Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 54-year-old male who has requested authorization and coverage for a home defibrillator kit. Review of the submitted medical documentation indicates the patient has a history of dilated cardiomyopathy. His most recent echocardiogram demonstrated left ventricular enlargement, moderate to severe, with global hypokinesis and an estimated ejection fraction of 20-25%. The patients physician has recommended the patient undergo implantation of an automatic internal cardioverter defibrillator (AICD). The patient wishes to receive a home defibrillator kit. The Health Plan has denied this request indicating that the requested device is considered investigational for treatment of the patients condition. The Health Plans denial should be upheld. The provided documentation indicates the patient has not had a recent cardiology evaluation. By ejection fraction criteria, it would appear the patient is a candidate for AICD insertion. There is no benefit to a home defibrillator unit if the patient warrants insertion of a permanent device. The reviewed literature demonstrates no established benefit of the home unit over the permanent AICD. The patients Holter study in May 2004 demonstrated only frequent PVCS. The patient needs an updated cardiology evaluation to determine the need for AICD insertion. The only scenario for use of the home kit would be if surgery was completely contraindicated for AICD insertion and it is determined by cardiology that the patient is at high risk for sudden death. Based upon the information set forth above, I have determined that the requested device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld. Physician 2: The patient is a 54-year-old male with an idiopathic, dilated cardiomyopathy. He has a left ventricular ejection fraction of 25%. The most recent Holter recording demonstrated 1800 PVCs in 24 hours. There was no ventricular tachycardia. His provider diagnosed the patient as at high risk for sudden death and recommended he undergo automatic internal cardiac defibrillator (AICD) implantation. The patient declined and has requested authorization for an automated external defibrillator for the home. The Health Plan denied this request indicating the device has not been shown to be more beneficial than the standard treatment, AICD. The 2000 American College of Cardiology/American Heart Association (ACC/AHA) guidelines rely on the MADIT II and SCD-HeFT trials, which demonstrated efficacy of AICD utilizing mortality as an end point. The ACC/AHA guidelines list severe left ventricular dysfunction as a Class IIa indication for AICD. AICD is the conventional therapy for prevention of sudden death in cardiomyopathy. None of the submitted articles regarding the home defibrillator kit involved peer-reviewed trials. Furthermore, there are few peer-reviewed studies of the home defibrillator kit that use mortality as the endpoint in determining effectiveness of this device. At this time, the home defibrillator kit is an unproven device and has not been shown to be more beneficial than AICD. Accordingly, I have determined that the requested device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld. Physician 3: The patient is a 54-year-old male who is seeking a home defibrillator. His provider has recommended implantation of an automatic internal cardioverter defibrillator (AICD); however, the patient prefers a home defibrillator. The patients injection ventricular ejection fraction is approximately 25% and therefore, he appears to be an appropriate candidate for an AICD. Home defibrillators are not proven to be more effective than AICDs. In fact, the expert opinion submitted with this review, indicates in-home defibrillators are meant for patients who have met the criteria for an AICD but for whom surgery is contraindicated. Based upon the information provided, this patient is a candidate for an AICD and surgery is not contraindicated. Furthermore, the expert opinion submitted with this review indicates external in-home defibrillators are far less satisfactory than AICDs. In summary, there is no evidence supporting an in-home external defibrillator as having an advantage over an AICD and there is evidence that an AICD has numerous advantages to an in-home external defibrillator for this patient. Based upon the information set forth above, I have determined that the requested device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.