Latest Review Date: April 2024

Category: Surgical                                                                 

POLICY:

Laser discectomy and radiofrequency coblation (DISC Nucleoplasty™) is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Laser energy (laser discectomy) and radiofrequency coblation (nucleoplasty) are being evaluated for decompression of the intervertebral disc. For laser discectomy under fluoroscopic guidance, a needle or catheter is inserted into the disc nucleus, and a laser beam is directed through it to vaporize tissue. For disc nucleoplasty, bipolar radiofrequency energy is directed into the disc to ablate tissue. These minimally invasive procedures are being evaluated for the treatment of discogenic back pain.

Discogenic low back pain is a common, multifactorial pain syndrome that involves low back pain without radicular symptoms findings, in conjunction with radiologically confirmed degenerative disc disease. Typical treatment includes conservative therapy with physical therapy and medication management, with potential for surgical decompression in more severe cases.

A variety of minimally invasive techniques have been investigated over the years as treatment of low back pain related to disc disease. Techniques can be broadly divided into techniques that are designed to remove or ablate disc material, and thus decompress the disc, and those designed to alter the biomechanics of the disc annulus. The former category includes chymopapain injection, automated percutaneous lumbar discectomy, laser discectomy, and most recently, disc decompression using radiofrequency energy, referred to as a DISC nucleoplasty™.

A variety of different lasers have been investigated for laser discectomy, including YAG, KTP, holmium, argon, and carbon dioxide lasers. Due to differences in absorption, the energy requirements and the rate of application differ among the lasers. In addition, it is unknown how much disc material must be removed to achieve decompression. Therefore, protocols vary according to the length of treatment, but typically the laser is activated for brief periods only.

Radiofrequency coblation uses bipolar low-frequency energy in an electrical conductive fluid (e.g., saline) to generate a highdensity plasma field around the energy source. This creates a low-temperature field of ionizing particles that break organic bonds within the target tissue. Coblation technology is used in a variety of surgical procedures, particularly related to otolaryngology. The disc nucleoplasty procedure is accomplished with a probe mounted using an RF coblation source. The proposed advantage of coblation is that the procedure provides for controlled and highly localized ablation, resulting in minimal damage to surrounding tissue.

KEY POINTS:

This policy was created in 2003 and updated periodically using the MEDLINE database. The most recent update was performed through February 13, 2024.

Summary of Evidence

For individuals who have discogenic back pain or radiculopathy who receive laser discectomy, the evidence includes systematic reviews of observational studies. Relevant outcomes are symptoms, functional outcomes, and treatment-related morbidity. While numerous case series and uncontrolled studies have reported improvements in pain and functioning following laser discectomy, the lack of well-designed and conducted controlled trials limits interpretation of reported data. 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 or radiculopathy who receive radiofrequency coblation, the evidence includes randomized controlled trials (RCTs), systematic reviews, and prospective and retrospective nonrandomized studies. Relevant outcomes are symptoms, functional outcomes, and treatment-related morbidity. For nucleoplasty, there are 3 randomized controlled trials in addition to the uncontrolled studies, but these trials are limited by the lack of blinding, an inadequate control condition in one trial, and inadequate data reporting in the second and low enrollment with early study termination in the third. The available evidence is insufficient to permit conclusions concerning the effect of these procedures on health outcomes due to multiple confounding factors that may bias results. High-quality randomized trials with adequate follow-up (at least 1 year), which control for selection bias, the placebo effect, and variability in the natural history of low back pain, are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

National Institute for Health and Care Excellence

In 2016, NICE updated its guidance on laser lumbar discectomy for the treatment of sciatica. The guidance stated that current evidence “is inadequate in quantity and quality.”

Also in 2016, NICE updated its guidance on percutaneous disc decompression using coblation for lower back pain and sciatica. NICE stated: “Current evidence on percutaneous coblation of the intervertebral disc for low back pain and sciatica raises no major safety concerns. The evidence on efficacy is adequate and includes large numbers of patients with appropriate follow-up periods.” The guidance also noted that the patient should be informed of the range of treatment options available.

American Society of Interventional Pain Physicians

Practice guidelines on lumber disc compression and chronic spinal pain were published in 2009 and updated in 2013, respectively, by the American Society of Interventional Pain Physicians. The systematic reviews informing the 2013 guidelines found limited evidence for percutaneous laser disc decompression and limited to fair evidence for nucleoplasty.

North American Spine Society

In 2012, the North American Spine Society (NASS) released clinical practice guidelines on the diagnosis and treatment of lumbar disc herniation with radiculopathy. NASS stated, "there is insufficient evidence to make a recommendation for or against the use of plasma disc decompression/nucleoplasty in the treatment of patients with lumbar disc herniation with radiculopathy."

U.S Preventive Services Task Force Recommendations

Not Applicable.

KEY WORDS:

Nucleoplasty, Perc-D SpineWand, chemonucleolysis, percutaneous laser discectomy, percutaneous lumbar discectomy, ArthroCare, radiofrequency coablation, contained disc herniation.

APPROVED BY GOVERNING BODIES:

A number of laser devices have received U.S. Food and Drug Administration (FDA) 510(k) clearance for incision, excision, resection, ablation, vaporization, and coagulation of tissue. Intended uses described in FDA summaries include a wide variety of procedures, including percutaneous discectomy. Trimedyne, Inc. received 510(k) clearance in 2002 for the Trimedyne® Holmium Laser System Ho1mium:Yttrium Aluminum Garnet (Ho1mium:YAG), Revolix Duo™ Laser System in 2007, and Quanta System LITHO Laser System in 2009. All were cleared, based on equivalence with predicate devices for percutaneous laser disc decompression/discectomy, including foraminoplasty, percutaneous cervical disc decompression/discectomy, and percutaneous thoracic disc decompression/discectomy. The summary for the Trimedyne system states that indications for cervical and thoracic decompression/discectomy include uncomplicated ruptured or herniated discs, sensory changes, imaging consistent with findings, and symptoms unresponsive to 12 weeks of conservative treatment. Indications for treatment of cervical discs also include positive nerve conduction studies. FDA product code: GEX.

In 2001, the Perc-D SpineWand™ (ArthroCare) was cleared for marketing by FDA through the 510(k) process. FDA determined that this device was substantially equivalent to predicate devices. It is used in conjunction with the Arthrocare Coblation® System 2000 for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs. Smith and Nephew acquired ArthroCare in 2014; as of 2024, Smith & Nephew has not provided any information about coblation devices specific to spine surgeries on its website.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING: 

CPT codes:

REFERENCES:

1. Birnbaum K. Percutaneous cervical disc decompression. Surg Radiol Anat 2009; 31(5):379-387.
2. 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.
3. Chen CH, Chiu YP, Ji HR, et al. Analysis of the clinical and radiological outcomes of percutaneous cervical nucleoplasty: A case-control study. PLoS One. 2022; 17(12): e0278883. 
4. 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.
5. Choy DS. Percutaneous laser disc decompression: an update. Photomed Laser Surg 2004; 22(5):393-406.
6. 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.
7. 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. Nov 2020; 23(6): 553-564.
8. 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.
9. Gibson JN, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane Database Syst Rev 2007; (2):CD001350.
10. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
11. 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-S283.
12. 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.
13. 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.
14. Menchetti PP, Canero G, Bini W. Percutaneous laser discectomy: experience and long term follow-up. Acta Neurochir Suppl 2011; 108:117-121.
15. National Institute for Health and Care Excellence (NICE). Epiduroscopic lumbar discectomy through sacral hiatus for sciatica [IPG570]. 2016; https://www.nice.org.uk/guidance/ipg570.
16. National Institute for Health and Care Excellence (NICE). Percutaneous coblation of the intervertebral disc for low back pain and sciatica [IPG543]. 2016; https://www.nice.org.uk/guidance/ipg543.
17. North American Spine Society. Clinical guidelines for diagnosis and treatment of lumbar disc herniation with radiculopathy. 2012; https://www.spine.org/Portals/0/Assets/Downloads/ResearchClinicalCare/Guidelines/LumbarDiscHerniation.pdf.
18. 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.
19. Singh V, Manchikanti L, Calodney AK et al. Percutaneous lumbar laser disc decompression: an update of current evidence. Pain Physician 2013; 16(2 Suppl):SE229-260.
20. 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.

POLICY HISTORY:

Medical Policy Group, January 2003, (1)

Medical Policy Administration Committee, January 2003

Available for comment February 6-March 24, 2003

Medical Policy Group, January 2005 (1)

Medical Policy Administration Committee, April 2005

Available for comment April 12-May 26, 2005

Medical Policy Group, January 2007 (1)

Medical Policy Group, July 2007 (1)

Medical Policy Administration Committee, July 2007

Available for comment July 27-September 10, 2007

Medical Policy Group, April 2008 (1)

Medical Policy Group, June 2009 (1)

Medical Policy Administration Committee, July 2009

Available for comment July 1-August 14, 2009

Medical Policy Group, July 2010, (1): Key Points updated, Description updated, Reference added

Medical Policy Group, December 2011 (1): 2012 Code Updates – Verbiage change to Code 62287

Medical Policy Group, July 2012 (4): Updated description, Key Points and References, Updated coding section, No changes to policy section were made.

Medical Policy Group, July 2013 (4): 2013 Updates to Key Points and References

Medical Policy Panel, July 2014

Medical Policy Group, July 2014 (4): Updated Key Points. No changes to the policy at this time.

Medical Policy Panel, 2015

Medical Policy Group, July 2015 (2): 2015 Update to Description and Key Points; no change to policy statement.

Medical Policy Group, December 2016: 2017 Annual Coding Update.  Updated revised verbiage for cpt code 62287.

Medical Policy Panel, January 2017

Medical Policy Group, January 2017 (7): Updates to Description and Key Points, no new References added; no change to policy statement.

Medical Policy Group, August 2017 (7): Removed Previous Coding Section: 76003, 0062T 0063T.

Medical Policy Panel, April 2018

Medical Policy Group, May 2018 (7): Updates to Description, Key Points, Approved by Governing Bodies and References; no change to policy statement.

Medical Policy Panel, April 2019

Medical Policy Group, April 2019 (7): Minor update to Key Points. No new literature to add. No change to policy statement.

Medical Policy Panel, April 2020

Medical Policy Group, May 2020 (7): Minor update to Key Points. No new literature to add. No change to policy statement.

Medical Policy Panel, April 2021

Medical Policy Group, April 2022 (7): Update to Key Points and References. Removed not medically necessary from statement from Policy Section. No change in policy intent.

Medical Policy Panel, April 2023

Medical Policy Group, April 2023 (7): Update to Key Points, Benefit Application, and References. No change to Policy Statement.

Medical Policy Panel, April 2024

Medical Policy Group, April 2024 (7): Minor update to Key Points and Approved by Governing Bodies. No new references added. No change to policy statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.

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