Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve the Intracept procedure. 
 
You asked the Plan to pre-approve the Intracept procedure. You say that medical evidence supports the use of 
the procedure. The Plan denied your request. The Plan says the Intracept procedure is considered 
investigational and therefore non-covered. 
 
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 the Intracept procedure. Our reviewer 
says that the requested service is not considered medically reasonable and necessary in this case. Our physician 
reviewer found that according to the Food and Drug Administration (FDA) Indications for Use, the Intracept 
Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency generators for 
the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at 
least six months duration that has not responded to at least six months of conservative care, and is also 
accompanied by features consistent with Type 1 or Type 2 Modic changes on imaging such as inflammation, 
edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within 
the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals. Studies concluded there is 
moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients 
with chronic low back pain who are selected based on type 1 or 2 Modic changes, among other inclusion and 
exclusion criteria used in the published literature to date. Success of the procedure appears to be dependent on 
effective targeting of the basivertebral nerve (BVN). Non-industry funded high-quality, large prospective 
studies are needed to confirm these findings. However, all studies performed to date have been industry 
sponsored, and future non-industry-funded trials will be needed to confirm results. Several studies have 
reported a high incidence of vertebral endplate damage in up to 43% of subjects suffering from chronic axial 
low back pain symptoms. These tend to manifest differently than when the etiology is from other structures. 
Often, vertebral endplate pain patients tend to present with significant functional impairment and debilitating 
pain while seated, standing, or during spinal flexion (in contrast to extension), with the pain reported as a 
burning, deep and achy, located in the midline region of the lumbar spine without radicular symptoms, and 
without motor weakness, numbness or tingling. In fact, vertebral pain from damaged endplates tends to present 
clinically different than non-specific etiologies with reported greater frequency and longer duration of painful 
episodes and worse outcomes with conservative treatment and surgery.  
 
This 75-year-old male was being treated for spondylosis without myelopathy or radiculopathy. He presents 
with low back pain. He was last seen on April 8, 2022, and notes the pain has not changed. The pain is in the 
low back and does not radiate. The pain is sharp/stabbing, dull/achy, like muscle spasms, and burning. The pain 
increases with sitting, standing, and bending forward and decreases with rest, medications, exercise, and 
physical therapy. The exam reveals pain with flexion at 40 degrees, pain with extension at 10 degrees, and pain 
with right facet loading bilaterally. There is tenderness to palpation midline at L4 and L5, L5 and S1. There is 
tenderness to palpation of the bilateral sacroiliac joints. FABER's is positive bilaterally. Bilateral 
Gaenslens/thigh thrust is positive. 
 
In this case, there were/are multiple plausible pathologic sources of significant pain generation. This is further 
evidenced by the lumbar magnetic resonance imaging on January 17, 2022, that corroborated multiple levels of 
pathology. The non-radiating back pain that is increased with sitting, standing, and bending forward and 
decreased with rest, medications, exercise, and physical therapy, along with the diminished and painful spinal 
motion (in all directions) and intact neurologic exam were/are all non-specific to any pathologic entities.  
Overall, documentation was/is lacking regarding reasonably detailed and/or evidenced findings supportive of 
the spinal vertebral bodies as being the overwhelming primary generators of the enrollees chronic persistent 
pain. Documentation does not support actual formal surgical ablation of pre-designated basivertebral nerves as 
being medically necessary and/or reasonable at this time. Overall, there is no compelling rationale presented or 
extenuating circumstances noted to support the medical necessity of this request as an exception. Therefore, the 
requested Intracept intraosseous basivertebral nerve ablation at L3 and L4, 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 the Intracept procedure have not been met. Therefore, we decided that the Plan 
does not have to pre-approve the Intracept procedure.