Appeal type: Experimental/Investigational
Decision: Upheld


Diagnosis: Lower back pain

Treatment: procedure code: 64628 (treatment for low back pain).

The insurer denied coverage for procedure code: 64628 (treatment for low back pain).

The denial is upheld.

 
This is a patient with a history of lower back pain, asthma and hyperlipidemia. A magnetic resonance imaging (MRI) was performed and demonstrated degenerative endplate changes at disc spaces lumbar (L) 5 - sacral (S) 1. The patient had a physician visit for low back pain and a follow up for a right translaminar epidural steroid injection (ESI), the patient stated no improvement following the procedure. The patient described a sharp and debilitating sensation that radiated down the right leg. The current pain level was 6/10. The patient had physical therapy and had performed a home exercise program in the past, without relief. The physician recommended the Intracept procedure to treat lower back pain.

It is unclear whether intraosseous basivertebral nerve (BVN) ablation (procedure code 64628) is considered more beneficial for this patient's diagnosis.There are several studies however no conclusions can be made. No definite statement nor guidelines showing  definitive efficacy have been reported. 

Food and Drug Administration (FDA) approval had been granted for Pre Market approval. The FDA does not provide statements regarding benefit.

This patient is not a good candidate for intraosseous basivertebral nerve ablation (procedure code 64628).

No defined pain generator is present. The records show chronic back pain with several sites of pathology. Injections and multiple conservative treatments have been completed for facet disease, disc disease, stenosis and herniations. There is evidence of nerve compression. The records show a herniation with extrusion and nerve root compression to S1. There are instability patterns and degenerative disease. The report of axial pain vs (versus) radicular pain is inconsistent. The likelihood of the basivertebral nerve causing the back pain is not credible. 

Intraosseous basivertebral nerve ablation (procedure code 64628) is not the best available treatment for this patient at this time. 

The procedure is invasive. There have been reported complications of infection, broken hardware and retroperitoneal hematoma.

The requested service is not likely to be more beneficial than any of the standard treatment/procedures. 

The Intracept procedure is "intraosseous ablation of the basivertebral nerve". It has been proposed to address low back pain identified by Modic changes. The procedure is performed within the vertebral body. It has been proposed that pain relief is manifested by patients who no longer require their narcotics. For one level of disc disease each vertebral body requires precise targeting. The operation is not recognized by practicing neurosurgeons nor spine surgeons. There are no national organizations which provide guidelines nor indications. 

A search was performed using PubMed. The key word was Intracept Lumbar. There were  references. The articles submitted by appeal were also reviewed. There was a reported 65% (percent) success rate and further high quality studies were recommended. 
 
There are several level 1 studies showing the benefit of this procedure up to 2 years after treatment compared to controls. However, all of these studies were either funded by the manufacturer and/or authored by consultants from the manufacturer. No high-quality study exists that does not have a significant conflict of interest with the manufacturer. 

In summary, the denial of procedure code: 64628 (treatment for low back pain) and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are substantially increased over standard treatments.