482 Form

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Medical Policy Percutaneous Intradiscal Electrothermal Annuloplasty, Radiofrequency Annuloplasty, and Biacuplasty
Table of Contents
• Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 482 BCBSA Reference Number: 7.01.72 (For Plan internal use only) Related Policies
• Automated Percutaneous and Percutaneous Endoscopic Discectomy, #231 • 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

Percutaneous annuloplasty (e.g., intradiscal electrothermal annuloplasty, intradiscal radiofrequency annuloplasty, or intradiscal biacuplasty) for the treatment of chronic discogenic back pain is considered INVESTIGATIONAL.

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) This is not a covered service. Commercial PPO and Indemnity This is not a covered service.

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.

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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 following CPT and HCPCS codes are 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 22526 Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; single level 22527 Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; 1 or more additional level

HCPCS Codes HCPCS codes: Code Description S2348 Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar

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. 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. With the intradiscal electrothermal annuloplasty procedure, a navigable catheter with an embedded thermal resistive coil is inserted posterolaterally into the disc annulus or nucleus. Using indirect radiofrequency energy, electrothermal heat is generated within the thermal resistive coil at a temperature of 90°C; the disc material is heated for up to 20 minutes. Proposed advantages of indirect electrothermal delivery of radiofrequency energy with intradiscal electrothermal annuloplasty include precise temperature feedback and control, and the ability to provide electrothermocoagulation to a broader tissue segment than would be allowed with a direct radiofrequency needle. Annuloplasty using a laser-assisted spinal endoscopy kit to coagulate the disc granulation tissue (percutaneous endoscopic laser annuloplasty) has also been described. Percutaneous intradiscal radiofrequency thermocoagulation uses direct application of radiofrequency energy. With percutaneous intradiscal radiofrequency thermocoagulation, 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°C. The procedure is not designed to coagulate, burn, or ablate tissue. The Radionics Radiofrequency Disc Catheter System has been specifically designed for this purpose.

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Intradiscal biacuplasty uses 2 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.

Summary Electrothermal intradiscal annuloplasty therapies use radiofrequency energy sources to treat discogenic low back pain arising from annular tears. These annuloplasty techniques are designed to decrease pain arising from the annulus by thermocoagulating nerves in the disc and tightening annular tissue. Summary of Evidence For individuals who have discogenic back pain who receive intradiscal electrothermal annuloplasty, the evidence includes a small number of randomized controlled trials (RCTs). Relevant outcomes are symptoms, functional outcomes, quality of life (QOL), and treatment-related morbidity. Two RCTs on intradiscal electrothermal annuloplasty reported conflicting results, with 1 reporting benefit for intradiscal electrothermal annuloplasty and the other reporting no benefit. Further study in a sham-controlled trial with a representative population of patients is needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. For individuals who have discogenic back pain who receive intradiscal radiofrequency annuloplasty, the evidence includes 2 RCTs. Relevant outcomes are symptoms, functional outcomes, QOL, and treatment- related morbidity. Neither RCT found evidence of benefit with the treatment. More sham-controlled trials are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. For individuals who have discogenic back pain who receive intradiscal biacuplasty, the evidence includes 2 industry-sponsored RCTs. Relevant outcomes are symptoms, functional outcomes, QOL, and treatment-related morbidity. One trial reported significant improvements at 6 months post-treatment, but not at 1 and 3 months. The other trial also showed a significant reduction in visual analog scale scores at 6 months that appeared to continue to the 12 month follow-up; however, it is unclear whether this trial was sufficiently powered. More sham-controlled trials are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Policy History
Date Action 6/2025 Annual policy review. References updated. Policy statements unchanged. 6/2024 Annual policy review. References updated. Policy statements unchanged. 2/2024 Policy statements on Intracept Procedure, intraosseuous basivertebral nerve ablation transferred to MP #485.
6/2023 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 12/2022 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2022 Clarified coding information. 12/2021 Annual policy review. Policy clarified. Policy statements updated to include ongoing investigational statement on Intraosseous radiofrequency ablation of the basivertebral nerve (e.g., Intracept® system) for the treatment of vertebrogenic back pain. Investigational statement was transferred from MP #400 Medical Technology Assessment Noncovered Services. 5/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2021 Medicare information removed. See MP #132 Medicare Advantage Management for local coverage determination and national coverage determination reference.

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6/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 5/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 2/2018 Annual policy review. New references added. 3/2017 Annual policy review. Title changed. Policy statement terminology revised to reflect the changes in the title, but the intent is unchanged. New references added.
12/2015 Added coding language. 8/2015 Annual policy review. New references added. 10/2013 Annual policy review. New references added. 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements.
6/2011 Reviewed - Medical Policy Group - Orthopedics, Rehabilitation Medicine and Rheumatology. No changes to policy statements. 7/2010 Reviewed - Medical Policy Group - Orthopedics, Rehabilitation Medicine and Rheumatology. No changes to policy statements. 7/2010 Annual policy review. No changes to policy statements. 7/2009 Reviewed - Medical Policy Group - Orthopedics, Rehabilitation Medicine and Rheumatology. No changes to policy statements. 5/2009 Annual policy review. No changes to policy statements. 7/2008 Reviewed - Medical Policy Group - Orthopedics, Rehabilitation Medicine and Rheumatology. No changes to policy statements. 5/2008 Annual policy review. Changes to policy statements. 12/2007 Annual policy review. No changes to policy statements. 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. U.S. Food & Drug Administration. K213836 Intracept Intraosseous Nerve Ablation System 510k Summary. 2022. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213836. Accessed March 1, 2025.
2. Pauza KJ, Howell S, Dreyfuss P, et al. A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain. Spine J. 2004; 4(1): 27-35. PMID 14749191
3. Freeman BJ, Fraser RD, Cain CM, et al. A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Spine (Phila Pa 1976). Nov 01 2005; 30(21): 2369-77; discussion 2378. PMID 16261111
4. Barendse GA, van Den Berg SG, Kessels AH, et al. Randomized controlled trial of percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain: lack of effect from a 90-second 70 C lesion. Spine (Phila Pa 1976). Feb 01 2001; 26(3): 287-92. PMID 11224865
5. Kvarstein G, Måwe L, Indahl A, et al. A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy--a 12-month follow-up. Pain. Oct 2009; 145(3): 279-286. PMID 19647940
6. Kapural L, Vrooman B, Sarwar S, et al. A randomized, placebo-controlled trial of transdiscal radiofrequency, biacuplasty for treatment of discogenic lower back pain. Pain Med. Mar 2013; 14(3): 362-73. PMID 23279658
7. Kapural L, Vrooman B, Sarwar S, et al. Radiofrequency intradiscal biacuplasty for treatment of discogenic lower back pain: a 12-month follow-up. Pain Med. Mar 2015; 16(3): 425-31. PMID 25339501

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8. Desai MJ, Kapural L, Petersohn JD, et al. A Prospective, Randomized, Multicenter, Open-label Clinical Trial Comparing Intradiscal Biacuplasty to Conventional Medical Management for Discogenic Lumbar Back Pain. Spine (Phila Pa 1976). Jul 01 2016; 41(13): 1065-1074. PMID 26689579
9. Desai MJ, Kapural L, Petersohn JD, et al. Twelve-Month Follow-up of a Randomized Clinical Trial Comparing Intradiscal Biacuplasty to Conventional Medical Management for Discogenic Lumbar Back Pain. Pain Med. Apr 01 2017; 18(4): 751-763. PMID 27570246
10. 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
11. 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
12. 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
13. 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
14. 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
15. 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
16. 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
17. 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
18. 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
19. Lorio M, Clerk-Lamalice O, Rivera M, et al. ISASS Policy Statement 2022: Literature Review of Intraosseous Basivertebral Nerve Ablation. Int J Spine Surg. Dec 2022; 16(6): 1084-1094. PMID 36266051
20. National Institute for Health and Care Excellence. Percutaneous intradiscal radiofrequency treatment of the intervertebral disc nucleus for low back pain [IPG545]. 2016; https://www.nice.org.uk/guidance/ipg545. Accessed March 10, 2025.
21. National Institute for Health and Care Excellence. Percutaneous electrothermal treatment of the intervertebral disc annulus for low back pain and sciatica [IPG544]. 2016; https://www.nice.org.uk/guidance/IPG544. Accessed March 9, 2025.
22. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Thermal Intradiscal Procedures (TIPs) (150.11). 2008; https://www.cms.gov/medicare-coverage- database/details/ncd- details.aspx?ncdid=324&ver=1. Accessed March 10, 2025.