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Medical Policy Bulletin

Nucleoplasty
11.15.19e

Policy

EXPERIMENTAL/INVESTIGATIONAL

Although the US Food and Drug Administration (FDA) has approved devices for nucleoplasty as a technique for intervertebral disc decompression, the Company has determined that the safety and/or effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature. Therefore, nucleoplasty as a technique for intervertebral disc decompression in the lumbar, thoracic, or cervical spine is considered experimental/investigational by the Company and not covered.

BILLING REQUIREMENTS

Providers must not report CPT code 62287 to represent nucleoplasty. Report the appropriate codes to represent nucleoplasty:

  • Nucleoplasty at the lumbar level must be reported using the Healthcare Common Procedure Coding System (HCPCS) code S2348.
  • Nucleoplasty of areas other than the lumbar spine must be reported with Current Procedural Terminology (CPT) code 22899.
These services are subject to post-payment review and audit procedures.

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, nucleoplasty as a technique for intervertebral disc decompression in the lumbar, thoracic, or cervical spine is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/ investigational and, therefore, not covered. Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The Perc-D® SpineWand® was approved by the FDA on May 30, 2001, for ablation, coagulation, and decompression of disc material to treat symptomatic individuals with contained herniated discs. Supplemental approvals for the Perc-D SpineWand have since been issued by the FDA.

Description

Back pain may occur as a result of a herniated intervertebral disc in the lumbar, thoracic, or cervical areas of the spine. Typically when a disc herniates, the annulus fibrosis (the outer band-like substance of the disc) opens and allows the nucleus pulposus (the center gel-like substance of the disc) to protrude, compressing structures such as nerves. This compression leads to pain along the length of the back.

Nucleoplasty aims to reduce pain caused by contained or mildly herniated discs by employing minimally invasive techniques that utilize bipolar radiofrequency energy in a process known as coblation technology, for which there are US Food and Drug Administration (FDA)–approved devices. During nucleoplasty, a low-temperature resister probe is inserted through a needle into the herniated disc. When activated, the probe generates a highly focused energy field that breaks the organic molecular bonds within the disc tissue, creating small channels in the disc. Disintegration and evacuation of a portion of the nucleus pulposus occurs, and thermal treatment of the channels on withdrawal of the probe results in coagulation. It is claimed that the tissue removal from the nucleus by nucleoplasty decompresses the disc, thereby relieving pressure on the nerve root and decreasing pain.

PEER-REVIEWED LITERATURE

Nucleoplasty has been studied for the treatment of discogenic low-back pain due to disc degeneration, as well as for the treatment of lumbar disc bulges or disc ruptures that cause radiculopathy. This procedure has been studied in case series that address disc decompression in the cervical area of the spine. Further research is required to provide evidence of the clinical efficacy and safety of the procedure.

In a randomized controlled trial (RCT), Chitragran et al. (2012) compared nucleoplasty with conservative therapy (e.g., anti-inflammatory medication, physical therapy, activity modification) in 64 individuals. The nucleoplasty group was reported to have a reduction in pain and medication use compared to conservatively treated controls, although the data were not presented in this report.

In an industry-sponsored, unblinded, multicenter RCT, Gerszten et al. (2010) compared nucleoplasty versus epidural steroid injections in a group of individuals in whom conservative therapy had already failed (e.g., anti-inflammatory medication, physical therapy, activity modification). In addition, all participants received an epidural steroid injection 3 weeks to 6 months previously with no relief, temporary relief, or partial relief of pain. At 6-month follow-up, scores for pain and functional status were superior for the nucleoplasty group; however, a similar percentage of individuals in the two groups had unresolved symptoms and received a secondary procedure during the first 6 months of the study. In the observational phase of the study (2-year follow-up), there was a higher percentage of individuals (50%) in the control group who crossed over from steroid treatment to nucleoplasty. The manner in which alternative interventions were offered in the observational phase is uncertain. Overall, interpretation of these study results is limited.

Results from a cohort study by Bokov et al. (2010) support the conclusion that nucleoplasty is not as effective as microdiscectomy for disc extrusion. Prospective controlled trials of nucleoplasty versus microdiscectomy are needed to evaluate efficacy and time for recovery in individuals with disc protrusion. Notably, one case series reported accelerated degeneration after nucleoplasty. However, adequate follow-up with magnetic resonance imaging is needed to determine if nucleoplasty accelerates disc degeneration.

De Rooij et al. (2020) reported results for an RCT comparing percutaneous cervical nuceloplasty and anterior cervical discectomy in 48 individuals with cervical radicular pain due to a single-level contained soft-disc herniation. Individuals in the cervical discectomy group had a statistically significant interaction between the groups on the primary outcome, arm pain intensity, and on the secondary outcome of the SF-36 item pain 3 months. At 12 months, there was a trend for more improvement of arm pain in favor of the cervical discectomy​ group and no statistical interactions were found on the secondary outcomes.​​​​ This study was discontinued before the appropriate sample size could be reached; thus, it was underpowered.

Although the proposed advantage of nucleoplasty is its controlled and highly localized ablation, which allows for only slight damage to nearby tissue, the current, peer-reviewed, published literature does not support the efficacy of this service. Additionally, no peer-reviewed published literature is available that supports the use of nucleoplasty in the thoracic area of the spine. Although numerous case series and uncontrolled studies report improvements in pain and functioning following nucleoplasty, the lack of well-designed and conducted controlled trials limits interpretation of reported data.

PROFESSIONAL SOCIETY GUIDELINE

In 2013, an update of the comprehensive evidence-based practice guidelines by the American Society of Interventional Pain Physicians stated that evidence on nucleoplasty was limited to fair, as described in the 2013 systematic reviews by Singh et al. and Manchikanti et al.

References

Al-Zain F, Lemcke J, Killeen T, et al. Minimally invasive spinal surgery using nucleoplasty: a 1-year follow-up study. Acta Neurochir (Wien). 2008;150(12):1257-1262.

Azzazi A, AlMekawi S, Zein M. Lumbar disc nucleoplasty using coblation technology: clinical outcome. J Neurointerv Surg. 2011;3(3):288-292. Epub 2010 Dec 8.

Birnbaum K. Percutaneous cervical disc decompression. Surg Radiol Anat. 2009;31(5):379-387.

Bokov A, Skorodumov A, Isrelov A, et al. Differential treatment of nerve root compression pain caused by lumbar disc herniation applying nucleoplasty. Pain Physician. 2010;13(5):469-480.

Boswell MV, Trescot AM, Datta S, et al. American Society of Interventional Pain Physicians. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. 2007;10(1):7-111.

Calisaneller T, Ozdemir O, Karadeli E, et al. Six months post-operative clinical and 24 hour post-operative MRI examinations after nucleoplasty with radiofrequency energy. Acta Neurochir (Wien). 2007;149(5):495-500.

Centers for Medicare & Medicaid Services (CMS). MLN Matters. Thermal Intradiscal Procedures – JA6291. [CMS Web site]. 01/05/09. Available at:
http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM6291.pdf. Accessed May 3, 2024.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD).150.11: Thermal Intradiscal Procedures (TIPs). [CMS Web site]. Original: 09/29/08. Available at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=324&ncdver=1&bc=0. Accessed May 3, 2024.

Chitragran R, Poopitaya S, Tassanawipas W. Result of percutaneous disc decompression using nucleoplasty in Thailand: a randomized controlled trial. J Med Assoc Thai. 2012; 95 Suppl 10:S198-205.

Chou R, Atlas SJ, Stanos SP, et al. Nonsurgical interventional therapies for low back pain: a review of the evidence for an American Pain Society clinical practice guideline. Spine. 2009;34(10):1078-1093.

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. 2009;34(10):1066-1077.


Choy DS. Percutaneous laser disc decompression: an update. Photomed Laser Surg. 2004;22(5):393-406.

Cohen SP, Williams S, Kurihara C, et al. Nucleoplasty with or without intradiscal electrothermal therapy (IDET) as a treatment for lumbar herniated disc. J Spinal Disord Tech. 2005;18(Suppl):S119-124.

Cuellar VG, Cuellar JM, Vaccaro AR, et al. Accelerated degeneration after failed cervical and lumbar nucleoplasty. J Spinal Disord Tech. 2010;23(8):521-524.


de Rooij J, Harhangi B, Aukes H, et al. The Effect of Percutaneous Nucleoplasty vs Anterior Discectomy in Patients with Cervical Radicular Pain due to a Single-Level Contained Soft-Disc Herniation: A Randomized Controlled Trial. Pain Physician. 2020;23(6):553-564.

Freeman BJ, Mehdian R. Intradiscal electrothermal therapy, percutaneous discectomy, and nucleoplasty: what is the current evidence? Curr Pain Headache Rep. 2008;12(1):14-21.

Gerszten PC, Smuck M, Rathmell JP, et al. Plasma disc decompression compared with fluoroscopy-guided transforaminal epidural steroid injections for symptomatic contained lumbar disc herniation: a prospective, randomized, controlled trial. J Neurosurg Spine. 2010;12(4):357-371.

Gibson JNA, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane Database Syst Rev. 2007; Issue 2. Art. No.: CD001350.

Haufe SM, Mork AR. Complications associated with cervical endoscopic discectomy with the holmium laser. J Clin Laser Med Surg. 2004;22(1):57-58.

Klessinger S. The frequency of re-surgery after cervical disc neucleoplasty. World Neurosurg. 2018;117:e552-e556.

Klessinger S. The frequency of re-surgery after lumbar disc Nucleoplasty in a ten-year period. Clin Neurol Neurosurg. 2018;170:79-83.

Li J, Yan DL, Zhang ZH. Percutaneous cervical nucleoplasty in the treatment of cervical disc herniation. Eur Spine J. 2008;17(21):1664-1669.


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. 2013;16(2 Suppl):S49-283.

Manchikanti L, Derby R, Benyamin RM, et al. A systematic review of mechanical lumbar disc decompression with nucleoplasty. Pain Physician. 2009;12(3):561-572.

Manchikanti L, Falco FJ, Benyamin RM, et al. An update of the systematic assessment of mechanical lumbar disc decompression with nucleoplasty. Pain Physician. 2013;16(2 Suppl):SE25-54.

Masala S, Massari F, Fabiano S, et al. Nucleoplasty in the treatment of lumbar diskogenic back pain: one year follow-up. Cardiovasc Intervent Radiol. 2007;30(3):426-432.


Menchetti PP, Canero G, Bini W. Percutaneous laser discectomy: experience and long term follow-up. Acta Neurochir Suppl. 2011;108:117-121.

Mirzai H, Tekin I, Yaman O, et al. The results of nucleoplasty in patients with lumbar herniated disc: a prospective clinical study of 52 consecutive patients. Spine J. 2007;7(1):88-93.


National Institute for Health and Care Excellence (NICE). Epiduroscopic lumbar discectomy through sacral hiatus for sciatica [IPG570]. December 2016. Available at: https://www.nice.org.uk/guidance/ipg570. Accessed May 3, 2024.


National Institute for Health and Care Excellence (NICE). Percutaneous coblation of the intervertebral disc for low back pain and sciatica [IPG543]. January 2016. Available at: https://www.nice.org.uk/guidance/ipg543. Accessed May 3, 2024.

National Institute for Health and Clinical Excellence (NICE). Percutaneous disc compression using coblation for lower back pain [IPG173]. [NICE Web site]. September 2010. Available at: https://www.nice.org.uk/guidance/IPG357. Accessed May 3, 2024.

Singh V, Manchikanti L, Benyamin RM, et al. Percutaneous lumbar laser disc decompression: a systematic review of current evidence. Pain Physician. 2009;12(3):573-588.

Singh V, Manchikanti L, Calodney AK, et al. Percutaneous lumbar laser disc decompression: an update of current evidence. Pain Physician. 2013;16(2 Suppl):SE229-60.

Singh V, Piryani C, Liao K, Nieschulz S. Percutaneous disc decompression using Coblation (Nucleoplasty™) in the treatment of chronic discogenic pain. Pain Physician. 2002;5(3):250-259.


Tassi GP. Comparison of results of 500 microdiscectomies and 500 percutaneous laser disc decompression procedures for lumbar disc herniation. Photomed Laser Surg. 2006;24(6):694-697.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Arthocare Perc-D Spinewand. 510(k) Summary. [FDA Web site]. 12/27/05. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K053447.pdf. May 3, 2024.

Yakovlev A, Tamimi MA, Liang H, et al. Outcomes of percutaneous disc decompression utilizing nucleoplasty for the treatment of chronic discogenic pain. Pain Physician. 2007;10(2):319-328.


Coding

CPT Procedure Code Number(s)
THE FOLLOWING CODE IS USED TO REPRESENT NUCLEOPLASTY TO AREAS OTHER THAN THE LUMBAR SPINE:

22899

ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)
This service is experimental/investigational for all diagnoses.

HCPCS Level II Code Number(s)
THE FOLLOWING CODE IS USED TO REPRESENT NUCLEOPLASTY AT THE LUMBAR SPINE:

S2348 Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar

Revenue Code Number(s)
N/A

Policy History

Revisions From 11.15.19e:

​​ 05/29/2024

This policy has been reissued in accordance with the Company's annual review process.​​​
05/03/2023This policy has been reissued in accordance with the Company's annual review process.​​​
​06/29/2022
​The policy has been reviewed and reissued to communicate the Company’s continuing position on Nucleoplasty​.
​06/16/2021
​This policy has been reissued in accordance with the Company's annual review process.
​09/09/2020

​The policy has been reviewed and reissued to communicate the Company’s continuing position on Nucleoplasty​.
​09/25/2019
This policy has been reissued in accordance with the Company's annual review process.
​11/07/2018
​This policy became effective 05/07/2014. It has been reviewed and reissued to communicate the Company’s continuing position on ​nucleoplasty.

Effective 10/05/2017 this policy has been updated to the new policy template format.
05/07/2014
05/07/2014
05/29/2024
11.15.19
Medical Policy Bulletin
Commercial
No