Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Obstructive Sleep Apnea
Treatment: Replacement continuous positive airway pressure (CPAP) device
The insurer denied coverage for replacement continuous positive airway pressure (CPAP) device
The denial is upheld.
 
This case involves a patient who was given a continuous positive airway pressure (CPAP) device years ago with claims that he faithfully used the device up until a recent recall. The patient reported a history of asthma and a "very strong" family history of cancer.  The email report stated that the patient stopped using the machine after receiving the recall due to the risks to his health.  

The patient submitted a copy of the recall letter regarding his machine and a copy of the final adverse determination that he received.  He noted that in the policy 1.01.06 letter E that the only requirement for providing him with a new machine is if there had been an unrepairable change in the devices condition or in a part of the device, due to normal wear and tear which he stated was clearly covered in the recall by the manufacturer.  

Current treatment notes that there was a voluntary recall notification in the United States and a field safety notice internationally of the vast majority of models of continuous positive airway pressure (CPAP), bilevel PAP (BPAP), and mechanical ventilator devices produced over the last decade. The goal was to "ensure patient safety in consultation with regulatory agencies" (1) because of 1) risk of exposure to particulates released from polyester-based polyurethane sound abatement foam and 2) off-gassing of potentially toxic or carcinogenic concentrations of volatile organic compounds (VOCs). High environmental humidity and use of unauthorized ozone-based cleaning devices may accelerate degradation of foam. Potential symptoms listed by the manufacturer include rhinitis and sinusitis, upper airway irritation, cough, chest pressure, headache, or dizziness. The patient stated that he was first given a CPAP years ago and use the device faithfully given his history of asthma and a strong family history of cancer.  He reportedly stopped using the machine only when he received the recall. The patient also referenced to undergoing a recent sleep study. While the reasoning behind the denial of the replacement CPAP device was not appropriate given the recall and claims of the patient used the previous CPAP device faithfully, it would be prudent to have supporting information from the treating/requesting physician to support the claims made by the patient. This would include obtaining a copy of the sleep study and any records that confirm the patient's prior prescription for the CPAP device and any records showing compliance reports. Therefore, with only the email from the patient submitted for the review along with the notice of denial and recall report, the prior determination cannot be overturned as confirmation pertaining to the medical necessity of the device needs to be submitted by the primary treating physician. As such, the request for a replacement continuous positive airway pressure device (CPAP) is not medically necessary.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for a replacement continuous positive airway pressure device (CPAP) service is not substantiated.