Description
Management of back pain that is persistent and disabling despite the use of recommended conservative treatment is challenging. Numerous diagnostic and therapeutic injections and other interventional and surgical treatments have therefore been proposed for the treatment of back pain. This policy addresses intraosseous radiofrequency ablation.

Policy
Intraosseous radiofrequency nerve ablation of the basivertebral nerve (i.e., Intracept^® Intraosseous Nerve Ablation System) is considered MEDICALLY NECSSARY for 
treatment of chronic, vertebrogenic low back for at least 12 months duration and at no more than three adjacent vertebral bodies (i.e., between L3-S1), during which time ALL 
of the following criteria have been met: 

• Unremitting back pain and significant functional impairment continues despite at least six consecutive months of structured*, physician supervised conservative medical management, including ALL of the following components:
  1. Exercise, including core stabilization exercises
  2. Nonsteroidal and/or steroidal medication (unless contraindicated) 
  3. Physical therapy, including passive and active treatment modalities
  4. Activity/lifestyle modification
  5. Participation in 3 or more individual or group cognitive behavioral therapy (CBT) sessions provided by a licensed healthcare professional (e.g., physical therapist, [PT], occupational therapist [OT], psychiatrist, psychologist, social worker, psychiatric nurse, other licensed professional) with competence in principles and practice of CBT and providing individualized treatment that includes ALL of the following elements:
     • Disease education
     • Activity and lifestyle modification
     • Stress management (stress management typically also includes strategies to deal with emotions such as fear, anxiety, sadness that can interfere with pain management)
• Imaging studies confirm Modic Type I changes on MRI report (i.e., hypointense T1 and hyperintense T2 in the vertebral endplates) at a maximum of three vertebrae between L3 and S1) or Type I and Type II changes on MRI (hyperintense T1 and hyperintense T2 in the vertebral endplates) at a maximum of three vertebrae between L3 and S1)
• Statement from a primary care physician, neurologist, physiatrist, psychiatrist, psychologist, or other licensed behavioral and/or medical health care provider not involved with the recommended plan of treatment attesting to the absence of untreated, underlying mental health conditions/issues (e.g., depression, drug, alcohol abuse) as a major contributor to chronic back pain

*Note: Structured medical management consists of medical care that is delivered through regularly scheduled appointments, including follow-up evaluation, with licensed healthcare professionals.

Intraosseous radiofrequency nerve ablation of the basivertebral nerve (i.e., INTRACEPT^® Intraosseous Nerve Ablation System) is considered NOT MEDICALLY NECESSARY for any other indication, including the following: 

• Metabolic bone disease (e.g., osteoporosis), treatment of spine fragility fracture, trauma/compression fracture or spinal cancer
• Spine infection or active systemic infection
• Neurogenic claudication, lumbar radiculopathy or radicular pain due to neurocompression (e.g., HNP, spinal stenosis), as primary symptoms
• Spondylolistheses > 2mm
• Disc protrusion > 5 mm
• Individuals with severe cardiac or pulmonary compromise
• Individuals with implantable pulse generators (e.g., pacemakers, defibrillators) or other electronic implants unless specific precautions are taken to maintain patient safety
• Treatment of other than L3-S1 vertebrae
• Treatment of more than three adjacent vertebral bodies (i.e., between L3-S1)
• Repeat treatment at the same level 

Rationale
Intraosseous Radiofrequency Nerve Ablation: Percutaneous radiofrequency ablation of intraosseous nerves is a technology intended for treatment of chronic low back pain. Intraosseous nerves are reportedly found within the vertebrae, are referred to as basivertebral nerves and are present in the basivertebral foramen. Authors contend the nerves may be a source of intraosseous back pain and that interruption of the nerve pathway using radiofrequency to ablate the nerve will relieve the associated pain. It has been purported that the basivertebral nerve transmits pain signals from the vertebral body to the central nervous system. One device under investigation, The Intracept^® System (Relievant MedSystems Inc., Redwood City, CA) received FDA approval for use as a minimally invasive radiofrequency system for treatment of chronic lumbar back pain at one or more levels (i.e., L3 to S1), when back pain is present despite at least six months of conservative care and is accompanied by either Type I or Type 2 Modic changes on 
MRI (FDA K153272). 

Modic changes are vertebral bone marrow signal intensity changes that are seen on magnetic resonance imaging (MRI). It is commonly seen in association with degenerative disc disease. Modic I changes represent bone marrow edema and inflammation, Modic II changes represent fatty marrow replacement, and Modic III represents subchondral bone sclerosis. Type I changes have been more strongly associated with back pain than Type II changes. It is unclear if the presence of Modic changes alone is an indication for treatment in subjects with back pain (Viswanathan, et al., 2020), with aging changes are often an asymptomatic finding. 

Evidence in the peer-reviewed scientific literature evaluating intraoeesous basivertebral nerve (BVN) ablation consists of two main RCTs (one comparing Intracept to sham treatment, [Fischgrund, et al., 2019] one comparing Intracept to conservative treatment [Khalil et al., 2019]), and retrospective and prospective case series and systematic reviews. 

In 2022, Conger et al. published an updated systematic review with single arm meta-analysis evaluating intraosseous BVN ablation. The authors included 12 total articles in the updated review (one RCT compared with sham [1, 2, and 5 year outcomes], one RCT compared with standard care, [3, 6, 12, and 24 months outcomes] and four single cohort studies with outcomes reported between three and 12 months. They calculated the aggregate rates of treatment success defined by clinically important pain and functional improvement observed in the trials. There were no changes to the review methodology, however a ≥ 15 point ODI threshold was used to avoid redundancy; according to the authors the value is considered a robust threshold and exceeds the known minimally clinically important difference for chronic pain. The primary outcome measure was the proportion of individuals with >50% pain reduction. Secondary outcome measures included ≥ 15 point improvement in function using ODI index as well as ≥ 2 point reduction in pain score using the VAS or NRS. The total number of participants in all studies receiving BVN ablation treatment were 414. Most patients reported pain for greater than five years although in one study 74% reported a duration of pain for one to two years. For ≥ 50% pain reduction at six and 12 month the calculated success rates were 65% and 64%, respectively. Rates of ≥ 15 point ODI improvement were 75% and 75% , respectively. Meta-analysis based on intention to treat and worst case scenario demonstrated slightly lower success rates for pain and functional improvement: at six, 12, 24 and 60 months in the RCT 61%, 59%, 49% and 50% of subjects reported ≥ 50% pain improvement. ODI of ≥ 15 point improvement at the same time points were 71%, 70%, 57%, and 57%. The authors concluded that according to GRADE there is moderate 
quality evidence to support safety and effectiveness of BVN ablation, to reduce pain and disability, in most individuals with vertebrogenic back pain. 

Urits and colleagues published a systematic review in 2021 evaluating vertebrogenic back pain and use of basivertebral nerve ablation as treatment. This group of authors concluded while the pathophysiology of low back pain may be vertebrogenic rather than discogenic, and that some evidence suggests ablation may be more beneficial compared with standard of care, additional large clinical trials are needed for clinicians to gain full confidence in this treatment modality (Urits et al, 2021).

Conger et al. (2021) published the results of a systematic review evaluating the effectiveness of intraosseous basivertebral radiofrequency for the treatment of chronic low back pain in subjects with Modic type I or II changes. The primary outcome measure was the proportion of individuals with > 50% pain reduction. Secondary outcome measures included ≥ 10 point improvement in function using ODI index as well as ≥ 2 point reduction in pain score using the VAS or NRS, and decreased use of pain medications. The review included seven publications (four studies in total, [RCTs, non RCTS, and single group observational studies]) involving 321 subjects. Comparators included sham, placebo procedure, active standard care or none. Due to the paucity of studies a meta-analysis was not performed. The reported three month success rates ranged from 45% to 63%, and rates of functional improvement ranged from 75% to 93%. When compared to sham treatment the risk of treatment success, defined by ≥ 50% pain reduction and ≥ 10 point reduction ODI, was 1.25 and 1.38 respectively. When compared to standard treatment the relative risk of treatment success defined using the same parameters was 4.16 and 2.32 respectively. Adverse events were rare and included leg pain, lumbar radiculopathy or nerve root injury (n = 6), incisional or buttock pain (n = 3), urinary retention (n = 1), transient motor or sensory deficit (n = 8), one case of retroperitoneal hemorrhage, and one case of vertebral compression fracture. The authors concluded that the effectiveness of radiofrequency of the basivertebral nerve for chronic low back pain is supported by moderate quality evidence for reducing pain and disability in carefully selected individuals compared to standard care or sham. It was however noted the differences between sham and treatment were small by some measures of success or absent when including data from participants who experienced targeting failure. Additional high quality, non-industry sponsored studies are needed to confirm these findings. 

DeVivo et al. (2021) published the results of a prospective uncontrolled trial involving 56 subjects who underwent radiofrequency ablation of the basivertebral nerve for chronic vertebrogenic low back pain. The primary aim was to assess pain and reduction in disability, secondary outcomes included feasibility and safety using a CT-guided technique. A one month follow-up MRI was performed to evaluate the area of ablation for target success and a three month follow-up CT study was performed to evaluate bone mineral density related to structural abnormalities resulting from the treatment. Pre and post procedure pain and disability scores were obtained using VAS and ODI with a 2 cm improvement threshold in VAS and 10 point improvement threshold in ODI used to define clinical success. Outcomes demonstrated that at three and 12 months follow-up both VAS and ODI scores decreased significantly when compared to baseline scores. A total of 54 subjects had clinical success (96.5%) for pain as well as disability and 100% of subjects had successful CT- assisted targeting of the ablation zone. Limitations of the study include small sample population and short-term follow-up. 

Fischgrund et al. (2020) published the five year results from the treatment arm of their multicenter, prospective RCT evaluating intraosseous basivertebral nerve ablation for chronic low back pain. (SMART Trial). Patient reported outcomes of ODI, VAS, post ablation treatments, and patient satisfaction were reported, mean change in ODI was the primary outcome. This study includes the outcomes of 117/133 subjects within the United States centers, 117 subjects were adjudicated as successful for targeting. Subjects in the global population from the original trial were not included. A total of 100 subjects were available for final follow-up, 3 subjects were deceased, 3 withdrew, 1 refused participation, and 10 were lost to follow-up. Long term results for ODI, VAS improvement and responder rates were statistically significant post treatment; ODI was reduced on average by 25.95 ± 18.54 (p < 0.001), VAS was 4.38 ± 2.35 (p < 0.001), and responder rate using a 15 point improvement in ODI for a successful response was 77% at 5 years following ablation (p < 0.001). Using a two point improvement in VAS for a successful response 88% reported a successful response (p <  0.001). Improvement in function and pain level seen at one and two year post treatment were sustained at five years and beyond. The authors also reported a 73% reduction in opioid use from baseline at five years, a 55% reduction in subjects who received an injection in the prior 12 months when compared to baseline, and that there were no patient reported complications. In addition to limitations of the initial trial (e.g., large placebo effect) limitations of this continued trial includes loss of the control group from the initial trial, lack of outcomes from the global population, and industry funding.

Fischgrund and colleagues published the results of three and twelve month outcomes from a RCT comparing Intracept (n = 147) with sham treatment (n = 78), as part of the FDA IDE trial (SMART Trial). Inclusion criteria consisted of chronic low back pain for at least six months, nonresponsive to at least six months of conservative treatment, and Modic type I or 2 changes at the vertebral endplate of the level targeted for treatment. Outcomes were measured at 2 and 6 weeks, and at 3, 6, 12, 18 and 24 months postoperative. At 12 months subjects randomized to the sham group were able to crossover to the treatment group. The authors noted due to a high crossover rate (57/78 subjects in the sham group crossed over at 12 months) the subjects treated with RF ablation acted as their own control for 24 month outcomes. ODI scores at three months demonstrated the treatment group had a 20.5 least squares mean improvement vs. 15.2 in the sham group. Using a 10 point improvement in ODI to define “clinically meaningful improvement” in the treatment group 75.6% were successful at 3 mos. and at 24 mos. 76.4% (81/106 subjects) were successful. The authors noted due to a high crossover rate the subjects treated with RF ablation acted as their own control for 24 month outcomes. The authors acknowledged a 17% per protocol patient fallout by month 24 (n = 106). The results of these subjects at 24 months were compared to the overall treated population at baseline (n = 128) and at 12 months to avoid unintentional bias. Clinical improvements in ODI, VAS, and the Medical Outcomes Trust Short Form Health Survey were statistically significant at all time points during the two years. The mean percent improvements in ODI and VAS compared to baseline at two years were 53.7 and 52.9%, respectively. In the authors’ opinion, RF ablation of the basivertebral nerve exhibited sustained clinical benefit in ODI and VAS scores for treatment of chronic low back pain. Limitations of the trial include short term outcomes and a large placebo response to sham treatment. (Fischgrund, et al., 2018; Fischgrund, et al., 2019) 

Khalil et al. (2019) published the results of a RCT comparing basivertebral nerve ablation to standard care for treatment of chronic low back pain. Inclusion criteria consisted of individuals with chronic pain, isolated to the back for at least 6 months, failure of 6 months of non-operative care, Type I or II Modic changes, and minimum ODI and VAS score of 30 and 4 cm, respectively. Primary outcome measures included ODI at baseline, 3, 6, 9, and 12-months post procedure. A 10 point VAS for low back pain, ODI and VAS responder rates, SF-36, and EQ-5D-5L were used as secondary outcome measures. The primary endpoint was a between-arm comparison of the mean change in ODI from baseline to 3 months post-treatment. An interim analysis to determine superiority was conducted when at least 60% of the patients had completed the 3 month primary 
endpoint visit. Treatment of up to four vertebrae in nonconsecutive levels from L3 to S1 was allowed using the Intracept System; standard care treatment included but was not limited to acupuncture, chiropractic treatment, physical therapy exercise, and spinal injections. The authors reported that at the interim analysis at 3 months showed statistical superiority for all primary and secondary patient reported outcomes in the treatment group (n = 51) compared with the standard care group (n = 53). As a result, the study enrollment was halted and an early crossover was allowed to the control arm. Twenty-two total adverse events were reported; 15 were reported in 13 of the subjects treated with ablation, seven were procedure related and resulted in back pain of a new location, and either leg pain or paresthesia. Limitations of the study included non-structured 
standard care among subjects, short term outcomes, and as noted by the authors inability to generalize results due to the strict clinical criteria for chronic low back pain. In 2021 Smuck et al. published results of the subjects who initially received standard care but were able to receive basivertebral nerve ablation following halting of the randomization (n = 66, 61 which underwent treatment as five declined). A total of 93% of these subjects had successful targeted treatment, the authors reported six month results were statistically significant and clinically meaningful when using VAS and ODI and furthermore that 65% received 50% reduction in VAS, 36.2% received >75% reduction, and 22.4% had 100% reduction. Twelve month outcomes for the initial treatment arm were also reported within this study and continued to demonstrate VAS and ODI improvements; 64% received 50% reduction, and 29% were pain free (Smock, et al., 2021). Koreckij et al. (2021) reported the 24 month outcomes of the treatment arm (n = 58/66). The authors reported that at two years results were statistically significant for improvement in ODI, VAS, SF-36 PCS, and EQ-5D-5L measures. 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 31.0% were pain-free at 2 years. At 24 months, only 3 (5%) of patients had BVNA-level steroid injections, and 62% fewer patients were actively taking opioids. There were no serious device or device-procedure related adverse events reported through 24 months. Limitations of the studies have been noted above.

Further evidence in the form of a post hoc analysis of the Fischgrund trial noted above (Markman, et al, 2019), and observational case series (Becker, et al., 2017; Kim, et al., 2018; Truumees et al., 2019, Macadaeg, et al., 2020) have been published and tend to support reduction of opioid use and improvement in pain and function in the short-term. 

Professional Societies/Organizations: Professional society recommendations lend support to intraosseous basivertebral nerve ablation as a treatment for a subset of individuals with chronic low back pain (North American Spine Society, [NASS], 2023; International Society for the Advancement of Spine Surgery [ISASS, 2022]; American Society of Pain and Neuroscience [ASPN], 2022). 

In 2023 the North American Spine Society published coverage recommendations for Basivertebral Nerve Ablation (NASS, 2023). Within this document NASS reported that “percutaneous interosseous approach has emerged as a possible interventional therapy for this condition. Current BVN ablation evidence demonstrates consistent short- to intermediate-term improvements in function and pain. In addition to two prospective single-arm studies reporting clinically significant improvements in ODI and VAS from baseline, two Level 1 RCTs have demonstrated superiority over standard care at 3 months and 12 months, and over sham control at 12 months.

According to the recommendations BVN ablation is indicated for the following: 

• Patients are skeletally mature and have CLBP for at least 6 months, and lower back pain is their main symptom
• Patients have failed to adequately improve despite attempts at nonsurgical management
• Patients have 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 (Type 1) involving in the endplates between L3 and S1. 

In 2020 the International Society for the Advancement of Spine Surgery published a guideline “Intraosseous ablation of the basivertebral nerve for relief of chronic low back pain” (Lorio et al., 2020, updated 2022) . Evidence reviewed by the authors included a multicenter, prospective, parallel RCT (Intracept Study), and the FDA IDE trial (SMART Trial, [12 and 24 month outcomes]), seven single arm observational studies, and a prospective single arm study. ISASS concluded the technology is supported as a treatment option for a well-defined subset of patients with chronic low back pain. The procedure is supported by level I evidence demonstrating a statistically significant decrease in pain and improvement in function with outcomes sustained > 5 years after a single treatment. based on their findings, patient selection criteria defined by ISASS include individuals with all of the following: 

• Chronic low back pain for at least 6 months duration
• Failure to respond to at least 6 months of nonsurgical management 
• Magnetic resonance imaging (MRI) demonstrated Modic 1 changes (MC1) or Modic 2 changes (MC2) in at least 1 vertebral endplate at 1 or more levels from L3 to S1  (*Endplate changes, inflammation, edema, disruption, and/or fissuring).
• Fibrovascular bone marrow changes (hypointense signal for Modic type 1)
• Fatty bone marrow changes (hyperintense signal for Modic type 2).

Additional clinical trials evaluating the Intracept system are currently underway (ClinicalTrials.gov database). However, in addition to increasing support from professional societies there is some evidence that lends support for a subset of individuals with chronic low back pain, in both industry sponsored studies and non- industry sponsored studies, that BVN ablation may be effective for reducing pain and disability, and for reducing opioid use, with no patient reported complications.

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Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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