Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Atrial Fibrillation
Treatment: Closure of left atrial appendage
The insurer denied the Closure of left atrial appendage.
The denial is overturned. 

The patient is a male with history of persistent atrial fibrillation, and co-morbidities of obesity, hypertension, chronic obstructive pulmonary disease (COPD), and hyperthyroidism. He had a recent ablation procedure for atrial fibrillation. Watchman device implantation was requested. "Intolerant to anticoagulation therapy" is noted. Due to risk of stroke, occlusion of atrial appendage was requested. The patient had treatment with Eliquis for anticoagulation in the past and is on beta blockers. 

The patient's letter of request states that he has been on blood thinners for a number of years, which causes anxiety. He stated that he cannot have dental procedures or other surgery.

Additional information provided stated that the patient has "significant intolerance to anticoagulation with extensive ecchymosis and hemorrhoidal bleeding".

Yes, the health plan should cover the proposed treatment. 

Yes, the requested 33340 (closure of left atrial appendage) is likely to be more beneficial than any standard treatment(s) due to his stated intolerance to anticoagulation.

Published recommendations note that the WATCHMAN implant may be suitable for a broad range of NVAF patients and may be an appropriate option for non-valvular atrial fibrillation (NVAF) patients who meet these criteria:

Eligible patients must:
1) Have an increased risk for stroke and be recommended for anticoagulation (greater than or equal to [>=] 2 for men, greater than or equal to [>=] 3 for women)*
2) Be suitable for short-term oral anticoagulation
3) Have an appropriate reason to seek a non-pharmacologic alternative to oral anticoagulants (OACs) 
PREVIOUS BLEED: A history of major or non-major bleeding
LIFESTYLE and OCCUPATION: An occupation or lifestyle where anticoagulation is not ideal 
NON-COMPLIANT: Prior inability to comply with oral anticoagulants (OAC) treatment 
DRUG INTERACTIONS: Comorbidities requiring treatments that may not be compatible with oral anticoagulants (OACs)
FUTURE BLEED RISK: A high risk of bleeding or at risk for falls

The following clinical occurrences may meet this criterion:
-Thrombocytopenia or known coagulation defect associated with bleeding
-Recurrent bleeding, including gastrointestinal, genitourinary, respiratory 
-Prior severe bleeding, including intracranial hemorrhage
-Combined use of dual antiplatelet and anticoagulant therapy
-Poor compliance or intolerance with anticoagulant therapy
-High risk of the patient falling or prior falls resulting in injury

The medical records note that in this case, there are indications for anticoagulation, and a statement that medical intolerance is present. 

In the patient's personal letter, he notes that he has used blood thinners for years, without any bleeding complications or any other untoward event. In the medical records, hemorrhoidal bleeding and ecchymosis are noted including significant intolerance.

The patient notes the future need for dental work and hip surgery.

The appeal letter from the patient's NYU electrophysiologist discusses the patient's clinical history and comorbidities, which justified the use of anticoagulation; and supplemental report notes history of factors that would make oral anticoagulation contraindicated.

The common criteria that are used in community practice and are indications for Watchman device implantation are listed above.