Medical Policy: 07.01.51
Original Effective Date: August 2010
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:
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 geno typical men and from 14%–35% in adult geno typical 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 geno typical women, 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 geno typical men than in geno typical women. 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.
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).
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.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
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