PROPOSED Local Coverage Determination (LCD)

Intraosseous Basivertebral Nerve Ablation

DL39642

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

Proposed LCD Information

Document Information

Source LCD ID
L39642
Proposed LCD ID
DL39642
Original ICD-9 LCD ID
Not Applicable
Proposed LCD Title
Intraosseous Basivertebral Nerve Ablation
Proposed LCD in Comment Period
Source Proposed LCD
Original Effective Date
N/A
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
ANTICIPATED 11/09/2024
Notice Period Start Date
N/A
Notice Period End Date
N/A
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Issue

Issue Description

This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity.

Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Section 1862(a)(1)(A) of Title XVIII of the Social Security Act excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) of Title XVIII of the Social Security Act prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Manual System. Publication 100-2, Medicare Benefit Policy Manual, Chapter 15, §80 describes coverage for physician supervision of diagnostic x-ray, lab and other diagnostic tests.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

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 hyposensitivity (Type 1) or hyperintensity (Type 2) on T1 images plus hyperintensity on T2 images (Type1) involving the endplates between L3 and S1
  • Absence of non-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 explain or contribute to symptoms or complaints.
  • Screening, evaluation, and diagnosis by a multidisciplinary team to include psychological and physical assessment.

Limitations

Thermal ablation of the Intraosseous Basivertebral nerve (BVN) is considered contraindicated with any of the following and precluded from coverage and reimbursement by Medicare:

  • Skeletal immaturity (<18 years of age)
  • Evidence on imaging (MRI, flexion/extension radiographs, CT) suggesting alternative 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.
  • Generalized systemic disease or complaints from which BVN pain cannot be differentiated from other aspects of the patient’s condition (e.g., morbid obesity, fibromyalgia, rheumatologic disease)
  • Previous history of BVN ablation at the level of treatment.
  • Treatment of more than 4 vertebral bodies per patient lifetime, within the confines of L3-S1 vertebral bodies.
  • Retreatment of a single vertebral body with BVN ablation within the patient’s lifetime.
  • Ongoing use or abuse of addictive medications without evidence of potential weaning or decreasing use with treatment of this and other causes of chronic pain.

General Information

Definitions

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

Conservative Measures/ Non-surgical Managment: 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.

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.

Summary of Evidence

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.

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.
Analysis of Evidence (Rationale for Determination)

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. 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.

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
Not Applicable N/A
Associated Information

Documentation Requirements

  1. Methods used for measurement of pain and/or disability must be documented in the medical record. Acceptable scales include, but are not limited to, 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 (OWS) Quebec Back Pain Disability Scare (QUE), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS) and the PROMIS profile domains to assess function.
  2. Complete history and physician exam, including laboratory and imaging findings and abnormalities.
  3. Patient assessment for pain and related conditions that may contribute to the complaint by a qualified health care provider trained in assessment of spinal and paraspinal disorders with relevant medical history including duration, treatments considered as well as documentation of success and failure of treatments prescribed.
  4. Treatments and procedures utilized for pain control including pertinent evaluation, medications, imaging and testing. Must include MRI documentation and reports demonstrating Modic changes (Type 1 or 2) in the L3-S1 vertebral body endplates.
  5. Provider assessment with order or recommendation for treatment including indication, method, and associated medications and therapies prescribed with provider signature and date. Patient acknowledgement of method, potential adverse effects and expected outcome, with consent for treatment.

Provider qualifications

Medicare considers BasiVertebral Nerve (BVN) ablation reasonable and necessary when furnished in accordance with the accepted standards of medical practice, furnished in a setting appropriate to the patient’s medical needs and condition, meets but does not exceed the patient’s medical need, and when ordered and furnished by qualified personnel, meeting the requirements of this LCD. Patient safety and consideration for coverage and reimbursement mandate that all provisions specified in the CMS policy manuals be followed.

BVN ablation services must be performed in a place of service demonstrating the appropriate equipment (e.g., fluoroscopy, CT, medical emergency equipment). It is expected that all clinical staff maintain appropriate training and credentials to support their role as first responders to potential medical emergencies.

Procedures listed and included in this LCD do not constitute anesthesia services. Evaluation, methods and techniques specified are not considered routine for surgical or perioperative anesthesia. Procedures to remedy pain emanating from the BasiVertebral Nerve constitute surgical intervention of a diseased body part, for which evaluation, diagnosis and management must be established by a medical provider trained in the specific discipline. It is expected that all providers of BVN ablative services are appropriately trained and credentialed by a formal residency/ fellowship program accredited by a nationally recognized organization or post-graduate training course accredited by an established national credentialing body in a relevant specialty.*

Services will be considered medically reasonable and necessary only if both of the following criteria are met:

  • All aspects of the procedure and its related care are within the scope of practice of the provider’s professional licensure; and
  • All procedures are performed by appropriately trained providers in the appropriate setting. Patient safety and quality of care mandate that healthcare professionals who perform injections or ablative techniques for treatment of specific nerve maladies and dysfunction are appropriately trained and are competent to perform all aspects of these procedures safely and effectively. The core curriculum of any training program should include the performance and management of the procedures addressed in this policy with documentation of trainee competency assessment by formal examination and case history document review.

* Health care providers performing intraosseous BVN nerve ablation must be appropriately trained and credentials by a formal residency or fellowship training program recognized in the United States or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program. At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics, proficiency in evaluation, diagnosis and management of diseases necessitating the procedures, technical performance of the procedure and performing and interpreting medically reasonable imaging modalities required for procedure performance (imaging technique, contrast material use, and image interpretation) as well as the evaluation, diagnosis and management of potential complications from the intervention. If a procedure requires facility credentialing or privilege approval when performed in an inpatient or outpatient hospital setting, the provider must possess those credentials to receive reimbursement for that procedure when performed in a healthcare facility or elsewhere. Only those settings with immediate availability of equivalent support services and personnel as those in a hospital will be considered appropriate place of service for purposes of Medicare reimbursement.

Reimbursement for procedures utilizing imaging may be made to providers who meet training requirements for the procedures in this policy when permitted under relevant state professional practice acts. In addition, all providers who seek Medicare payment for the procedures included in this policy must meet any applicable federal, state, or local licensing requirements and statutes for owning, operating, handling, or utilizing ionizing radiation, and relevant imaging equipment, materials, and contrast.

Utilization Guidelines

All aspects of evaluation and treatment must be documented in the patient’s chart, to include time, date and signature of the providing clinician and made available to Medicare on request.

All medications, and equipment utilized in the procedure must be documented at the time of the procedure, including name, identification/ serial number, dose, route of administration and site of administration. Therapeutic equipment including type, brand name, energy level attained and method of deployment must be documented in the patient’s record, including pertinent identifying imaging used for deployment. All documentation must be made available to Medicare on request.

No payment will be made for procedures not performed with appropriate imaging (fluoroscopic or computerized tomography) with formal report or reproduced images documented in the patient record and made available to Medicare on request.

It is not expected that anesthesia for the procedure will require other than administration of local anesthetizing agents at the site of entrance, with addition mild sedation. The rationale for the use of higher levels of sedation or general anesthesia should be documented in the patient’s record, without which denial of claim reimbursement may be made.

The injection of medications other than agents recognized as local anesthetics are not considered reasonable or medically appropriate at the site of administration of this procedure and will result in claim denial as inconsistent with patient safety. This specifically applies to the use of steroids, anti-inflammatories, biologics and any form of pharmaceutical not specifically designated as a local anesthetic agent.

Sources of Information
N/A
Bibliography
  1. Conger A, Schuster NM, Cheng DS, et al. The Effectiveness of Intraosseous Basivertebral Nerve Radiofrequency Neurotomy for the Treatment of Chronic Low Back Pain in Patients with Modic Changes: A Systematic Review. Pain Med. 2021;22(5):1039-1054. doi:10.1093/pm/pnab040
  2. *ECRI Institute. Clinical Evidence Assessment. Intracept intraosseous nerve ablation system (Relievant Medsystems, Inc.) for treating low-back pain. October 2020b.
  3. Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2018;27(5):1146-1156. doi:10.1007/s00586-018-5496-1
  4. Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study. Int J Spine Surg. 2019;13(2):110-119. Published 2019 Apr 30. doi:10.14444/6015
  5. Fischgrund JS, Rhyne A, Macadaeg K, et al. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2020;29(8):1925-1934. doi:10.1007/s00586-020-06448-x
  6. *Jarvinen J, Karppinen J, Niinimäki J, et al. Association between changes in lumbar Modic changes and low back symptoms over a two-year period. BMC Musculoskelet Disord.2015;16:98.
  7. *Jensen TS, Karppinen J, Sorensen JS, Niinimäki J, Leboeuf-Yde C. Vertebral endplate signal changes (Modic change): a systematic literature review of prevalence and association with non-specific low back pain. Eur Spine J.2008;17(11):1407–1422.
  8. Khalil JG, Smuck M, Koreckij T, et al. A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Spine J. 2019;19(10):1620-1632. doi:10.1016/j.spinee.2019.05.598
  9. Kim HS, Adsul N, Yudoyono F, et al. Transforaminal Epiduroscopic Basivertebral Nerve Laser Ablation for Chronic Low Back Pain Associated with Modic Changes: A Preliminary Open-Label Study. Pain Res Manag. 2018;2018:6857983. Published 2018 Aug 14. doi:10.1155/2018/6857983
  10. *Koreckij T, Kreiner S, Khalil J, et al. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-month treatment arm results. NASSJ. 2021;8:100089-100098.
  11. Lorio M, Clerk-Lamalice O, Beall DP, Julien T. International Society for the Advancement of Spine Surgery Guideline-Intraosseous Ablation of the Basivertebral Nerve for the Relief of Chronic Low Back Pain. Int J Spine Surg. 2020;14(1):18-25. Published 2020 Feb 29. doi:10.14444/7002
  12. *Luoma K, Vehmas T, Kerttula L, Gronblad M, Rinne E. Chronic low back pain in relation to Modic changes, bony endplate lesions, and disc degeneration in a prospective MRI study. Eur Spine J.2016;25(9):2873-2881.
  13. Macadaeg K, Truumees E, Boody B, et al. A prospective, single arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results [published correction appears in N Am Spine Soc J. 2020 Dec 01;4:100039]. N Am Spine Soc J. 2020;3:100030. Published 2020 Sep 18. doi:10.1016/j.xnsj.2020.100030
  14. Markman JD, Rhyne AL, Sasso RC, et al. Association Between Opioid Use and Patient-Reported Outcomes in a Randomized Trial Evaluating Basivertebral Nerve Ablation for the Relief of Chronic Low Back Pain. Neurosurgery. 2020;86(3):343-347. doi:10.1093/neuros/nyz093
  15. *Michalik A, Conger A, Smuck M, Maus TP, McCormick ZL. Intraosseous basivertebral nerve radiofrequency ablation for the treatment of vertebral body endplate low back pain: current evidence and future directions. Pain Medicine.2021;22(S1):S24-S30.
  16. North American Spine Society (NASS). Basivertebral nerve ablation: defining appropriate coverage positions. North American Spine Society. 2023; spine.org
  17. Sayed D, Naidu RK, Patel KV, et al. Best practice guidelines on the diagnosis and treatment of vertebrogenic pain with basivertebral nerve ablation from the American Society of Pain and Neuroscience.JPR. 2022;15:2801–2819.
  18. *Smuck M, Khalil J, Barrette K, et al. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results. Reg Anesth Pain Med. 2021;0:1-11.
  19. Truumees E, Macadaeg K, Pena E, et al. A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Eur Spine J. 2019;28(7):1594-1602. doi:10.1007/s00586-019-05995-2
Open Meetings
Meeting Date Meeting States Meeting Information
08/31/2023 American Samoa
California - Entire State
California - Northern
California - Southern
Guam
Hawaii
Nevada
Northern Mariana Islands

Teleconference

N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
08/03/2023
Comment Period Start Date
08/03/2023
Comment Period End Date
09/16/2023
Reason for Proposed LCD
  • Provider Education/Guidance
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
N/A
Contact for Comments on Proposed LCD
Noridian Healthcare Solutions, LLC JE Part B Contractor Medical Director(s)
Attention: Draft LCD Comments
PO Box 6781
Fargo, ND 58108-6781
policydraft@noridian.com

Coding Information

Bill Type Codes

Code Description
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Revenue Codes

Code Description
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CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

  1. Methods used for measurement of pain and/or disability must be documented in the medical record. Acceptable scales include, but are not limited to, 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 (OWS) Quebec Back Pain Disability Scare (QUE), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS) and the PROMIS profile domains to assess function.
  2. Complete history and physician exam, including laboratory and imaging findings and abnormalities.
  3. Patient assessment for pain and related conditions that may contribute to the complaint by a qualified health care provider trained in assessment of spinal and paraspinal disorders with relevant medical history including duration, treatments considered as well as documentation of success and failure of treatments prescribed.
  4. Treatments and procedures utilized for pain control including pertinent evaluation, medications, imaging and testing. Must include MRI documentation and reports demonstrating Modic changes (Type 1 or 2) in the L3-S1 vertebral body endplates.
  5. Provider assessment with order or recommendation for treatment including indication, method, and associated medications and therapies prescribed with provider signature and date. Patient acknowledgement of method, potential adverse effects and expected outcome, with consent for treatment.

Provider qualifications

Medicare considers BasiVertebral Nerve (BVN) ablation reasonable and necessary when furnished in accordance with the accepted standards of medical practice, furnished in a setting appropriate to the patient’s medical needs and condition, meets but does not exceed the patient’s medical need, and when ordered and furnished by qualified personnel, meeting the requirements of this LCD. Patient safety and consideration for coverage and reimbursement mandate that all provisions specified in the CMS policy manuals be followed.

BVN ablation services must be performed in a place of service demonstrating the appropriate equipment (e.g., fluoroscopy, CT, medical emergency equipment). It is expected that all clinical staff maintain appropriate training and credentials to support their role as first responders to potential medical emergencies.

Procedures listed and included in this LCD do not constitute anesthesia services. Evaluation, methods and techniques specified are not considered routine for surgical or perioperative anesthesia. Procedures to remedy pain emanating from the BasiVertebral Nerve constitute surgical intervention of a diseased body part, for which evaluation, diagnosis and management must be established by a medical provider trained in the specific discipline. It is expected that all providers of BVN ablative services are appropriately trained and credentialed by a formal residency/ fellowship program accredited by a nationally recognized organization or post-graduate training course accredited by an established national credentialing body in a relevant specialty.*

Services will be considered medically reasonable and necessary only if both of the following criteria are met:

  • All aspects of the procedure and its related care are within the scope of practice of the provider’s professional licensure; and
  • All procedures are performed by appropriately trained providers in the appropriate setting. Patient safety and quality of care mandate that healthcare professionals who perform injections or ablative techniques for treatment of specific nerve maladies and dysfunction are appropriately trained and are competent to perform all aspects of these procedures safely and effectively. The core curriculum of any training program should include the performance and management of the procedures addressed in this policy with documentation of trainee competency assessment by formal examination and case history document review.

* Health care providers performing intraosseous BVN nerve ablation must be appropriately trained and credentials by a formal residency or fellowship training program recognized in the United States or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program. At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics, proficiency in evaluation, diagnosis and management of diseases necessitating the procedures, technical performance of the procedure and performing and interpreting medically reasonable imaging modalities required for procedure performance (imaging technique, contrast material use, and image interpretation) as well as the evaluation, diagnosis and management of potential complications from the intervention. If a procedure requires facility credentialing or privilege approval when performed in an inpatient or outpatient hospital setting, the provider must possess those credentials to receive reimbursement for that procedure when performed in a healthcare facility or elsewhere. Only those settings with immediate availability of equivalent support services and personnel as those in a hospital will be considered appropriate place of service for purposes of Medicare reimbursement.

Reimbursement for procedures utilizing imaging may be made to providers who meet training requirements for the procedures in this policy when permitted under relevant state professional practice acts. In addition, all providers who seek Medicare payment for the procedures included in this policy must meet any applicable federal, state, or local licensing requirements and statutes for owning, operating, handling, or utilizing ionizing radiation, and relevant imaging equipment, materials, and contrast.

Utilization Guidelines

All aspects of evaluation and treatment must be documented in the patient’s chart, to include time, date and signature of the providing clinician and made available to Medicare on request.

All medications, and equipment utilized in the procedure must be documented at the time of the procedure, including name, identification/ serial number, dose, route of administration and site of administration. Therapeutic equipment including type, brand name, energy level attained and method of deployment must be documented in the patient’s record, including pertinent identifying imaging used for deployment. All documentation must be made available to Medicare on request.

No payment will be made for procedures not performed with appropriate imaging (fluoroscopic or computerized tomography) with formal report or reproduced images documented in the patient record and made available to Medicare on request.

It is not expected that anesthesia for the procedure will require other than administration of local anesthetizing agents at the site of entrance, with addition mild sedation. The rationale for the use of higher levels of sedation or general anesthesia should be documented in the patient’s record, without which denial of claim reimbursement may be made.

The injection of medications other than agents recognized as local anesthetics are not considered reasonable or medically appropriate at the site of administration of this procedure and will result in claim denial as inconsistent with patient safety. This specifically applies to the use of steroids, anti-inflammatories, biologics and any form of pharmaceutical not specifically designated as a local anesthetic agent.

Sources of Information
N/A
Bibliography
  1. Conger A, Schuster NM, Cheng DS, et al. The Effectiveness of Intraosseous Basivertebral Nerve Radiofrequency Neurotomy for the Treatment of Chronic Low Back Pain in Patients with Modic Changes: A Systematic Review. Pain Med. 2021;22(5):1039-1054. doi:10.1093/pm/pnab040
  2. *ECRI Institute. Clinical Evidence Assessment. Intracept intraosseous nerve ablation system (Relievant Medsystems, Inc.) for treating low-back pain. October 2020b.
  3. Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2018;27(5):1146-1156. doi:10.1007/s00586-018-5496-1
  4. Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study. Int J Spine Surg. 2019;13(2):110-119. Published 2019 Apr 30. doi:10.14444/6015
  5. Fischgrund JS, Rhyne A, Macadaeg K, et al. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2020;29(8):1925-1934. doi:10.1007/s00586-020-06448-x
  6. *Jarvinen J, Karppinen J, Niinimäki J, et al. Association between changes in lumbar Modic changes and low back symptoms over a two-year period. BMC Musculoskelet Disord.2015;16:98.
  7. *Jensen TS, Karppinen J, Sorensen JS, Niinimäki J, Leboeuf-Yde C. Vertebral endplate signal changes (Modic change): a systematic literature review of prevalence and association with non-specific low back pain. Eur Spine J.2008;17(11):1407–1422.
  8. Khalil JG, Smuck M, Koreckij T, et al. A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Spine J. 2019;19(10):1620-1632. doi:10.1016/j.spinee.2019.05.598
  9. Kim HS, Adsul N, Yudoyono F, et al. Transforaminal Epiduroscopic Basivertebral Nerve Laser Ablation for Chronic Low Back Pain Associated with Modic Changes: A Preliminary Open-Label Study. Pain Res Manag. 2018;2018:6857983. Published 2018 Aug 14. doi:10.1155/2018/6857983
  10. *Koreckij T, Kreiner S, Khalil J, et al. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-month treatment arm results. NASSJ. 2021;8:100089-100098.
  11. Lorio M, Clerk-Lamalice O, Beall DP, Julien T. International Society for the Advancement of Spine Surgery Guideline-Intraosseous Ablation of the Basivertebral Nerve for the Relief of Chronic Low Back Pain. Int J Spine Surg. 2020;14(1):18-25. Published 2020 Feb 29. doi:10.14444/7002
  12. *Luoma K, Vehmas T, Kerttula L, Gronblad M, Rinne E. Chronic low back pain in relation to Modic changes, bony endplate lesions, and disc degeneration in a prospective MRI study. Eur Spine J.2016;25(9):2873-2881.
  13. Macadaeg K, Truumees E, Boody B, et al. A prospective, single arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results [published correction appears in N Am Spine Soc J. 2020 Dec 01;4:100039]. N Am Spine Soc J. 2020;3:100030. Published 2020 Sep 18. doi:10.1016/j.xnsj.2020.100030
  14. Markman JD, Rhyne AL, Sasso RC, et al. Association Between Opioid Use and Patient-Reported Outcomes in a Randomized Trial Evaluating Basivertebral Nerve Ablation for the Relief of Chronic Low Back Pain. Neurosurgery. 2020;86(3):343-347. doi:10.1093/neuros/nyz093
  15. *Michalik A, Conger A, Smuck M, Maus TP, McCormick ZL. Intraosseous basivertebral nerve radiofrequency ablation for the treatment of vertebral body endplate low back pain: current evidence and future directions. Pain Medicine.2021;22(S1):S24-S30.
  16. North American Spine Society (NASS). Basivertebral nerve ablation: defining appropriate coverage positions. North American Spine Society. 2023; spine.org
  17. Sayed D, Naidu RK, Patel KV, et al. Best practice guidelines on the diagnosis and treatment of vertebrogenic pain with basivertebral nerve ablation from the American Society of Pain and Neuroscience.JPR. 2022;15:2801–2819.
  18. *Smuck M, Khalil J, Barrette K, et al. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results. Reg Anesth Pain Med. 2021;0:1-11.
  19. Truumees E, Macadaeg K, Pena E, et al. A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Eur Spine J. 2019;28(7):1594-1602. doi:10.1007/s00586-019-05995-2

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Updated On Effective Dates Status
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