**Coverage Guidance**

Compliance with the provisions in this policy may be monitored and addressed
through post payment data analysis and subsequent medical review audits.

Low back pain (LBP) is the most expensive occupational disorder in the United
States and the leading cause of disability worldwide.1 Chronic low back pain
(cLBP) is defined as persistent pain in the lumbar region lasting for >12
weeks. cLBP has many different etiologies. Research shows evidence that one
etiology is associated with degeneration of the vertebral body or vertebral
body endplates, resulting in inflammation. The inflammatory response is
perceived by the basivertebral nerve (BVN), a sensory nerve that enters the
posterior vertebral body and branches out to the superior and inferior
endplates. The pain signals are then transmitted to the central nervous
system, causing what is known as vertebrogenic pain.2

Clinically, vertebrogenic pain is generally described as a midline, deep,
aching, burning pain that is progressive. Also, it is often associated with an
intermittent electrical shock sensation. Vertebrogenic pain is also
characterized by absence of radicular expression, lower extremity weakness, or
sensory deficits, and the neural tension sign and pain is generally worse with
spinal flexion, sitting, standing and general physical activity, when compared
to extension.3,4

Diagnosis of vertebrogenic cLBP focuses on the chronic inflammatory response
caused by endplate damage, which is visible on MRI.5 These signal changes,
known as Modic changes (MC), are found in the vertebral body bone marrow that
is adjacent to the degenerative endplates. Modic 1 changes indicate
inflammation and edema, and Modic 2 changes occur in the setting of marrow
ischemia when the red hematopoietic bone marrow has converted into yellow
fatty marrow.6,7,8

Thermal destruction (i.e., ablation) of the intraosseous BVN
([Intracept](https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190504.pdf)
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.

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 25.718.5-point reduction in mean ODI (p<0.001), and a 3.82.7
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 25.915.5 point mean ODI reduction (p<0.001) from
baseline. The proportion of opioid use did not change in either group
(p=0.56). Seventy-four per cent (74%) of BVN ablation arm patients reported
improvement of their condition at 12 months; 75% indicating treatment success.
Similar satisfaction (78% improvement, 72% success) was reported 6 months post
BVN ablation for participants who formerly underwent standard care. No serious
device-related adverse events were reported.

Twenty-four (24) month treatment arm results for the INTRACEPT Trial were
published by Koreckij, et al (2021).11 Baseline characteristics for the 58 BVN
ablation patients completing a 24-month visit showed that 67% had back pain
for _> _5 years, 36% were taking opioids at baseline, 50% had prior epidural
steroid injections, and 12% had prior low back surgery. At 24 months, ODI and
VAS improved 28.5  16.2 points (from baseline 44.5; p _< _0.001) and 4.1 
2.7 cm (from baseline 6.6; p _< _0.001), respectively. A combined responder
rate of ODI  15 and VAS  2 was 73.7%. A  50% reduction in pain was reported
in 72.4% of patients and 31% reported being pain-free at 2 years. At 24
months, 62% fewer patients were actively taking opioids. No serious device or
device-procedure related adverse events were reported by the authors through
24 months.

A prospective, single-arm, open-label study to evaluate the effectiveness of
intraosseous BVN RF ablation for the treatment of vertebrogenic-related cLBP
in a typical spine practice setting was conducted by Truumees, et al.
(2019).12 The authors sought to employ more permissive criteria for study
inclusion than that used in the SMART Trial1,2,9, such as patients who had
prior discectomy and those who took extended-release narcotics. Consecutive
patients with cLBP of at least 6 months duration, at least 6 months of
conservative care, and with Modic Type 1 or 2 vertebral endplate changes
between L3 and S1 were treated with RF ablation of the BVN in up to 4
vertebral bodies. The primary endpoint was patient-reported change in ODI from
baseline to 3 months post-BVN ablation. Secondary outcome measures included
change in VAS, SF-36, EQ-5D-5L, and responder rates.

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

Macadaeg, et al. (2020) reported the 12-month results for all patients
enrolled and treated with BVN ablation the clinical trial first reported by
Truumees, et al.13 Forty-eight (48) patients from community spine and pain
practices were treated with BVN ablation. Patients were followed post
procedure for 12 months using ODI, VAS, EQ-5D-5L, and SF-36 patient reported
outcome metrics. Results showed that 47 patients successfully received BVN
ablation, and 45 patients completed 12 months of follow up. Mean reduction in
ODI at 12 months was 32.31  14.07 (p _<_ 0.001) with 88.89% (40/45) patients
reporting a  15-point ODI decrease at 12 months. Mean VAS pain score decrease
was 4.31  2.51 at 12 months (p _<_ 0.001) and >69% reported a 50% reduction
in VAS pain scale. SF-36 and EQ-5D-5L scores improved 26.27  17.19 and 0.22 
0.15, respectively (each p _< _0.001). The authors concluded that this data
supports the clinical effectiveness of BVN ablation in the community practice
setting.

A systematic review of the published literature on the efficacy,
effectiveness, and complications associated with BVN ablation for the
treatment of cLBP was published by Conger, et al. (2021).14 Evidence was
evaluated using the Grades of Recommendation, Assessment, Development and
Evaluation (GRADE) system of appraisal to determine the quality of the
evidence of the effectiveness of intraosseous BVN radiofrequency neurotomy
(RFN). According to GRADE, there is moderate-quality evidence that BVN RFN is
both an effective treatment compared to sham procedure and superior to
continued standard care management for reduction of pain and disability in
stringently selected patients with cLBP and corresponding Modic type 1 and 2
changes at a minimum of 3 months.

Additional reviews3,4,15 are supportive of BVN ablation as an effective
treatment and more beneficial than current standard of care for a subset of
patients with cLBP based on moderate-quality evidence.

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

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

cLBP is a significant clinical problem and a socioeconomic burden that affects
approximately 30 million people in the United States. Basic
science17,18,19,20,21 and clinical trials1,2,5,9,10,11,12,13 have validated
the diagnosis of vertebrogenic pain. The associations of Modic changes (MC)
types 1 and 2 with cLBP and vertebral body endplate (VEP) injury have also
been established.6,7,8,22

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

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