**Coverage Indications, Contraindications, Medical Necessity, Non-Coverage and
Limitations**

**Covered Indications**

Thermal ablation of the intraosseous Basivertebral Nerve (BVN) is considered
medically reasonable and necessary for the treatment of Chronic Low Back Pain
(CLBP) in patient who meet ALL the following criteria for coverage and
reimbursement.

  * Individual is skeletally mature and has had CLBP for at least 6 months, with lower back pain as the dominant symptom.
  * Has failed to adequately improve despite documented non-surgical management, to include at least 3 or more of the following modalities: 
    * Avoidance of activities that aggravate pain.
    * Course of physical therapy or professionally directed therapeutic exercise program.
    * Chiropractic manipulation
    * Cognitive therapy
    * Pharmacotherapy, including narcotic and non-narcotic analgesics, muscle relaxants, neuroleptics, and anti-inflammatories.
    * Injection therapy of epidural or facet joint implicated pain sources in the region of concern
  * Type 1 or Type 2 Modic changes on MRI: Endplate hypointensity (Type 1) or hyperintensity (Type 2) on T1 images plus hyperintensity on T2 images (Type1) involving the endplates between L3 and S1
  * Absence of additional vertebral pathology by physical, history, radiologic or clinical assessment including, but not limited to, fracture, tumor, infection, deformity, trauma, or post-surgical change which could cause the patient's symptoms or complicate the procedure and outcome. 
  * Physical and psychological assessment of patient's ability to tolerate and benefit from BVN ablation. 

**Contraindications to BVN Ablation, Medical Necessity and Non-Coverage**

The following conditions are considered relative contraindications to BVN
ablation as suboptimal outcome and adverse exacerbation of symptoms may occur,
precluding expected benefit from the procedure. Documentation in the patient's
medical record must explain the precautionary provisions taken for the
individual patient to preclude anticipated or potential adverse events
secondary to treatment. In the absence of documentation to support the
procedure in individuals with the following concomitant conditions, medical
necessity cannot be established. These conditions represent contraindication
to treatment and render the service not medically appropriate, reasonable and
necessary, or eligible for Medicare Coverage and Reimbursement.  

  * Skeletal immaturity (<18 years of age)
  * Evidence on imaging (MRI, flexion/extension radiographs, CT) of another etiology for LBP symptoms, including, but not limited to, lumbar spinal stenosis, spondylolisthesis, segmental instability, disc herniation, degenerative scoliosis, facet arthropathy or effusion with clinically suspected facet joint pain.
  * Metabolic bone disease (e.g., osteoporosis with T score _<_ -2.5), treatment of spine fragility fracture, trauma/compression fracture, or spinal primary or metastatic tumor.
  * Active Spine or Systemic Infection
  * Neurogenic claudication, lumbar radiculopathy, radicular pain, nerve impingement or compression (e.g., NHP, stenosis), as primary symptoms.
  * Patients with severe cardiac or pulmonary compromise, systemic vulnerability to bleeding, or concern for further compromise of existing disease.
  * Patients with implantable pulse generators (e.g., pacemakers, defibrillators, or neurostimulator) and other electronic implants, unless type specific precautions are taken to maintain patient safety.
  * Ongoing use or abuse of addictive medications without evidence of potential weaning or decreased use with treatment. 

**Limitations**

**Basivertebral Nerve Ablation is limited to the following;**

  * No previous history of BVN ablation at the planned level of treatement.
  * No more than one to two (1-2) vertebral bodies may be treated at a single session.
  * Treatment of no more than 4 vertebral bodies per patient lifetime.
  * Treatment is within the confines of L3-S1 vertebral bodies.
  * Retreatment of a single vertebral body with BVN ablation within the patient's lifetime.is not considered reasonable and necessary.
  * Local anesthesia is considered appropriate for the region treated. Mild sedation may be administered by the performing physician or staff under his direction but should not be coded separately. Additional anesthesia services may not be billed separately without documentation of medical necessity.

**Definitions**

**Chronic Pain/Chronic Low Back Pain** : Pain lasting longer than six months
in the same location, seemingly resistant to conservative measures.

**Conservative Measures/ Non-surgical Management** : Any single or combination
use of medication, physical therapeutic regimens, psychological or cognitive
therapy designed by a qualified health care provider to affect relief of a
disability or disease, based on a patient's needs and physical findings.
Incidental encounters are not considered therapeutic unless prescribed and
monitored for defined purpose, time, and frequency by a qualified
practitioner.

**Functional impairment** : A physical, functional or physiologic impairment
causing deviation from the normal function of a tissue, organ or body member,
resulting in a significant limitation or impairment of the capacity to move,
coordinate actions or perform physical activities, demonstrated by difficulty
performing physical and motor tasks, independent movement or basic life
functions.

**Modic Changes:** (Magnetic Resonance Imaging): MRI features consistent with
Type 1 or Type 2 Modic changes such as inflammation, edema, vertebral endplate
changes, disruption and fissuring of the endplate, vascularized fibrous
tissues within the adjacent marrow, hypointensive signals (Type 1 Modic
change), and changes to the vertebral body marrow including replacement of
normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

**Radicular pain or radiculopathy** : pain radiating or identified in the path
and distribution or dermatomal pattern of a named spinal nerve. Pain that is
localized and does not travel in the distribution of an identified spinal
nerve and remains axial in location is considered to have a non-radicular
pattern.

**Spinal stenosis:** Narrowing of the central spinal canal and /or the
foraminal openings through which nerve or neural tissue are located, causing
compression and irritation of the involved neural structures. A wide range of
symptoms may be present, contributing to back and extremity pain and
dysfunction.

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

Khalil, et al. (2019), conducted a multicentered RCT that compared the
effectiveness of intraosseous radiofrequency (RF) ablation of the BVN to
standard care for the treatment of cLBP in a specific subgroup of patients
suspected to have vertebrogenic-related symptomatology.8 A total of 140
patients (mean age 50 years) with cLBP of at least 6 months duration, with
Modic Type 1 or 2 vertebral endplate changes between L3 and S1, were
randomized to undergo either RF ablation of the BVN or continue standard care.
Oswestry disability index scores (ODI) were collected at baseline, 3, 6, 9 and
12-months post-procedure. Secondary outcome measures included the visual
analog scale (VAS) for pain intensity and responder rates, and quality of life
measures (SF-36 and EQ-5D-5L). The primary endpoint was a between-arm
comparison of the mean change in ODI from baseline to 3 months post-treatment.
At 3 months follow-up, the minimally invasive RF ablation group demonstrated
clinically significant improvement of pain and function compared to the
standard care group. Treatment success was significantly greater in the RF
group (74.5%) compared with patients in the standard care arm (32.7%)
[p<.001].

Health-related quality of life outcomes showed a statistically significant
difference favoring the RF group. The study was stopped for benefit at 3
months, which followed an interim analysis showing superiority of the
intervention arm. This resulted in a high rate of cross-over. Study
limitations include the use of a nonstructured standard care control, open
label design, and short-term results. In addition, industry funding was a
potential source of study bias.

Fischgrund, et al. (2018) conducted a prospective randomized double-blind
sham-controlled clinical trial that evaluated the safety and efficacy of
radiofrequency (RF) ablation of the BVN for treatment of cLBP.3 The trial
involved 225 patients with a mean age of 47 years who were diagnosed with
cLBP. Participants were randomized to either a sham (78) or treatment
intervention (147). Treatment arm patients underwent thermal ablation at the
terminus of the BVN using the Intracept System. Skeletally mature patients
with chronic ( 6 months), isolated lumbar pain, who had not responded to at
least 6 months of non-operative management and had Type 1 or Type 2 Modic
changes at 3 or less contiguous levels at L3-S1 on MRI were included in the
study. Furthermore, patients were required to have a minimum ODI of 30 points
(100-point scale) and a minimum VAS of 4cm (10cm scale). Mean baseline ODI was
42 and mean baseline VAS was 6.7cm. Stringent exclusion criteria were applied,
which included: radicular pain, previous lumbar spine surgery, symptomatic
spinal stenosis, diagnosed osteoporosis (T<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. Patients were
evaluated at baseline, and at 2 weeks, 6 weeks, and 3, 6, and 12 months post
procedure. The primary endpoint was the comparative change in ODI at 3 months.
Results showed the mean between group difference was 5.3 points favoring the
intervention group. This difference was not clinically significant; however,
the responder analysis, based on ODI decrease  10 points, showed that 75.6%
of patients in the treatment arm as compared to 55.3% in the sham control arm
exhibited a clinically meaningful improvement at 3 months.

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

In 2020, Fischgrund, et al. reported the 5-year outcomes for 100 patients
treated with BVN ablation for vertebrogenic cLBP in the SMART randomized
control trial (RCT).5 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.

A prospective, single-arm study performed by Truumees, et al. (2019), observed
the effects of intraosseous RF ablation of the BVN for the treatment of
vertebrogenic-related cLBP.19 Patients with cLBP of at least 6 months duration
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 four vertebral bodies. Ninety-
three percent (93%) of patients achieved a 10-point improvement in ODI, and
75% reported 20-point improvement. They concluded that minimally invasive RF
ablation of the BVN results in a significant improvement in pain and function
in this population of real-world patients with chronic vertebrogenic-related
LBP.

Markman, et al. (2020) evaluated the hypothesis that cLBP patients reporting
reduced opioid use have superior functional outcomes following BVN
radiofrequency ablation.14 Data were obtained from 225 patients enrolled in a
2:1, randomized, sham-controlled, double-blind trial examining the effects of
BVN ablation on cLBP. Patients who demonstrated Modic Type 1 or 2 vertebral
endplate changes in one or more L3 to S1 segments and were nonresponsive to a
minimum of 6 months of nonsurgical treatment were included in the study. The
authors concluded that subjects undergoing BVN ablation reported lower opioid
use and had greater improvement in ODI and VAS scores. This post hoc analysis
has several limitations including the small subgroup sample size (N=77), the
self-reported use of opioids (potential for recall bias), and the exclusion of
patients receiving long-acting opioid therapy (potential selection bias).

Macadaeg, et al. (2020) conducted a prospective, single arm trial including 48
patients with more than 6 months of cLBP and Type 1 or 2 Modic changes on
MRI.13 Patients were followed post-procedure for 12 months using ODI, VAS,
EQ-5D-5L and SF-36 patient-reported outcome metrics. 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 more than 69% reported a 50%
reduction in VAS pain scale. Similarly, SF-36 and EQ-5D-5L scores improved
26.27+/-17.19 and 0.22+/-0.15 (each p < 0.001). Limitations include the
observational, open label design, relatively small sample size, uncertainty
about generalizability, and the risk of bias associated with industry
sponsorship.

Transforaminal epiduroscopic basivertebral nerve laser ablation was studied by
Kim, et al, (2018) who presented a cohort of 14 patients with cLBP greater
than 6 months which was unresponsive to at least 4 months of conservative
care.9 This cohort included patients with MRI findings of Modic Type 1 or 2
changes and positive confirmatory provocation discography to determine the
affected levels. The results of this preliminary, single-arm case series were
promising, yet the role of the transforaminal epiduroscopic ablation remains
to be further investigated.

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 Pain 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."11 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.17 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.

Providence Health Plan submitted a review of peer-reviewed, published clinical
evidence suggesting evidence is insufficient to support the clinical utility
of basivertebral nerve (BVN) ablation (Intracept procedure) for the treatment
of low back pain. One double-blind, randomized controlled trial (RCT) reported
that both Intracept and a control sham procedure reduced pain and improved
patient functional status at 1-year follow-up; however, this improvement was
not clinically significant. Additional studies (1 RCT and 3 case series)
concluded that Intracept is more effective than conservative treatment for
resolving LBP; however, these studies report too few events and are at too
high a risk of bias to be conclusive. Concern was expressed for device
manufacturer conflict of interest in publication and financial support of
several referenced studies. Support was expressed for NASS guidelines but
noted blinded RCTs with long-term follow-up are needed to validate results
reported to date and determine the clinical utility of Intracept BVN ablation
relative to current gold standard treatments for low back pain.
Recommendations were for allowance of no more than one level treatment per
session with exclusion of concomitant combination with any other paravertebral
injection or intervention.

The North American Spine Society (NASS)16 position statement defines
appropriate coverage of BVN ablation. BVN is indicated when:

  * 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 hypo-intensity (Type 1) or hyperintensity (Type 2) on T1 images plus hyperintensity on T2 images (Type 1) involving in the endplates between L3 and S1.

BVN ablation is NOT indicated in ANY of the following scenarios:

  * Evidence on imaging (MRI, flexion/extension radiographs, etc.) suggests another obvious etiology for the patient's LBP symptoms, including but not limited to lumbar stenosis, spondylolisthesis, segmental instability, disc herniation, degenerative scoliosis or facet arthropathy or effusion with clinically suspected facet joint pain.
  * 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 neuro-compression (e.g., HNP, stenosis), as primary symptoms.
  * Patients with severe cardiac or pulmonary compromise.
  * Patients with implantable pulse generators (e.g., pacemakers, defibrillators) or other electronic implants unless specific precautions are taken to maintain patient safety.

Chronic low back pain (cLBP) is a major contributor to patient disability and
affects a significant portion of Medicare Beneficiaries. Persistent lower back
pain lasting longer than 12 weeks is considered Chronic Low Back Pain (cLBP)
and is frequently attributed to disease of the intervertebral discs,
suggesting sensitized nociceptors in the annulus fibrosus of degenerating
discs, etiologic for discomfort or pain. Arthritic processes in and around the
spinal vertebral bodies have been implicated for localized tenderness as well
as radicular pain due to compression or irritation of adjacent nerve roots or
their branches. However, elevation of intraosseous pressure has also been
implicated in the development and persistence of low back pain, while little
evidence suggests an etiology for symptoms above the mid lumbar level. A
degenerative process in the spine resulting in an intraosseous source of pain
is plausible, given the observations made using peri-endplate magnetic
resonance imaging (MRI) signal changes, demonstrating intraosseous edema,
inflammation, or ischemic injury, and correlating with the region or site of
clinical low back pain. Damage to the innervated vertebral endplates can
reasonably result in vertebrogenic back pain (VBP) transmitted through
branches of the basivertebral nerve (BVN), entering the posterior vertebral
body and branching to superior and inferior endplates. Inflammation and edema
noted at these sites have been implicated as the source of pain reflected by
the enervating BVN. Radiofrequency ablation of the BVN via a percutaneous
intraosseous approach has emerged as a possible interventional therapy for
this condition. Current evidence suggests BVN ablation offers short- to
intermediate-term improvements in function and pain. Prospective single-arm
studies have reported clinically significant improvements in Oswestry
Disability Index (ODI) and Visual Analog Scale (VAS) from baseline, while
Level 1 randomized controlled trials (RCTs) have demonstrated superiority over
standard care at 3 months and 12 months and over sham control at 12 months.

Diagnosis of vertebrogenic pain transmitted by the Basivertebral Nerve (BVN)
is made by demonstration of Magnetic Resonance Imaging signal changes, either
Modic 1 or Modic 2, in the affected vertebral body marrow, signifying
inflammation, edema or ischemia, corresponding to the region of patient
reported pain.

Thermal destruction or ablation of the of the intraosseous Basivertebral Nerve
(BVN) is a therapeutic surgical procedure projected to treat cLBP of a
vertebrogenic origin only. The procedure uses fluoroscopic imaging to guide a
thermal probe to the region of enervation in the vertebral body.
Radiofrequency (RF) energy is applied to selectively destroy the BVN within
the vertebral body. Concomitant paraspinal or paravertebral procedures or
injections are excluded from coverage at the same session and same spinal
region.