Why Do You Need a Prescription for a CPAP Machine?
Under federal law, medical devices will be categorized into three different classes based on risk and the regulatory controls that are necessary to provide reasonable assurance of effectiveness and safety by the FDA. A CPAP machine is a Class II medical device, which means it needs a prescription for distribution.
A prescription is needed for a CPAP machine for a few different reasons. Insurance requires a prescription in order to cover payments. Without a prescription, insurance won’t pay. Prescriptions also come with a set pressure setting based on the results of the sleep study. A machine can’t work properly without pressure settings. Onlya sleep specialist should determine pressure settings. Inadequate settings can be harmful to someone’s health. Patients that are being treated with a CPAP can sometimes develop mixed sleep apnea. Patients with this will need a different machine that responds to various events. In order to get a prescription, you will need to have a sleep study done first.