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 overturned. 


This patient is a male who suffers from severe chronic obstructive pulmonary disease (COPD) and hyperinflation. The patient is on maximum inhaled therapy. The patient is not a carbon dioxide (CO2) retainer.  His pulmonary function test (PFT) showed post bronchodilator forced expiratory volume (FEV1) of 33%, total lung capacity (TLC) of 118%, residual volume (RV) of 168%, and diffusing capacity for carbon monoxide (DLCO) of 26%. The treating provider is requesting for placement of endobronchial valves. 
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 overturned in whole.

The proposed health service or treatment Zephyr valve procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Endobronchial valves (EBV) placement is supported by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and National Institute for Health and Care Excellence (NICE) guidelines for selected patients with hyperinflation associated with severe emphysema. 
In the Liberate trial, 190 subjects with severe emphysema were randomly assigned to endobronchial valve (EBV) placement or usual care (UC). At 12 months, 48 percent of participants receiving EBV treatment and 17 percent of those receiving usual care had an improvement in FEV1 greater than (>)15 percent. FEV1, 6-minute walking distance (6MWD), dyspnea, and quality of life were all significantly better in the EBV group.
A separate multicenter trial (TRANSFORM) randomly assigned 97 patients with severe heterogeneous emphysema to receive EBV or standard of care (SOC). At six months, there was improvement in residual volume, 6MWD and modified Medical Research Council dyspnea score in the EBV group. The improvement in quality of life was also greater in the EBV group.
Criner et al performed a multicenter, open label, randomized, controlled trial, subjects aged 40 years or older with severe, heterogeneous emphysema were randomized 2:1 to endobronchial valve with medical management (treatment) or medical management alone (control). The primary efficacy outcome was the difference in mean FEV1 from baseline to 6 months. Secondary effectiveness outcomes included: difference in FEV1 responder rates, target lobe volume reduction, hyperinflation, health status, dyspnea, and exercise capacity. At 6 months, the treatment group had statistically significant improvements in all secondary endpoints except 6-minute-walk distance. The final authors conclusions were that in patients with severe heterogeneous emphysema, the endobronchial valves show significant improvement in multiple efficacy outcomes.
This patient suffers from very severe COPD. The patient continues to be symptomatic despite maximum medical therapy. The zephyr valves are indicated and medically necessary to improve the patient symptoms.