Appeal type: unknown
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 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: 
a. LAAC devices are covered when the device has received Food and Drug Administration (FDA) 
Premarket Approval (PMA) for that device?s FDA-approved indication and meet all of the conditions 
specified below: 
The patient must have: 
? A CHADS2 score greater than or equal to 2 (Congestive heart failure, Hypertension, Age greater than 
75, Diabetes, Stroke/transient ischemia attack/thromboembolism) or CHA2DS2-VASc score greater 
than or equal to 3 (Congestive heart failure, Hypertension, Age greater than or equal to 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 greater than or equal to 25 interventional cardiac procedures that involve transeptal 
puncture through an intact septum; and, 
? Continues to perform greater than or equal to 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 
The registry must be designed to permit identification and analysis of patient, practitioner, and facility level 
factors that predict patient risk for these outcomes. The registry must collect all data necessary to conduct 
analyses adjusted for relevant confounders, and have a written executable analysis plan in place to address the 
following questions: 
? How do the outcomes listed above compare to outcomes in the pivotal clinical trials in the short term 
(less than or equal to 12 months) and in the long term (greater than or equal to 4 years)? 
? What is the long term (greater than or equal to 4 year) durability of the device? 
? What are the short term (less than or equal to 12 months) and the long term (greater than or equal to 4 
years) device-specific complications including device thromboses? 
You can find this rule in the National Coverage Determination Manual Chapter 1, Section 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.