Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Acute on chronic respiratory failure
Treatment: E1399 Volara System, Oscillation and Lung Expansion Therapy
The insurer denied: E1399 Volara System, Oscillation and Lung 
Expansion Therapy
The denial is overturned

The patient is an adult male who has a history of respiratory failure. In a letter, the patient is described by his physician as non-ambulatory, with tracheostomy and is continuously mechanically ventilated in his private home. He has recurring episodes of mucus plugging and volume loss in the left lower lobe of his lung. The patient's physician indicates that the Volara system will improve his care in the home and reduce hospitalization. At issue is health plan approval for the Volara system (oscillation and lung expansion therapy), which has been deemed as not medically necessary. In addition to cerebral palsy, the patient is listed as having acute on chronic respiratory failure with hypoxia and hypercapnia, tracheostomy, mucus plugging, left upper lobe pneumonia due to Pseudomonas and scoliosis of the thoracic region. He also has a history of significant cognitive and functional limitations, blindness and chronic seizures. The most recent clinic notes from the patient's Pulmonologist also indicated recurrent left lower lobe pneumonia requiring prolonged intensive care unit (ICU) stay last year. The patient is being ventilated via tracheostomy with as Astral ventilator with inspiratory positive airway pressure (IPAP) 20, expiratory positive airway pressure (EPAP) 8 with a backup rate of 15 with 6 liters per minute (L/min) of oxygen. The patient is taking inhaled tobramycin, two weeks on followed by two weeks off, for suppression of Pseudomonas. Notes from the Hill-Rom company indicate that the patient has tried manual or percussor chest physiotherapy, High Frequency Chest Wall Oscillation (HFCWO) and nebulizers or inhalers, but these did not mobilize secretions. Their efficacy was also limited due to the patient's cognitive level and spasticity and/or contractures. Despite their use, the patient continued to have mucus plugging and pneumonia with prolonged hospitalization last year.

The proposed treatment is medically necessary.

As indicated on the Hill-Rom website, Volara consists of three components: CPEP (Continuous Positive Expiratory Pressure) -Treat and help prevent pulmonary atelectasis by combining continuous positive pressure with aerosol medication to help expand and hold the airways open; CHFO (Continuous High Frequency Oscillation) - this pneumatic form of chest therapy delivers continuous pulses of positive pressure, combined with aerosol medication, to mobilize and treat retained secretions; NEBULIZER - Integrated with CPEP (Continuous Positive Expiratory Pressure) and CHFO (Continuous High Frequency Oscillation) for the most efficient treatment, the system delivers medication during therapy to help loosen secretions.
The patient is an adult male who has a history of cerebral palsy, severe cognitive impairment and respiratory failure. He has a tracheostomy and is ventilator dependent. He has had multiple episodes of mucus plugging and pneumonia that were not prevented by other means of airway clearance. This patient has already gone through the usual measures without success. 
The Volara system is used widely for this purpose.