Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Intracept procedure  thermal destruction of intraosseous basivertebral nerve, including imaging guidance; first two vertebral bodies, lumbar or sacral.Findings:  The physician reviewer found that Intracept procedure  thermal destruction of intraosseous basivertebral nerve, including imaging guidance; first two vertebral bodies, lumbar or sacral is medically necessary for treatment of this patient. According to the U.S. Food and Drug Administration (FDA), the Intracept procedure 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 accompanied by features consistent with Type 1 or Type 2 Modic changes on an magnetic resonance imaging (MRI). Conger and colleagues concluded that there is moderate quality evidence demonstrating the safety and efficacy of the Intracept procedure in reducing pain and disability in well selected patients with chronic low back pain with type 1 or 2 Modic changes. Success of the procedure appears to be dependent on effective targeting of the basivertebral nerve. De Vivo and colleagues reported that percutaneous computed tomography (CT) guided intraosseous basivertebral nerve ablation has been found to be a safe, fast, and powerful technique for pain relief in patients with vertebrogenic chronic low back pain, when the selection of patients is based on a multidisciplinary approach. This patients records document a history of chronic axial low back pain. The patient presents with an increased amount of low back pain over the last year localized in the L5-S1 region that is worse with sitting with pain slightly into the right buttock. The patient experienced worsening of pain with bilateral L5 selective nerve root injection. An L5-S1 functional anesthetic discogram resulted in 100% benefit for several hours. However, detailed documentation is not evident regarding the MRI diagnostic report stating Modic changes at the requested L5-S1 level. The provider noted that this finding should be added, but an addendum was not provided for review. Overall, documentation is lacking regarding detailed and evidence-based findings supportive of the spinal vertebral bodies as being the overwhelming primary generators of the patients chronic persistent pain. In this case, there are multiple plausible pathologic sources of significant pain generation. The available documentation does not demonstrate that surgical ablation of the basivertebral nerves with the Intracept procedure is appropriate for this patient. Therefore, the requested Intracept procedure  thermal destruction of intraosseous basivertebral nerve, including imaging guidance; first two vertebral bodies, lumbar or sacral is not medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested services are not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in orthopedic surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.