibrillation (NVAF) under a Coverage with Evidence Development (CED) framework—meaning coverage is contingent on participation in an approved national registry, not just on meeting clinical criteria. The March 2026 modification to NCD 367 refines the conditions under which Medicare will reimburse this procedure, and the bar is specific.
For billing teams, CED coverage is a different animal from standard covered benefits. A claim that looks clinically appropriate can be denied outright if the registry enrollment requirement isn't documented, or if the physician performing the procedure doesn't meet volume thresholds. Every condition in this NCD is a potential denial vector.
CMS Medical Necessity Criteria for LAAC: The Full Requirement Set
CMS will cover percutaneous LAAC only when an FDA-approved device is used for its FDA-approved indication and all of the following conditions are satisfied simultaneously.
Patient-level requirements:
| # | Covered Indication |
|---|---|
| 1 | The patient must have a CHADS₂ score ≥ 2 or a CHA₂DS₂-VASc score ≥ 3, confirming elevated stroke risk in the context of non-valvular AF |
| 2 | The patient must be deemed suitable for short-term warfarin but unable to take long-term oral anticoagulation (OAC)—this is a firm second-line therapy designation |
| 3 | A formal shared decision-making (SDM) interaction must occur with an independent, non-interventional physician using an evidence-based decision tool on OAC in NVAF patients, prior to the procedure |
| 4 | That SDM interaction must be documented in the medical record—absence of this note is a clean denial |
| 5 | The patient must be under the care of a cohesive, multidisciplinary team (MDT) both preoperatively and postoperatively |
Facility requirements:
| # | Covered Indication |
|---|---|
| 1 | The procedure must be performed at a hospital with an established structural heart disease (SHD) and/or electrophysiology (EP) program |
| 2 | The facility's MDT must be enrolled in and actively participating in a prospective, national, audited LAAC registry |
Physician volume and credentialing requirements:
CMS is explicit here, and these thresholds are non-negotiable for coverage:
| # | Covered Indication |
|---|---|
| 1 | The performing physician must have completed manufacturer-prescribed training on the device before performing LAAC |
| 2 | Must have performed ≥ 25 interventional cardiac procedures involving transeptal puncture through an intact septum prior to the procedure |
| 3 | Must continue to perform ≥ 25 such procedures over a 2-year rolling period, of which at least 12 must be LAAC procedures |
That ongoing volume requirement is worth flagging for credentialing and privileging staff. A physician who qualified at the time of initial enrollment may fall out of compliance if procedure volume drops—and that exposes those claims to recoupment risk.
The Registry Requirement: What CMS Is Collecting and Why It Matters for Billing
LAAC under NCD 367 is a CED benefit, which means the procedure is covered in part because CMS is still gathering long-term outcomes data. Patient enrollment in a qualifying registry isn't optional—it's a coverage condition.
The registry must consecutively enroll LAAC patients and track the following outcomes for at least 4 years per patient:
- Operator-specific and device-specific complications (including device thrombosis)
- Adjudicated stroke, by type
- Transient ischemic attack (TIA)
- Systemic embolism
- Death
- Major bleeding, by site and severity
The registry must also be designed to answer specific research questions, including how real-world outcomes compare to pivotal trial data at ≤ 12 months and ≥ 4 years, and what the long-term durability of the device looks like. CMS requires that the registry have a written, executable analysis plan addressing these questions.
For billing purposes: if your patient is not enrolled in a CMS-approved registry, the claim does not meet CED requirements and should not be submitted as covered. Work with your compliance and clinical teams to confirm registry enrollment is captured in the medical record before claim submission.
| 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
This policy does not list specific CPT or HCPCS procedure codes in the version of the policy document reviewed. CMS NCD 367 is a coverage determination policy tied to FDA-approved LAAC devices and CED conditions rather than to a defined code set in the document provided.
What this means for your billing team: Confirm with your coding team which CPT codes your facility uses to bill LAAC procedures (typically found in the cardiac catheterization and structural heart procedure families), and map those codes to the NCD 367 coverage criteria manually. Do not assume any LAAC-related code is billable to Medicare without verifying the full CED requirement set is met and documented.
There are no ICD-10-CM codes specified in the policy document. However, the clinical criteria reference NVAF with elevated CHADS₂ or CHA₂DS₂-VASc scores—your diagnosis coding should accurately reflect the AF diagnosis and stroke risk factors documented in the record.
What Your Billing Team Should Do
| # | Action Item |
|---|---|
| 1 | Audit your physician roster now, before March 12, 2026. Pull a list of every cardiologist, electrophysiologist, and cardiovascular surgeon performing LAAC at your facility. Verify that each has completed manufacturer training and meets the transeptal puncture volume thresholds (≥ 25 historical, ≥ 25 ongoing with ≥ 12 LAAC over 2 years). Flag any physicians who are close to falling below the ongoing threshold and escalate to your medical director. |
| 2 | Confirm active registry enrollment for every LAAC patient. Before a claim goes out the door, there should be documented evidence in the chart that the patient is enrolled in a prospective, CMS-qualifying LAAC registry. Build a hard stop into your pre-bill review workflow that requires this confirmation. |
| 3 | Create a shared decision-making documentation checklist. The SDM requirement—an independent, non-interventional physician, using an evidence-based OAC decision tool, with the interaction documented in the medical record—has multiple components that can each become a denial if missing. Work with your clinical documentation improvement (CDI) team to create a standardized SDM note template that covers every element CMS requires. |
| 4 | Establish a CHADS₂/CHA₂DS₂-VASc score documentation standard. The applicable score must appear in the medical record with enough specificity to confirm the patient meets the ≥ 2 or ≥ 3 threshold. Vague language like "elevated stroke risk" will not satisfy a medical necessity review. The specific score and contributing factors should be explicitly documented by the treating physician. |
| 5 | Review your facility's SHD/EP program designation. The procedure must be performed in a hospital with an established structural heart disease and/or electrophysiology program. If your facility has undergone administrative or program changes since last credentialing this service line, confirm the program status is current and documented. |
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.