CG-DME-47 Noninvasive Home Ventilator Therapy for Respiratory Failure Form

This document addresses the medically necessary indications for home use of noninvasive home ventilators. A home ventilator is a mechanical device capable of providing pressurized air with or without supplemental oxygen and two or more of the following features: pressure support; rate support; volume support; or various combinations of pressure, rate, and volume support. A noninvasive home ventilator delivers the air through a mask or nasal interface tightly sealed to the face.

Notes:  This document does not address the use of ventilation therapy:

• Of hospitalized individuals;
• With a device that does not match this document’s definition of a ventilator;
• For the treatment of obstructive sleep apnea (OSA);
• Through a tracheostomy.

Clinical Indications

Medically Necessary:

Noninvasive positive pressure ventilation therapy (NPPV) with a home ventilator is considered medically necessary for the following conditions (A, B, or C):

1. The primary cause of respiratory failure is neuromuscular disease (for example, amyotrophic lateral sclerosis) or restrictive thoracic disease (for example, thoracic cage abnormalities) when either of the following criteria 1 or 2 are met:
   1. An arterial blood gas PaCO₂ level is greater than or equal to 45 mm Hg while awake and breathing the individual's usual FIO₂; or
   2. The individual has a maximum inspiratory pressure of less than or equal to 60 cm H₂0.
      or
2. Hypercapnic end-stage chronic obstructive pulmonary disease (COPD) when criteria 1 or 2 are met:
   1. Palliative use for individuals with advanced COPD and an active advance directive not to intubate; or
   2. Persistent hypercapnia with a PaCO₂ level of 53 mm Hg or greater on room air;
      or
3. Obesity Hypoventilation Syndrome (OHS) when criteria 1 and 2 are met:
   1. OHS is diagnosed based on ALL of the following (a, b, and c):
      1. Body mass index (BMI) is greater than or equal to 30 kg/m²; and
      2. Sleep-disordered hypoventilation has been documented by polysomnography and other conditions are not considered the sole cause of hypoventilation. Examples include, but are not limited to: neuromuscular or restrictive thoracic disease (see criterion A above), COPD (see criterion B above), interstitial lung disease, pleural restriction, hypothyroidism, or medications; and
      3. Hypoventilation is documented with an awake PaCO₂ level greater than or equal to 45 mm Hg; and
   2. CPAP or BiPAP treatment is not appropriate as evidenced by any of the following (a, b or c):
      1. OSA is not present as confirmed by polysomnography with an apnea/hypopnea index (AHI) less than 5; or
      2. Hypoventilation was not corrected with CPAP or BiPAP titration as evidenced by persistence of an awake PaCO₂ level greater than 45 mm Hg after 3 months of compliant use of CPAP or BiPAP; or
      3. Individuals started on NPPV therapy as OHS treatment during hospitalization can continue for up to 3 months of home therapy to provide time to complete outpatient CPAP or BiPAP titration.

Continuing use:

Continuing use of NPPV therapy with a home ventilator is considered medically necessary when BOTH of the following are met (A and B):

1. Documentation of compliant use must be reported every 3 months; and
2. The device monitor documents compliant use for an average of 4 or more hours per 24 hours and the requesting physician documents ongoing benefit from its use.

Not Medically Necessary:

Home use of NPPV therapy with a home ventilator is considered not medically necessary when the above criteria are not met and for all other conditions, including but not limited to: chronic stable COPD without hypercapnia, and central sleep apnea of heart failure.