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

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act, §1862(a)(7) excludes routine physical examinations.

42 CFR §410.32 indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements)

42 CFR §416.65 Covered surgical procedures

CMS Internet-Only Manual, Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, §220.2 Magnetic Resonance Imaging (MRI)

CMS Internet-Only Manual, Publication 100-08, Medicare Program Integrity Manual, Chapter 13, §13.5.4 Reasonable and Necessary Provision in an LCD

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 (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.

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<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.

Schnapp et al. 2023 presents a study on the use of basivertebral nerve ablation (BVNA) to treat chronic low back pain (CLBP).³⁶ The study involved 16 patients treated in a community setting with the INTRACEPT® device and evaluated using the Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and SF-36 at various intervals up to six months. Key findings include significant improvements in ODI and VAS scores at 1, 3, and 6 months post-treatment, with a promising reduction in VAS from 7.88 at baseline to 4.44 at 6 months. The study concludes that BVNA is a durable, minimally invasive option for managing CLBP effectively in community settings. The research noted several limitations, such as a small sample size and lack of control group, and was noted as independently funded with no competing financial interests.

Schnapp et al. 2024 presents a study on the effectiveness of basivertebral nerve ablation (BVNA) for treating chronic low back pain (CLBP) in patients with Modic changes.³⁷ Conducted in a single-center, community private practice, the study followed 35 patients treated with the INTRACEPT® device, with evaluations using the Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and SF-36 at baseline and at intervals up to 12 months. Key results showed statistically significant improvements in all measured outcomes, with 67.7% of patients exhibiting a clinically significant improvement in ODI and 77.4% in VAS at 12 months. The study reported a mean reduction in ODIs from 46.7% to 21.5% and a decrease in VAS from 7.4 to 3.5 cm over 12 months. The SF-36 Physical and Mental Component Summaries also showed meaningful improvements. The study concludes that BVNA is an effective, minimally invasive treatment for CLBP, showing substantial benefits in a real-world cohort. Limitations included the absence of a control group, potential unintentional bias in patient selection, and lack of post-operative imaging. The study was funded internally and was noted for its independent and community-based focus, aiming to provide real-world evidence on the procedure's effectiveness.

Conger et al. (2022) conducted a comprehensive review on vertebrogenic pain, focusing on its diagnosis and treatment strategies.⁴⁶ The review emphasizes that vertebrogenic pain is a type of axial low back pain believed to originate from the vertebral body endplates, involving the basivertebral nerve (BVN). Clinically, this pain presents as midline low lumbar pain with minimal extension beyond the gluteal region. A significant diagnostic indicator is the presence of Type 1 or Type 2 Modic changes on MRI, associated with bone marrow edema or fatty transformations. Treatment through basivertebral nerve radiofrequency ablation (BVN RFA) has yielded promising results, with selected patients experiencing notable pain relief and functional enhancement. Effective treatment entails precise patient selection based on clinical assessment and imaging criteria. Outcomes from BVN RFA indicate significant reductions in pain and disability, consistent across different Modic change types. Future research is directed at enhancing diagnostic techniques, including imaging and serum biomarkers, to better identify vertebrogenic pain and improve intervention approaches.

Conger et al. 2022 assesses the effectiveness of basivertebral nerve (BVN) radiofrequency ablation (RFA) in treating vertebrogenic low back pain (LBP) associated with Modic type 1 or 2 changes.⁴⁷ This systematic review and single-arm meta-analysis included 12 publications out of 856 screened records, involving 414 participants.

The results demonstrated a 65% success rate in achieving a ≥50% pain reduction at 6 months and a 64% rate at 12 months. Additionally, 75% of participants showed a ≥15-point improvement in the Oswestry Disability Index (ODI) at both 6 and 12 months. The study concluded with moderate-quality evidence suggesting that BVN RFA effectively reduces pain and disability in most patients. However, further high-quality studies are recommended for more definitive conclusions. The study noted potential conflicts of interest due to funding from Relievant MedSystems and recognized the inclusion criteria limited generalizability. Common prior treatments for participants included spinal injections, opioids, and physical therapy. Adverse events were minimal, with transient leg pain and an 11% rate of pedicle breach being the most noted issues. The review highlighted significant pain relief and reduced healthcare utilization and opioid use post-treatment but pointed out the necessity for more high-quality, non-industry funded research.

McCormick et al. 2023 conducted a study to investigate the relationship between low back pain (LBP) location, exacerbating activities, and treatment success following basivertebral nerve radiofrequency ablation (BVN RFA) in patients with clinically suspected vertebral endplate pain (VEP).³⁹ The study comprised a cohort of 296 patients treated across 33 centers. The study identified several factors for increased treatment success: midline LBP, a pain duration of five years or less, no prior epidural steroid injections, no baseline opioid use, LBP exacerbation with activity, and an absence of exacerbation during spinal extension. Despite these factors, the regression models showed limited predictive accuracy, with AUCs under 70%. The authors highlighted the importance of objective imaging biomarkers, such as Modic changes, in selecting candidates for BVN RFA. They acknowledged the study's limitations, including the potential for confounding factors and the limited predictive value of the analyzed characteristics.

McCormick et al. 2022 explores MRI features linked to outcomes following basivertebral nerve radiofrequency ablation (BVN RFA) for vertebrogenic low back pain.⁵⁰ The study pooled data from 296 participants across three prospective clinical trials, focusing on MRI predictors of treatment success. Significant findings include the correlation between lumbar facet joint fluid and decreased odds of treatment success, while extensive bone marrow intensity changes prove predictive in cases with less advanced disc degeneration. Despite these findings, the models showed low overall predictive accuracy. Key patient inclusion criteria involved chronic lumbar back pain with Modic changes, and the study utilized logistic regression to identify pretreatment MRI predictors. The presence of facet joint fluid emerged as a weak predictor of treatment success, with overall predictive value hampered by low area under the ROC curve (AUC) values. Highlighted conclusions emphasize the importance of objective biomarkers such as Modic changes for patient selection over conventional MRI predictors. The document stresses the limitations of MRI characteristics in predicting outcomes post-BVN RFA and suggests a need for advanced imaging innovations and consideration of psychological aspects in pain management. It underscores the clinical necessity of contextualizing MRI findings, especially in the presence of lumbar facet joint pain or spondylolisthesis and recommends future research on advanced imaging techniques and psychological factors affecting treatment efficacy.

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.

DeVivo et al. 2020 presents a study focused on evaluating the effectiveness of intra-osseous basivertebral nerve radiofrequency ablation (BVA) for treating chronic low back pain (LBP) caused by vertebrogenic pain.³⁴ Conducted as a prospective experimental uncontrolled trial, the study involved 56 patients with chronic LBP who underwent CT-guided BVA as they exhibited vertebral endplate degeneration and inflammation identified through specific MRI findings (Modic changes). The study assessed pain and disability using the Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI), reporting significant reductions in both scores at 3- and 12-month follow-ups. Clinically meaningful success for both pain and disability was achieved in 96.5% of the participants, with no complications and a successful targeting of the ablation zone in 100% of cases. The study concluded that BVA is a safe and effective technique for pain relief in vertebrogenic chronic LBP, emphasizing the importance of comprehensive imaging for appropriate patient selection.

Fishchenko et al. 2021 evaluates the efficacy and safety of radiofrequency ablation (RFA) of the basivertebral nerve in the treatment of chronic low back pain associated with Modic I and II changes.³⁵ The study involved 19 patients with an average age of 52.6 years, each suffering from chronic low back pain for over six months. RFA was performed under local anesthesia, with the procedure averaging 28.0 ± 4.8 minutes. Results indicated substantial benefits, including an average Oswestry Disability Index decrease of 24.3 points, immediate pain reduction to 2.1 ± 1.1 cm on the VAS, and significant pain improvement (over 50% reduction) reported by 84.2% of participants. Additionally, participants saw improvements in the Beck Depression Scale scores, reducing from 13.8 to 3.4 over 12 months, and a regression of Modic changes on MRI observed at 6 months. The authors concluded that RFA is effective for long-term remission of pain associated with these Modic changes, though they noted the small sample size and limited literature on complications as study limitations.

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.

Khalil et al. 2024 evaluates the long-term outcomes of basivertebral nerve ablation (BVNA) as a treatment for vertebrogenic chronic low back pain (CLBP).³³ The analysis combines data from three clinical trials: SMART, INTRACEPT, and a single-arm study, involving 320 participants, 249 of whom completed 5-year follow-ups. Key findings include significant improvements in pain and functionality, with an average pain reduction of 4.32 points and a 28-point increase in functionality as measured by the Oswestry Disability Index (ODI). A notable 32.1% of participants reported being pain-free after five years, and the study observed a significant reduction in opioid use and the frequency of spinal injections. The safety profile was favorable, with no serious adverse events reported. The study concludes that BVNA offers a safe, effective, and long-lasting treatment option for vertebrogenic pain, highlighting the procedure's potential to reduce the necessity for additional invasive treatments. The improvements were seen across various measures of pain and function over the five-year period, demonstrating durability and a strong safety profile.

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.

McCormick et al. 2023 evaluates the impact of basivertebral nerve ablation (BVNA) on healthcare utilization in patients with vertebrogenic low back pain.⁵¹ Conducted at various institutions including the University of Utah School of Medicine and Stanford University, the research pools data from three prospective studies. It assesses categories such as conservative care, opioid use, spinal injections, radiofrequency ablation, and surgeries, with follow-ups at 1 year and over 5 years post-BVNA. Key findings show significant reductions in healthcare utilization: a 27% decrease in conservative treatments initiated, a 40.3% decrease in opioid use at 1-year and 61.7% at 5.3 years, and an 81.2% reduction in spinal injections. Lumbar fusion rates were notably low, with 0.8% at 1 year and 6.5% at 5.3 years post-BVNA. These results emphasize BVNA’s effectiveness in reducing long-term dependency on healthcare interventions for low back pain. The study highlights the potential of BVNA to substantially decrease medical interventions in vertebrogenic back pain management, even among patients with advanced degenerative disc disease. Despite positive outcomes, limitations include a lack of long-term comparative groups and potential underreporting of pre-BVNA utilization. Funded by the University of Utah and Relievant Medsystems, it shows promising results for integrating BVNA in international treatment models.

Smuck et al. 2024 assesses the economic efficiency of using BVNA compared to standard care for chronic low back pain (cLBP).⁴⁰ The analysis is model-based, drawing data from the INTRACEPT trial, involving 140 patients, with additional scenario analyses incorporating data from other studies like the SMART trial. Key findings indicate that BVNA is cost-effective, presenting an Incremental Cost-Effectiveness Ratio (ICER) of US$11,376 per Quality-Adjusted Life Year (QALY) over a 5-year horizon. The procedure has a 99% probability of being cost-effective in the US at a willingness-to-pay threshold of US$100,000 to US$150,000. The study also notes that the cost of BVNA is $12,553, based on the 2024 national average hospital payment for the procedure. The methodology involved using Microsoft Excel for cost-effectiveness modeling, evaluating costs, and health outcomes from a US payer perspective. Health-related quality of life was assessed using EQ-5D-5L and other measures. The study concludes that BVNA is a financially viable treatment option for patients with vertebrogenic cLBP, aligning with significant reductions in healthcare costs and interventions.

Boody et al. 2022 conducted a study to analyze the relationship between demographic and clinical characteristics and the treatment success of basivertebral nerve radiofrequency ablation (BVN RFA) for chronic low back pain linked to Type 1 and/or Type 2 Modic changes.⁴⁹ The study included a cohort of 296 patients with an average age of 48 years and a mean pain duration of 6.8 years. BVN RFA was performed to target the basivertebral nerve, followed by assessments at multiple intervals up to five years post-procedure. The study found that patients experienced an average Oswestry Disability Index (ODI) improvement of 23.6 points and a visual analog scale (VAS) pain score reduction of 3.33 cm at three months post-treatment. Factors contributing to a higher likelihood of treatment success included a pain duration of five years or less and higher baseline ODI scores, while opioid use and higher Beck Depression Inventory scores were associated with reduced treatment outcomes. The authors concluded that while demographic and clinical characteristics offer some insights, objective imaging biomarkers like Modic changes provide better guidance in selecting candidates for BVN RFA. They acknowledged the study's limitations, including variable predictive capacity and potential unknown confounding factors.

Kim et al. 2018 investigates the efficacy of using a transforaminal epiduroscopic approach to perform laser ablation on the basivertebral nerve for treating chronic low back pain linked to Modic changes in vertebral bodies.³⁸ The study included 14 patients who had been experiencing chronic low back pain for more than six months and had not responded to conservative treatment for at least four months. These patients were selected based on MRI findings showing Modic type I or II changes and underwent the procedure using a 1414 nm Nd:YAG laser. The outcomes were assessed using the Visual Analog Scale (VAS) and Macnab’s criteria over an average follow-up period of 15.3 months. Results showed significant pain reduction, with average VAS scores dropping from 7.79 preoperatively to 1.92 postoperatively. In terms of outcomes according to Macnab’s criteria, 50% of patients reported excellent results, 42.85% reported good results, and 7.14% reported fair results. No serious complications were observed, indicating that this laser ablation technique is promising for managing chronic low back pain in patients with specific Modic changes. However, the study highlighted limitations such as a small sample size and lack of a control group.

Lee et al. 2024 explores the use of basivertebral nerve ablation (BVNA) as a treatment for chronic lower back pain (LBP), specifically in patients with Modic changes.⁴⁵ Lower back pain is a significant global health issue affecting over half a billion people and is a leading cause of disability. The study highlights vertebrogenic back pain (VBP) associated with Modic changes, which are alterations in vertebral endplates, as a focal point. These changes, identified as Type I or II through MRI, indicate inflammation and tissue changes linked to intraosseous pain sources. BVNA involves radiofrequency ablation of the basivertebral nerve, yielding positive outcomes as supported by multiple studies, including randomized controlled trials and meta-analyses. This procedure has shown significant improvements in pain and function, as measured by the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS). The study reports clinically significant improvements, such as ODI scores decreasing from 52 to 23 and VAS scores from 61 to 45 over follow-up periods. The SMART trial and the Fischgrund study are referenced, indicating sustained improvements and reduced opioid use among patients. While some non-serious adverse events like transient pain and numbness were noted, no major complications occurred. Overall, the findings suggest that BVNA is an effective and safe treatment for chronic LBP associated with Modic changes. The technique offers significant pain relief, improved functionality, and could potentially reduce healthcare costs related to LBP. Further long-term studies and inclusion of appropriate control groups are recommended to validate these results and refine patient selection criteria.

Additional reviews^{3,4,15,43,44,45,48,49}, 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. (Add Schnapp 2022 scoping review + Huang 2022 comp review + Nwosu, Loan & Kieser 2021 + Mekhail 2023 (51))

The American Society of Pain and Neuroscience (ASPN) 2022 guideline by Sayed et al. concluded that "The guideline embraces evidence-based practices to construct interventional treatment guidelines for low back pain (LBP), addressing safety, quality, and efficacy across varying interventional strategies.⁵⁴ Key methodologies encompass a comprehensive literature review emphasizing high-quality studies, primarily randomized controlled trials (RCTs) and observational studies, with a grading system aligned to categorize recommendations from A (high net benefit) to D (against the service), and 'I' for insufficient evidence. These processes aim to enhance transparency and precision in clinical decision-making, continually refining recommendations through emerging research and clinical feedback." Recommendations are graded based on the strength of evidence, with interventions assessed for their risks, benefits, and long-term outcomes. The guidelines aim to improve clinical care through patient-specific approaches while emphasizing conservative management prior to surgical intervention, aligning practices with evidence-based outcomes and evolving patient care needs.

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.

The U.S. Preventive Services Task Force (USPSTF) 2001 guideline – Current methods of the U.S. Preventive Services Task Force concluded that "The Task Force employs evidence-based processes to establish clinical practice guidelines focused on significant health burdens and effective preventive services.⁵³ Key methodologies include the scope and selection of topics pertaining to preventive measures for asymptomatic individuals, an analytic framework linking services to health outcomes, and evidence stratification and grading to ensure recommendations are based on good, fair, or poor evaluations. These processes underscore transparency, minimize bias, and constantly evolve through feedback and high-quality evidence consideration." Recommendations are graded from A to D, with "I" for insufficient evidence, highlighting the magnitude of benefits and harms in clinical practice, specifically targeting the health of asymptomatic patients and integrating factors like feasibility and patient expectations.

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. Patient satisfaction with BVNA is also notably high underscoring it’s positive impact on patients’ quality of life, complementing the clinical improvements in pain and functionality

Comparative studies reveal that BVNA offers significant advantages over traditional conservative management and other invasive procedures. These studies highlight BVNA's superior reduction in healthcare resource demand and enhanced pain management effectiveness, which significantly reduce opioid reliance.

Economic assessments also favor BVNA as a cost-effective intervention, with studies reporting favorable incremental cost-effectiveness ratios (ICERs) per Quality-Adjusted Life Year (QALY), showcasing its potential to alleviate the financial burden of CLBP management

In summary, the collected evidence positions BVNA as a highly effective, minimally invasive option for treating CLBP, especially in patients with Modic changes. It offers substantial pain and functional improvements, a strong safety profile, and economic benefits, making it a viable option for clinicians. 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).

Documentation Requirements

The scales used for measurement of pain and/or disability must be documented in the medical record. Acceptable scales include but are not limited to verbal rating scales, Numerical Rating Scale (NRS) and Visual Analog Scale (VAS) for pain assessment, and Pain Disability Assessment Scale (PDAS), Oswestry Disability Index (ODI), Oswestry Low Back Pain Disability Questionnaire (OSW), Quebec Back Pain Disability Scare (QUE), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS), and the PROMIS profile domains to assess function.

The patient’s medical record should include but is not limited to:

• The assessment of the patient by the performing provider as it relates to the complaint of the patient for that visit,

• Relevant medical history (including a history of chronic vertebrogenic LBP for at least 6 months and failure of non-surgical management of at least 6 months),

• Results of pertinent tests/procedures (including pertinent radiological studies, which must include MRI images and radiology reports of evidence of Modic changes Type 1 or 2 in the L3-S1 vertebral body endplates),

• Signed and dated office visit record/operative report (Please note that all services ordered or rendered to Medicare beneficiaries must be signed).

Notice: Services performed for any given diagnosis must meet all the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, all existing CMS national coverage determinations, and all Medicare payment rules.

Provider Qualifications:

Medicare Program Integrity Manual states services will be considered medically reasonable and necessary only if performed by appropriately trained providers.

Patient safety and quality of care mandate that healthcare professionals who perform thermal destruction of the intraosseous BVN are appropriately trained and/or credentialed by a formal residency/fellowship program and/or are certified by either an accredited and nationally recognized organization or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program whose core curriculum includes the performance and management of the procedures addressed in this policy. If the practitioner works in a hospital facility at any time and/or is credentialed by a hospital for any procedure, the practitioner must be credentialed to perform the same procedure in the outpatient setting. At a minimum, training must cover and develop an understanding of anatomy and kinetics as well as proficiency in diagnosis and management of disease, the technical performance of the procedure, and utilization of the required associated imaging modalities.

In addition to the above requirements, non-physician providers, such as certified nurse anesthetist, with certain exceptions, may certify, order, and establish the plan of care as authorized by State law. (See Sections 1861[s][2] and 1862[a][14] of Title XVIII of the Social Security Act; 42 CFR, Sections 410.74, 410.75, 410.76 and 419.22; 58 FR 18543, April 7, 2000.) Each practitioner must provide only those services within the scope of practice for each state.

Definitions

Chronic low back pain – The temporal definition of pain persisting for greater than or equal to 12 weeks after the onset of the pain.

Conservative therapy - Appropriate combination of medication (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, etc.) in addition to physical therapy, acupuncture (applies to only chronic low back pain), spinal manipulation therapy, cognitive behavioral therapy (CBT), or other interventions individualized to meet the needs of each patient based on the individual’s specific presentation, physical findings, and imaging results. This management should include the application of biopsychosocial treatment techniques.

Disability – Activity limitations and/or participation restrictions in an individual with a health condition, disorder, or disease.

Epidural steroid injection – The administration via injection of contrast (absent allergy to contrast), followed by the introduction of steroid medicine into the potential epidural space in the spinal column to deliver steroids to the spinal nerves.

Impairment – A significant deviation or loss of use of any body structure or body function in an individual with a health condition, disorder, or disease.

Neurogenic claudication - intermittent leg pain, leg weakness, or leg heaviness from impingement of the nerves emanating from the spinal cord (also called pseuduoclaudication); often exacerbated by walking and relieved with leaning forward or sitting down.

Non-radicular back pain - The radiating non-neuropathic pain which is not causally related to a spinal nerve root irritation and does not produce reproducible neuropathic symptoms in an objective dermatomal pattern.

Nonspecific low back pain – Back pain that cannot be attributed to a specific disease or spinal pathology.

Radicular back pain - The radiating neuropathic pain causally related to the spinal nerve root irritation which extends into the distal distribution, typically the lower extremity, producing neuropathic pain in a dermatomal pattern.

Radiculopathy - Radiating neuropathic pain causally related to the spinal nerve root irritation, which extends distal producing neuropathic pain in a dermatomal pattern.

Radiculitis – Inflammation of the nerve roots which produces radicular pain without objective neurological findings on physical examination.

Spinal stenosis – The narrowing of the central spinal canal or foraminal openings, usually due to spinal degeneration that occurs with aging is a radiographic diagnosis. It may also be the result of spinal disc herniation, osteoarthritis, or a tumor. Lumbar spinal stenosis may result in low back pain and pain or abnormal sensations in the legs, thighs, feet, or buttocks, or loss of bladder and bowel control. Neurogenic claudication is often a clinical condition that results from spinal stenosis.

Regulatory Status

• Intracept Intraosseous Nerve Ablation System
• K190504 – FDA Clearance May 3, 2019

The Pain Society of the Carolinas

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• Provider Education/Guidance
• Request for Coverage by a Practitioner (Part B)
• Creation of Uniform LCDs With Other MAC Jurisdiction