Do I need a prescription for CPAP Machine?

Do I need a prescription for CPAP Machine?

Under the law, medical devices are categorized into 3 classes–class I, II, or III- based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness by the Food and Drug Administration (FDA).

CPAP devices are considered a Class II Medical Device, and as such require a prescription for distribution.

There are a few reasons why a prescription is necessary to purchase CPAP medical equipment:

Insurances require a prescription to cover payments. Without a prescription, they will not pay for equipment.

Prescriptions come with a set pressure setting based on the results of the sleep study. A machine cannot be adequately set without pressure settings. Pressure settings should only ever be determined by a board-certified sleep specialist’s interpretation of the sleep study.

Some patients being treated with CPAP for obstructive sleep apnea develop mixed sleep apnea (central sleep apnea events that emerge after therapy). Patients with mixed sleep apnea may need a different PAP machine that responds to central events such as a BiPAP machine or ASV machine.

Without a prescription that includes pressure settings based on the patient’s apnea/hypopnea index (AHI) and lowest oxygen saturation (SaO2), patients may not receive the best care. Inadequate settings can be harmful to a patient’s health.

How Do I get a CPAP prescription?

The first thing you need to do is have a sleep study. In order to obtain a prescription, a sleep study is necessary to confirm a diagnosis of sleep apnea. Patients can opt to have an attended sleep study at a sleep clinic (Polysomnogram/PSG), or an unattended sleep study at home (Home Sleep Test/HST).

For the most part, a prescription may be filled out by any Medical doctor or Doctor of Osteopathy. It is always best to have a prescription from a board-certified sleep specialist.