Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Pulmonary disease, heart disease
Treatment: High frequency chest compression device 
The High frequency chest compression device is medically necessary.
The patient is a female child with medical history significant for trisomy 21, significant obstructive sleep apnea on BiPAP (bi-level positive airway pressure), moderate persistent asthma, pulmonary hypertension on supplemental oxygen, residual congenital heart disease (ASD/VSD [atrial septal defect/ ventricular septal defect] with fenestrations), recurrent aspiration, and recurrent sinopulmonary infections. She does not have impaired cough, but has ineffective airway clearance because of her other conditions. Chest x-ray has revealed increased markings of a chronic and fibrotic character. 
The patient has failed manual chest physiotherapy, with persistent and recurrent infections. She is developmentally delayed and unable to participate with flow-dependent devices (e.g., acapella, flutter). She has had the opportunity to trial several different Vest systems, did particularly well with the InCourage, and her mother has noted the following improvements: easier breathing, able to cough out secretions easier, able to sleep better, increased energy levels, missing less school. 
High-frequency chest wall oscillation (HFCWO) was developed to improve airway clearance in those where the normal mucociliary transport system has failed (e.g., chronic/recurrent bronchitis/pneumonia, bronchiectasis, cystic fibrosis). The majority of patients in whom airway clearance systems have been studied have cystic fibrosis. Research bears out the utility of these systems in airway clearance. In stable outpatients with cystic fibrosis, high-frequency oscillation and chest physiotherapy (CPT) were found to "have comparable augmenting effects on expectorated sputum weight without changing PFTs or oxygen saturation." (1) In a different study of cystic fibrosis patients, both wet and dry expectorated secretion weights were greater with HFCWO compared to CPT, suggesting that "HFCWO is at least as effective as manual CPT/PD [postural drainage] in clearing secretions from the airways in patients with cystic fibrosis." (2) 
Over a decade ago, a high-frequency chest clearance (HFCC) device was tested in 16 patients with cystic fibrosis: "ninety-four percent of patients' regression line slopes for percent predicted forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) became more positive during self-administered HFCC therapy as compared to slopes before HFCC therapy when manual chest physical therapy was used." (3) 
Vest therapy (VT) has also been studied in children with quadriplegic cerebral palsy: "VT resulted in more effective suctioning of pulmonary secretions, reduced incidence of pneumonia, and reduced number of hospitalizations for pneumonia." (4) In patients with familial dysautonomia, "HFCWO effected significant improvements in all health outcomes and oxygen saturation." (5) 
In a study of children with either cerebral palsy or neuromuscular diseases, the authors conclude, "our data suggest safety, tolerability, and better compliance with high-frequency chest wall oscillation. Improvement in airway clearance may help prevent hospitalizations." (6) And finally, in other studies of both children and adults with neuromuscular diseases, there were lower medical burden, hospitalizations, and pneumonia claims after initiation of high frequency chest wall oscillation than before, supporting routine use in patients with neuromuscular diseases. (7-8)
This medically fragile child with multiple medical problems has difficulty with airway clearance. She has failed treatment with manual chest physiotherapy and is unable to use any of the flow-based modalities. She has successfully trialed the InCourage Vest system with noted improvements. This high frequency compression device is medically necessary and appropriate for her, consistent with the current relevant literature.