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Medical Policy Intraosseous Basivertebral Nerve Ablation Table of Contents
• Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 485 BCBSA Reference Number: N/A

Related Policies
• Automated Percutaneous and Percutaneous Endoscopic Discectomy, #231 • Percutaneous Intradiscal Electrothermal Annuloplasty, Radiofrequency Annuloplasty and Biacuplasty

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• Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency Coblation (Nucleoplasty), #271 Policy
Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Intraosseous radiofrequency ablation of the basivertebral nerve (BVN) (e.g., Intracept® system) for the treatment of vertebrogenic back pain is considered MEDICALLY NECESSARY in individuals 18 and over when all of the following are met:
• Chronic lower back pain >6 months, and • Refractory to optimal nonsurgical medical management including but not limited to physical therapy and chiropractic therapy, epidural or facet injection therapy, lumbar exercise and low impact exercise programs, home use of heat/cold therapies, pharmacotherapy, cognitive support and recovery assurance, and • Modic type I or II changes on MRI, endplate hypointensity (Type 1) or hyperintensity (Type 2) on T1 images plus hyperintensity on T2 images (Type 1) involving in the endplates between L3 and S1 as evidenced by inflammation, edema, disruption, and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and • No previous history of BVN ablation at the planned level of treatment, and • No more than one to two (1-2) vertebral bodies treated during a single session, and • Treatment of no more than 4 vertebral bodies per patient lifetime.

Treatment of 3 or more vertebral bodies during a single session is considered INVESTIGATIONAL.

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Retreatment of a single vertebral body with BVN ablation is considered NOT MEDICALLY NECESSARY.

Intraosseus radiofrequency ablation of the basivertebral nerve (e.g., Intracept® system) for the treatment of vertebrogenic back pain is considered INVESTIGATIONAL when any of the following are present:
• Evidence on imaging (MRI, flexion/extension radiographs, etc.) indicating that pain may be due to another condition 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, or • Metabolic bone disease (eg, osteoporosis), treatment of spine fragility fracture, trauma/compression fracture, or • History of or active spinal cancer, or • Spine infection or active systemic infection, or
• Bleeding diathesis, or • Neurogenic claudication, lumbar radiculopathy or radicular pain due to neurocompression (eg, HNP, stenosis), as primary symptoms, or • Radiographic evidence of: o Lumbar/lumbosacral disc extrusion or protrusion >5mm at levels L3-S1; o Lumbar/lumbosacral spondylolisthesis > Grade 2 at any level; o Lumbar/lumbosacral spondylolysis at levels L3-S1; o Lumbar/lumbosacral facet arthrosis/effusion correlated with facet-mediated pain at levels L3- S1 • Patients with severe cardiac or pulmonary compromise, or • Patients with implantable pulse generators (eg, pacemakers, defibrillators) or other electronic implants, or
• Pregnancy, or • BMI >40.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) Prior authorization is required. Commercial PPO and Indemnity Prior authorization is required. Medicare HMO BlueSM Prior authorization is required. Medicare PPO BlueSM Prior authorization is required.

*Prior Authorization Request Form: Intraosseous Basivertebral Nerve Ablation Intracept® system

This form must be completed and faxed to: Medical and Surgical: 1-888-282-0780; Medicare Advantage: 1-800-447-2994.

Click here for Intraosseous Basivertebral Nerve Ablation Intracept® system Prior Authorization Request Form MP #486

Requesting Prior Authorization Using Authorization Manager Providers will need to use Authorization Manager to submit initial authorization requests for services. Authorization Manager, available 24/7, is the quickest way to review authorization requirements, request authorizations, submit clinical documentation, check existing case status, and view/print the decision letter. For commercial members, the requests must meet medical policy guidelines.

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To ensure the service request is processed accurately and quickly: • Enter the facility’s NPI or provider ID for where services are being performed. • Enter the appropriate surgeon’s NPI or provider ID as the servicing provider, not the billing group.

Authorization Manager Resources Refer to our Authorization Manager page for tips, guides, and video demonstrations.

CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue:

CPT Codes CPT codes: Code Description 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral

The following CPT code is considered investigational for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue:

CPT Codes CPT
codes:

Code Description 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral (List separately in addition to code for primary procedure)

Description Discogenic Low Back Pain Discogenic low back pain is a common, multifactorial pain syndrome that involves low back pain without radicular symptom findings, in conjunction with radiologically confirmed degenerative disc disease. Treatment Typical treatment includes conservative therapy with physical therapy and medication management, with potential for surgical decompression in more severe cases. Vertebral body endplates have been proposed as a source of lower back pain, caused by intraosseous nerves. The basivertebral nerve enters the posterior vertebral body and sends branches to the superior and inferior endplates. Vertebrogenic pain, transmitted via the basivertebral nerve, has been purported to occur with endplate damage or degeneration.

Summary Summary of Evidence

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For individuals who have vertebrogenic back pain who receive intraosseous ablation of basivertebral nerves, the evidence includes 2 RCTs (the SMART and INTRACEPT trials). Relevant outcomes are symptoms, functional outcomes, QOL, and treatment-related morbidity. The SMART trial did not find a difference in the Oswestry Disability Index between patients treated with basivertebral nerve ablation or sham control at 3 months using an intent-to-treat analysis. Although the per protocol analysis showed a significant difference; results for the per protocol population at 12 months were not significantly different. Additionally, 73% of patients in this trial crossed over to the active treatment group at 12 months and therefore, long-term comparative data are not available. The INTRACEPT trial found a significant difference in the Oswestry Disability Index and other pain scores between patients treated with basivertebral nerve ablation and standard care at 3 months.

In a 2, 3, and 5 year randomized controlled trial and follow up study published by Fischgrund et al (2020), multiple health outcome measures including low back pain, opioid use over 30 days post procedure, activity levels and quality of life measures demonstrated improvement. Clinically meaningful outcomes in function and pain were demonstrated beyond the 5-year follow up period with half of the patients reporting a 75% or greater reduction in pain as well as reduced need for ongoing injections and opioid use. In patients with type I or II modic changes on MRI, who have not responded to medical standards of care including but not limited to physical therapy and chiropractic therapy, epidural or facet injection therapy, lumbar exercise and low impact exercise programs, home use of heat/cold therapies, pharmacotherapy, cognitive support and recovery assurance, Intracept provides sustained clinical benefits and reductions in pain. The international Society for the Advancement of Spine Surgery designated a level 1 evidence grade for the available randomized controlled trials and recommends the use of BVNA in carefully selected patients with vertebrogenic low back pain who are refractory to medical management. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome. Policy History Date Action 5/2025 Policy revised to include that treatment of 3 or more vertebral bodies during a single session (code 64629) is investigational. Coding clarified. Effective 5/1/2025.
7/2024 Policy inclusion criteria revised. 7/1/2024 2/2024 New medically necessary and investigational indications added for Intraosseous Basivertebral Nerve ablation (Intracept) procedure. Effective 2/1/2024.

Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

1. 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. May 2018; 27(5): 1146-1156. PMID 29423885
2. 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. Apr 2019; 13(2): 110-119. PMID 31131209
3. 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. Aug 2020; 29(8): 1925-1934. PMID 32451777
4. 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

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Back Pain. Int J Spine Surg. 2020 Feb 29;14(1):18-25. doi: 10.14444/7002. PMID: 32128298; PMCID: PMC7043835.

5. Lorio M, Clerk-Lamalice O, Rivera M, Lewandrowski KU. ISASS Policy Statement 2022: Literature Review of Intraosseous Basivertebral Nerve Ablation. Int J Spine Surg. 2022 Dec;16(6):1084-1094. doi: 10.14444/8362. Epub 2022 Oct 20. PMID: 36266051; PMCID: PMC9807041.
6. 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. Oct 2019; 19(10): 1620-1632. PMID 31229663
7. 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. Aug 2021; 46(8): 683-693. PMID 34031220
8. Koreckij T, Kreiner S, Khalil JG, et al. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results. N Am Spine Soc J. Dec 2021; 8: 100089. PMID 35141653
9. Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. Apr 2013; 16(2 Suppl): S49-283. PMID 23615883
10. Boswell MV, Trescot AM, Datta S, et al. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. Jan 2007; 10(1): 7-111. PMID 17256025
11. McCormick ZL, Sperry BP, Boody BS, Hirsch JA, Conger A, Harper K, Lotz JC, Burnham TR. Pain Location and Exacerbating Activities Associated with Treatment Success Following Basivertebral Nerve Ablation: An Aggregated Cohort Study of Multicenter Prospective Clinical Trial Data.Pain Med. 2022 Jul 20;23(Suppl 2):S14-S33. doi: 10.1093/pm/pnac069. PMID: 35856332
12. McCormick ZL, Conger A, Smuck M, Lotz JC, Hirsch JA, Hickman C, Harper K, Burnham TR. Magnetic Resonance Imaging Characteristics Associated with Treatment Success from Basivertebral Nerve Ablation: An Aggregated Cohort Study of Multicenter Prospective Clinical Trials Data. Pain Med. 2022 Jul 20;23(Suppl 2):S34-S49. doi: 10.1093/pm/pnac093.PMID: 35856328