Thermal Destruction of the Intraosseous Basivertebral Nerve (BVN) for Vertebrogenic Lower Back Pain

Jurisdiction: JM Part B. States: North Carolina, South Carolina, Virginia, West Virginia. Type: Active LCD

Coverage Guidance Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits. Low back pain (LBP) is the most expensive occupational disorder in the United States and the leading cause of disability worldwide. 1 Chronic low back pain (cLBP) is defined as persistent pain in the lumbar region lasting for >12 weeks. cLBP has many different etiologies. Research shows evidence that one etiology is associated with degeneration of the vertebral body or vertebral body endplates, resulting in inflammation. The inflammatory response is perceived by the basivertebral nerve (BVN), a sensory nerve that enters the posterior vertebral body and branches out to the superior and inferior endplates. The pain signals are then transmitted to the central nervous system, causing what is known as vertebrogenic pain. 2 Clinically, vertebrogenic pain is generally described as a midline, deep, aching, burning pain that is progressive. Also, it is often associated with an intermittent electrical shock sensation. Vertebrogenic pain is also characterized by absence of radicular expression, lower extremity weakness, or sensory deficits, and the neural tension sign and pain is generally worse with spinal flexion, sitting, standing and general physical activity, when compared to extension. 3,4 Diagnosis of vertebrogenic cLBP focuses on the chronic inflammatory response caused by endplate damage, which is visible on MRI. 5 These signal changes, known as Modic changes (MC), are found in the vertebral body bone marrow that is adjacent to the degenerative endplates. Modic 1 changes indicate inflammation and edema, and Modic 2 changes occur in the setting of marrow ischemia when the red hematopoietic bone marrow has converted into yellow fatty marrow. 6,7,8 Thermal destruction (i.e., ablation) of the intraosseous BVN ( Intracept ® Procedure) is a therapeutic, interventional surgical procedure used to treat cLBP of vertebrogenic origin. The procedure is performed using fluoroscopic imaging under moderate/conscious sedation or general anesthesia. Radiofrequency energy is applied for 15 minutes at 85 degrees Celsius to produce a lesion to destroy the BVN within the vertebral body. At a minimum, the BVN is ablated in at least 1 vertebral body. Covered Indications Thermal destruction of the intraosseous BVN will be considered medically reasonable and necessary for the treatment of cLBP in patients who meet ALL the following criteria: 1,2,5,9,10,11,12,13 Chronic lumbar back pain of ≥6 months duration that causes functional deficit measured on a pain or disability scale*, AND Documented failure to respond to ≥6 months of non-surgical management**, AND Absence of non-vertebrogenic pathology per clinical assessment or radiology studies that could explain the source of the patient’s pain, including but not limited to fracture, tumor, infection, or significant deformity, AND Evidence of Type 1 or Type 2 Modic changes on MRI, such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypotensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hypertensive signals (Type 2 Modic change), in 1 or more vertebrae from L3-S1. * Pain assessment and a disability scale must be obtained at baseline to be used for functional assessment. ** Non-surgical management may include but is not limited to: Avoidance of activities that aggravate pain; Trial of Chiropractic manipulation; Trial of Physical Therapy; Cognitive support and recovery reassurance; Injection therapy – epidural and/or facet; Spine biomechanics education; Specific lumbar exercise program; Home use of heat/cold modalities; Low impact aerobic exercise as tolerated; Pharmacotherapy (e.g., non-narcotic analgesics, NSAIDs, muscle relaxants, neuroleptics, and narcotics). Patients must have undergone careful screening, evaluation, and diagnosis by a multidisciplinary team prior to thermal destruction of the intraosseous BVN (such screening must include psychological, as well as, physical evaluation). Documentation of the history and careful screening must be available in the patient chart if requested. Limitations Services that are not reasonable and necessary cannot be covered by Medicare in the following: 1,2,5,9,10,11,12,13 Skeletally immature patients (≤18 years old); Severe cardiac or pulmonary compromise; Active systemic infection or local infection at the intended treatment level; Bleeding diathesis; Pregnancy; Primary radicular pain into the lower extremities (defined as nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging); Previous lumbar/lumbosacral spine surgery at the intended treatment level (with the exception of discectomy/laminectomy if performed >6 months prior to BVN nerve ablation and radicular pain resolved); Primary symptomatic lumbar or lumbosacral spinal stenosis (defined as the presence of neurogenic claudication and confirmed by imaging); Diagnosed osteoporosis (T-score of -2.5 or less), spine fragility fracture history, trauma/compression fracture at the intended treatment level, or spinal cancer; Radiographic evidence of any of the following that correlates with predominant physical complaints: Lumbar/lumbosacral disc extrusion or protrusion >5mm at levels L3-S1; Lumbar/lumbosacral spondylolisthesis > 2mm at any level; Lumbar/lumbosacral spondylolysis at levels L3-S1; Lumbar/lumbosacral facet arthrosis/effusion correlated with facet-mediated pain at levels L3-S1. BMI >40; Advanced generalized systemic disease that limits quality-of-life (QOL) improvements would require a statement of the objective of treatment in such cases; Active, untreated substance abuse disorder. NOTE : Thermal destruction of the intraosseous BVN must only be performed once per vertebral body from L3-S1 per lifetime. Up to 4 vertebral bodies may be treated during 1 procedure.