Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve L1 kyphoplasty (22511), bilateral open sacroiliac (SI) 
fusion (27280), and a bone marrow aspirate (20939). 
 
You asked the Plan to pre-approve L1 kyphoplasty, bilateral open SI fusion, and a bone marrow aspirate. You 
say that this is medically necessary. The Plan denied your request. The Plan says the enrollee does not have 
documentation of an acute/subacute L1 compression fracture. The clinical value and effectiveness of bone 
marrow aspirate in the setting of spinal fusion surgery have not been demonstrated in the peer-reviewed 
literature. The clinical value and effectiveness of an open SI joint fusion procedure in the setting of clinical 
documentation that does not demonstrate any evidence of sacroiliac joint instability, fracture, or tumor 
presence have not been demonstrated in the peer-reviewed literature. 
 
The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically 
necessary are not covered. Medicare rules say that kyphoplasty can be covered when specific criteria are met. 
 
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 L1 kyphoplasty, bilateral open SI 
fusion, and a bone marrow aspirate. Our reviewer says that the requested items/services are not considered 
medically reasonable and necessary in this case. Our physician reviewer found detailed documentation is not 
evident regarding any acute or subacute L1 compression fracture. Additionally, there is no documentation of a 
progression of the body height loss, greater than 25% vertebral body height loss, kyphotic deformity, or a 
severe impact on daily activities. Moreover, there is magnetic resonance imaging (MRI) corroboration of other 
plausible causes of pain. Therefore, the enrollee does not meet the LCD criteria for coverage of kyphoplasty. 
Detailed documentation is not evident regarding imaging or radiographic evidence supporting a sacroiliitis 
pathology. There is no clear history of SI joint pain onset or failure of conservative treatment directed to the SI 
joint. Multiple other plausible pain generators including at the lumbosacral spine are evident. There are limited 
large-scale, long-term references showing the safety and efficacy of the requested surgery in this clinical 
setting. There is no specific indication provided to support the request for bone marrow aspirate for the 
approved surgery. There is a lack of large volume, long-term peer-reviewed outcome studies to support the use 
of bone marrow aspirate for this enrollees medical condition as discussed above. There is no compelling 
rationale presented or extenuating circumstances noted to support the medical necessity of this request as an 
exception.  
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of L1 kyphoplasty, bilateral open SI fusion, and a bone marrow aspirate have not 
been met. Therefore, we decided that the Plan does not have to pre-approve L1 kyphoplasty (22511), bilateral 
open sacroiliac (SI) fusion (27280), and a bone marrow aspirate (20939).