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Osteogenesis Stimulators

An osteogenesis stimulator is a device that provides electrical stimulation to augment bone repair. A noninvasive stimulator is characterized by an external power source that is attached to a coil or electrodes placed on the skin or on a cast or brace over a fracture or fusion site. Medicare covers non-spinal electrical, spinal electrical and ultrasonic osteogenesis stimulators if coverage criteria are met for those items.

A nonspinal electrical osteogenesis stimulator is covered only if any of the following criteria are met:

• Nonunion of a long bone fracture defined as radiographic evidence that fracture healing has ceased for three or more months prior to starting treatment with the osteogenesis stimulator OR
• Failed fusion of a joint other than in the spine where a minimum of nine months has elapsed since the last surgery OR
• Congenital pseudarthrosis

Nonunion of a long bone fracture must be documented by a minimum of two sets of radiographs obtained prior to starting treatment with the osteogenesis stimulator, separated by a minimum of 90 days, each including multiple views of the fracture site, and with a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs.

A spinal electrical osteogenesis stimulator is covered only if any of the following criteria are met:

• Failed spinal fusion where a minimum of nine months has elapsed since the last surgery OR
• Following a multilevel spinal fusion surgery OR
• Following spinal fusion surgery where there is a history of a previously failed spinal fusion at the same site.

An ultrasonic osteogenesis stimulator is covered only if all of the following criteria are met:

• Nonunion of a fracture documented by a minimum of two sets of radiographs obtained prior to starting treatment with the osteogenic stimulator, separated by a minimum of 90 days. Each radiograph set must include multiple views of the fracture site accompanied by a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs; AND
• The fracture is not of the skull or vertebrae AND
• The fracture is not tumor related.

Use of an ultrasonic osteogenic stimulator for the treatment of a fresh fracture or delayed union will be denied as not medically necessary. Ultrasound conductive coupling gel is covered and separately payable if an ultrasonic osteogenesis stimulator is covered. An ultrasonic osteogenesis stimulator will be denied as not medically necessary if it is used with other noninvasive osteogenesis stimulators.