Appeal type: DME/ Orthotics
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve osteogenesis stimulator, electrical, non-invasive, spinal 
applications (E0748). 
 
You asked the Plan to pre-approve osteogenesis stimulator, electrical, non-invasive, spinal applications. The 
Plan denied your request. The Plan says osteogenesis stimulator, electrical, non-invasive, spinal applications is 
not medically necessary. 
 
The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically 
necessary are not covered.  
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve osteogenesis stimulator, electrical, non-
invasive, spinal applications. Our reviewer says that the requested osteogenesis stimulator, electrical, non-
invasive, spinal applications is not considered medically reasonable and necessary in this case. Our physician 
reviewer found Kaiser et al recommended the use of electrical bone growth stimulation as an option for patients 
younger than 60 years of age, since a positive effect on fusion has been observed. The same, however, could 
not be stated for patients over 60, because electrical bone growth stimulation did not appear to have an impact 
on fusion rates in this population. Park et al concluded that the implications in clinical practice of the use of 
electrical stimulation to promote bone fusion following lumbar spine surgery cannot be determined from the available evidence. However, it appears complications associated with its use are low. Additional large randomized controlled trials are warranted, and future randomized controlled trials need to focus on a single pathological process, encompass similar surgical procedures, and standardize electrical stimulation protocols.  Hijji et al concluded that the results from the present study suggest no significant effect of spinal fusion stimulators on rates of spinal fusion when compared to control treatments. Physicians should use caution when interpreting these studies. Further randomized controlled trials demonstrating uniformity are necessary to better understand the effects of electrical stimulators on spinal fusion. This 59-year-old female was being treated for 
arthrodesis status. She underwent a single-level lumbar fusion at L5-S1 on February 23, 2022. However, there 
have been no follow-up exams with imaging evidence provided for review to corroborate failed fusion. There is 
limited published, large-scale, long-term peer-reviewed literature that shows this request to be an effective 
and/or safe treatment for the noted pathology. There is no compelling rationale presented or extenuating 
circumstances noted to support the medical necessity of this request as an exception. Therefore, the requested 
osteogenesis stimulator, electrical, non-invasive, spinal applications (E0748), in this case, is not medically 
reasonable or necessary. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of osteogenesis stimulator, electrical, non-invasive, spinal applications have not 
been met. Therefore, we decided that the Plan does not have to pre-approve osteogenesis stimulator, electrical, 
non-invasive, spinal applications (E0748).