Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Respiratory System- pulmonary disease (COPD) and hyperinflation.
Treatment: Surgical Services-Zephyr.
The insurer denied the Zephyr valve procedure as Experimental/Investigational. The denial was upleld.

The patient is a male former smoker with symptomatic chronic obstructive pulmonary disease (COPD), a high-resolution computed tomography (HRCT) that demonstrates centrilobular emphysema and a forced expiratory volume in 1 second (FEV1) of 33%, total lung capacity (TLC) of 118% of predicted, carbon monoxide diffusing capacity (DLCO) of 35% predicted while he is on maximal medical therapy. 
At issue is whether the Zephyr valve procedure is likely to be more beneficial than standard treatment.

The health plan's determination regarding the proposed health service or treatment is upheld in whole.

The proposed health service or treatment Zephyr valve procedure is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The United States Food and Drug Administration (FDA) has approved the Zephyr Endobronchial Valve System for bronchoscopic implantation in lung regions with little to no collateral ventilation to treat patients with hyperinflation associated with severe emphysema. Based on the inclusion criteria for the pivotal clinical trials, candidate selection for Zephyr Endobronchial valves(EBV) placement will include a modified Medical Research Council (MRC) dyspnea score greater than or equal to (>=) 2, FEV1 between 15 and 45 percent predicted, total lung capacity (TLC) >= 100 percent predicted, residual volume (RV) >=175 percent predicted, DLCO >= 20 percent predicted and a six-minute walk distance (6MWD) between 100 and 500 meters. A key step in evaluation of potential patients is high-resolution computed tomography (HRCT) to measure lobar volumes and determine the amount of emphysematous destruction of each lobe. Multiple studies have demonstrated that Zephyr valve treatment in hyperinflated patients with heterogeneous or homogeneous emphysema without collateral ventilation resulted in significant and clinically meaningful benefits in lung function, dyspnea, exercise tolerance, and quality of life, with an acceptable safety profile.
The patient has a diagnosis of symptomatic chronic obstructive pulmonary disease (COPD), an HRCT that demonstrates centrilobular emphysema and an FEV1 of 33%, TLC of 118% of predicted, DLCO of 35% predicted while he is on maximal medical therapy. However, there is no documentation that the patient completed a full course of pulmonary rehabilitation, an RV >= 175 percent predicted, a six-minute walk distance between 100 and 500 meters or an HRCT measuring lobar volumes to determine the amount of emphysematous destruction of each lobe. Therefore, based on the clinical documentation provided and per the current literature regarding optimal candidates for the Zephyr valve for lung volume reduction, the proposed health service or treatment Zephyr valve procedure is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.