Card Valve Repl denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for a MitraClip procedure with a one-day hospital inpatient stay. The U.S. Food and Drug Administration (FDA) approves the use of percutaneous mitral valve repair using the MitraClip device for high-risk patients with degenerative or other primary mitral valve regurgitation. Asch and colleagues report that the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial demonstrated that patients with 3+ or 4+ mitral regurgitation who remained symptomatic despite maximally tolerated guideline directed medical therapy benefited from MitraClip implantation, regardless of their degree of left ventricle (LV) dysfunction, LV dilatation, pulmonary hypertension, severity of tricuspid regurgitation, or individual…

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for transcatheter aortic valve replacement with prosthetic valve, percutaneous femoral artery approach.Findings: Two out of three physician reviewers found that the medical evidence supports the requested services in this clinical setting. The medical records demonstrate that the patient has symptomatic aortic stenosis, based on recent onset symptoms of dyspnea with limited (1 block or incline) exertion, fatigue and dizziness, and she therefore has Class II heart failure symptoms. The patient had a recent transthoracic echocardiogram (TTE) which revealed moderately severe to severe aortic stenosis secondary to a bicuspid valve.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for transcatheter mitral valve replacement. There is a lack of formal guidelines or consensus statements available to support treatment with transcatheter mitral valve-in-valve replacement for treatment of this patient’s bioprosthetic mitral valve failure. Urena and colleagues noted that patients may be eligible for transcatheter mitral valve-in-valve replacement if “they are symptomatic, they are considered at high surgical risk, and their anatomy is suitable.” However, the available clinical trials comparing transcatheter mitral valve-in-valve replacement and surgical mitral valve replacement have not reported superior health outcomes with transcatheter approach. The U.S.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for mitral valve repair (MitraClip). Findings: The physician reviewer found that U.S. Food and Drug Administration (FDA) approved percutaneous mitral valve repair using the MitraClip device for high risk patients with degenerative or other primary mitral valve regurgitation. The COAPT trial evaluated patients with 3-4+ mitral regurgitation who remained symptomatic despite maximally tolerated guideline directed medical therapy (Asch, et al.). The authors found that the patients benefited from MitraClip implantation, regardless of their degree of left ventricle (LV) dysfunction, LV dilatation, pulmonary hypertension or individual mitral regurgitation characteristics.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Card Valve Repl, then check the rights and deadlines that apply to your plan.