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Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that patients with atrial fibrillation (AF), an irregular heartbeat, are at an increased risk of stroke. 
The left atrial appendage (LAA) is a tubular structure that opens into the left atrium and has been shown to be 
one potential source for blood clots that can cause strokes. While thinning the blood with anticoagulant 
medications has been proven to prevent strokes, percutaneous LAA closure (LAAC) has been studied as a non-
pharmacologic alternative for patients with AF. 
 
The Centers for Medicare & Medicaid Services (CMS) covers percutaneous LAAC for non-valvular atrial 
fibrillation (NVAF) through Coverage with Evidence Development (CED) with the following conditions: 
 
LAAC devices are covered when the device has received Food and Drug Administration (FDA) Premarket 
Approval (PMA) for that devices FDA-approved indication and meet all of the conditions specified below: 
The patient must have: 
 
A CHADS2 score = 2 (Congestive heart failure, Hypertension, Age > 75, Diabetes, Stroke/transient ischemia 
attack/thromboembolism) or CHA2DS2-VASc score = 3 (Congestive heart failure, Hypertension, Age = 65, 
Diabetes, Stroke/transient ischemia attack/thromboembolism, Vascular disease, Sex category) 
A formal shared decision making interaction with an independent non-interventional physician using an 
evidence-based decision tool on oral anticoagulation in patients with NVAF prior to LAAC. Additionally, the 
shared decision-making interaction must be documented in the medical record. 
A suitability for short-term warfarin but deemed unable to take long-term oral anticoagulation following the 
conclusion of shared decision making, as LAAC is only covered as a second line therapy to oral anticoagulants. 
The patient (preoperatively and postoperatively) is under the care of a cohesive, multidisciplinary team (MDT) 
of medical professionals. The procedure must be furnished in a hospital with an established structural heart 
disease (SHD) and/or electrophysiology (EP) program. 
The procedure must be performed by an interventional cardiologist(s), electrophysiologist(s), or cardiovascular 
surgeon (s) that meet the following criteria: 
 
Has received training prescribed by the manufacturer on the safe and effective use of the device prior to 
performing LAAC; and, Has performed = 25 interventional cardiac procedures that involve transeptal puncture through an intact 
septum; and, 
Continues to perform = 25 interventional cardiac procedures that involve transeptal puncture through an intact 
septum, of which at least 12 are LAAC, over a 2-year period. 
The patient is enrolled in, and the MDT and hospital must participate in, a prospective, national, audited 
registry that: 1) consecutively enrolls LAAC patients, and, 2) tracks the following annual outcomes for each 
patient for a period of at least 4 years from the time of the LAAC: 
 
Operator-specific complications 
Device-specific complications including device thrombosis 
Stroke, adjudicated, by type 
Transient Ischemic Attack (TIA) 
Systemic embolism 
Death 
Major bleeding, by site and severity 
 
You can find these rules in the National Coverage Determination (NCD) Percutaneous Left Atrial Appendage 
Closure (LAAC) 20.34. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.