Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Severe mitral regurgitation

Treatment: Transcatheter Mitral Valve Replacement (TMVR)

The insurer denied the transcatheter mitral valve replacement (TMVR). The denial was upheld.   

This is a female patient with a history of morbid obesity, chronic obstructive pulmonary disease (COPD), restrictive lung disease, obstructive sleep apnea, dilated ascending aortic aneurysm, and diabetes mellitus, paroxysmal atrial fibrillation, mitral regurgitation. She presented to a cardiac surgeon with complaints of exertional fatigue and dyspnea after walking one to two blocks. Exercise tolerance testing using a modified Bruce protocol was performed but was terminated due to fatigue after 4 minutes 51 seconds with peak heart rate 123 (78% predicted) and drop in oxygen saturation from 98% at rest to 93% with exercise. She had a transesophageal echocardiogram (TEE) that revealed flail A2 leaflet of the mitral valve with severe mitral regurgitation, normal left ventricular cavity size, left ventricular ejection fraction (LVEF) 60%, no regional wall motion abnormalities, severely enlarged left atrium, calcification at the posterior mitral annulus, and moderate pulmonary hypertension, with mitral valve anatomy described as appropriate for transcatheter edge-to-edge mitral valve repair. She was evaluated by an interventional cardiologist and cardiovascular surgeon regarding surgical and transcatheter mitral valve repair due to her high risk for surgical repair. The patient chose transcatheter mitral valve repair rather than surgical repair.

The denial of coverage for transcatheter mitral valve replacement is upheld because this procedure has not been approved by the FDA.  Based on the appeal and clinical documents submitted, this patient was appealing for coverage by the health care plan for transcatheter mitral valve repair, and not replacement.  Transcatheter mitral valve repair was approved by the FDA for patients with significant symptomatic mitral regurgitation (MR > 3x) due to primary cell normality of the mitral apparatus (degenerative mitral regurgitation) in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team.  However, this patient did not meet the criteria of transcatheter mitral valve repair, based on this patient's clinical characteristics including her Society of Thoracic Surgery (STS) risk score, score on fragile measures, and the fact that the heart team did not determine that her surgical risk was prohibitive.

Neither the cardiovascular surgeon nor the interventional cardiologist used the words prohibitive risk for surgical repair in their reports, which was appropriate, based on results of testing.  Although the patient was at increased risk for surgery, it should be noted that this patient's STS score of 3.6% was much lower than the patients enrolled in the EVEREST trial (STS scores 13.2 + 7.3%), which led to FDA approval for use of the MitraClip device on patients with symptomatic severe degenerative mitral regurgitation.  This supports that this patient's risk for surgical mitral valve repair does not meet the criteria for use of transcatheter mitral valve repair.  The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of coverage for transcatheter mitral valve replacement (TMVR) is upheld.