DESCRIPTION
Intradiscal annuloplasty therapies use energy sources to thermally treat discogenic low back pain arising from tears in the tough outer wall, or annulus of the spinal disc. Thermal annuloplasty procedures are done under fluoroscopy and are intended to decrease low back pain and enhance the structural integrity of the disc.
With the intradiscal electrothermal annuloplasty procedure, a navigable catheter is inserted posterolaterally into the disc. The catheter is then navigated through the disc to the desired position. Using indirect radiofrequency energy, heat is generated to a temperature of 90 degrees centigrade (195 degrees F) for up to 20 minutes. Proposed advantages of indirect electrothermal delivery of radiofrequency energy include precise temperature feedback, and heat-induced shrinkage of collagen fibers to seal annular fissures without excessive damage and thermocoagulate nerve tissue, thereby stabilizing the disc and reducing pain.
Another procedure, referred to as percutaneous intradiscal radiofrequency thermocoagulation (PIRFT), uses direct application of radiofrequency energy. With PIRFT, the radiofrequency probe is placed into the center of the disc, and the device is activated for only 90 seconds at a temperature of 70 degrees centigrade. The procedure is not designed to coagulate, burn, or ablate tissue.
A more recently developed annuloplasty procedure, referred to as intradiscal biacuplasty, involves the use of two cooled radiofrequency electrodes placed on the posterolateral sides of the intervertebral annulus fibrosus. It is believed that by cooling the probes, a larger area may be treated than could occur with a regular needle probe.
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. A proposed treatment for basivertebral nerve pain is an intraosseous radiofrequency ablation. This procedure involves fluoroscopic guidance with the application of radiofrequency energy to accomplish thermal ablation of the basivertebral nerve.
Examples of devices used for these procedures include the Intracept® Intraosseous Nerve Ablation System, Oratec SpineCath®, discTRODE™, Radionics RF Disc Catheter System® and Baylis Pain Management Cooled Probe.
POLICY
Intradiscal annuloplasty (e.g., intradiscal electrothermal annuloplasty, percutaneous intradiscal radiofrequency thermocoagulation, or intradiscal biacuplasty) for the treatment of chronic discogenic back pain is considered investigational.
Intraosseous radiofrequency ablation of the basivertebral nerve (e.g., Intracept® system) for the treatment of vertebrogenic back pain is considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g., statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
There is insufficient evidence to determine effectiveness of these technologies compared to established alternative treatments.
SOURCES
BlueCross BlueShield Association. Evidence Positioning System. (10:2023). Percutaneous intradiscal electrothermal annuloplasty, radiofrequency annuloplasty, biacuplasty and intraosseous basivertebral nerve ablation (7.01.72). Retrieved January 9, 2024 from www.bcbsaoca.com/eps/. (19 articles and/or guidelines reviewed)
Centers for Medicare & Medicaid Services. CMS.gov. LCD for thermal destruction of the intraosseous basivertebral nerve (BVN) for vertebrogenic lower back pain (L39420). Retrieved January 9, 2024.
Centers for Medicare & Medicaid Services. CMS.gov. NCD for thermal intradiscal procedures (TIPs) (150.11). Retrieved December 2, 2015 from https://www.cms.gov.
De Vivo, A.E., D’Agostino, G., D’Anna, G., Quatami, H.A., Gil, I., Ventura, F., el al. (2021). Intra-osseous basivertebral nerve radiofrequency ablation (BVA) for the treatment of vertebrogenic chronic low back pain. Neuroradiology, 63 (5), 809-815. Abstract retrieved January 10, 2024 from PubMed database.
Desai, M., Kapural, L., Petersohn, J., Vallejo, R., Menzies, R, Creamer, M., & Gofeld, M. (2017). Twelve-month follow-up of a randomized clinical trial comparing intradiscal biacuplasty to conventional medical management for discogenic lumbar back pain. Pain Medicine, 18 (4), 751-763. Abstract retrieved October 2, 2017 from PubMed database.
Fischgrund, J. S., Rhyne, A., Macadaeg, K., Moore, G., Kamrava, E., Yeung, C., et al. (2020). 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. European Spine Journal: Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 29(8), 1925–1934. Abstract retrieved November 1, 2021 from PubMed database.
Helm, S., Simopoulos, T., Stojanovic, M., Abdi, S., El Terany, M. (2017). Effectiveness of thermal annular procedures in treating discogenic low back pain. Pain Physician, 20 (6), 447-470. (Level 1 evidence)
International Society for the Advancement of Spine Surgery. (2022, November). ISASS Policy Statement 2022: intraosseous basivertebral nerve ablation for. Retrieved January 9, 2022 from http://isass.org.
Kapural, L., Vrooman, B., Sarwar, S., Krizanac-Bengez, L., Rauck, R., Gilmore, C., et al. (2015). Radiofrequency intradiscal biacuplasty for treatment of discogenic lower back pain: a 12-month follow-up. Pain Medicine, 16 (3), 425-431. Abstract retrieved August 2, 2018 from PubMed database.
Khalil, J. G., Smuck, M., Koreckij, T., Keel, J., Beall, D., Goodman, B., et al. (2019). A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. The Spine Journal: Official Journal of the North American Spine Society, 19(10), 1620-1632. (Level 2 evidence)
Koreckij, T., Kreiner, S., Khalil, J.G., Smuck, M., Markman, J., & Garfin, S. (2021). Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results. North American Spine Society Journal, 8, 100089. Doi: 10.1016/j.xnsj.2021. (Level 2 evidence)
McCormick, Z.L., Curtis, T., Cooper, A., Wheatley, M., & Smuck, M. (2024). Low back pain-related healthcare utilization following intraosseous basivertebral nerve radiofrequency ablation: a pooled analysis from three prospective clinical trials. Pain Medicine, 25 (1), 20-32. (Level 2 evidence).
National Institute for Health and Care Excellence. (2016, January). Percutaneous electrothermal treatment of the intervertebral disc annulus for low back pain and sciatica. Retrieved October 2, 2017 from www.nice.org.uk/guidance/ipg544.
National Institute for Health and Care Excellence. (2016, January). Percutaneous intradiscal radiofrequency treatment of the intervertebral disc nucleus for low back pain. Retrieved October 2, 2017 from www.nice.org.uk/guidance/ipg545.
Nwosu, M., Agyeman, W.Y., Bisht, A., Gopinath, A., Cheema, A.H., Chaludiya, K., et al. (2023). The effectiveness of intraosseous basivertebral nerve ablation in the treatment of nonradiating vertebrogenic pain: A systematic review. Cureus, 15 (4), e37114. (Level 3 evidence)
Smuck, M., Khalil, J., Barrette, K., Hirsch, J.A., Kreiner, S., Koreckij, T., et al. (2021). Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results. Regional Anesthesia and Pain Medicine, 46 (8), 683-693. (Level 3 evidence)
U. S. Food and Drug Administration. (2019, May). Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator. 510(k) Premarket Notification Database. K190504. Retrieved October 29, 2021 from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190504.
U. S. Food and Drug Administration. (2022, March). Intracept Intraosseous Nerve Ablation System (Radiofrequency Lesion Probe), Intracept Intraosseous Nerve Ablation. 510(k) Premarket Notification Database. K213836. Retrieved November 15, 2022 from https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213836.pdf.
Winifred S. Hayes, Inc. Evolving Evidence Review. (2022, October). Intracept intraosseous nerve ablation system (Relievant Medsystems Inc.) for treatment of adults with low back pain. Retrieved November 15, 2022 from www.Hayesinc.com/subscribers. (18 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 8/1/2000
MOST RECENT REVIEW DATE: 2/8/2024
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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