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A doctor’s prescription is needed to obtain the airflow generators, humidifiers, and face masks used in CPAP, BiPAP, and APAP therapy. These components are considered Class II Medical Devices. Under federal law, all devices in this category require a prescription. However, some CPAP, BiPAP, and APAP components — such as connective hoses and air filters — are available without a prescription.
This guide will address prescription requirements for CPAP, BiPAP, and APAP components, as well as other common questions about legally obtaining these devices.
Sleep apnea is a medical condition that causes temporary loss of breath during sleep. The condition falls into three general categories:
Positive air pressure therapy, or PAP therapy, is used to treat sleep apnea. PAP therapy involves a generator that draws in outside air using a built-in fan, pressurizes and humidifies the air, and then delivers it to sleepers via a connective hose and breathing mask. The airflow is measured in centimeters of water, or cmh20. Most PAP machines deliver air at a range of 4 to 20 cmH20.
The two most common types of this therapy are continuous positive air pressure (CPAP), which delivers air at a prescribed rate throughout the night and is primarily used to treat obstructive sleep apnea; and bi-level positive air pressure (BiPAP), which delivers air at different rates during inhalation and exhalation and is primarily used to treat central sleep apnea. A third form of this therapy, Auto-PAP (or APAP), delivers air at variable rates depending on the sleeper’s breathing patterns.
A sleep apnea diagnosis is needed to obtain a prescription for PAP devices. According to the Mayo Clinic, the patient’s physician may provide a sleep apnea diagnosis. Alternatively, the physician may refer the patient to a sleep disorder specialist for additional evaluation. This specialist may direct one of the following procedures:
Because they are simpler, many sleep disorder specialists will initially prescribe the home test. However, the home test often produces inconclusive results. If this occurs, the specialist may decide to perform the nocturnal polysomnography procedure.
If either the home test or the nocturnal polysomnography yield abnormal results, the specialist may prescribe PAP therapy or choose to refer their patient to an additional specialist, such as an ear, nose, and throat doctor for OSA or a neurologist for CSA.
Regardless of who the patient is referred to, a PAP device prescription must be written by one of the following medical professionals:
Likewise, prescriptions from the following medical professionals are usually not acceptable for obtaining classified CPAP, BiPAP, and APAP devices:
There are several reasons why a prescription is required for PAP equipment. These include:
Complex equipment: CPAP, BiPAP, and APAP machines are all programmed to specific pressure settings based on the patient’s prescription (see next section). Board certified sleep specialists determine these pressure settings by evaluating the results of the patient’s medical exams and/or sleep studies. For this reason, CPAP, BiPAP, and APAP machine owners should never attempt to recalibrate the machines on their own.
Patient risks: PAP prescriptions require careful consideration from the patient’s physician. If wrong or inadequate equipment is prescribed, the patient may not receive the treatment they need — and in some cases, their sleep apnea will become more intense. A recognized PAP prescription includes detailed information about the patient’s condition, including:
Insurance purposes: Medical insurance is not needed to purchase Class II Medical Devices used in PAP therapy. However, insurance providers require a prescription in order to cover payments for this equipment. The difference in out-of-pocket costs between insured and non-insured individuals an amount to hundreds — potentially even thousands — of dollars, depending on the equipment they are purchasing.
Now let’s look at the unique criteria for CPAP, BiPAP, and APAP prescriptions.
CPAP machines deliver airflow at a steady (or ‘continuous’) rate throughout the night. In order to obtain a CPAP device, the prescription must feature the following:
BiPAP machines deliver airflow at two pressure settings; the first setting (breathing in pressure, or IPAP) is based on the patient’s breathing during inhalation, and the second setting (breathing out pressure, or EPAP) is based on their breathing during exhalation. The following items are needed for a BiPAP device prescription:
APAP machines deliver airflow at a variable range depending on the individual sleeper’s breathing patterns. An APAP device prescription requires the following:
In addition to the machines, PAP humidifiers and face masks both require an individual prescription. Both of these components are compatible with CPAP, BiPAP, and APAP machines. The following items are needed for humidifier and face mask prescriptions:
Next, let’s answer some other common questions about prescriptions for PAP therapy.
Most insurance providers cover CPAP therapy as long as the patient has received a prescription. However, some providers may mandate that the patient rent their PAP equipment from a medical equipment company, rather than buying the supplies outright.
Most PAP prescriptions are ‘lifetime.’ However, some may include a maximum refill number. Once this number has been reached, a new prescription will be required.
Patients in the U.S. can select from many PAP equipment providers. After receiving the prescription, the patient may choose to submit the prescription to the equipment provider themselves or have their physician submit it on their behalf.
Non-prescribed PAP supplies, such as connective hoses and air filters, can be obtained over-the-counter from a wide range of brick-and-mortar sellers, as well as online retailers like Amazon.com.
PAP machines should only be reset by board certified professionals. If a patient believes their optimal pressure settings have changed, they should contact their physician or sleep disorder specialist to schedule a new exam that will determine which, if any, changes are needed.