CMS Pub. 100-03, ch. 1, § 150.2

CIM-35-48

Electrical Osteogenic Stimulators

A. General

Electrical stimulation to augment bone repair can be attained either invasively or non-invasively. Invasive

devices provide electrical stimulation directly at the fracture site either through percutaneously placed

cathodes or by implantation of a coiled cathode wire into the fracture site. The power pack for the latter

device is implanted into soft tissue near the fracture site and subcutaneously connected to the cathode,

creating a self-contained system with no external components. The power supply for the former device is

externally placed and the leads connected to the inserted cathodes. With the non-invasive device, opposing

pads, wired to an external power supply, are placed over the cast. An electromagnetic field is created

between the pads at the fracture site.

B. Nationally Covered Indications

1. Noninvasive Stimulator

The noninvasive stimulator device is covered only for the following indications:

• Nonunion of long bone fractures;

• Failed fusion, where a minimum of 9 months has elapsed since the last surgery;

• Congenital pseudarthroses;

• Effective July 1, 1996, as an adjunct to spinal fusion surgery for patients at high risk of pseudarthrosis

due to previously failed spinal fusion at the same site or for those undergoing multiple level fusion. A

multiple level fusion involves 3 or more vertebrae (e.g., L3-L5, L4-S1, etc).

• Effective September 15, 1980, nonunion of long bone fractures is considered to exist only after 6 or

more months have elapsed without healing of the fracture.

• Effective April 1, 2000, nonunion of long bone fractures is considered to exist only when serial

radiographs have confirmed that fracture healing has ceased for 3 or more months prior to starting treatment

with the electrical osteogenic stimulator. Serial radiographs must include a minimum of 2 sets of

radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days.

2. Invasive (Implantable) Stimulator

The invasive stimulator device is covered only for the following indications:

• Nonunion of long bone fractures;

• Effective July 1, 1996, as an adjunct to spinal fusion surgery for patients at high risk of pseudarthrosis

due to previously failed spinal fusion at the same site or for those undergoing multiple level fusion. A

multiple level fusion involves 3 or more vertebrae (e.g., L3-L5, L4-S1, etc).

• Effective September 15, 1980, nonunion of long bone fractures is considered to exist only after 6 or

more months have elapsed without healing of the fracture.

• Effective April 1, 2000, nonunion of long bone fractures is considered to exist only when serial

radiographs have confirmed that fracture healing has ceased for 3 or more months prior to starting treatment

with the electrical osteogenic stimulator. Serial radiographs must include a minimum of 2 sets of

radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days.

Ultrasonic Osteogenic Stimulators

A. General

An ultrasonic osteogenic stimulator is a noninvasive device that emits low intensity, pulsed ultrasound. The

device is applied to the surface of the skin at the fracture site and ultrasound waves are emitted via a

conductive coupling gel to stimulate fracture healing. The ultrasonic osteogenic stimulators are not be used

concurrently with other non-invasive osteogenic devices.

B. Nationally Covered Indications

Effective January 1, 2001, ultrasonic osteogenic stimulators are covered as medically reasonable and

necessary for the treatment of nonunion fractures. In demonstrating non-union fractures, CMS expects:

• A minimum of 2 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 with a written interpretation by a physician stating that there has been no clinically

significant evidence of fracture healing between the 2 sets of radiographs; and,

• Indications that the patient failed at least one surgical intervention for the treatment of the fracture.

• Effective April 27, 2005, upon reconsideration of ultrasound stimulation for nonunion fracture

healing, CMS determines that the evidence is adequate to conclude that noninvasive ultrasound stimulation

for the treatment of nonunion bone fractures prior to surgical intervention is reasonable and necessary. In

demonstrating non-union fractures, CMS expects:

• A minimum of 2 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 with a written interpretation by a physician stating that there has been no clinically

significant evidence of fracture healing between the 2 sets of radiographs.

C. Nationally Non-Covered Indications

Nonunion fractures of the skull, vertebrae and those that are tumor-related are excluded from coverage.

Ultrasonic osteogenic stimulators may not be used concurrently with other non-invasive osteogenic devices.

Ultrasonic osteogenic stimulators for fresh fractures and delayed unions remains non-covered.

(This NCD last reviewed June 2005.)