Summary Of Evidence

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<2.5), disc extrusion or protrusion >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.

Fischgrund, et al. (2019) then reported the 2-year results from their original clinical trial (SMART Trial).¹ 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. Therefore, secondary to the high rate of crossover, RF ablation treated patients acted as their own control in a comparison to baseline for the 24-month outcomes. Clinical improvements in the ODI, 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. The mean percent improvements in ODI and VAS compared to baseline at 2 years were 53.7% (p<0.001) and 52.9% (p<0.001), respectively. Responder rates for ODI and VAS were also maintained through 2 years with patients reporting clinically meaningful improvements in both. Using a 10-point improvement in ODI, the commonly accepted minimum clinically important difference (MCID) in the treatment of cLBP, 75.6% of treated patients exhibited a successful response at 3 months. This result was sustained at 24 months with 76.4% of treated patients continuing to receive clinical benefit from BVN ablation. When considering a 20-point threshold for reduction in ODI, 57.5% of treated patients reported clinical benefit at 24 months. At the primary 3-month follow up, 65.4% of patients met or exceeded the VAS MCID of 1.5 cm improvement. The VAS responder rate was sustained at 24 months with 70.2% of patients meeting or exceeding the MCID improvement in VAS.

In 2020, Fischgrund, et al. reported the 5-year outcomes for patients treated with BVN ablation for vertebrogenic cLBP in the SMART randomized control trial (RCT).⁹ Five-year study results following BVN ablation showed a significant mean reduction in ODI of 25.95 ± 18.54 (60.6%) compared to a baseline of 42.81 (p<0.001). Mean reduction in VAS pain score was 4.38 points (baseline of 6.74, p<0.001). In total, 66% of patients reported a > 50% reduction in pain, 47% reported a > 75% reduction in pain, and 34% of patients reported complete resolution of their pain. Composite responder rate using thresholds of ≥ 15-point ODI and ≥ 2-point VAS for function and pain at 5 years was 75%. Patients reported a high degree of patient satisfaction: 70% rated their condition as improved; 27% reported no change; and 3% reported their condition had worsened. Seventy-nine percent (79%) of patients indicated they would repeat the BVN ablation for the same condition, and 65% reported resumption of their level of activity prior to having low back pain.

Khalil, et al. (2019) conducted the INTRACEPT Trial, which was a prospective, randomized multicenter study at 20 U.S. sites.⁵ This RCT compared the effectiveness of intraosseous RF ablation of the BVN to standard of care for the treatment of cLBP in a specific subgroup of patients suspected to have vertebrogenic symptoms. The trial involved 140 patients with cLBP of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between L3 and S1, and who had not responded to at least 6 months of non-operative management. Participants were also required to be skeletally mature, have isolated lumbar pain, have a minimum ODI of 30 points (100-point scale) and a minimum VAS of 4cm (10cm scale). Baseline ODI was 46.1 (p=.064) and VAS was 6.67 (p=.231). Exclusion criteria included: MRI evidence of Modic at levels other than L3-S1, radicular pain, previous lumbar spine surgery, symptomatic spinal stenosis, metabolic bone disease, spine fragility fracture history, trauma/compression fracture, spinal cancer, spine infection, active systemic infection, bleeding diathesis, radiographic evidence of other pain etiology (disc extrusion or protrusion >5mm, spondylolisthesis >2mm at any level, facet arthrosis/effusion correlated with facet-mediated LBP), either ≥3 Waddell’s signs of Inorganic Behavior or Beck Depression Inventory >24, patients receiving injury compensation or involved in litigation, patients currently taking extended-release narcotics with addiction behaviors, BMI >40, bedbound or neurological condition that prevents early mobility or any medical condition that impairs follow up, a contraindication to MRI, allergies to components of the device, or active implantable devices, and pregnancy or lactating. The exclusion criteria of previous lumbar spine surgery did allow an exception for discectomy/laminectomy if performed >6 months before baseline and radicular pain had resolved. Radicular pain was defined as nerve pain that follows a dermatomal distribution and correlates with nerve compression imaging. Symptomatic spinal stenosis was defined as presence of neurogenic claudication as confirmed by imaging. Patients were randomized 1:1 to undergo either RF ablation of the BVN using the Intracept^® System or continue standard care, which included, but not limited to, pain medications, physical therapy, exercise, chiropractic treatment, acupuncture, and spinal injections. ODI was reported at baseline, 3, 6, 9, and 12-months post-procedure. Secondary outcome measures included a 10-point VAS for LBP, ODI and VAS responder rates, Short Form (SF-36) and EuroQual Group 5 Dimension 5-Level Quality of Life (EQ-5D-5L) questionnaires. The primary endpoint was a comparison between the treatment arm and standard care arm of the mean change in ODI from baseline to 3 months post-treatment. The interim analysis demonstrated a clear statistical superiority (p<.001) for all primary and secondary patient-reported outcome measures in the RF ablation arm compared with the standard care arm; therefore, participants were offered early cross-over to the control arm. 3-month results between the RF ablation arm and the standard care arm showed the mean changes in ODI were -25.3 points versus -4.4 points, respectively; an adjusted difference of 20.9 points (p<0.001). Mean changes in VAS were -3.46 versus -1.02, respectively; an adjusted difference of 2.44 cm (p<0.001). 74.5% of patients achieved a ≥10-point improvement in ODI in the RF ablation arm, compared with 32.7% in the standard care arm (p<0.001). The authors concluded that minimally invasive RF ablation of the BVN for chronic vertebrogenic LBP resulted in significant improvement of pain and function at 3 months.

Smuck, et al. (2021) published the 12-month results from the INTRACEPT Trial.¹⁰ Participants were followed up at 6 weeks, 3, 6, 9, and 12 months. Standard care patients were re-baselined and followed up for 6 months after BVN ablation. The primary endpoint was the comparison between the BVN ablation and standard care arms of mean ODI change from baseline. Secondary endpoints were VAS, SF-36, EQ-5D-5L, responder rates, and rates of continued opioid use. At the time of the interim analysis at 3 months, 140 participants were randomized. Results showed that BVN ablation (n=66) was superior to standard care (n=74) at 3 months for the primary endpoint (mean ODI reduction, difference between arms of −20.3 (CI −25.9 to −14.7 points; p<0.001)), VAS pain improvement (difference of −2.5 cm between arms (CI −3.37 to −1.64, p<0.001)) and quality of life outcomes. At 12 months, BVN ablation demonstrated a 25.7±18.5-point reduction in mean ODI (p<0.001), and a 3.8±2.7 cm VAS reduction (p<0.001) from baseline, with 64% demonstrating ≥50% reduction and 29% pain free. The former standard care arm patients who elected BVN ablation (92%) showed a 25.9±15.5 point mean ODI reduction (p<0.001) from baseline. The proportion of opioid use did not change in either group (p=0.56). Seventy-four per cent (74%) of BVN ablation arm patients reported improvement of their condition at 12 months; 75% indicating treatment success. Similar satisfaction (78% improvement, 72% success) was reported 6 months post BVN ablation for participants who formerly underwent standard care. No serious device-related adverse events were reported.

Twenty-four (24) month treatment arm results for the INTRACEPT Trial were published by Koreckij, et al (2021).¹¹ Baseline characteristics for the 58 BVN ablation patients completing a 24-month visit showed that 67% had back pain for > 5 years, 36% were taking opioids at baseline, 50% had prior epidural steroid injections, and 12% had prior low back surgery. At 24 months, ODI and VAS improved 28.5 ± 16.2 points (from baseline 44.5; p< 0.001) and 4.1 ± 2.7 cm (from baseline 6.6; p< 0.001), respectively. A combined responder rate of ODI ≥ 15 and VAS ≥ 2 was 73.7%. A ≥ 50% reduction in pain was reported in 72.4% of patients and 31% reported being pain-free at 2 years. At 24 months, 62% fewer patients were actively taking opioids. No serious device or device-procedure related adverse events were reported by the authors through 24 months. 

A prospective, single-arm, open-label study to evaluate the effectiveness of intraosseous BVN RF ablation for the treatment of vertebrogenic-related cLBP in a typical spine practice setting was conducted by Truumees, et al. (2019).¹² The authors sought to employ more permissive criteria for study inclusion than that used in the SMART Trial^1,2,9, such as patients who had prior discectomy and those who took extended-release narcotics. Consecutive patients with cLBP of at least 6 months duration, at least 6 months of conservative care, and with Modic Type 1 or 2 vertebral endplate changes between L3 and S1 were treated with RF ablation of the BVN in up to 4 vertebral bodies. The primary endpoint was patient-reported change in ODI from baseline to 3 months post-BVN ablation. Secondary outcome measures included change in VAS, SF-36, EQ-5D-5L, and responder rates.

An interim analysis was conducted and reported when the first 28 patients treated reached their 3-month post procedure visit. Baseline ODI was 48.5; VAS was 6.36 cm. Seventy-five percent (75%) of the study patients reported LBP symptoms for ≥ 5 years; 25% were actively using opioids; and 61% were previously treated with injections. Mean change in ODI at 3 months post-BVN ablation was -30.07+14.52 points (p< 0.0001); mean change in VAS was -3.50+2.33 (p<0.0001). Ninety-three percent (93%) of patients achieved a ≥10-point improvement in ODI, and 75% reported ≥20-point improvement. The authors concluded that minimally invasive RF ablation of the BVN demonstrated a significant improvement in pain and function in this population of real-world patients with cLBP of a vertebrogenic origin. 

Macadaeg, et al. (2020) reported the 12-month results for all patients enrolled and treated with BVN ablation the clinical trial first reported by Truumees, et al.¹³ Forty-eight (48) patients from community spine and pain practices were treated with BVN ablation. Patients were followed post procedure for 12 months using ODI, VAS, EQ-5D-5L, and SF-36 patient reported outcome metrics. Results showed that 47 patients successfully received BVN ablation, and 45 patients completed 12 months of follow up. Mean reduction in ODI at 12 months was 32.31 ± 14.07 (p<0.001) with 88.89% (40/45) patients reporting a ≥ 15-point ODI decrease at 12 months. Mean VAS pain score decrease was 4.31 ± 2.51 at 12 months (p<0.001) and >69% reported a 50% reduction in VAS pain scale. SF-36 and EQ-5D-5L scores improved 26.27 ± 17.19 and 0.22 ± 0.15, respectively (each p< 0.001). The authors concluded that this data supports the clinical effectiveness of BVN ablation in the community practice setting.

A systematic review of the published literature on the efficacy, effectiveness, and complications associated with BVN ablation for the treatment of cLBP was published by Conger, et al. (2021).¹⁴ Evidence was evaluated using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) system of appraisal to determine the quality of the evidence of the effectiveness of intraosseous BVN radiofrequency neurotomy (RFN). According to GRADE, there is 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.

Additional reviews^3,4,15 are supportive of BVN ablation as an effective treatment and more beneficial than current standard of care for a subset of patients with cLBP based on moderate-quality evidence.

The International Society for the Advancement of Spine Surgery (ISASS) 2020 guideline – Intraosseous Ablation of the Basivertebral Nerve for the Relief of Chronic Low Back Pain¹⁶ concluded that “The procedure is supported by level 1 evidence including 2 RCTs demonstrating a statistically significant decrease in pain and an improvement in function with outcomes sustained to at least 24 months in a limited number of studies.” BVN ablation may be indicated as a treatment option for cLBP for patients that fail nonsurgical treatment and their cLBP is diagnosed using well-established clinical and MRI findings.

The American Society of Pain and Neuroscience (ASPN) identified evidence-based guidelines from the available literature for the proper identification and selection of patients with vertebrogenic low back pain for BVN ablation.²³ The systematic review was conducted using United States Preventive Services Task Force Criteria Modified for Interventional Spine Procedures and assigned a Grade A rating of the quality of evidence for BVN ablation indicating a high certainty that the net benefit is substantial in appropriately selected individuals.

Analysis of Evidence

cLBP is a significant clinical problem and a socioeconomic burden that affects approximately 30 million people in the United States. Basic science^{17,18,19,20,21} and clinical trials^{1,2,5,9,10,11,12,13} have validated the diagnosis of vertebrogenic pain. The associations of Modic changes (MC) types 1 and 2 with cLBP and vertebral body endplate (VEP) injury have also been established.^6,7,8,22

Promising short- and long-term follow-up results support the safety, durability, and efficacy of radiofrequency ablation of the BVN for a subset of patients with vertebrogenic cLBP, corresponding with Modic change types 1 and 2 in the L3-S1 VEPs who have failed to respond to conservative treatment for at least 6 months. Published RCTs as well as prospective pre-post intervention studies have resulted in moderate-quality evidence that BVN RFN is safe and both an effective treatment compared to sham procedure and superior to continued standard care management for reduction of pain and disability when proper patient selection and procedural techniques are implemented.

Therefore, thermal destruction of the intraosseous BVN for vertebrogenic cLBP is considered to be medically reasonable and necessary when performed as outlined in the current published literature and this Local Coverage Determination (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}

1. Chronic lumbar back pain of ≥6 months duration that causes functional deficit measured on a pain or disability scale*, AND
2. Documented failure to respond to ≥6 months of non-surgical management**, AND
3. 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
4. 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}

1. Skeletally immature patients (≤18 years old);
2. Severe cardiac or pulmonary compromise;
3. Active systemic infection or local infection at the intended treatment level;
4. Bleeding diathesis;
5. Pregnancy;
6. Primary radicular pain into the lower extremities (defined as nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging);
7. 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);
8. Primary symptomatic lumbar or lumbosacral spinal stenosis (defined as the presence of neurogenic claudication and confirmed by imaging);
9. Diagnosed osteoporosis (T-score of -2.5 or less), spine fragility fracture history, trauma/compression fracture at the intended treatment level, or spinal cancer;
10. Radiographic evidence of any of the following that correlates with predominant physical complaints:
    1. Lumbar/lumbosacral disc extrusion or protrusion >5mm at levels L3-S1;
    2. Lumbar/lumbosacral spondylolisthesis > 2mm at any level;
    3. Lumbar/lumbosacral spondylolysis at levels L3-S1;
    4. Lumbar/lumbosacral facet arthrosis/effusion correlated with facet-mediated pain at levels L3-S1.
11. BMI >40;
12. Advanced generalized systemic disease that limits quality-of-life (QOL) improvements would require a statement of the objective of treatment in such cases;
13. 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.