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202109-141834

2021

Empire BlueCross BlueShield HealthPlus

Medicaid

Cardiac/ Circulatory Problems

Durable Medical Equipment (DME) (including Wearable Defibrilllators)

Medical necessity

Upheld

Case Summary

Diagnosis: Systolic Heart Failure

Treatment wearable cardiac defibrillator (K0606)

The insurer denied coverage for wearable cardiac defibrillator (K0606)

The denial is upheld

The patient was diagnosed with systolic heart failure and prescribed an external lifevest defibrillator. The patient presented to the hospital complaining of worsening shortness of breath. Past medical history was relevant for a prior work up for systolic congestive heart failure including cardiac catheterization and treatment with guideline directed medical therapy and psychiatric disease treated with Seroquel and Buproprion. Upon arrival to the hospital, vital signs were stable. Serum blood testing revealed an elevated troponin level (0.22ng/ml [nanogram per milliliter]) and (BNP) B type natriuretic peptide was over 2000 pg/ml [picogram per milliliter]. Echocardiogram revealed a severely depressed left ventricular ejection fraction (LVEF) 15-20% (percent) with an apical thrombus and moderate mitral regurgitation. Electrocardiogram (ECG) revealed sinus tachycardia with no ectopy. The patient noted that he was non-compliant with medications. He was restarted on guideline directed medical therapy and discharged home with an external lifevest defibrillator.

The health plan acted reasonably with sound medical judgment and in the best interest of the patient. The proposed treatment is not likely to be more beneficial than any available standard therapy. The SCD HFT [sudden cardiac death in heart failure] trial demonstrated a survival benefit in patients with NYHA [New York Heart Association] functional class II symptoms of CHF [congestive heart failure] and an LVEF less than or equal to 35% (1). Current guidelines do not recommend primary prevention of sudden cardiac death prior to treatment with anti-congestive therapies (2). The patient presented with a reduced ejection fraction and new onset heart failure. His clinical presentation and hospitalization did not suggest high risk features for sustained ventricular arrhythmia. Based on current available guidelines and clinical trial data the proposed treatment was not medically necessary and was unlikely to be beneficial for the patient (2).

In conclusion, evidence-based indications do not support the routine use of external lifevest defibrillators in patients with heart failure without high risk features for arrhythmia (3). This patient presented with new onset heart failure and without significant arrhythmia during hospitalization. External lifevest defibrillator was not medically necessary in this case.

Based on the above, the medical necessity for the wearable cardiac defibrillator (K0606) is not substantiated. The insurer's denial is upheld.

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