CurrentBlue Cross Blue Shield - MassachusettsPolicy 334

Percutaneous Left Atrial Appendage Closure

Defines medical necessity, investigational status, authorization and coding guidance for percutaneous left atrial appendage closure devices (specifically FDA‑approved Watchman and Amplatzer Amulet) for prevention of stroke in individuals with atrial fibrillation, and states investigational status for other devices (e.g., Lariat, Amplatzer Cardiac Plug).

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyPercutaneous Left Atrial Appendage Closure

Policy CodePolicy 334

Change TypeClarifications and annual review

Effective Date

Next Review Date

Key ActionPrecertification/preauthorization is required for inpatient procedures and providers must document stroke risk (CHADS2 or CHA2DS2‑VASc) and that long‑term anticoagulation risks outweigh device implantation risks.

SourceLink

POLICY UPDATE CHANGES

7/2025 annual policy review: Description, summary, and references updated; policy statements unchanged.

5/2024 clarified prior authorization table.

7/2022 policy statements clarified to include the FDA‑approved Amplatzer Amulet device.

2FDA‑approved devices mentioned

2Investigational devices listed

1Covered CPT code groups

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Coverage Summary

Scope: Defines medical necessity, investigational status, authorization, and coding guidance for percutaneous left atrial appendage closure (LAAC) devices for prevention of stroke in individuals with atrial fibrillation, with specific reference to FDA‑approved devices Watchman and Amplatzer Amulet. Other devices (for example, Lariat and Amplatzer Cardiac Plug) are stated as investigational.

Background summary: Percutaneous LAAC devices occlude the left atrial appendage to reduce thrombus formation and embolic stroke risk in patients with atrial fibrillation. Anticoagulation is the primary treatment for stroke prevention in AF but carries an increased bleeding risk; LAAC devices offer a nonpharmacologic alternative for selected patients. The policy notes that the Watchman and Amplatzer Amulet devices have U.S. Food and Drug Administration approval for LAAC, while other devices lack FDA approval for this indication and are considered investigational. The coverage stance is mixed: FDA‑approved devices may be considered medically necessary when criteria are met, and non‑approved devices or uses that do not meet criteria are investigational / not medically necessary.

Key thresholds and quick facts from policy

CHADS2/CHA2DS2‑VASc requirementIncreased stroke risk per CHADS2 or CHA2DS2‑VASc where systemic anticoagulation is recommended

HAS‑BLED threshold>= 3 indicates high bleeding risk (signals need for closer monitoring; used when considering anticoagulation vs device)

FDA‑approved devices count2 (Watchman, Amplatzer Amulet)

Example investigational devices count2 (Lariat, Amplatzer Cardiac Plug cited as not FDA‑approved for LAAC)

Covered CPT code count1 (33340)

Last policy review year2025

Medical‑Necessity / Investigational Criteria

Medically Necessary

Percutaneous LAAC with an FDA‑approved device (e.g., Watchman or Amplatzer Amulet) may be considered MEDICALLY NECESSARY when ALL of the following are met:

ALL of the following

Stroke risk: There is an increased risk of stroke and systemic embolism based on CHADS2 or CHA2DS2‑VASc score and systemic anticoagulation therapy is recommended.See CHADS2/CHA2DS2‑VASc scoring
Refer to documented CHADS2 or CHA2DS2‑VASc score
Bleeding/anticoagulation risk: The long‑term risks of systemic anticoagulation outweigh the risks of the device implantation.Consider HAS‑BLED score; scores ≥3 indicate high bleeding risk
Documentation should show anticoagulation risks (eg, bleeding history, HAS‑BLED score) or contraindication

Coding

Covered CPTCPTCovered

33340

Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation

Informational — Other codesmixed

No codes listed

Provider Actions & Billing

Prior Authorization

Precertification/Preauthorization Required

Precertification/preauthorization is required when the procedure is performed inpatient; prior authorization requirements for outpatient vary by product and plan — follow plan-specific guidance.

Affected code(s): 33340

Documentation Required

Documentation of Stroke Risk and Anticoagulation Risk

Document the patient’s stroke risk using a CHADS2 or CHA2DS2‑VASc score and document that the long‑term risks of systemic anticoagulation outweigh the procedural/device risks. Provide evidence of bleeding risk or contraindication to anticoagulation (for example, a history of major bleeding, or a high HAS‑BLED score). Examples of acceptable documentation include an explicit CHADS2/CHA2DS2‑VASc score in the chart and notes describing prior bleeding events, HAS‑BLED calculation, or other clinical contraindications to anticoagulation.

Reference bleeding risk tool: HAS‑BLED (scores 0–9; score ≥3 indicates high bleeding risk)

Background & Evidence

LAAC purpose: Stroke in atrial fibrillation most commonly arises from thrombus formation in the left atrial appendage (LAA); percutaneous LAAC devices occlude the LAA to prevent thrombus formation and reduce embolic stroke risk.

Anticoagulation and bleeding risk: Systemic anticoagulation is the main pharmacologic approach to stroke prevention in AF and is effective, but it carries an increased risk of bleeding. Risk scores such as CHADS2 / CHA2DS2‑VASc are used to estimate stroke risk and guide anticoagulation, and bleeding risk assessment using scores like HAS‑BLED (scores range 0–9; scores ≥3 are considered high bleeding risk) is recommended when considering anticoagulation versus device therapy.

FDA approvals and investigational devices: The Watchman left atrial appendage closure system (including Watchman FLX) and the Amplatzer Amulet device have U.S. Food and Drug Administration approval for LAAC. Other devices, including epicardial suture ligation devices (e.g., the Lariat) and earlier Amplatzer Cardiac Plug versions, do not have FDA approval for LAAC and are considered investigational for stroke prevention in AF.

Evidence summary

Medicare Determinations

NCD name	NCD number	Effective date
National Coverage Determination for Percutaneous atrial appendage closure

Revision History

2025-07annual_reviewLatest

Annual policy review: Description, summary, and references updated; policy statements unchanged.

2024-05administrative_clarification

Clarified prior authorization table.

2022-07material_revision

Policy statements clarified to include the FDA-approved Amplatzer Amulet device.