Medical Policy: 07.01.58
Original Effective Date: July 2002
Reviewed: August 2016
Revised: August 2016
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy 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 will be reviewed regularly and be updated as scientific
and medical literature becomes available.
A variety of terms may be used to describe percutaneous radiofrequency denervation including radiofrequency ablation (RFA), non-pulsed radiofrequency, radiofrequency neuroablation, radiofrequency lesioning, radiofrequency neurotomy, radiofrequency facet rhizotomy and radiofrequency articular rhizolysis.
The facet joints, also known as apophyseal or zygapophyseal joints, are formed by the superior and inferior articular processes of sequential vertebrae. The nerves that communicate with these joints sometimes become inflamed or impinged, which leads to facet joint pain.
Percutaneous radiofrequency facet joint ablation/denervation is used to treat neck or back pain originating in the facet joints with degenerative changes. Diagnosis of facet joint pain is confirmed by a positive response from at least two diagnostic blocks i.e. facet joint injections or medial branch block. The goal of facet joint denervation is long-term pain relief. However, the nerve(s) regenerate, and repeat procedures may be required.
Radiofrequency facet joint denervation is performed under local anesthetic with fluoroscopic guidance. A percutaneously introduced electrode applies heat from radio waves to selectively destroy sensory afferent nerve fibers, thereby interrupting pain signals from a specific site. A minimum of two levels must be addressed to ablate/denervate a single joint. Radiofreqency (RF) denervation is directed at each of the levels to be lesioned. Destruction of the nerve may be permanent or temporary. In some cases, the treated nerve repairs itself and becomes less irritable, thus resulting in continued resolution of the pain. In cases where the pain returns, the procedure can be repeated in the same joint.
Based on the peer reviewed medical literature there is insufficient evidence of high quality data evaluating the safety and effectiveness of treatment with radiofrequency ablation/denervation in the thoracic facet joints for chronic pain. Additional well designed comparative studies are needed to determine the effects of this technology on health outcomes. Therefore, radiofrequency denervation for thoracic facet joint pain is considered investigational.
Radiofrequency Ablation/Denervation of Sacroiliac Joint Pain
Similar to other structures in the spine, it is assumed that the sacroiliac joint may be a source of low back pain. In fact, before 1928, the sacroiliac joint was thought to be the most common cause of sciatica. In 1928, as the role of intervertebral disc became more clear, and from that point forward, the sacroiliac joint received less research attention.
Research into sacroiliac joint pain has been thwarted by any criterion standard to measure its prevalence and against which various clinical examinations can be validated. For example, sacroiliac joint pain is typically without any consistent, demonstrable radiography or laboratory features and most commonly exists in the setting of morphologically normal joints. Clinical tests for sacroiliac joint pain may include various movement tests, palpation to detect tenderness, and pain descriptions by the patient. Further confounding study of the sacroiliac joint is that multiple structures, such as posterior facet joints and lumbar discs, may refer pain the area surrounding the sacroiliac joint. Treatments being investigated for sacroiliac joint pain include radiofrequency ablation/denervation.
The literature on radiofrequency ablation/denervation of the sacroiliac joint is limited. There are two small randomized controlled trials (RCTs) that report short term benefit, but these are insufficient to determine the overall effect on health outcomes. Further high quality controlled trials are needed that compare this procedure in defined populations with placebo and with alternative treatments. The current evidence on sacroiliac joint radiofrequency ablation/denervation is insufficient to permit conclusions regarding the effect of this procedure on health outcomes and therefore is considered investigational for the treatment of sacroiliac joint pain.
Radiofrequency Ablation/Denervation of Cervical Facet Joints for Occipital Neuralgia and Chronic Headaches
The available evidence from the smaller number of studies published in the peer reviewed literature is insufficient to conclude that ablative treatment to the cervical facet joint is an effective treatment for occipital neuralgia and chronic headaches (including but not limited to cervicogenic headache, migraines, cluster headaches, tension headaches). The limited data suggests that some patients may obtain short term relief from the use of ablative treatment along with the reduction of pain, however, the long term efficacy remains unknown.
Alternative Methods of Ablation/Denervation in the Treatment of Facet Joint and Sacroiliac Joint Pain
Alternative methods of ablation/denervation in the treatment of facet joint and sacroiliac joint pain including but not limited to the following: laser denervation, chemical neurolysis (chemodenervation) (e.g. alcohol, phenol or high concentrations local anesthetic), cryodenervation (cryoablation), pulsed radiofrequency denervation and cooled radiofrequency denervation based on the peer reviewed medical literature long term controlled studies are lacking, additional studies are needed to establish safety and long term efficacy to support the use of these methods and therefore, these techniques are considered investigational.
Practice Guidelines and Position Statements
The American Society of Interventional Pain Physicians (ASIPP)
Update of Comprehensive Evidence Based Guidelines for Interventional Techniques in Chronic Spinal Pain. 2013 Guidance and Recommendations:
Management of Neck Pain
Therapeutic Cervical Facet Joint Interventions
- The evidence is fair for cervical radiofrequency neurotomy and cervical medial branch blocks, and limited for cervical intra-articular injections.
- Conventional radiofrequency neurotomy or therapeutic facet joint nerve blocks are recommended in managing chronic neck pain after the appropriate diagnosis from controlled diagnostic blocks.
Management of Low Back Pain
Therapeutic Lumbar Facet Joint Interventions
- The evidence for lumbar conventional radiofrequency neurotomy is good; limited for pulsed radiofrequency neurotomy; fair to good for lumbar facet joint nerve blocks, and limited for intra-articular blocks.
Therapeutic Sacroiliac Joint Interventions
- The evidence is limited for both pulsed radiofrequency and conventional radiofrequency neurotomy
Management of Thoracic Pain
- Radiofrequency neurotomy and conventional radiofrequency neurotomy may be performed on emerging evidence.
American Academy of Neurology
In 2012 the American Academy of Neurology and the American Headache Society issued and evidence based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults which does not mention local injection therapies, ablative treatments, electrical stimulation or neurosurgeries as complimentary treatments for migraines.
A number of radiofrequency generators and probes have been cleared for marketing through the U.S. Food and Drug Administration’s (FDA) 510(k) process. One device, the Sinergy by Kimberly Clark/Baylis, is a water cooled single use probe that received FDA clearance in 2005, listing the Baylis Pain Management Probe as a predicate device. The intended use is in conjunction with a radiofrequency generator to create radiofrequency lesions in nervous tissue.
Prior approval is required.
See Related Medical Policies
Radiofrequency ablation (RFA/denervation is considered investigational for the treatment of thoracic facet joint pain or sacroiliac joint pain.
The peer reviewed medical literature regarding radiofrequency ablation (RFA)/denervation for the treatment of thoracic facet joint and sacroiliac joint pain is limited, there is insufficient evidence regarding the safety and efficacy, and further high quality controlled trials are needed that compare these procedures in defined populations with placebo and with alternative treatments. Therefore, radiofrequency ablation (RFA)/denervation for treatment of thoracic facet joint and sacroiliac joint pain is considered investigational.
Radiofrequency ablation (RFA) of the cervical facet joints for the treatment of chronic headaches (including but not limited to cervicogenic headache, migraines, cluster headaches, tension headaches) or occipital neuralgia is considered investigational because the safety and effectiveness for these indications has not been established.
All other methods of ablation/denervation for the treatment of chronic neck and spinal/back pain, including but not limited to facet joint or sacroiliac joint pain are considered investigational (not an all-inclusive list):
- Laser denervation,
- Chemical neurolysis (chemodenervation) (e.g. alcohol, phenol, or high concentrations local anesthetics)
- Cryodenervation (cryoablation)
- Cooled radiofrequency ablation/denervation
- Pulsed radiofrequency ablation/denervation
Based on the peer reviewed medical literature there is insufficient evidence to evaluate the safety and effectiveness of these other methods of denervation for facet joint and sacroiliac joint pain. Long term controlled studies are lacking and additional studies are needed to establish safety and long term efficacy to support the use of these methods in the treatment of facet joint and sacroiliac joint pain and therefore, these techniques are considered investigational.
Procedure Codes and Billing Guidelines:
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 64633 Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); cervical or thoracic, single facet joint
- 64635 Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); lumbar or sacral, single facet joint
- Tzaan W-C, Taskere RR. Percutaneous radiofrequency facet rhizotomy-experience with 118 procedures and reappraisal of its value. Canadian Journal of Neurological Sciences 2002;27:125-130.
- Manchikanti L. Facet joint pain and the role of neural blockade in its management. Current Review of Pain 1999;3:348-358.
- Dreyfuss P, Halbrook B, Pauza K, Joshi A, McLarty J, Bogduk N. Efficacy and validity of radiofrequency neurotomy for chronic lumbar zygapophysial joint pain. Spine 2000;25:1270-1277.
- McDonald GJ, Lord SM, Bogduk N. Long-term follow-up of patients treated with cervical radiofrequency neurotomy of chronic neck pain. Neurosurgery1999;45(1):61-68.
- Van Kleef et al. Randomized trial of RF lumber facet denervation for chronic low back pain. Spine 1999;24(18):1937-1942.
- Lord SM, Barnsley L, Wallis BJ et al. RF neurotomy in chronic ZA pain. New England Journal of Medicine 1996.
- Gallagher J. et al. RF facet joint denervation in treatment of LBP: Prospective controlled double blind study. Pain Clinic 1994'7:193-198.
- Ban Wijk, de al. Proven efficacy of RF for cervical and lumber ZA pain. 2001
- Pevsner Y, Shabat S, Catz A, Folman Y, Gepstein R.: The role of radiofrequency in the treatment of mechanical pain of spinal origin. Eur Spine J. 2003 Oct 28 [Epub ahead of print].
- ECRI Institute External SiteRadiofrequency Neuroablation for Low Back Pain. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 May 19. 13p. (ECRI Hotline Response).
- Boswell MV et al. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician 2007 Jan;10(1):7-111.
- ECRI Institute External SiteRadiofrequency Neuroablation for Low-back Pain. Plymouth Meeting (PA): ECRI Institute; 2009 Sept 30. 12 p. [ECRI hotline response].
- ECRI Institute External SiteRadiofrequency Neuroablation for Low-back Pain. Plymouth Meeting (PA): ECRI Institute; 2010 Jul 2111 p. [ECRI hotline response]. Also available at the American Society of Anesthesiologists Task Force on Chronic Pain Management, American Society of Regional Anesthesia and Pain Medicine. 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. Anesthesiology 2010 Apr;112(4):810-33.
- Chua NH, Vissers KC, Sluijter ME. Pulsed radiofrequency treatment in interventional pain management: mechanism and potential indications-a review. Acta Neurochir. 2011 Apr;153(4):763-71.
- Patel N, Gross A, Brown L, Gekht G. A Randomized, Placebo-Controlled Study to Assess the Efficacy of Lateral Branch Neurotomy for Chronic Sacroiliac Joint Pain. Pain Medicine 2012;13:383-398.
- ECRI Institute External SiteRadiofrequency Denervation for Low-back Pain. Plymouth Meeting (PA): ECRI Institute; 2011 August 8. [Hotline Response].
- ECRI Institute External Site2012 October, Hotline Response, Radiofrequency Denervation for Treating Chronic Low Back Pain.
- American Society of Interventional Pain Physicians (ASIPP). 2013 Practice Guidelines for Chronic Spinal Pain.
- 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
- UpToDate® External Site Subacute and chronic low back pain: nonsurgical interventional treatment. September 2013.
- Chou Roger M.D., Loeser John D, M.D., et. al., Interventional Therapies, Surgery and Interdisciplinary Rehabilitation for Low Back Pain an Evidence Based Clinical Practice Guideline from the American Pain Society. Spine Volume 34, Number 10, pp 1066-1077
- National Guideline Clearinghouse Cervical and Thoracic Spine Disorders, American College of Occupational and Environmental Medicine (ACOEM); 2011 p. 1-332
- Medscape External SiteRadiofrequency Treatment in Chronic Pain.
- Gupta Anita D.O., PharmD, Evidence Based Review of Radiofrequency Ablation Techniques for Chronic Sacral Iliac Joint Pain, PainMedicine News June 2010
- UpToDate® External SiteTreatment of Neck Pain, Zacharia Isaac, M.D., Topic last updated March 16, 2015.
- UpToDate® External SiteSubacute and Chronic Low Back Pain: Nonsurgical Interventional Treatment, Roger Chou, M.D., Topic last updated May 13, 2014.
- Kok-Yuen Ho, Mohamed Abdul Hadi, et. al. Cooled Radiofrequency Denervation for Treatment of Sacroiliac Joint Pain: Two Year Results from 20 Cases, J Pain Res. 2013; 6:505511
- Stelzer Wolfgang M.D, Aiglesberger Michael, BScN, et. al. Use of Cooled Radiofrequency Lateral Branch Neurotomy for the Treatment of Sacroiliac Joint Mediated Low Back Pain: A Large Case Series, Pain Medicine, Volume 14, Issue 1 pages 29-35, January 2013
- Patel Nilesh M.D., Gross Andrew M.D. et. al, A Randomized, Placebo Controlled Study to Assess the Efficacy of Lateral Branch Neurotomy for Chronic Sacroiliac Joint Pain, Pain Medicine Volume 13, Issue 3, Pages 383-398 March 2012
- Haktan Karaman, Gonul Olmex Kavak, et. al. Cooled Radiofrequency for Treatment of Sacroiliac Joint Pain, Acta Neurochirurugica, July 2011, Volume 153, Issue 7, pages 1461-1468
- American Acadey of Neurology and American Headache Society, Evidence Based Guideline Update: NSAIDs and other Complementary Treatments for Episodic Migraine Prevention in Adults. Neurology 2012;78:1346-1363
- Falco FJ, Datta S, Manchikanti L, et al. An updated review of the diagnostic utility of cervical facet joint injections. Pain Physician. Nov-Dec 2012;15(6):E807-838. PMID 23159977
- Falco FJ, Manchikanti L, Datta S, et al. Systematic review of the therapeutic effectiveness of cervical facet joint interventions: an update. Pain Physician. Nov-Dec 2012;15(6):E839-868. PMID 23159978
- Falco FJ, Manchikanti L, Datta S, et al. An update of the systematic assessment of the diagnostic accuracy of lumbar facet joint nerve blocks. Pain Physician. Nov-Dec 2012;15(6):E869-907. PMID 23159979
- Falco FJ, Manchikanti L, Datta S, et al. An update of the effectiveness of therapeutic lumbar facet joint interventions. Pain Physician. Nov-Dec 2012;15(6):E909-953. PMID 23159980
- Boswell MV, Manchikanti L, Kaye AD, et al. A best-evidence systematic appraisal of the diagnostic accuracy and utility of facet (zygapophysial) joint injections in chronic spinal pain. Pain Physician. Jul-Aug 2015;18(4):E497-533. PMID 26218947
- Cohen SP, Strassels SA, Kurihara C, et al. Randomized study assessing the accuracy of cervical facet joint nerve (medial branch) blocks using different injectate volumes. Anesthesiology. Jan 2010;112(1):144-152. PMID 19996954
- Cohen SP, Stojanovic MP, Crooks M, et al. Lumbar zygapophysial (facet) joint radiofrequency denervation success as a function of pain relief during diagnostic medial branch blocks: a multicenter analysis. Spine J. May-Jun 2008;8(3):498-504. PMID 17662665
- Pampati S, Cash KA, Manchikanti L. Accuracy of diagnostic lumbar facet joint nerve blocks: a 2-year follow-up of 152 patients diagnosed with controlled diagnostic blocks. Pain Physician. Sep-Oct 2009;12(5):855-866. PMID 19787011
- Manchikanti L, Pampati S, Cash KA. Making sense of the accuracy of diagnostic lumbar facet joint nerve blocks: an assessment of the implications of 50% relief, 80% relief, single block, or controlled diagnostic blocks. Pain Physician. Mar-Apr 2010;13(2):133-143. PMID 20309379
- Manchikanti L, Kaye AD, Boswell MV, et al. A systematic review and best evidence synthesis of the effectiveness of therapeutic facet joint interventions in managing chronic spinal pain. Pain Physician. Jul-Aug 2015;18(4):E535-582. PMID 26218948
- Civelek E, Cansever T, Kabatas S, et al. Comparison of effectiveness of facet joint injection and radiofrequency denervation in chronic low back pain. Turk Neurosurg. 2012;22(2):200-206. PMID 22437295
- Lakemeier S, Lind M, Schultz W, et al. A comparison of intraarticular lumbar facet joint steroid injections and lumbar facet joint radiofrequency denervation in the treatment of low back pain: a randomized, controlled, double-blind trial. Anesth Analg. Jul 2013;117(1):228-235. PMID 23632051
- Nath S, Nath CA, Pettersson K. Percutaneous lumbar zygapophysial (facet) joint neurotomy using radiofrequency current, in the management of chronic low back pain: a randomized double-blind trial. Spine (Phila Pa 1976). May 20 2008;33(12):1291-1297; discussion 1298. PMID 18496338
- van Wijk RM, Geurts JW, Wynne HJ, et al. Radiofrequency denervation of lumbar facet joints in the treatment of chronic low back pain: a randomized, double-blind, sham lesion-controlled trial. Clin J Pain. Jul-Aug 2005;21(4):335-344. PMID 15951652
- Haspeslagh SR, Van Suijlekom HA, Lame IE, et al. Randomised controlled trial of cervical radiofrequency lesions as a treatment for cervicogenic headache [ISRCTN07444684]. BMC Anesthesiol. 2006;6:1. PMID 16483374
- Husted DS, Orton D, Schofferman J, et al. Effectiveness of repeated radiofrequency neurotomy for cervical facet joint pain. J Spinal Disord Tech. Aug 2008;21(6):406-408. PMID 18679094
- Schofferman J, Kine G. Effectiveness of repeated radiofrequency neurotomy for lumbar facet pain. Spine (Phila Pa 1976). Nov 1 2004;29(21):2471-2473. PMID 15507813
- Rambaransingh B, Stanford G, Burnham R. The effect of repeated zygapophysial joint radiofrequency neurotomy on pain, disability, and improvement duration. Pain Med. Sep 2010;11(9):1343-1347. PMID 20667024
- Smuck M, Crisostomo RA, Trivedi K, et al. Success of initial and repeated medial branch neurotomy for zygapophysial joint pain: a systematic review. PM R. Sep 2012;4(9):686-692. PMID 22980421
- Hashemi M, Hashemian M, Mohajerani SA, et al. Effect of pulsed radiofrequency in treatment of facet-joint origin back pain in patients with degenerative spondylolisthesis. Eur Spine J. Sep 2014;23(9):1927-1932. PMID 24997616
- Van Zundert J, Patijn J, Kessels A, et al. Pulsed radiofrequency adjacent to the cervical dorsal root ganglion in chronic cervical radicular pain: a double blind sham controlled randomized clinical trial. Pain. Jan 2007;127(1-2):173-182. PMID 17055165
- Tekin I, Mirzai H, Ok G, et al. A comparison of conventional and pulsed radiofrequency denervation in the treatment of chronic facet joint pain. Clin J Pain. Jul-Aug 2007;23(6):524-529. PMID 17575493
- Kroll HR, Kim D, Danic MJ, et al. A randomized, double-blind, prospective study comparing the efficacy of continuous versus pulsed radiofrequency in the treatment of lumbar facet syndrome. J Clin Anesth. Nov 2008;20(7):534-537. PMID 19041042
- Joo YC, Park JY, Kim KH. Comparison of alcohol ablation with repeated thermal radiofrequency ablation in medial branch neurotomy for the treatment of recurrent thoracolumbar facet joint pain. J Anesth. Jun 2013;27(3):390-395. PMID 23192698
- Haufe SM, Mork AR. Endoscopic facet debridement for the treatment of facet arthritic pain--a novel new technique. Int J Med Sci. 2010;7(3):120-123. PMID 20567612
- Manchikanti L, Singh V, Falco FJ, et al. Comparative outcomes of a 2-year follow-up of cervical medial branch blocks in management of chronic neck pain: a randomized, double-blind controlled trial. Pain Physician. Sep-Oct 2010;13(5):437-450. PMID 20859313
- Manchikanti L, Singh V, Falco FJ, et al. Evaluation of lumbar facet joint nerve blocks in managing chronic low back pain: a randomized, double-blind, controlled trial with a 2-year follow-up. Int J Med Sci. 2010;7(3):124-135. PMID 20567613
- Manchikanti L, Singh V, Falco FJ, et al. Comparative effectiveness of a one-year follow-up of thoracic medial branch blocks in management of chronic thoracic pain: a randomized, double-blind active controlled trial. Pain Physician. Nov-Dec 2010;13(6):535-548. PMID 21102966
- Manchikanti L, Singh V, Falco FJ, et al. The role of thoracic medial branch blocks in managing chronic mid and upper back pain: a randomized, double-blind, active-control trial with a 2-year followup. Anesthesiol Res Pract. 2012;2012:585806. PMID 22851967
- Watters WC, 3rd, Resnick DK, Eck JC, et al. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 13: injection therapies, low-back pain, and lumbar fusion. J Neurosurg Spine. 2014; 21(1):79-90. 2014/07/02:http://thejns.org/doi/abs/10.3171/2014.4.SPINE14281.
- American Society of Anesthesiologists Task Force on Chronic Pain Management, American Society of Regional Anesthesia and Pain Medicine. 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. Anesthesiology. Apr 2010;112(4):810-833. PMID 20124882
- National Institute for Health and Clinical Excellence External Site (NICE). Early management of non-specific low back pain. Clinical guideline 88 2009.
- California Technology Assessment Forum External Site (CTAF). Percutaneous radiofrequency neurotomy for treatment of chronic pain from the upper cervical (C2-3) spine. A Technology Assessment 2007.
- Aydin SM, Gharibo CG, Mehnert M, et al. The role of radiofrequency ablation for sacroiliac joint pain: a metaanalysis. PM R. Sep 2010;2(9):842-851. PMID 20869684
- Cohen SP, Hurley RW, Buckenmaier CC, 3rd, et al. Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint pain. Anesthesiology. Aug 2008;109(2):279-288. PMID 18648237
- Patel N. Twelve-Month Follow-Up of a Randomized Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Region Pain. Pain Pract. Jan 7 2015. PMID 25565322
- Zheng Y, Gu M, Shi D, et al. Tomography-guided palisade sacroiliac joint radiofrequency neurotomy versus celecoxib for ankylosing spondylitis: a open-label, randomized, and controlled trial. Rheumatol Int. Sep 2014;34(9):1195-1202. PMID 24518967
- August 2016 - Annual Review, Policy Revised
- May 2016 - Annual review, Policy Revised
- November 2015 - Interim review, Policy Revised
- September 2015 - Interim review, Policy Revised
- June 2015 - Annual review, Policy Revised
- July 2014 - Annual review, Policy Renewed
- September 2013 - New Policy
- September 1, 2012 - Policy Retired
- April 2012, Annual review, Policy Renewed
- May 2011, Annual review, Policy Renewed
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