CMS Pub. 100-03, ch. 1, § 160.19

CIM 65-13

The implantation of a phrenic nerve stimulator is covered for selected patients with

partial or complete respiratory insufficiency.

The phrenic nerve stimulator provides electrical stimulation of the patient’s phrenic nerve

to contract the diaphragm rhythmically and produce breathing in patients who have

hypoventilation (a state in which an abnormally low amount of air enters the lungs). The

device has been used successfully to treat hypoventilation caused by a variety of

conditions, including respiratory paralysis resulting from lesions of the brain stem and

cervical spinal cord and chronic pulmonary disease with ventilatory insufficiency. The

phrenic nerve stimulator is intended to be an alternative to management of patients with

respiratory insufficiency who are dependent upon the usual therapy of intermittent or

permanent use of a mechanical ventilator as well as maintenance of a permanent

tracheotomy stoma.

However, an implanted phrenic nerve stimulator can be effective only if the patient has

an intact phrenic nerve and diaphragm. Moreover, nerve injury may occur during the

surgical procedure and if sufficient injury is incurred, the device will not prove useful to

the patient. Consequently, it is possible for such a device to be indicated for a patient but,

due to injury sustained during implant, fail to assist the patient, resulting in a return to the

use of mechanical ventilation.

Cross reference to §160.7, “Electrical Nerve Stimulators.”