Appeal type: unknown
Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say Nationally Covered Indications 
 
    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. 
    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.) 
 
You can find this information in Medicare's National Coverage Determination (NCD): Osteogenic Stimulators 
(150.2). 
 
The rules say that a non-spinal electrical osteogenesis stimulator (E0747) is covered only if any of the 
following criteria are met: 
 
        1. Nonunion of a long bone fracture (see Appendices section) defined as radiographic evidence that 
fracture healing has ceased for three or more months prior to starting treatment with the osteogenesis 
stimulator, or 
        2. Failed fusion of a joint other than in the spine where a minimum of nine months has elapsed since the 
last surgery, or 
        3. Congenital pseudarthrosis. 
 
You can find this information in Medicare's Local Coverage Determination (LCD): Osteogenesis Stimulators 
(L33796). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.