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DESCRIPTIONOccipital Nerve Stimulation (ONS) delivers a small electric 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.
There are four types of headache: vascular, muscle contraction (tension), traction and inflammatory. Primary (not the result of another condition) chronic headache is defined as headache occurring more than 15 days of the month for at least three 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 percent in adult men and from 14 - 35 percent in adult women. Migraine headaches may last a day or more and 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 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:
Bouts of headache every other day to eight (8) attacks per day may last from weeks to months, usually followed by remission periods when the headache attaches stop completely. The pattern varies from one person to another, but most people have one or two cluster periods per 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 women. One-year prevalence is estimated to be 0.5 to 1.0/1,000. Management of cluster headaches 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 responses.
As of September 2013, the U.S. Food and Drug Administration (FDA) has not cleared any occipital nerve stimulation (ONS) device for treatment of headache. The Synergy™ IPG (implantable pulse generator) device from Medtronic received marketing clearance in 1999 for management of chronic, intractable pain of the trunk or limbs, and off-label use for headache is described in the literature. The Genesis™ neuromodulation system (St. Jude Medical) is approved by the FDA for spinal cord stimulation and the Eon™ stimulator has received CE mark approval in Europe for the treatment of chronic migraines. Medtronic and Boston Scientific Neuromodulation Systems (Precision™) are currently conducting clinical trials of devices.
POLICYOccipital nerve stimulation is considered investigational for all indications.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved drugs, devices or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device or supply not recognized by certifying boards and / or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.
POLICY HISTORY4/20/2010: New policy added.
04/20/2011: Policy reviewed; no changes.
01/17/2012: Policy reviewed; no changes.
03/13/2013: Policy reviewed; no changes.
03/10/2014: Policy reviewed; description updated regarding available devices. Policy statement unchanged.
SOURCESBlue Cross Blue Shield Association Policy # 7.01.125
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.