Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Back Pain
Treatment: Intracept Procedure
The insurer denied the Intracept procedure.
The determination is upheld.

The patient was diagnosed with lumbar spondylosis without myelopathy or radiculopathy, lumbosacral spondylosis without myelopathy or telepathy, lumbar intervertebral disc degeneration and low back pain. The provider noted that the patient has a history of chronic low back pain that began after a motor vehicle accident and the pain has persisted despite multiple treatments including various medications, epidural steroid injections, facet joint injections, medial branch blocks, trigger point injections, physical therapy and home exercise. It was noted that pain has impacted the patient's activities of daily living and the patient's pain averages from 8.5/10 to 10/10. It was noted that the patient's magnetic resonance imaging (MRI) scan demonstrated Modic type I and II changes at lumbar (L) 5 - sacral (S) 1 disc spaces and therefore was felt that the patient's chronic low back pain was coming from the vertebrogenic changes at L5 and S1. The pain has persisted for more than 25 years and it was felt that the patient had exhausted all traditional nonoperative measures and the provider stated that nothing else would relieve the patient's pain. It was stated that his presentations do not warrant any type of fusion or disc replacement surgery. It was recommended the patient be approved for an Intracept procedure. At issue is the medical necessity of the Intracept procedure.

The requested health service/treatment of outpatient surgery-Intracept procedure is not medically necessary for this patient. Notwithstanding the nonspecific low back pain (LBP) descriptor, spine care practitioners have historically presumed that the intervertebral disc was the source of most chronic low back pain. The discogenic low back pain model holds that sensitized nociceptors within the posterior annulus of degenerating discs cause LBP. However, anatomic studies have shown that the vertebral endplate is actually often the source of most of the pathologic innervation that occurs with disc degeneration. These studies suggest that, in some patients, the origin of LBP is the vertebral endplates, with pain transmitted via the basivertebral nerve (BVN). This patient is noted to have a history of chronic back pain that has not responded to conventional conservative treatment and the provider feels that the patient's pain is coming from Modic changes and was recommended to undergo the Intracept System (intra-osseous basivertebral nerve ablation). However, there are a lack of high quality studies evaluating the long-term risks and benefits of this procedure. Although some results have been promising, additional studies are needed to establish the safety and efficacy. Per Backer et al, "Ablation of the BVN for the treatment of chronic lumbar back pain significantly improves patients' self-reported outcome early in the follow-up period; the improvement persisted throughout the 1-year study period." However, this is noted to be an industry sponsored study and does not demonstrate long-term effects of the procedure beyond one year. Per Fischgrund, et al, "Patients treated with radiofrequency (RF) ablation of the basivertebral nerve (BVN) for chronic low back pain (CLBP) exhibited significantly greater improvement in the 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." There appears to positive initial results, however, the study was fairly small (225 patients with chronic back pain) and there continues to be a lack of long-term studies evaluating long-term risks/benefits when compared to other standard means of treatment and further large, high-quality studies are needed. This treatment is not currently considered 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. Additional studies are needed to evaluate long-term risks and benefits of this procedure. Therefore, the requested procedure is not medically necessary.