LCD L39642: Intraosseous Basivertebral Nerve Ablation

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 ( -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.

A systematic review of the published literature on the efficacy, effectiveness, and complications associated with BVN ablation for the treatment of chronic low back pain (cLBP) was published by Conger, et al. (2021). 1 Evidence was evaluated using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) system of appraisal to determine the certainty of the evidence of the effectiveness of intraosseous BVN radiofrequency neurotomy (RFN). The reviewers found moderate-quality evidence that BVN RFN is both an effective treatment compared to sham procedure and superior to continued standard care management for reduction of pain and disability in stringently selected patients with cLBP and corresponding Modic type 1 and 2 changes at a minimum of 3 months.

Khalil, et al. (2019), conducted a multicentered RCT that compared the effectiveness of intraosseous radiofrequency (RF) ablation of the BVN to standard care for the treatment of cLBP in a specific subgroup of patients suspected to have vertebrogenic-related symptomatology. 8 A total of 140 patients (mean age 50 years) with cLBP of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between L3 and S1, were randomized to undergo either RF ablation of the BVN or continue standard care. Oswestry disability index scores (ODI) were collected at baseline, 3, 6, 9 and 12-months post-procedure. Secondary outcome measures included the visual analog scale (VAS) for pain intensity and responder rates, and quality of life measures (SF-36 and EQ-5D-5L). The primary endpoint was a between-arm comparison of the mean change in ODI from baseline to 3 months post-treatment. At 3 months follow-up, the minimally invasive RF ablation group demonstrated clinically significant improvement of pain and function compared to the standard care group. Treatment success was significantly greater in the RF group (74.5%) compared with patients in the standard care arm (32.7%) [p Health-related quality of life outcomes showed a statistically significant difference favoring the RF group. The study was stopped for benefit at 3 months, which followed an interim analysis showing superiority of the intervention arm. This resulted in a high rate of cross-over. Study limitations include the use of a nonstructured standard care control, open label design, and short-term results. In addition, industry funding was a potential source of study bias.

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. 3 The trial involved 225 patients with a mean age of 47 years who were diagnosed with cLBP. Participants were 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 ODI of 30 points (100-point scale) and a minimum 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. 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 mean between group difference was 5.3 points favoring the intervention group. This difference was not clinically significant; however, the 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.

Fischgrund, et al. (2019) subsequently reported the 2-year results from their original clinical trial (SMART Trial). 4 Originally, patient evaluations, including patient self -assessments, physical and neurological examinations, and safety assessments, were performed out to 12 months. The protocol was subsequently modified to include longer-term follow up to 24 months. Sham control arm patients were also allowed to cross to RF ablation at 12 months. Of the 78 patients in the control arm, 57 (73%) elected to cross over to receive the Intracept ® treatment. Overall, 106 participants, who received BVN ablation, were included in the 24-month analysis. Participants exhibited a durable ODI mean improvement (23.4 points) at 24 months compared to the mean improvements observed during their first year of follow up (20.3, 20.8, and 19.8 points at 3, 6, and 12 months, respectively). At 24 months, the previously reported treatment success (75.6% at 3 months) result was sustained with 76.4% of treated patients continuing to receive clinical benefit from BVN ablation. Improvements in the VAS, and the Medical Outcomes Trust Short-Form Health Survey Physical Component Summary were statistically significant compared to baseline at all follow-up time points through 2 years.