Appeal type: Medical necessity
Decision: Upheld

Chronic Obstructive Pulmonary Disease (COPD)
Durable Medical Equipment (DME)

This is the case of a male patient who suffers from chronic obstructive pulmonary disease (COPD) and sleep apnea. The patient has been complaining of chronic cough pulmonary function test showed reduced forced expired volume in 1 second (FEV1) and diffusing capacity of the lungs for carbon monoxide (DLCO). The patient had the computerized axial tomography (CAT) scan of the chest that showed extensive is centrilobular emphysema. The computed tomography (CT) scan of the chest did not show frank evidence of bronchiectasis. The patient is on inhalers. The treating physician is requesting the coverage of a vest to enhance clearance of the airways from retained secretions. The subject under review is the medical necessity of the inCourage airway clearance therapy high frequency chest compression device (VEST).

The health plan's determination is upheld.

No, the requested health service/treatment of inCourage Airway Clearance Therapy High Frequency Chest Compression (HFCC) Device is not medically necessary for this patient
The VEST has been studied mainly in patients with cystic fibrosis (CF) with bronchiectasis. Various physical methods have also been suggested to facilitate clearance of airway secretions in patients with stable COPD, but there is little information documenting their efficacy and safety. In general, for non-cystic fibrosis patients requiring assisted clearance of secretions, information on high frequency chest compression is very limited.
Mahajan et al. did a randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients received active or sham treatment for 15 minutes three times a day for four treatments. Medical management was standardized across groups. The primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed) and satisfaction. Secondary outcomes included change in Borg dyspnea score (1 unit indicates a clinically significant change), spontaneously expectorated sputum volume, and forced expired volume in 1 second.
Fifty-two participants were randomized to active (number [n] = 25) or sham (n = 27) treatment. Patient adherence was similarly high in both groups (91% vs. 93%; probability [p] = 0.70). Patient satisfaction was also similarly high in both groups. After four treatments, a higher proportion of patients in the active treatment group had a clinically significant improvement in dyspnea (70.8% vs. 42.3%, p = 0.04). There were no significant differences in other secondary outcomes. The final conclusion was that high frequency chest wall oscillation (HFCWO) is well tolerated in adults hospitalized for acute asthma or COPD and significantly improves dyspnea. Additional studies are needed to more fully evaluate the "long term" role of HFCWO in improving in-hospital and post-discharge outcomes in this population.
A randomized, controlled, crossover, pilot study (Chakravorty et al., 2011) that was not statistically powered, which included 22 patients with advanced COPD and a mean age of 71 years, showed that high frequency chest wall oscillation reduced symptoms and improved quality of life; however, future studies are needed to explore possible effects on lung function or possible prevention of exacerbations.
A randomized controlled trial (Goktalay et al. 2013 ) of 50 hospitalized patients with COPD and an infective exacerbation found that standard therapy plus high frequency chest wall oscillation offered no additional improvement in symptoms or functional parameters as compared with standard therapy alone.
This patient has history of COPD. He has difficulty getting rid of his sputum. Clearing the airways from the retained secretion should be of help (at least in theory) to improve the patient clinical condition and decrease the risk of recurrent pneumonia. However, there is no clear evidence to prove that the VEST can achieve such outcome in this patient. There are no long term trials on the safety and efficacy of the VEST in patient with COPD and difficulty to clear the airway from retained secretion. There is no evidence that the VEST improves the overall outcome in such patients.