BlueCross BlueShield of Tennessee Medical Policy Manual

Intervertebral Disc Decompression using Radiofrequency Coblation (Nucleoplasty) or Laser Energy (Laser Discectomy)

DESCRIPTION

A variety of minimally invasive techniques have been investigated over the years as a treatment of low back pain related to disc disease. Techniques can be broadly divided into those that are designed to remove or ablate disc material which results in the decompression of the disc [e.g. laser disc decompression and radiofrequency coblation (nucleoplasty)] or those that are designed to alter the biomechanics of the disc annulus. [e.g., intradiscal electrothermal annuloplasty (IDET procedure) and the percutaneous intradiscal radiofrequency thermocoagulation (PIRFT)]. It should be noted that three of these procedures use radiofrequency energy - disc nucleoplasty, IDET, and PIRFT - but apply the energy in distinctly different ways such that the procedures are unique.

The DISC nucleoplasty™ procedure uses bipolar radiofrequency energy in a process referred to as coblation technology. The technique consists of small, multiple electrodes that emit a fraction of the energy required by traditional radiofrequency energy systems. The result is that a portion of nucleus tissue is ablated not with heat, but with a low-temperature plasma field of ionized particles. These particles have sufficient energy to break organic molecular bonds within tissue, creating small channels in the disc. The proposed advantage of this coblation technology is that the procedure provides for a controlled and highly localized ablation, resulting in minimal damage to surrounding tissue.

For laser disc decompression/discectomy a needle or catheter is inserted into the disc nucleus under fluoroscopic guidance, and a laser beam is directed through it to vaporize tissue. A variety of different lasers have been investigated for laser disc decompression, 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.

Examples of devices used for percutaneous disc decompression by laser or radiofrequency are: ArthroCare® Orthopedic Electrosurgery System, Quanta System LITHO Laser System, Radionics RF Disc Catheter Electrode System®, YAG Laser System. and the RevoLix Duo Laser System.

Techniques that alter the biomechanics of the disc annulus (IDET and PIRFT) are addressed in a separate policy.

POLICY

See also:

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

Percutaneous disc decompression and treatment of associated low back pain using low-temperature, localized, radiofrequency is relatively new technology, with minimal published literature and no controlled trials.

The American Pain Society reported in the 2013 clinical practice guidelines on nonsurgical interventions for low back pain, stating that there is poor evidence from randomized trials due to conflicting trials, sparse and lower quality data, or no randomized trials to reliably evaluate a number of interventions including coblation.

SOURCES 

American Society of Anesthesiologists and American Society of Regional Anesthesia and Pain Medicine. (2010, April). Practice guidelines for chronic pain management. An updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Retrieved January 21, 2011 from http://www.guidelines.gov.

BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2015). Decompression of intervertebral disc using laser (laser discectomy) or radiofrequency coblation (nucleoplasty) (7.01.93). Retrieved September 17, 2015 from BlueWeb. (25 articles and/or guidelines reviewed)

Centers for Medicare & Medicaid Services. CMS.gov. NCD for thermal intradiscal procedures (TIPs) (150.11). Retrieved September 17, 2015 from http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx?from2=search1.asp&.

Chou, R., Atlas, S. J., Stanos, S. P., Stanos, S. P., & Rosenquist, R. W. (2009). Nonsurgical interventional therapies for low back pain: A review of the evidence for an American Pain Society clinical practice guideline. Spine, 34 (10), 1078-1093. (Level 1 evidence - Independent)

ECRI Institute. Custom Rapid Reviews - Guidance. (2014, August). Laser discectomy for treating herniated lumbar discs. Retrieved September 17, 2015 from ECRI Institute. (18 articles and/or guidelines reviewed)

ECRI Institute. Health Technology Information Service. Evidence Reports. (2010, April). Radiofrequency ablation for chronic spinal pain. Retrieved August 29, 2012 from ECRI Institute. (250 articles and/or guidelines reviewed)

Eichen, P., Achilles, N., Konig, V., Mosges, R., Hellmich, M., Himpe, B., et al. (2014). Nucleoplasty, a minimally invasive procedure for disc decompression: A systematic review and meta-analysis of published clinical studies. Pain Physician, 2014 (17), E149-E173.

Manchikanti, L., Abdi, S., Atluri, S., Benyamin, R., Boswell, M., Buenaventura, R., et al. (2013). An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician, 16 (2 Suppl), S49-S283.

National Institute for Health and Clinical Excellence (NICE). (2009, May). Percutaneous endoscopic laser lumbar discectomy. Retrieved August 29, 2012 from http://www.nice.org.uk/nicemedia/live/12073/44256/44256.pdf.

North American Spine Society. (2012).Clinical guidelines for diagnosis and treatment of lumbar disc herniation with radiculopathy. Retrieved September 17, 2015 from the National Guideline Clearinghouse.

Singh, V., Manchikanti, L., Benyamin, R. M., Helm, S., & Hirch, J. A. (2009). Percutaneous lumbar laser disc decompression: A systematic review of current evidence. Pain Physician, 12 (3), 573-588.

U. S. Food and Drug Administration. (2000, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K000044. Retrieved January 21, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf/K000044.pdf.

U. S. Food and Drug Administration. (2000, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K001741. Retrieved January 21, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf/K001741.pdf.

U. S. Food and Drug Administration. (2007, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K070466. Retrieved January 21, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/K070466.pdf.

U. S. Food and Drug Administration. (2009, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K091909. Retrieved January 21, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K091909.pdf.

ORIGINAL EFFECTIVE DATE:  6/1/2004

MOST RECENT REVIEW DATE:  10/22/2015

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