Medical Policy: 07.01.51
Original Effective Date: July 2016
Reviewed: June 2016
Revised: July 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.
“Neurostimulation” and other surgical techniques have been used to treat certain types of headache that are refractory to medications and other therapies. These techniques include occipital nerve stimulation, vagal nerve stimulation (VNS), deep brain stimulation (DBS) and “surgical deactivation” procedures.
The theory of neuromodulation refers to therapeutic alteration of activity, electrically or chemically, in the central, peripheral, or autonomic nervous system via the process of inhibition, stimulation, modification, or other forms of regulation. Occipital nerve stimulation is a form of neuromodulation that is reversible and adjustable and can be tailored to an individual’s specific needs. However, the mechanisms of action for the paresthesia patterns and pain relief obtained from an occipital nerve stimulation is not completely understood.
Occipital nerve stimulation (ONS) delivers a small electrical charge to the occipital nerve in an attempt to prevent migraines and other headaches in patients who have not responded to medications. The device consists of a subcutaneously implanted pulse generator (in the chest wall or abdomen) attached to extension leads that are tunneled to join electrodes placed across one or both occipital nerves at the base of the skull. Continuous or intermittent stimulation may be used.
Prior to permanent implantation, a trial is performed in which leads are placed under the skin and are connected to an external battery. The trial period is typically 4-7 days and the patient keeps a detailed pain diary. A permanent device is considered only if the patient reports significant improvements in pain and quality of life.
There are four types of headache:
- muscle contraction (tension)
Primary (not the result of another condition) chronic headache is defined as headache occurring more than 15 days of the month for at least 3 months. An estimated 45 million Americans experience chronic headaches. For at least half of these people, the problem is severe and sometimes disabling.
Migraine: is the most common type of vascular headache. Migraine headaches are usually characterized by severe pain on one or both sides of the head, an upset stomach, and, at times, disturbed vision. One- year prevalence of migraine ranges from 6%–15% in adult men and from 14%–35% in adult women. Migraine headaches may last a day or more and can strike as often as several times a week or as rarely as once every few years. Drug therapy for migraine is often combined with biofeedback and relaxation training. Sumatriptan is commonly used for relief of symptoms. Drugs used to prevent migraine include methysergide maleate, propranolol hydrochloride, ergotamine tartrate; amitriptyline, valproic acid, and verapamil.
Hemicrania continua: also a vascular headache, causes moderate pain with occasional severe pain on only one side of the head. At least one of the following symptoms must also occur; conjunctival injection and/or lacrimation, nasal congestion and/or rhinorrhea, or ptosis and/or miosis. Headache occurs daily and is continuous with no pain-free periods. Hemicrania continua occurs mainly in woman, and its true prevalence is not known. Indomethacin usually provides rapid relief of symptoms. Other NSAIDs, including ibuprofen, celecoxib, and naproxen, can provide some relief from symptoms. Amitriptyline and other tricyclic antidepressants are effective in some patients.
Cluster headache: is a vascular headache that occurs in cyclical patterns or clusters of severe or very severe unilateral orbital or supraorbital and/or temporal pain. The headache is accompanied by at least one of the following autonomic symptoms: ptosis (drooping eyelid), conjunctival injection, lacrimation, rhinorrhea, and, less commonly, facial blushing, swelling, or sweating. Bouts of one headache every other day to 8 attacks per day may last from weeks to months, usually followed by remission periods when the headache attacks stop completely. The pattern varies from one person to another, but most people have one or two cluster periods a year. During remission, no headaches occur for months, and sometimes even years. The intense pain is caused by the dilation of blood vessels, which creates pressure on the trigeminal nerve. While this process is the immediate cause of the pain, the etiology is not fully understood. It is more common in men than in woman. One-year prevalence is estimated to be 0.5 to 1.0/1,000. Management of cluster headache consists of abortive and preventive treatment. Abortive treatments include subcutaneous injection of sumatriptan, topical anesthetics sprayed into the nasal cavity, and strong coffee. Some patients respond to rapidly inhaled pure oxygen. A variety of other pharmacologic and behavioral methods of aborting and preventing attacks have been reported with wide variation in patient response.
Occipital nerve stimulation (ONS) has been investigated in selected cases of severe occipital neuralgia unresponsive to less invasive measures, but at present it is not a routine therapeutic method. A 2015 systemic review by Sweet et. al. identified 9 small case series (< 15 patients each) assessing the efficacy of ONS for treating medically refractory occipital neuralgia. Based on this information unable to draw conclusions about the impact of ONS on occipital neuralgia due to the lack of RTCs or other controlled studies.
Occipital nerve stimulation (ONS) is being studied for the treatment of fibromyalgia in adults not responsive to initial therapies. Several trials have evaluated the effect of occipital and C2 nerve stimulation, results were positive, but the trials were small and not well-controlled.
Based on peer reviewed medical literature the evidence is insufficient to permit conclusions concerning the impact of occipital nerve stimulation (ONS) on net health outcome for any indication. Randomized clinical trials (RCTs) with greater number of patients and longer follow up are needed. In addition, no implanted occipital nerve stimulators have received U.S. Food and Drug Administration (FDA) approval. Therefore, the use of occipital nerve stimulation (ONS) is considered investigational.
Practice Guidelines and Position Statements:
2013 Guidance from the National Institute for Health and Care Excellence (NICE) states that the evidence on occipital nerve stimulation (ONS) for intractable chronic migraine shows some efficacy in the short term but there is very little evidence about long term outcomes. With regard to safety, there is a risk of complications, needing further surgery. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
Currently, there are no occipital nerve stimulation devices approved or cleared for marketing by the U.S. Food and Drug Administration (FDA).
- Vagus Nerve Stimulation 07.01.60
- Deep Brain Stimulation 07.01.59
- Sacral Nerve Stimulation/Neuromodulation 08.01.21
- Gastric Electrical Stimulation 07.01.62
Occipital nerve stimulation is considered investigational for all indications.
Based on peer reviewed medical literature the evidence is insufficient to permit conclusions concerning the impact of occipital nerve stimulation (ONS) on net health outcome for any indication. Randomized clinical trials (RCTs) with greater number of patients and longer follow up are needed. In addition, no implanted occipital nerve stimulators have received U.S. Food and Drug Administration (FDA) approval. Therefore, the use of occipital nerve stimulation (ONS) would be considered investigational for all indications.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- There is no specific code for this procedure. The following CPT codes may be used.
- 61885 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array
- 61886 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to 2 or more electrode arrays
- 64553 Percutaneous implantation of neurostimulator electrodes; cranial nerve
- 64555 Percutaneous implantation of neurostimulator electrodes; peripheral nerve (excludes sacral nerve)
- 64568 Incision for implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator
64569 Revision or replacement of cranial nerve (eg vagus nerve) neurostimulator electrode array, including connection to existing pulse generator
- 64575 Incision for implantation of neurostimulator electrodes; peripheral nerve (excludes sacral nerve)
64590 Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling
64595 Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver
64999 unlisted procedure, nervous system
- C1767 Generator neurostimulator (implantable) non-rechargeable
- C1778 Lead, neurostimulator
- C1787 Patient programmer, neurostimulator
- C1816 Receiver and/or transmitter neurostimulator (implantable)
- C1820 Generator, neurostimulator (implantable), non high-frequency with rechargeable battery and charging system
- C1822 Generator, neurostimulator (implantable), high frequency, with rechargeable battery and charging system
- C1897 Lead neurostimulator test kit (implantable)
- L8679 Implantable neurostimulator, pulse generator any type
- L8680 Implantable neurostimulator electrode, each
- L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only
- L8682 Implantable neurostimulator radiofrequency receiver
- L8683 Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver
- L8685 Implantable neurostimulator pulse generator, single array, rechargeable includes extension
- L8686 Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension
- L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
- L8688 Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension
- L8689 External recharging system for battery (internal)for use with implantable neurostimulator, replacement only
- Trentman TL, Rosenfeld DM, Vargas BB et al. Greater occipital nerve stimulation via the Bion Microstimulatro; implantation technique and stimulation parameters Clinical Trial: NCT00205894. Pain Physician 2009; 12(3):621-8.
- Schwedt TJ, Dodick DW, Trentman TL et al. Occipital nerve stimulation for chronic headache--long-term safety and efficacy. Cephalalgia 2007; 27(2):153-7.
- Schwedt TJ, Dodick DW, Trentman TL et al. Response to occipital nerve block is not useful in predicting efficacy of occipital nerve stimulation. Cephalalgia 2007; 27(3):271-4.
- Burns B, Watkins L, Goadsby P. Treatment of intractable chronic cluster headache by occipital nerve stimulation in 14 patients. Neurology 2009; 72(4):341-5.
- Burns B, Watkins L, Goadsby P. Treatment of hemicrania continua by occipital nerve stimulation with a bion device: long-term follow-up of a crossover study. Lancet Neurol 2008; 7(11):1001-12.
- Reed KL, Black SB, Bant CJ 2 nd et al. Combined occipital and supraorbital neurostimulation for the treatment of chronic migraine headaches: initial experience. Cephalalgia 2009 Sep 3 [Epub ahead of print].
- Saper JR, Dodick DW, Silberstein SD, et al. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia. 2011 Feb;31(3):271-85.
- Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2000 Sep 26;55(6):754-62.
- ECRI. Implantable Peripheral Nerve Stimulation Devices for Treating Chronic Pain. Plymouth Meeting (PA): Health Technology Assessment Information Service. February 2012. [Hotline Response].Silberstein SD, Dodick DW, Saper J, et al. Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: Results from a randomized, multicenter, double-blinded, controlled study. Cephalalgia. 2012 Oct3. [Epub ahead of print]
- Serra G & Marchioretto F. Occipital nerve stimulation for chronic migraine: a randomized trial. Pain Physician. 2012 May-Jun;15(3):245-53
- National Institute for Health and Care Excellence: Issued April 2013: Occipital Nerve Stimulation for Intractable Chronic Migraine
- Giorgil Lambru and Manjit S. Matharu. Therapeutic Advances in Neurological Disorders, Occipital Nerve Stimulation in Primary Headache Syndromes. Ther Adv Neural Disord, 2012 5 57-67.
- American Pain Society, Management of Acute Pain and Chronic Noncancer Pain. www.americanpainsociety.org
- American Headache Society, Surgical Treatment for HeadacheExternal Site.
- External SiteOccipital Nerve Stimulation, Updated October 14, 2015.
- UpToDateExternal Site. Occipital Neuralgia. Ivan Garza M.D., Topic last updated January 29, 2014.
- UpToDateExternal Site. Overview of Chronic Daily Headache. Ivan Garza, M.D., Todd J. Schwedt M.D., MSCI. Topic last updated December 22, 2015.
- UpToDateExternal Site. Treatment of Fibromyalgia in Adults not Responsive to Initial Therapies. Don L. Goldenberg M.D.. Topic last updated January 2, 2016. Chen YF, Bramley G, Unwin G, et al. Occipital nerve stimulation for chronic migraine--a systematic review and meta-analysis. PLoS One. 2015;10(3):e0116786. PMID 25793740
- UpToDate. Chronic Migraine. Ivan Garza, M.D., Todd J. Schwedt, M.D., MSCI. Topic last updated: May 12, 2015
- Yang Y, Song M, Fan Y, et al. Occipital Nerve Stimulation for Migraine: A Systematic Review. Pain Pract. Apr 11 2015. PMID 25865962
- Silberstein SD, Dodick DW, Saper J, et al. Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: results from a randomized, multicenter, double-blinded, controlled study. Cephalalgia. Dec 2012;32(16):1165-1179. PMID 23034698
- Dodick DW, Silberstein SD, Reed KL, et al. Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: Long-term results from a randomized, multicenter, double-blinded, controlled study. Cephalalgia. Apr 2015;35(4):344-358. PMID 25078718
- Mueller OM, Gaul C, Katsarava Z, et al. Occipital nerve stimulation for the treatment of chronic cluster headache - lessons learned from 18 months experience. Cen Eur Neurosurg. May 2011;72(2):84-89. PMID 21448856
- Magis D, Gerardy PY, Remacle JM, et al. Sustained effectiveness of occipital nerve stimulation in drug-resistant chronic cluster headache. Headache. Sep 2011;51(8):1191-1201. PMID 21848953
- Vadivelu S, Bolognese P, Milhorat TH, et al. Occipital nerve stimulation for refractory headache in the Chiari malformation population. Neurosurgery. Jun 2012;70(6):1430-1436; discussion 1436-1437. PMID 22418582
- Sweet JA, Mitchell LS, Narouze S, et al. Occipital nerve stimulation for the treatment of patients with medically refractory occipital neuralgia: Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline. Neurosurgery. Sep 2015;77(3):332-341. PMID 26125672
June 2016 - Annual review, Policy renewed
July 2015 - Annual review, Policy revised
February 2015 - Policy revised
August 2014 - Annual review, Policy revised
September 2013 - Annual review, Policy renewed
October 2012 - Annual review, Policy renewed
October 2011 - Annual review, Policy renewed
August 2010 - New policy, Policy implemented
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.