Intraosseous Basivertebral Nerve Ablation

Jurisdiction: JF Part B. States: Alaska, Arizona, Idaho, Montana, North Dakota, Oregon, South Dakota, Utah, Washington, Wyoming. Type: Active LCD

Coverage Indications, Contraindications, Medical Necessity, Non-Coverage and Limitations Covered Indications Thermal ablation of the intraosseous Basivertebral Nerve (BVN) is considered medically reasonable and necessary for the treatment of Chronic Low Back Pain (CLBP) in patient who meet ALL the following criteria for coverage and reimbursement. Individual is skeletally mature and has had CLBP for at least 6 months, with lower back pain as the dominant symptom. Has failed to adequately improve despite documented non-surgical management, to include at least 3 or more of the following modalities: Avoidance of activities that aggravate pain. Course of physical therapy or professionally directed therapeutic exercise program. Chiropractic manipulation Cognitive therapy Pharmacotherapy, including narcotic and non-narcotic analgesics, muscle relaxants, neuroleptics, and anti-inflammatories. Injection therapy of epidural or facet joint implicated pain sources in the region of concern Type 1 or Type 2 Modic changes on MRI: Endplate hypointensity (Type 1) or hyperintensity (Type 2) on T1 images plus hyperintensity on T2 images (Type1) involving the endplates between L3 and S1 Absence of additional vertebral pathology by physical, history, radiologic or clinical assessment including, but not limited to, fracture, tumor, infection, deformity, trauma, or post-surgical change which could cause the patient's symptoms or complicate the procedure and outcome. Physical and psychological assessment of patient’s ability to tolerate and benefit from BVN ablation. Contraindications to BVN Ablation, Medical Necessity and Non-Coverage The following conditions are considered relative contraindications to BVN ablation as suboptimal outcome and adverse exacerbation of symptoms may occur, precluding expected benefit from the procedure. Documentation in the patient’s medical record must explain the precautionary provisions taken for the individual patient to preclude anticipated or potential adverse events secondary to treatment. In the absence of documentation to support the procedure in individuals with the following concomitant conditions, medical necessity cannot be established. These conditions represent contraindication to treatment and render the service not medically appropriate, reasonable and necessary, or eligible for Medicare Coverage and Reimbursement. Skeletal immaturity ( Evidence on imaging (MRI, flexion/extension radiographs, CT) of another etiology for LBP symptoms, including, but not limited to, lumbar spinal stenosis, spondylolisthesis, segmental instability, disc herniation, degenerative scoliosis, facet arthropathy or effusion with clinically suspected facet joint pain. Metabolic bone disease (e.g., osteoporosis with T score -2.5), treatment of spine fragility fracture, trauma/compression fracture, or spinal primary or metastatic tumor. Active Spine or Systemic Infection Neurogenic claudication, lumbar radiculopathy, radicular pain, nerve impingement or compression (e.g., NHP, stenosis), as primary symptoms. Patients with severe cardiac or pulmonary compromise, systemic vulnerability to bleeding, or concern for further compromise of existing disease. Patients with implantable pulse generators (e.g., pacemakers, defibrillators, or neurostimulator) and other electronic implants, unless type specific precautions are taken to maintain patient safety. Ongoing use or abuse of addictive medications without evidence of potential weaning or decreased use with treatment. Limitations Basivertebral Nerve Ablation is limited to the following: No previous history of BVN ablation at the planned level of treatment. No more than one to two (1-2) vertebral bodies may be treated at a single session. Treatment of no more than 4 vertebral bodies per patient lifetime. Treatment is within the confines of L3-S1 vertebral bodies. Retreatment of a single vertebral body with BVN ablation within the patient's lifetime is not considered reasonable and necessary. Local anesthesia is considered appropriate for the region treated. Mild sedation may be administered by the performing physician or staff under his direction but should not be coded separately. Additional anesthesia services may not be billed separately without documentation of medical necessity. Definitions Chronic Pain/Chronic Low Back Pain : Pain lasting longer than six months in the same location, seemingly resistant to conservative measures. Conservative Measures/ Non-surgical Management : Any single or combination use of medication, physical therapeutic regimens, psychological or cognitive therapy designed by a qualified health care provider to affect relief of a disability or disease, based on a patient’s needs and physical findings. Incidental encounters are not considered therapeutic unless prescribed and monitored for defined purpose, time, and frequency by a qualified practitioner. Functional impairment : A physical, functional or physiologic impairment causing deviation from the normal function of a tissue, organ or body member, resulting in a significant limitation or impairment of the capacity to move, coordinate actions or perform physical activities, demonstrated by difficulty performing physical and motor tasks, independent movement or basic life functions. Modic Changes (Magnetic Resonance Imaging): MRI features consistent with Type 1 or Type 2 Modic changes 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 (Type 2 Modic change). Radicular pain or radiculopathy : pain radiating or identified in the path and distribution or dermatomal pattern of a named spinal nerve. Pain that is localized and does not travel in the distribution of an identified spinal nerve and remains axial in location is considered to have a non-radicular pattern. Spinal stenosis: Narrowing of the central spinal canal and /or the foraminal openings through which nerve or neural tissue are located, causing compression and irritation of the involved neural structures. A wide range of symptoms may be present, contributing to back and extremity pain and dysfunction.