Noninvasive positive pressure respiratory assistance (NPPRA) is the administration of positive air pressure, using a nasal and/or oral mask interface which creates a seal, avoiding the use of more invasive airway access (e.g. tracheostomy). 

A respiratory assist device (RAD) without backup rate delivers adjustable, variable levels (within a single respiratory cycle) of positive air pressure by way of tubing and a noninvasive interface (such as a nasal or oral facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs.

A RAD with backup rate delivers adjustable, variable levels (within a single respiratory cycle) of positive air pressure by way of tubing and a noninvasive interface (such as a nasal or oral facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs. In addition, a RAD with backup rate has a timed feature that is triggered to deliver this air pressure whenever spontaneous inspiratory efforts fail to occur and the respiratory rate decreases below a set threshold.

• Individual 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 individual's prescribed fractional concentration of oxygen (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 (5) minutes, done while breathing the individual's prescribed FIO2; or
•  Individual 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 (COPD) does not contribute significantly to the individual's pulmonary limitation.

A RAD not meeting the criteria as indicated in this policy is considered not medically necessary.

A RAD may be considered medically necessary for the first three (3) months of therapy for individuals with severe COPD when ALL of the following criteria are met:

• An arterial blood gas PaCO2, done while awake and breathing the individual’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 (5) minutes, done while breathing oxygen at two (2) liters per minute (LPM) or the individual's prescribed FIO2,whichever is higher; and
• Prior to initiating therapy, obstructive sleep apnea (OSA) and treatment with continuous positive airway pressure (CPAP) has been considered and ruled out.

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

A RAD with backup rate device is considered not medically necessary for an individual with COPD during the first two (2) months.

Note: 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.

An RAD with back-up device may be considered medically necessary when ALL of the following criteria have been met:

• The individual has used an RAD without back-up for 61 days; and
• An arterial blood gas PaCO2 is repeated while the individual is awake and breathing their prescribed FIO2 and the level remains 52 mm HG; and
• A sleep oximetry, while the individual is breathing with the RAD without back-up device demonstrates O2 saturation of less than 88% for at least five (5) continuous minutes, done while breathing oxygen at two (2) LPM or the individual’s prescribed FIO2, whichever is higher.

A RAD with a back-up device not meeting the criteria as indicated in this policy is considered not medically necessary.

A RAD may be considered medically necessary for the first three (3) months of therapy for those individuals with central sleep apnea (CSA) that have had an attended polysomnogram, performed on stationary equipment and meet ALL of the following criteria:

• The diagnosis of CSA; and
• The exclusion of 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 individual's prescribed FIO2.

A RAD not meeting the criteria as indicated in this policy is considered not medically necessary.

Heated and non-heated humidification may be considered medically necessary when prescribed by the treating physician to meet the needs of the individual and when the RAD meets the above criteria.

A non-invasive open ventilation (NIOV) system is/are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature. 

If the device does not meet the criteria as indicated in this policy, the device and related accessories are considered not medically necessary. 

For coverage beyond the initial three (3) 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 identified as the usual maximum amounts are considered not medically necessary.

A physician must prescribe ALL equipment and accessory durable medical equipment (DME) 

See table below for accessory quantity level limits.

* Allows for a 10 day delivery before run-out

** Allowing for a 3 month supply

Total payments for a rental item may not exceed its allowable purchase price, except for those items identified as life sustaining DME. 

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.