Medical policy: Intraosseous Basivertebral Nerve Ablation

Número de política: MP 1.124

Fecha de entrada en vigor: 6/1/2026

Política

Intraosseous radiofrequency ablation of the basivertebral nerve (e.g., Intracept^® system) for the treatment of vertebrogenic back pain is considered investigational.

Actualmente no hay evidencia suficiente para llegar a una conclusión general sobre los resultados o beneficios para la salud asociados con estos procedimientos.

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Refer to FEP medical policy manual. The FEP medical policy manual can be found at: FEP Medical Policy Manual.

Descripción/antecedentes

Discogenic Low Back Pain

Discogenic low back pain is a common, multifactorial pain syndrome that involves low back pain without radicular symptoms findings, in conjunction with radiologically confirmed degenerative disc disease.

Tratamiento

Typical treatment includes conservative therapy with physical therapy and medication management, with potential for surgical decompression in more severe cases.

A number of electrothermal intradiscal procedures have been introduced to treat discogenic low back pain; they rely on various probe designs to introduce radiofrequency energy into the disc. It has been proposed that heat-induced denaturation of collagen fibers in the annular lamellae may stabilize the disc and potentially seal annular fissures. Pain reduction may occur through the thermal coagulation of nociceptors in the outer annulus.

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.

Situación reglamentaria

The Intracept Intraosseous Nerve Ablation System "is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least 6 months of conservative care". FDA reviewed the device and issued a substantially equivalent designation in August 2017 (K170827). In March of 2022, FDA issued a substantially equivalent designation for an additional Intracept Intraosseous Nerve Ablation System (Relievant Medsystems. Inc.; K213836). The prior device (K170827) is listed as the reference access instrument and the new indication adds a description of accompanying use case features, "…is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruptions and fissuring of the endplate, vascular fibrous tissue 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)". FDA product code: GXI.

Fundamento

Summary of evidence

For individuals who have vertebrogenic back pain who receive intraosseous ablation of the basivertebral nerves, the evidence includes 2 RCTs (the SMART and INTRACEPT trials). Los resultados pertinentes son los síntomas, los resultados funcionales, la calidad de vida y la morbilidad relacionada con el tratamiento. 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. Comparative data at 6 months post randomization showed similar results. However, 92% of patients initially assigned to standard care elected to cross over to receive early basivertebral nerve ablation, thus, long-term comparative data beyond 6 months are not available. Additional limitations to this RCT include lack of a sham control. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Definiciones

Annular lamellae are circular plates of collagen fibers found in secondary (mature, adult) bone.

Intervertebral Disc is the fibrocartilaginous tissue between the vertebral bodies. The outer portion is the annulus fibrosus; the inner portion is the nucleus pulposus. The disc is the shock absorber, or cushion, and permits movement.

Nociceptors are free nerve endings that are receptors for painful stimuli.

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen un consejo médico y están sujetas a cambios según lo permita la ley o la evidencia clínica aplicable de las pautas de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios del miembro, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Nota: Es posible que esta lista de códigos no sea exhaustiva y que los códigos estén sujetos a cambios en cualquier momento. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Objeto de investigación y, por lo tanto, no cubierto:

Referencias

1. U.S. Food & Drug Administration. K213836 Intracept Intraosseous Nerve Ablation System. 510k Summary. 2022
2. 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
3. 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
4. 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
5. 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
6. 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
7. Koreckij T, Kreiner S, Khalil JG, et al. Prospective, randomized 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 35147653
8. 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-S283. PMID 23615883
9. 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
10. Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain. J Pain Res. 2022; 15: 3729-3832. PMID 36510616
11. Lorio M, Uercl-Laulacie O, Beall DP, et al. 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. Feb 2020; 14(1): 18-25. PMID 32128298
12. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Thermal Intradiscal Procedures (TIPs) (150.11)