Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal -Back Pain. 
Treatment: Surgical Services (All). 

The insurer denied Intracept Procedure. 
The denial is upheld. 

This is a female patient diagnosed with spondylosis without myelopathy or radiculopathy, lumbar region. The provider feels that the patient's pain is coming from Modic changes at the lumbar (L)5 - sacral (S)1 disc space and requested to perform the Intracept procedure. 
The provider noted that the patient has had pain for more than one year and tried and failed multiple treatments including acupuncture, chiropractic care, home exercises, injections, medial branch blocks, medication management, physical therapy, radiofrequency ablation and transforaminal epidural steroid injections. Medications tried include cyclobenzaprine, Flexeril, gabapentin, and ibuprofen. It was noted the patient's pain is affecting activities of daily living. Her pain is rated at 8/10. 
At issue is whether the treatment Intracept Procedure is likely to be more beneficial than any standard treatment. 

The health plan's determination regarding the proposed health services or treatment is upheld in whole. 

The proposed health service or treatment Intracept procedure is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The patient is noted to have a long history of chronic back pain with radiculopathy and has previously tried and failed multiple conservative treatments including acupuncture, chiropractic care, home exercises, injections, medial branch blocks, medication management, physical therapy, radiofrequency ablation and transforaminal epidural steroid injections. 
The requested procedure is considered experimental and investigational and there is no evidence to suggest this procedure would be beneficial over that of traditional treatment options. Per Official Disability Guidelines (ODG) by Milliman Care Guidelines (MCG), "Not recommended. Despite promising early reports, further trials with longer-term outcomes and less risk of bias are required. If approved despite non-recommendation, there should be at least 6 months of chronic low back pain following a defined injury, refractory to conservative care, as well as Modic type I or II changes between L3 and S1 on magnetic resonance imaging." The International Society for the Advancement of Spine Surgery's guideline on "Intraosseous ablation of the basivertebral nerve for the relief of chronic low back pain" (Lorio et al, 2020) stated that intraosseous ablation of the basivertebral nerve (BVN) is a new procedure; its limitations included industry funding is a potential source of study bias for the available data reviewed, limited number of studies, short-term follow-up for the majority of studied patients, and unknown effect on the primary degenerative process." Per Fischgrund et al, "Patients treated with radiofrequency (RF) ablation of the BVN for chronic low back pain (CLBP) exhibited significantly greater improvement in Oswestry Disability Index (ODI) at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain." Again, there appears to be positive initial results, however, the study was fairly small. 
This treatment is not currently considered the standard of care in the general medical community. There is a lack of high-grade evidence and large, long-term studies found in the peer-reviewed medical literature demonstrating this treatment to be either safe or effective or resulting in superior benefits over that of other standard means of treatment.
Therefore, the proposed health service or treatment Intracept procedure is not likely to be more beneficial than any standard treatment or treatments.