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.

A 2009 American Pain Society clinical practice guideline on nonsurgical interventions for low back pain states that “there is insufficient (poor) evidence from randomized trials (conflicting trials, sparse and lower quality data, or no randomized trials) to reliably evaluate a number of interventions including coblation.”

Data from small studies and case series of laser disc decompressions are poor in quantity and quality and should be cautiously interpreted.

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. (7:2013). Decompression of intervertebral disc using laser (laser discectomy) or radiofrequency coblation (nucleoplasty) (7.01.93). Retrieved April 2, 2014 from BlueWeb. (25 articles and/or guidelines reviewed)

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)

Complete Guide to Medicare Coverage Issues [Computer software]. (2013, November). Thermal intradiscal procedures (TIPS) (NCD 150.11, p. 2-75). OptumInsight, Inc.

ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2009, December). Percutaneous disc decompression for cervical disc herniation. Retrieved August 29, 2012 from ECRI Institute. (15 articles and/or guidelines reviewed)

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

Haute, S., Mork, A., Pyne, M., & Baker, R. (2010). Percutaneous laser disc decompression for thoracic disc disease: report of 10 cases. International Journal of Medical Science, 7 (3), 155-159. (Level 3 Evidence - Independent)

Manchikanti, L., Boswell, M., Singh, V., Benyamin, R., Fellows, B., Abdi, S., et al. (2009, July-August). Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician, 12 (4), 699-802.

National Institute for Health and Clinical Excellence (NICE). (2006, May). Percutaneous disc decompression using coblation for lower back pain. Retrieved August 29, 2012 from http://www.nice.org.uk/nicemedia/live/11147/31277/31277.pdf.

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.

Schenk, B., Brouwer, P., Peul, W., & van Buchem, M. (2006). Percutaneous laser disk decompression: A review of the literature. American Journal of Neuroradiology, 27 (1), 232-235. (level 1 Evidence - Independent)

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:  5/22/2014

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