Medical Policy: 07.01.58
Original Effective Date: July 2002
Reviewed: June 2015
Revised: November 2015
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.
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 difficult and typically is confirmed by a positive response from nerve blocks. The goal of facet joint denervation is long-term pain relief. However, the nerve(s) regenerate, and repeat procedures may be required.
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 pain.
Prior to having a percutaneous facet joint ablation/denervation procedure, two separate sets of diagnostic paravertebral facet joint nerve blocks are performed to assess the relative contribution of sympathetic and somatosensory nerves in relation to the pain syndrome. A diagnostic nerve block localizes the nerve(s) responsible for the pain or neuromuscular dysfunction, particularly when multiple sources of pain are potentially present. A diagnostic facet joint injection involves fluoroscopy guided injection of local anesthetic with or without steroid into the facet joint or around the nerve supply to the joint (i.e. medial branch nerve). The individual is asked to engage in the activities that had previously precipitated pain, and to evaluate the effect of the procedure at 4 to 8 hours post injection. A temporary or prolonged absence of spinal pain strongly suggest that the facet joint is the source of the symptoms.
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) denvervation 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, following an elapsed time of at least 6 months and a previously positive result from RF denervation, as measured by more than 50% pain relief and associated functional improvement (i.e. related to improvement in work related activities and care for their activities of daily living (ADLs).
Based on the medical literature data indicates that in carefully selected individuals with cervical (C2 thru C7) and lumbar or lumbosacral (L1 thru L5-S1) facet joint pain, percutaneous radiofrequency facet joint ablation/denervation can result in improved outcomes.
The literature on radiofrequency ablation/denervation for thoracic facet joint and sacroiliac joint pain is limited, there is insufficient evidence regarding the safety and effectiveness and additional well designed comparative studies are needed. Therefore, radiofrequency denervation for thoracic facet joint and sacroiliac joint pain is considered investigational.
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.
Additional 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
Repeat radiofrequency ablation (RFA)/denervation of the cervical facet joints (C2 thru C7) and lumbar facet joints (L1 thru L5-S1) may be considered medically necessary when all of the following criteria are met:
- > 6 months has elapsed since the previous radiofrequency ablation (RFA)/denervation (per side, per anatomical level of the spine); and
- More than 50% pain relief has been obtained from the previous RFA/denervation.
If the above medical necessity criteria is not met, the repeat radiofrequency ablation (RFA)/denervation procedure would be considered not medically necessary.
- There should be documentation (progress notes) supporting response to prior RFA treatment.
- If no prior diagnostic medial branch block (MBB) or facet joint injection have ever been done, even if the patient responded well to prior RF ablation/denervation, those ablations/denervations are NOT a substitute for an initial trial of blocks, and, therefore, medial branch blocks (MBB) or facet joint injections would be necessary before RF ablation/denervation is done.
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 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 investigation (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 Sciences2002;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. Radiofrequency Neuroablation for Low Back Pain. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 May 19. 13p. (ECRI Hotline Response). Also available: http://www.ecri.org.
- 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. Radiofrequency Neuroablation for Low-back Pain. Plymouth Meeting (PA): ECRI Institute; 2009 Sept 30. 12 p. [ECRI hotline response]. Also available: http://www.ecri.org.
- ECRI Institute. Radiofrequency Neuroablation for Low-back Pain. Plymouth Meeting (PA): ECRI Institute; 2010 Jul 2111 p. [ECRI hotline response]. Also available: http://www.ecri.org
- 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. Radiofrequency Denervation for Low-back Pain. Plymouth Meeting (PA): ECRI Institute; 2011 August 8. [Hotline Response]. Also available at: http://www.ecri.org.
- ECRI Institute; 2012 October, Hotline Response, Radiofrequency Denervation for Treating Chronic Low Back Pain. Also available at http://www.ecri.org
- 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® Website. Subacute and chronic low back pain: nonsurgical interventional treatment. September 2013. Available at: https://www.uptodate.com/home/index.html
- 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. Radiofrequency Treatment in Chronic Pain. Also available at www.medscape.com/viewarticle/718292
- Gupta Anita D.O., PharmD, Evidence Based Review of Radiofrequency Ablation Techniques for Chronic Sacral Iliac Joint Pain, PainMedicine News June 2010
- UpToDate. Treatment of Neck Pain, Zacharia Isaac, M.D., Topic last updated March 16, 2015. Also available at www.uptodate.com
- UpToDate. Subacute and Chronic Low Back Pain: Nonsurgical Interventional Treatment, Roger Chou, M.D., Topic last updated May 13, 2014. Also available at www.uptodate.com
- 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
Date Reason Action
May 2011 Annual review Renew policy
April 2012 Annual review Renew policy
Policy was retired September 1, 2012
September 2013 New policy
July 2014 Annual review Renew policy
June 2015 Annual review Policy revised
September 2015 Interim review Policy revised
November 2015 Interim review Policy revised
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.