Diagnosis: Non-ischemic cardiomyopathy.
Treatment: Wearable Cardioverter Defibrillator (K0606).
The insurer denied the Wearable Cardioverter Defibrillator (K0606).
The denial is upheld.

This patient is a female with a new diagnosis of non-ischemic cardiomyopathy with ejection fraction (EF) of 34% (percent). She was started on guideline directed medical therapy. A LifeVest was placed. This was denied as not medically necessary. The company appealed the denial.

No, the proposed treatment was not medically necessary.
The typical indication for the use of a LifeVest is in a patient who has an indication for implantation of an implantable cardioverter defibrillator (ICD), but also has a contraindication to its implantation. This can be an ongoing infection, especially of a pacemaker system, or while a patient is awaiting heart transplantation. There are no good randomized studies of patients without these indications. The only data that has been published comes from the company's database. This demonstrated a low utilization rate for the LifeVest in patients without the typical indications for its use. The editorial that accompanied this article questioned the role of the LifeVest in the patient without the typical indication for the use of the LIfeVest.

This patient was just started on heart failure medical therapy and had not reached optimal dosing. Therefore, there is no indication that the LifeVest is medically necessary in a patient such as this.

Yes, the health plan acted reasonably, with sound medical judgment and in the best interest of the patient.
The patient does not have an indication for the implantation of an implantable cardioverter defibrillator (ICD). There is no randomized data that demonstrates that this therapy improves survival in patients with non-ischemic cardiomyopathy. Therefore, there is no demonstrated medical necessity for this device.