This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

A respiratory assist device (RAD) may be considered medically necessary for the first three months of therapy for those patients with Restrictive Thoracic Disorders that meet the following criteria:

• Patient has presence of a neuromuscular disease (e.g., amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (e.g., post-thoracoplasty for TB); and
  • An arterial blood gas PaCO2, done while awake and breathing the patient's prescribed FIO2, is greater than or equal to 45 mm Hg; or
  • Sleep oximetry demonstrates oxygen saturation level is equal to or less than 88% for at least five minutes, done while breathing the patient’s prescribed fractional concentration of oxygen delivered for inspiration (FIO2); or
• Patient has presence of neuromuscular disease (only):
  • maximal inspiratory pressure is less than 60 cm H2O or forced vital capacity is less than 50% predicted; and
  • Chronic obstructive pulmonary disease does not contribute significantly to the patient's pulmonary limitation.

A respiratory assist device (RAD) may be considered medically necessary for the first three months of therapy for those patients with Severe COPD that meet ALL of the following criteria:

• An arterial blood gas PaCO2, done while awake and breathing the patient's prescribed FIO2, is equal to or greater than 52 mm Hg; and
• Sleep oximetry demonstrates oxygen saturation level equal to or less than 88% for at least five minutes, done while breathing oxygen at two LPM or the patient's prescribed FIO2,whichever is higher; and
• Prior to initiating therapy, obstructive sleep apnea (OSA) and treatment with CPAP has been considered and ruled out.

If a respiratory assist device (RAD) with backup rate is billed, but the criteria for a respiratory assist device (RAD) without backup rate device are met, payment will be based on the RAD without backup rate.

A RAD with backup rate device will be considered not medically necessary for a patient with COPD during the first two months. Therapy with a RAD without back-up device with proper adjustments of the settings, and patient accommodation to its use, will usually result in sufficient improvement without need of a back-up rate.

Following 61 days of use of a RAD without back-up device; the following criteria may be considered medically necessary when establishing the need for a RAD with back-up device:

• An arterial blood gas PaCO2 is repeated while the patient is awake and breathing their prescribed FIO2 and the level remains 52 mm HG; and
• A sleep oximetry, while the patient is breathing with the RAD without back-up device demonstrates O2 saturation of less than 88% for at least five continuous minutes, done while breathing oxygen at two LPM or the patient's prescribed FIO2, whichever is higher.

A respiratory assist device (RAD) may be considered medically necessary for the first three months of therapy for those patients with Central Sleep Apnea that have had an attended polysomnogram, performed on stationary equipment and meet ALL of the following criteria:

• The diagnosis of central sleep apnea (CSA); and
• The exclusion of obstructive sleep apnea (OSA) as the predominant cause of sleep-associated hypoventilation; and
• The ruling out of CPAP as effective therapy if OSA is a component of the sleep-associated hypoventilation; and
• Significant improvement of the sleep-associated hypoventilation with the use of either RAD device on the settings that will be prescribed for initial use at home, while breathing the patient's prescribed FIO2.

Heated and non-heated humidification is covered for use with a medically necessary respiratory assist device when prescribed by the treating physician to meet the needs of the individual patient.

If the above criteria are not met, the device and related accessories (see table attachment) will be denied as not medically necessary

For coverage beyond the initial three months of therapy, medical necessity of continued coverage of these devices must occur within 61 to 90 days from the date the therapy was initiated.

Quantities of supplies greater than those described in the policy, as the usual maximum amounts will be considered not medically necessary.

A physician must prescribe all equipment and accessory durable medical equipment. 

See Table Attachment for accessory quantity level limits.

For the purpose of this policy, arterial blood gas, sleep oximetry and polysomnographic studies may not be performed by a DME supplier. A DME supplier is not considered a qualified provider or supplier of these tests for purposes of this policy's coverage and payment guidelines. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.

See Medical Policy E-20 Devices Used for the Treatment of Obstructive Sleep Apnea in Adults for additional information.

The use of a respiratory assist device is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Quantity level limits or quantity of supplies that exceed the frequency guidelines listed on the policy will be denied as non-covered. A network provider cannot bill the member for the non-covered service.

A network provider can bill the member for the non-covered service.

• Link to Diagnosis Codes

• Link to Table Attachment(s)

• Link to References