This document addresses diaphragmatic/phrenic (D/P) nerve stimulation and diaphragm pacing systems with devices that have obtained approval or clearance from the U.S. Food and Drug Administration (FDA). Diaphragmatic/phrenic nerve stimulator devices and diaphragm pacing systems are indicated for certain ventilator-dependent individuals who lack voluntary control of their diaphragm muscles to enable independent breathing without the assistance of a mechanical ventilator.

Clinical Indications

Medically Necessary:

1. Diaphragmatic/Phrenic Stimulation
   
   Diaphragmatic/phrenic nerve stimulation with an FDA-approved device is considered medically necessary as an alternative to invasive mechanical ventilation for individuals who are 18 years of age or older when ALL of the following criteria are met:
   1. The individual has ventilatory failure from stable, high spinal cord injury or ventilatory failure from central alveolar hypoventilation syndrome; and
   2. The individual cannot breathe spontaneously for 4 continuous hours or more without use of a mechanical ventilator; and
   3. Diaphragm movement with stimulation is visible under fluoroscopy; and
   4. Stimulation of the diaphragm either directly or through the phrenic nerve results in sufficient muscle activity to accommodate independent breathing without the support of a ventilator for at least 4 continuous hours a day; and
   5. Individual has normal chest anatomy, a normal level of consciousness, and has the ability to participate in and complete the training and rehabilitation associated with the use of the device; and
   6. Bilateral clinically acceptable phrenic nerve function is demonstrated with electromyography recordings and nerve conduction times.
       
2. Diaphragmatic Stimulation
   
   Diaphragm stimulation with an FDA approved diaphragm pacing system is considered medically necessary as an alternative to invasive mechanical ventilation in individuals who are 18 years of age or older when ALL of the following criteria are met:
   1. The individual has ventilatory failure from stable, high spinal cord injury or ventilatory failure from central alveolar hypoventilation syndrome or ventilatory failure from motor neuron disease, for example amyotrophic lateral sclerosis; and
   2. The individual cannot breathe spontaneously for 4 continuous hours or more without use of a mechanical ventilator; and
   3. Diaphragm movement with stimulation is visible under fluoroscopy; and
   4. Stimulation of the diaphragm directly results in sufficient muscle activity to accommodate independent breathing without the support of a ventilator for at least 4 continuous hours a day; and
   5. Individual has normal chest anatomy, a normal level of consciousness, and has the ability to participate in and complete the training and rehabilitation associated with the use of the device.

Not Medically Necessary:

Diaphragmatic/phrenic nerve stimulation devices and Diaphragm Pacing Systems are considered not medically necessary when:

• The individual can breathe spontaneously for 4 continuous hours or more without use of a mechanical ventilator; or
• The respiratory insufficiency is temporary.

Diaphragmatic/phrenic nerve stimulation and Diaphragm Pacing Systems are considered not medically necessary for all other indications including, but not limited to:

• Underlying cardiac, pulmonary or chest wall disease is present which is significant enough to prevent spontaneous breathing off a ventilator for more than 4 hours even with the use of the phrenic nerve or diaphragm pacemaker device; or
• In individuals with intact phrenic nerve and diaphragm function; or
• For treatment of any other condition where the phrenic nerve and diaphragm are intact (for example, chronic obstructive lung disease, restrictive lung disease, singultus [hiccups], central sleep apnea); or
• For adolescents, children and infants; or
• When the above criteria are not met.