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 devices FDA-approved indication and meet all of the conditions specified below: 
 
The patient must have: 
 
    A CHADS2 score equals 2 (Congestive heart failure, Hypertension, Age greater than 75, Diabetes, 
Stroke/transient ischemia attack/thromboembolism) or CHA2DS2-VASc score equals 3 (Congestive heart 
failure, Hypertension, Age equals 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 equals 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 
 
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 (equals 
12 months) and in the long term (equals 4 years)? 
    What is the long term (equals 4 year) durability of the device? 
    What are the short term (equals 12 months) and the long term (equals 4 years) device-specific complications 
including device thromboses? 
 
To appropriately address some of these questions, Medicare claims or other outside data may be necessary. 
 
Registries must be reviewed and approved by CMS. Potential registry sponsors must submit all registry 
documentation to CMS for approval, including the written executable analysis plan and auditing plan. CMS 
will review the qualifications of candidate registries to ensure that the approved registry follows standard data 
collection practices, and collects data necessary to evaluate the patient outcomes specified above. The 
registrys national clinical trial number must be recorded on the claim. 
 
Consistent with section 1142 of the Social Security Act (the Act), the Agency for Healthcare Research and 
Quality (AHRQ) supports clinical research studies that CMS determines address the above-listed research 
questions and the a-m criteria listed in Section c. of this decision. 
 
You can find this information in Medicare's 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.