Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Nucleoplasty

Policy #:11.15.19e

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

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-DŽ SpineWandŽ 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-DŽ SpineWandŽ 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 was not presented in this report.

In an industry-sponsored, unblinded, multi-center RCT Gerszten et al. (2010) compared nucleoplasty versus epidural steroid injections in a group of individuals who had already failed conservative therapy (e.g., anti-inflammatory medication, physical therapy, activity modification). In addition, all participants received an epidural steroid injection three weeks to six months previously with no relief, temporary relief, or partial relief of pain. At six-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 six months of the study. In the observational phase of the study (two-year follow-up), there was a higher percentage of individuals (50 percent) 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.

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. While 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 states 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):1257-62.

Azzazi A, AlMekawi S, Zein M. Lumbar disc nucleoplasty using coblation technology: clinical outcome. J Neurointerv Surg. 2011;3(3):288-92. Epub 2010 Dec 8.

Birnbaum K. Percutaneous cervical disc decompression. Surg Radiol Anat. 2009;31(5):379-87.

BlueCross BlueShield Association. Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency Coblation (Nucleoplasty). 2003. Available at: https://www.evidencepositioningsystem.com/BCBSA-policies/70193_laser%20rf%20discnucleoplasty.pdf. Accessed September 13, 2018.

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):469-80.

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 January 14, 2016.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD).150.11: Thermal intradiscal procedures (TIPs). [CMS Web site]. Original: 09/29/08. (Revised: December 2008). Available at: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=150.11&ncd_version=1&basket=ncd%3A150%2E11%3A1%3AThermal+Intradiscal+Procedures+%28TIPs%29. Accessed January 14, 2016.

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):1078-93.

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.

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):521-4.

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 of Systematic Reviews. 2007, Issue 2. Art. No.: CD001350. DOI: 10.1002/14651858.CD001350.pub4. [Interscience Web site]. 04/18/07. Available at: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001350/frame.html. Accessed January 14, 2016.

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):1664-9.

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.

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 Clinical Excellence (NICE). Interventional Procedure Guidance 173: Percutaneous disc compression using coblation for lower back pain. [NICE Web site]. September 2010. Available at: https://www.nice.org.uk/guidance/IPG357. Accessed January 14, 2016.

Singh V, Manchikanti L, Benyamin RM, et al. Percutaneous lumbar laser disc decompression: a systematic review of current evidence. Pain Physician. 2009;12(3):573-88.

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.

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. January 14, 2016.

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):319-28.





Coding

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

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

THE FOLLOWING CODE IS USED TO REPRESENT NUCLEOPLASTY TO AREAS OTHER THAN THE LUMBAR SPINE:


22899



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


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

Coding and Billing Requirements


Cross References


Policy History

Revisions from 11.15.19e:
11/07/2018This 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.


Version Effective Date: 05/07/2014
Version Issued Date: 05/07/2014
Version Reissued Date: 11/07/2018

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