**Electrical Osteogenic Stimulators**

**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**

**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.)