Medical Policy Bulletin

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Title:

Radiofrequency Lesioning of the Spinal Nerves for Chronic Pain

Policy #:

11.15.09b

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The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service. This Medical Policy Bulletin 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 Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.

Intent

The intent of this policy is to communicate the medical necessity criteria for radiofrequency lesioning of the spinal nerves for chronic pain.

For information on policies related to this topic, refer to the Cross References section in this policy.

Description with Scientific Evidence:

The spine is a major source of pain and disability in the adult population. Most back pain resolves with conservative treatment, but a significant group of individuals may develop chronic spinal pain. The causes of chronic back or neck pain are obscure, and imaging techniques are not dependable diagnostic tools. Nerve block studies indicate that non-specific pain is often attributed to disorders of the facet (zygapophyseal) joint; however, non-specific pain is a condition with no clear pathological etiology. Although no definitive treatment is available, radiofrequency (RF) lesioning of the facet joint has been advocated and used with increasing frequency.

RF lesioning (also known as RF ablation, RF facet denervation, RF rhizotomy, facet rhizotomy, and percutaneous RF neurotomy) for disorders of the facet joint is performed in an outpatient setting. The procedure employs a percutaneously introduced electrode that 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 denervate a single joint; RF lesioning 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.

There is significant agreement among experts that the inconsistent outcomes seen in much of the available research were caused by poor technique, inaccurate anatomic location of the electrode, and questionable patient selection. Favorable outcomes are generally reported for RF lesioning studies that are well designed. Moreover, RF lesioning has been common practice in clinical settings for two decades. The American Society of Interventional Pain Physicians (ASIPP) found strong-to-moderate evidence for RF neurotomy as a therapeutic intervention in facet joint pain. Other experts support the use of RF lesioning of the facet joints for relief of chronic neck or back pain in individuals who have failed a course of conservative treatment and who have responded to diagnostic medial branch blocks of the facet joints.

Researchers emphasize that, in order to ensure the success of RF lesioning, there is a need for careful patient selection based on a positive response to medial branch block, an accurate diagnosis, and meticulous technique performed according to best-practice standards. Individuals who would not benefit from RF lesioning include those with radicular syndromes, coagulopathies, cancer, infections or other treatable conditions, and those who are not psychologically stable. The American Society of Anesthesiologists (ASA) suggests that RF lesioning (which should be preceded by a local anesthetic and imaging or electrical stimulation to confirm needle placement) can provide some control of chronic pain and produce a reduction of symptoms. The ASA notes that RF lesioning can be used in a comprehensive approach to pain management, but only as a last resort after other therapies have failed. Conservative treatments directed at the etiology of spinal pain that should be attempted before RF lesioning include, but are not limited to, rest, medication, temporary nerve blocks, injection of steroids, and physical therapy.

Policy

MEDICALLY NECESSARY

Radiofrequency (RF) lesioning of the spinal nerves is considered medically necessary and, therefore, covered when all of the following criteria are met:

• There is a history of severe neck or back pain.
• There is documented failure of a six-month or longer trial of conservative treatments such as rest, physical therapy, and/or medication.
• Other treatable causes of pain (eg, tumors, infections, spinal stenosis, herniated discs, psychiatric etiologies) have been ruled out.
• Pre-procedure diagnostic facet joint injection provides at least a 50 percent reduction of pain.

RF lesioning procedure may be repeated if both of the following medical necessity criteria are met:

• There was a response after the previous RF lesioning procedure of at least a 50 percent relief of pain.
• At least six months have elapsed since the previous RF lesioning procedure.

NOT MEDICALLY NECESSARY

All other uses for radiofrequency lesioning of spinal nerves are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the diagnosis or treatment of illness or injury.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, RF lesioning of the spinal nerves is covered under the medical benefits of the Company’s products when medical necessity criteria in the medical policy are met.

MEDICARE

There is no Medicare coverage criteria addressing this service; therefore, the Company policy is applicable.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

At least one RF device used in RF lesioning of the spinal nerves, the Cool-Tip™ RF System (Radionics, Inc., Burlington, MA), has received 510(k) FDA marketing approval for coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures. This approval was not based on data from clinical trials but on the device's substantial equivalency to other devices already on the market.

References

American Society of Anesthesiologists (ASA). Practice guidelines for chronic pain management. [ASA Web site]. 04/01/97. Available at: http://www.asahq.org/clinical/ChronicPainUpdateGuidelines071609.pdf. Accessed November 5, 2009. Barnsley L. Percutaneous radiofrequency neurotomy for chronic neck pain: outcomes in a series of consecutive patients. Pain Med. 2005;6(4):282-286. Bogduk N. Management of chronic low back pain. Med J Aust. 2004;180(2):79-83. Boswell MV, Colson JD, Sehgal N, Dunbar EE, Epter R. A systematic review of therapeutic facet joint interventions in chronic spinal pain. Pain Physician. 2007;10(1):229-253. Boswell MV, Colson JD, Spillane WF. Therapeutic facet joint interventions in chronic spinal pain: a systematic review of effectiveness and complications. Pain Physician. 2005;8(1):101-114. Boswell MV, Trescot AM, Datta S, et al. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. 2007;10(1):7-111. Also available on the National Guideline Clearinghouse Web site at: http://www.guideline.gov/summary/summary.aspx?doc_id=10531&nbr=005510&string=boswell+AND+shah+AND+everett. Accessed November 5, 2009. Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007;106(3):591-614. 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. 2008;8(3):498-504. Dreyfuss P, Halbrook B, Pauza K, et al. Efficacy and validity of radiofrequency neurotomy for chronic lumbar zygapophysial joint pain. Spine. 2000;25(10):1270-1277. Gofeld M, Jitendra J, Faclier G. Radiofrequency denervation of the lumbar zygapophysial joints: 10-year prospective clinical audit. Pain Physician. 2007;10(2):291-300. Hooten WM, Martin DP, Huntoon MA. Radiofrequency neurotomy for low back pain: evidence-based procedural guidelines. Pain Med. 2005;6(2):129-138. A Husted DS, Orton D, Schofferman J, Kine G. Effectiveness of repeated radiofrequency neurotomy for cervical facet joint pain. J Spinal Disord Tech. 2008;21(6):406-408. Kline MT, Yin W. Radiofrequency techniques in clinical practice. In: Waldman SD, ed. Interventional Pain Management. Philadelphia, PA: WB Saunders Co.; 2001: 249-250; 475. Kornick C, Kramarich SS, Lamer TJ, Todd Sitzmann B. Complications of lumbar facet radiofrequency denervation. Spine. 2004;29(12):1352-1354. Management of chronic pain syndromes: issues and interventions. Pain Med.2005;6 Suppl 1:S1-S20. Also available on the MD Consult Web site at: http://home.mdconsult.com/das/article/body/50430546-2/jorg=journal&source=&sp=15637424&sid=403554003/N/476408/s006ps001.pdf. Accessed November 5, 2009. Manchikanti L, Boswell MV, Singh V, et al. Prevalence of facet joint pain in chronic spinal pain of cervical, thoracic, and lumbar regions. BMC Musculoskelet Disord. 2004;5:15. Manchikanti L, Staats PS, Singh V, et al. Evidence-based practice guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician. 2003;6(1):3-81. McDonald GJ, Lord SM, Bogduk N. Long-term followup of patients treated with cervical radiofrequency neurotomy for chronic neck pain. Neurosurgery. 1999;45(1);61-67. Nath S, Nath CA, Petterson K. Percutaneous lumbar zygapophysial (facet) joint neurotomy using radiofrequency current, in the management of chronic low back pain: a randomized double blind trial. Available at: http://www.medscape.com/viewarticle/574921_5. Accessed November 5, 2009. Orbegozo M, Sizer PS Jr. Facet block and denervation. In: Raj PP, ed. Textbook of Regional Anesthesia. New York, NY: Churchill Livingstone. 2003: 728-729; 959. Schofferman J, Kine G. Effectiveness of repeated radiofrequency neurotomy for lumbar facet pain. Spine. 2004;29(21):2471-2473. US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Cool-Tip™ RF System. [FDA Web site]. Premarket approval letter. 03/15/06. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K053290.pdf. Accessed November 5, 2009. Vad VB, Cano WG, Basrai D, Lutz GE, Bhat AL. Role of radiofrequency denervation in lumbar zygapophyseal joint synovitis in baseball pitchers: a clinical experience. Pain Physician. 2003;6(3):307-312. 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. 2005;21(4):335-344. Wenban AB. Letters. Med J Aust. 2004;181(1):55. (Reply to Bogduk N. Med J Aust. 2004;180(2):79-83.)

Coding Table

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply. The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates. In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

Code System	Code Number(s) and Narrative(s)
CPT	64622, 64623, 64626, 64627
ICD Procedure	N/A
ICD Diagnosis	719.48: Pain in joint, other specified sites 722.4: Degeneration of cervical intervertebral disc 722.51: Degeneration of thoracic or thoracolumbar intervertebral disc 722.52: Degeneration of lumbar or lumbosacral intervertebral disc 722.81: Postlaminectomy syndrome, cervical region 722.82: Postlaminectomy syndrome, thoracic region 722.83: Postlaminectomy syndrome, lumbar region 723.1: Cervicalgia 723.3: Cervicobrachial syndrome (diffuse) 723.4: Brachial neuritis or radiculitis nos 724.1: Pain in thoracic spine 724.2: Lumbago 724.3: Sciatica 724.4: Thoracic or lumbosacral neuritis or radiculitis, unspecified 724.5: Unspecified backache 724.8 Other symptoms referable to back 724.79 Other disorder of coccyx 729.2: Unspecified neuralgia, neuritis, and radiculitis
HCPCS Level II	N/A
Revenue Codes	N/A

Cross References

Version Effective Date: 04/07/2009