Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Mitral Regurgitation. 
Treatment: Heart Procedure (Procedure Codes: 33418 & 33419 - Transcatheter Mitral Valve Replacement). 

The insurer denied the Heart Procedure (Procedure Codes: 33418 & 33419 - Transcatheter Mitral Valve Replacement). 
The denial is overturned. 

The patient is a gentleman that presented to his physician with dyspnea and congestive heart failure. His past medical history included SLE (systemic lupus erythematosus), ischemic heart disease with Heart failure, reduced LV (left ventricle) ejection fraction (30%) and CRT (cardiac resynchronization therapy) ICD (implantable cardioverter defibrillator) implant. Echocardiography revealed severe functional mitral regurgitation. As a result of chronic steroid treatment for SLE (systemic lupus erythematosus) the patient also suffered from adrenal insufficiency. Transcatheter mitral valve repair with a Mitraclip device was recommended. 

Yes, the health plan should cover the Transcatheter Mitral Valve Replacement. 

Surgical repair of functional mitral regurgitation is a class IIB indication in patients with systolic congestive heart failure and severe MR (mitral regurgitation) (Reference 1). Although currently there are no indications recommended by the AHA (American Heart Association)/ACC (American College of Cardiology) for transcatheter mitral repair in patients with functional MR (mitral regurgitation), this patient was deemed to be a high risk candidate for surgical mitral valve repair. 

Yes, the Transcatheter Mitral Valve Replacement is likely to be more beneficial for the enrollee than any available standard therapy. 

This patient was treated with maximal medical therapy and cardiac resynchronization pacing in order to minimize mitral regurgitation. Moreover, the patient has severe co-morbidities including SLE (systemic lupus erythematosus) and adrenal insufficiency. A heart team deemed the patient high risk for surgical intervention. Findings on echocardiography support the use of a Mitraclip device. 

Several trials have evaluated outcomes in patients with congestive heart failure and severe functional mitral regurgitation.  These trials had conflicting outcomes.  The COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial demonstrated that patients with NYHA (New York Heart Association) class III heart failure and severe functional MR (mitral regurgitation) benefit from percutaneous mitral valve repair with the Mitraclip device.  This study demonstrated an improvement in decreased hospitalizations for heart failure as well as a lower two-year mortality (Reference 2). 

However the MITRA-FR (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation) trial failed to show a mortality difference or a difference in heart failure hospitalizations between patients that were treated with medical therapy and those that underwent transcatheter mitral valve repair (Reference 3).  Several other trials have demonstrated that percutaneous mitral valve repair in patients with functional mitral regurgitation and heart failure is feasible and improves patient functional status (References 4-6). 

European society guidelines support a IIb indication for such patients to undergo transcatheter mitral repair following heart team evaluation (Reference 7). 

Given this patient's co-morbid conditions, surgical MVR (mitral valve repair) would not be possible. The requested therapy is likely to be more beneficial.