LCD L40302: Thermal Destruction of the Intraosseous Basivertebral Nerve (BVN) for Vertebrogenic Lower Back Pain

Low back pain (LBP) is the most expensive occupational disorder in the United States and the leading cause of disability worldwide. 1,24 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. 5,31,32 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. 6,7,8,25,26,27,28,29,30

Thermal destruction (i.e., ablation) of the intraosseous BVN 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.

Mirza et al. 2013 investigates one-year outcomes of surgical versus non-surgical treatments for discogenic back pain through a community-based prospective cohort study involving 495 patients.55 Conducted at multiple sites, including Dartmouth Medical School and the University of Washington, the study explores surgical consultation outcomes for patients with documented disc degeneration.

Key findings indicate that surgical treatment yields superior outcomes compared to non-surgical approaches, with a 5.4-point improvement in the modified Roland-Morris Back Disability score at one year. Surgical patients exhibit greater reductions in pain severity and improvements in overall mental health measures. Composite success rates are 33% for surgical and 15% for non-surgical groups. Despite these benefits, approximately 15% of surgical patients report worsened conditions, and adverse outcomes are similar between groups.The study highlights the limited effectiveness of existing treatments, the variability in treatment success, and the challenges of managing discogenic back pain. It emphasizes the need for structured rehabilitation and cognitive behavioral therapy, which are often inaccessible, and calls for improved adherence to care guidelines to enhance patient outcomes. Funded by the National Institutes of Health and the Spine End-Results Research Fund, the research suggests surgery can provide greater benefits than non-surgical options, particularly in quality of life and functional outcomes.

Becker et al. 2017 discusses a clinical study on the effectiveness of radiofrequency ablation of the basivertebral nerve (BVN) for treating chronic lumbar back pain attributed to degenerative disc disease. 41 The study, conducted by Stephan Becker and colleagues and published in The Spine Journal in 2017, involved 17 patients who had not responded to conservative treatments. Using the INTRACEPT System, BVN ablation was performed, aimed at alleviating pain and improving disability scores.The study found significant improvements in patient outcomes, with a noticeable reduction in the Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) pain scores, maintained over a 12-month follow-up period. The treatment did not result in any serious adverse events, although some minor complications were noted. The study concludes that BVN ablation is a promising option for chronic back pain management, warranting further research through ongoing randomized controlled trials. The study was funded by Relievant Medsystems.

Fischgrund, et al. (2018) conducted a prospective randomized double-blind sham-controlled clinical trial that evaluated the safety and efficacy of radiofrequency (RF) ablation of the BVN for treatment of cLBP. 2 The trial involved 225 patients diagnosed with cLBP, and each patient was randomized to either a sham (78) or treatment intervention (147). Treatment arm patients underwent thermal ablation at the terminus of the BVN using the Intracept ® System. Skeletally mature patients with chronic (≥ 6 months), isolated lumbar pain, who had not responded to at least 6 months of non-operative management and had Type 1 or Type 2 Modic changes at 3 or less contiguous levels at L3-S1 on MRI were included in the study. Furthermore, patients were required to have a minimum Oswestry Disability Index (ODI) of 30 points (100-point scale) and a minimum visual analog scale (VAS) of 4cm (10cm scale). Mean baseline ODI was 42 and mean baseline VAS was 6.7cm. Stringent exclusion criteria were applied, which included: radicular pain, previous lumbar spine surgery, symptomatic spinal stenosis, diagnosed osteoporosis (T 5mm, spondylolisthesis >2mm at any level, ≥3 Waddell’s signs of Inorganic Behavior, Beck Depression Inventory >24, patients involved in litigation related to back pain or injury, patients receiving disability compensation, and patients currently taking extended-release narcotics. Radicular pain was defined as pain that traveled along a dermatomal distribution into the lower extremity, causing pain, numbness, and/or weakness/heaviness of the affected area. Symptomatic spinal stenosis was defined as presence of neurogenic claudication as confirmed by imaging, with symptoms typically including a combination of discomfort, pain, numbness, and weakness in the calves, buttocks, and/or thighs, often brought on by walking or prolonged standing, but relieved by flexion or sitting. Patients were evaluated at baseline, and at 2 weeks, 6 weeks, and 3-, 6-, and 12-months post procedure. The primary endpoint was the comparative change in ODI at 3 months. Results showed the average ODI in the treatment arm decreased 20.5 points when compared to the sham arm decrease of 15.2 points (p=0.019). A responder analysis based on ODI decrease ≥ 10 points showed that 75.6% of patients in the treatment arm as compared to 55.3% in the sham control arm exhibited a clinically meaningful improvement at 3 months. The authors concluded that patients treated with ablation of the BVN for cLBP showed significantly greater improvement in ODI at 3 months and a higher responder rate when compared to the sham treated control group.