Appeal type: Medical necessity
Decision: Overturned

Diagnosis: heart failure with reduced left ventricular (LV) ejection fraction (25-30 % [percent]),

Treatment: transcatheter heart valve replacement (TAVR) surgery; the JenaValve, code 33361

The insurer denied coverage for transcatheter heart valve replacement (TAVR) surgery; the JenaValve, code 33361.

The denial is overturned.

This is the case of an female with a history of middle cerebral artery (MCA) stroke, heart failure with reduced left ventricular (LV) ejection fraction (25-30 % [percent]), severe aortic regurgitation and frailty.  She was not a candidate for surgical repair as the risks for perioperative morbidity and mortality were prohibitive risk. She was referred for percutaneous aortic valve replacement. Further evaluation revealed no significant calcification of the aortic valve and no evidence of concomitant aortic valve stenosis. Recommendations were made for TAVR utilizing a new type of valve specifically designed for aortic regurgitation; the JenaValve.

It is well known that patients with prohibitive risk for surgical aortic valve replacement benefit from transcatheter aortic valve implantation (TAVI) (1-2). The patient in this case was a high risk for open heart surgery. In one study of 5,000 patients, approximately two thirds of patients with valvular heart disease and a depressed ejection fraction were never sent for open surgical repair due to co-morbidities (3). Although transcatheter aortic valve replacement has been shown to be the treatment of choice in individuals with aortic stenosis that cannot tolerate open heart surgery, the same cannot be said for patients with aortic regurgitation (2). 

Multiple centers have reported that patients with isolated aortic regurgitation, in need of valve replacement, have a much higher complication rate following TAVI due to the different anatomical abnormalities associated with regurgitant aortic valves. A retrospective study of 1,222 patients demonstrated significantly higher rates of renal failure, surgical bailout and death when compared to TAVI performed (4). Another study demonstrated more promising outcomes in terms of morbidity and mortality but had a 7.4% paravalvular leak rate, significantly higher than seen with patients that undergo TAVI for aortic stenosis (5). Specifically, regurgitant aortic valves tend to have a wider and more dynamic orifice that may explain reports of traditional TAVI valve embolization or paravalvular leakage (6). Second generation TAVI valves have been shown to be effective in patients with aortic regurgitation when concomitant aortic stenosis and or a calcified orifice allows for effective valve anchoring.  

This was specifically noted to be absent in this patient's case.  The JenaValve was the first TAVI device dedicated to the treatment of aortic regurgitation that was given the CE (conformite europeenne) mark in Europe (7).  In a meta-analysis comparing second generation TAVI valves (approved for the treatment of aortic stenosis) with the JenaValve, the use of the JenaValve was associated with a significantly higher procedural success rate without any effect on mortality (8). The JenaValve has been demonstrated to be the best option for patients with noncalcified aortic valves and pure aortic regurgitation.

In conclusion, there was sufficient evidence to support that coverage for transcatheter heart valve surgery to correct aortic regurgitation with the JenaValve in this high risk patient was medically necessary.  

The health care plan did not act reasonably, with sound clinical judgment, and in the best interest of the patient.

The insurer's denial of coverage for transcatheter heart valve replacement (TAVR) surgery; the JenaValve, code 33361 is reversed. Medical necessity is substantiated.