Electrophrenic Pacemaker
DESCRIPTION
The electrophrenic pacemaker consists of an electrode implanted on the phrenic nerves connected by leads to a stimulator implanted under the skin. It is powered and controlled from a battery-powered transmitter outside the body. The device electrically stimulates the phrenic nerves to contract the diaphragm rhythmically, which causes breathing.
POLICY
The use of an electrophrenic pacemaker for the treatment of permanent, severe hypoventilation is considered medically necessary if medical appropriateness criteria are met. (See Medical Appropriateness below.)
The use of an electrophrenic pacemaker for all other conditions including, but not limited to, the following: chronic obstructive pulmonary disease (COPD) and use in young children and infants, is considered investigational.
MEDICAL APPROPRIATENESS
The use of an electrophrenic pacemaker is considered medically appropriate if ALL of the following criteria are met:
There is severe hypoventilation due to brain or high spinal cord lesions, as in the case of high C3 (or above) quadriplegia, or central alveolar hypoventilation syndrome
There is no possibility of independent existence away from a mechanical respirator
Respiratory insufficiency is considered permanent
ADDITIONAL INFORMATION
Electrophrenic pacemakers are contraindicated when preoperative screening tests do not demonstrate that the phrenic nerves, lungs and diaphragm can sustain ventilation by electrical stimulation and when an individual has another serious disorder that might affect nerve conduction (e.g., tumor, vascular disease, diabetes, multiple sclerosis).
No well-designed randomized controlled trials were found in published peer review journals that validated the use of electrophrenic pacemakers for COPD or in young children and infants. The available studies found have not sought to evaluate the clinical importance of the data generated by electrophrenic pacemakers in respect to the management of COPD and permanent, severe hypoventilation in young children and infants.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2006). Electrophrenic pacemaker (7.01.37). Retrieved May 29, 2009 from BlueWeb. (0 articles and/or guidelines reviewed)
Complete Guide to Medicare Coverage Issues [Computer software]. (2009, April). Phrenic nerve stimulator (NCD 160.19, p. 2-79). The Ingenix Complete Guide to Medicare Coverage Issues.
DiMarco, A. F., Onders, R. P., Ignagni, A., & Kowalski, K. E. (2006). Inspiratory muscle pacing in spinal cord injury: Case report and clinical commentary. The Journal of Spinal Cord Medicine, 29 (2), 95-108. (Level 4 Evidence - Independent study)
DiMarco, A. F., Onders, R. P., Ignagni, A., Kowalski, K. E., & Mortimer, J. T (2005). Phrenic nerve pacing via intramuscular diaphragm electrodes in tetraplegic subjects. Chest, 127 (2), 671-678. (Level 4 Evidence - Independent study)
National Guideline Clearinghouse. (2005, January). Respiratory management following spinal cord injury: A clinical practice guideline for health-care professionals. Retrieved May 29, 2009 from http://www.guidelines.gov.
Onders, R. P., Elmo, M. J., & Ignagni, A. R. (2007). Diaphragm pacing stimulation system for tetraplegia in individuals injured during childhood or adolescence. The Journal of Spinal Cord Medicine, 30 (Suppl.1), S25-S29.
U. S. Food and Drug Administration. (2008, June). Center for Devices and Radiological Health. Synapse-NeuRx DPS™ RA/4 diaphragm pacing stimulation system - H070003. Retrieved May 29, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/H070003a.pdf.
Zimmer, M. B., Nantwi, K., & Goshgarian, H. G. (2007). Effect of spinal cord injury on the respiratory system: Basic research and current clinical treatment options. The Journal of Spinal Cord Medicine, 30 (4), 319-330.
ORIGINAL EFFECTIVE DATE: 6/1985
MOST RECENT REVIEW DATE: 7/9/2009
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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