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Medical Policy Artificial Intervertebral Disc: Lumbar Spine Table of Contents
• Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 592

BCBSA Reference Number: 7.01.87 (For Plan internal use only) Related Policies
None Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity

Artificial intervertebral discs of the lumbar spine are 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.

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

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

The following CPT codes are considered investigational for Commercial Members: Managed Care (HMO and POS), PPO and Indemnity: CPT Codes CPT codes:

Code Description 22857 Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression); single interspace, lumbar 22860 Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression); second interspace, lumbar 22862 Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; lumbar 0164T Removal of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, lumbar 0165T Revision including replacement of total disc arthroplasty, anterior approach, each additional interspace, lumbar

Description Degenerative disc disease (DDD), the most frequent cause of back pain requiring surgery, is common with age or trauma. Spine imaging, such as magnetic resonance imaging (MRI), computed tomography, or plain radiography, shows that lumbar disc degeneration is widespread, but for most people it does not cause symptoms. Potential candidates for artificial disc replacement have chronic low back pain attributed to DDD, lack of improvement with nonoperative treatment, and no contraindications for the procedure, which include multilevel disease, spinal stenosis, spondylolisthesis, scoliosis, previous major spine surgery, neurologic symptoms, and other minor contraindications. Patients who require procedures in addition to fusion (eg, laminectomy, decompression) are not candidates for the artificial disc.

When conservative treatment of DDD fails, a common surgical approach is spinal fusion. More than 200,000 spinal fusions are performed each year. However, outcomes with spinal fusion have been controversial, in part due to the difficulty in determining if a patient's back pain is related to DDD and in part due to the success of the procedure itself. Also, spinal fusion alters the spine biomechanics, potentially leading to premature disc degeneration at adjacent levels, a particular concern for younger patients. During the past 30 years, various artificial intervertebral discs have been investigated as an alternative approach to fusion. This approach, also referred to as total disc replacement (TDR) or spinal arthroplasty, is intended to maintain normal biomechanics of the adjacent vertebrae and motion at the operative level once the damaged disc has been removed.

Use of a motion-preserving artificial disc increases the potential for various types of implant failure. They include device failure (eg, device fracture, dislocation, or wear), bone-implant interface failure
(eg, subsidence, dislocation-migration, vertebral body fracture), and host response to the implant
(eg, osteolysis, heterotopic ossification, pseudotumor formation).

Summary Description Total disc replacement, using an artificial intervertebral disc designed for the lumbar spine, is proposed as an alternative to spinal fusion in patients with degenerative disc disease leading to disabling symptoms.

Summary of Evidence For individuals who have degenerative disc disease who receive a lumbar artificial intervertebral disc, the evidence includes systematic reviews, randomized controlled trials (RCTs) of artificial discs versus fusion with 5-year outcomes, and observational studies with longer term outcomes. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Evidence from systematic reviews indicates that total disc replacement (TDR) for lumbar degenerative disc disease provides modest

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improvements in pain and function compared to fusion, with low-quality evidence and high potential for bias. A meta-analysis shows TDR offers better pain relief than anterior and circumferential fusions, though complication rates vary by procedure. Outcomes with at least 5 years of post-operative follow-up demonstrate sustained clinical success and patient satisfaction, with complication and reoperation rates around 18% and 14%, respectively. Significant heterogeneity and inclusion of non-FDA approved devices limit generalizability, and definitions for complications differ among studies.

Five-year outcomes for the ProDisc-L RCT have provided evidence for the noninferiority of TDR compared to spinal fusion. The superiority of ProDisc-L with circumferential fusion was achieved at 2 years but not at 5 years in this unblinded trial. The potential benefits of the artificial disc (eg, faster recovery, reduced adjacent-level disc degeneration) have not been demonstrated. No RCTs compared activL to spinal fusion or conservative care. Five-year data confirmed noninferiority of activL compared to ProDisc-L or Charité devices, and fewer serious adverse events with no increase in complications up to 7-years of follow-up. These findings provide indirect evidence of the efficacy of activL, with limitations including high loss to follow-up, unblinded outcome assessments, and inclusion of a now-withdrawn device (Charité) in the control group. A retrospective single-center study found that lumbar TDR with ProDisc-L led to sustained improvements in function and pain scores across groups, with slower recovery in those with prior surgery. Revision rates and new adjacent-level surgeries were low over 7–21 years, but prior surgery increased adjacent-level degeneration and intervention risk. A second retrospective multi-site study reported a 1.26% removal or revision rate in lumbar TDR, mainly due to device migration, loosening, and complications, often occurring early post-implantation. Both observational studies demonstrate favorable long-term outcomes and low revision rates, though previous surgery heightens certain risks. Significant uncertainty exists regarding the long-term performance of TDR, particularly with concerns about declining success rates and the emergence of late-stage complications. Studies are limited by a lack of blinding, insufficient follow-up to evaluate potential harms, and lack of comparison to the criterion standard of spinal fusion for treatment of degenerative disc disease. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Policy History Date Action 4/2026 Policy updated with literature review through January 25, 2026; references added. Policy statement unchanged. 8/2025 Annual policy review. Policy updated with literature review through February 20, 2025; no references added. Policy statement unchanged. 6/2024 Annual policy review. References updated. Policy statements unchanged. 5/2024 Clarified language above code table. 6/2023 Annual policy review. References updated. Policy statements unchanged. 1/2023 Coding clarified.
6/2022 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 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.
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. 5/2018 New references added from Annual policy review. Summary clarified. 6/2017 Annual policy review. Discussion of artificial discs not available in the United States was removed. Policy statement unchanged. 6/1/2017 5/2016 Annual policy review. New references added. 3/2015 Annual policy review. New references added. 4/2014 Annual policy review. New references added.

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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 and Rheumatology. No changes to policy statements. 1/2011 Updated - Medical Policy Group – Neurology and Neurosurgery. No changes to policy statements. 10/20/2010 Medical Policy 592 effective 10/20/2010.
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. The prodisc L Total Disc Replacement P050010/S020. April 10,
2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050010S020 Accessed February 20, 2025.
3. Highridge Medical to Introduce activL Lumbar Disc. July 8, 2025.
4. Centinel Spine. ProDisc devices.
5. Jacobs WC, van der Gaag NA, Kruyt MC, et al. Total disc replacement for chronic discogenic low back pain: a Cochrane review. Spine (Phila Pa 1976). Jan 01 2013; 38(1): 24-36. PMID 22996268
6. Lang SAJ, Bohn T, Barleben L, et al. Advanced meta-analyses comparing the three surgical techniques total disc replacement, anterior stand-alone fusion and circumferential fusion regarding pain, function and complications up to 3 years to treat lumbar degenerative disc disease. Eur Spine J. Dec 2021; 30(12): 3688-3701. PMID 33837832
7. Wen DJ, Tavakoli J, Tipper JL. Lumbar Total Disc Replacements for Degenerative Disc Disease: A Systematic Review of Outcomes With a Minimum of 5 years Follow-Up. Global Spine J. Jul 2024; 14(6): 1827-1837. PMID 38263726
8. Zigler J, Gornet MF, Ferko N, et al. Comparison of Lumbar Total Disc Replacement With Surgical Spinal Fusion for the Treatment of Single-Level Degenerative Disc Disease: A Meta-Analysis of 5-Year Outcomes From Randomized Controlled Trials. Global Spine J. Jun 2018; 8(4): 413-423. PMID 29977727
9. Radcliff K, Zigler J, Braxton E, et al. Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results. Int J Spine Surg. Aug 2021; 15(4): 612-632. PMID 34266934
10. Gornet MF, Burkus JK, Dryer RF, et al. Lumbar disc arthroplasty versus anterior lumbar interbody fusion: 5-year outcomes for patients in the Maverick disc investigational device exemption study. J Neurosurg Spine. Sep 01 2019; 31(3): 347-356. PMID 31100723
11. Yue JJ, Garcia R, Blumenthal S, et al. Five-year Results of a Randomized Controlled Trial for Lumbar Artificial Discs in Single-level Degenerative Disc Disease. Spine (Phila Pa 1976). Dec 15 2019; 44(24): 1685-1696. PMID 31404055
12. Furunes H, Storheim K, Brox JI, et al. Total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back pain and degenerative discs: 8-year follow-up of a randomized controlled multicenter trial. Spine J. Oct 2017; 17(10): 1480-1488. PMID 28583869
13. Guyer RD, Pettine K, Roh JS, et al. Five-Year Follow-Up of a Prospective, Randomized Trial Comparing Two Lumbar Total Disc Replacements. Spine (Phila Pa 1976). Jan 2016; 41(1): 3-8. PMID 26335669
14. Sköld C, Tropp H, Berg S. Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial. Eur Spine J. Oct 2013; 22(10): 2288-95. PMID 23893083
15. Guyer et al. (2012). Outcomes of CHARITE Lumbar Artificial Disk versus Fusion: 5-Year Data. Seminars in Spine Surgery, Volume 24, Issue 1, March 2012, Pages 32-36.
16. Zigler JE, Delamarter RB. Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus

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circumferential arthrodesis for the treatment of single-level degenerative disc disease. J Neurosurg Spine. Dec 2012; 17(6): 493-501. PMID 23082846

16. Delamarter R, Zigler JE, Balderston RA, et al. Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement compared with circumferential arthrodesis for the treatment of two-level lumbar degenerative disc disease: results at twenty-four months. J Bone Joint Surg Am. Apr 20 2011; 93(8): 705-15. PMID 21398574
17. Gornet MF, Burkus JK, Dryer RF, et al. Lumbar disc arthroplasty with Maverick disc versus stand-alone interbody fusion: a prospective, randomized, controlled, multicenter investigational device exemption trial. Spine (Phila Pa 1976). Dec 01 2011; 36(25): E1600-11. PMID 21415812
18. Hellum C, Johnsen LG, Storheim K, et al. Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study. BMJ. May 19 2011; 342: d2786. PMID 21596740
19. Berg S, Tullberg T, Branth B, et al. Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up. Eur Spine J. Oct 2009; 18(10): 1512-9. PMID 19506919
20. Guyer RD, McAfee PC, Banco RJ, et al. Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: five-year follow-up. Spine J. May 2009; 9(5): 374-86. PMID 18805066
21. Moreno P, Boulot J. [Comparative study of short-term results between total artificial disc prosthesis and anterior lumbar interbody fusion]. Rev Chir Orthop Reparatrice Appar Mot. May 2008; 94(3): 282-8. PMID 18456064
22. Zigler J, Delamarter R, Spivak JM, et al. Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease. Spine (Phila Pa 1976). May 15 2007; 32(11): 1155-62; discussion 1163. PMID 17495770
23. Blumenthal S, McAfee PC, Guyer RD, et al. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine (Phila Pa 1976). Jul 15 2005; 30(14): 1565-75; discussion E387-91. PMID 16025024
24. U.S. Food and Drug Administration. Draft: PRODISC-L Total Disc Replacement package insert. 2005; https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050010c.pdf. Accessed January 9, 2026.
25. U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data: PRODISC-L Total Disc Replacement. 2006; https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050010b.pdf. Accessed January 10, 2026.
26. Zigler JE, Glenn J, Delamarter RB. Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion. J Neurosurg Spine. Dec 2012; 17(6): 504-11. PMID 23082849
27. Schoenfeld AJ. Commentary on an article by Rick Delamarter, MD, et al.: "Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement compared with circumferential arthrodesis for the treatment of two-level degenerative lumbar disc disease. Results at twenty-four months". J Bone Joint Surg Am. Apr 20 2011; 93(8): e41. PMID 21398573
28. Hellum C, Berg L, Gjertsen Ø, et al. Adjacent level degeneration and facet arthropathy after disc prosthesis surgery or rehabilitation in patients with chronic low back pain and degenerative disc: second report of a randomized study. Spine (Phila Pa 1976). Dec 01 2012; 37(25): 2063-73. PMID 22706091
29. Garcia R, Yue JJ, Blumenthal S, et al. Lumbar Total Disc Replacement for Discogenic Low Back Pain: Two-year Outcomes of the activL Multicenter Randomized Controlled IDE Clinical Trial. Spine (Phila Pa 1976). Dec 2015; 40(24): 1873-81. PMID 26630435
30. Marnay TP, Geneste GY, Edgard-Rosa GW, et al. Clinical Outcomes After 1 and 2-Level Lumbar Total Disc Arthroplasty: 1,187 Patients with 7 to 21-Year Follow-up. J Bone Joint Surg Am. Jan 01 2025; 107(1): 53-65. PMID 40100011
31. Guyer RD, Blumenthal SL, Shellock JL, et al. Lumbar Total Disk Replacement Device Removals and Revisions Performed During a 20-Year Experience with 2141 Patients. Spine (Phila Pa 1976). May 15 2024; 49(10): 671-676. PMID 38282440

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32. Chou R, Loeser JD, Owens DK, et al. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine (Phila Pa 1976). May 01 2009; 34(10): 1066-77. PMID 19363457
33. Chou R, Baisden J, Carragee EJ, et al. Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine (Phila Pa 1976). May 01 2009; 34(10): 1094-
34. PMID 19363455
35. North American Spine Society (NASS). NASS coverage policy recommendations: Lumbar Artificial Disc Replacement. 2019; https://www.spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations. Accessed January 9, 2026.
36. Schroeder GD, Vaccaro AR, Divi SN, et al. 2021 Position Statement From the International Society for the Advancement of Spine Surgery on Cervical and Lumbar Disc Replacement. Int J Spine Surg. Feb 2021; 15(1): 37-46. PMID 33900955
37. National Institute for Health and Care Excellence (NICE). Prosthetic intervertebral disc replacement in the lumbar spine [IPG306]. 2009; https://www.nice.org.uk/guidance/IPG306. Accessed January 8,
39. National Institute for Health and Care Excellence (NICE). Low back pain and sciatica in over 16s: assessment and management. NICE guideline Reference number: NG59. Published: 30 November 2016 Last updated: 11 December 2020.
40. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Lumbar Artificial Disk Replacement (LADR) (150.10). 2007; https://www.cms.gov/medicare-coverage- database/details/ncd- details.aspx?NCDId=313&ncdver=2&CoverageSelection=National&KeyWord=lumbar+artificial+disc& KeyWordLookUp=Title&KeyWordSearchType=And&id=170&bc=gAAAABAAAAAA&. Accessed January 6, 2026.
41. Centers for Medicare & Medicaid Services (CMS). Medicare Learning Network Matters: Lumbar Artificial Disc Replacement (LADR). Change request 5727. 2007; https://www.cms.gov/Regulations- and-Guidance/Guidance/Transmittals/Downloads/R1340CP.pdf. Accessed January 5, 2026.