BlueCross and BlueShield of Montana Medical Policy/Codes
Occipital Nerve Stimulation
Chapter: Surgery: Procedures
Current Effective Date: July 18, 2013
Original Effective Date: December 14, 2010
Publish Date: July 18, 2013
Revised Dates: February 15, 2012; April 15, 2013
Description

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.

Implanted peripheral nerve stimulators have been used for treatment of refractory pain for many years but only recently proposed for management of craniofacial pain. Occipital, supraorbital, and infraorbital stimulation have been reported in the literature.

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% 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, lacrimation, nasal congestion, rhinorrhea, ptosis 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, conjunctival injection, lacrimation, rhinorrhea, and, less commonly, facial blushing, swelling, or sweating.  Bouts of one headache every other day to eight 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 per1,000. 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.

As of January 26, 2010, the U.S. Food and Drug Administration (FDA) have not cleared any occipital nerve stimulation device for treatment of headache.  The Synergy IPG implanted stimulator 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.  Medtronic and Boston Scientific Neuromodulation Systems are currently conducting clinical trials of devices.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Investigational

 Blue Cross and Blue Shield of Montana (BCBSMT) considers occipital nerve stimulation experimental, investigational and unproven for all indications.

Rationale

Evidence of efficacy for occipital nerve stimulation (ONS) for treatment of chronic headache is limited to reports of small case series with short follow-up.

Trentman et al. reported outcome measures at one year post-implant in nine patients who participated in a feasibility trial of the Bion microstimulator.  One patient stopped using the device before one year because of the time required to recharge the device.  At one year, seven of the eight remaining patients had fair or better results in terms of reduction of disability with five having greater than 90% reduction in disability.

Schwedt and colleagues published a retrospective analysis of pre- and post-implant data from 15 patients with chronic, intractable headache implanted with the Synergy implantable pulse generator.  Eight patients had chronic migraine, three chronic cluster, two hemicrania continua, and two post-traumatic headaches.  Eight patients had bilateral and seven had unilateral lead placement.  Data were collected on headache frequency, severity, disability, depression, and post-stimulator complications.  Nine patients reported at least a 50% reduction in headache pain, and none reported worsening of pain.  The mean subjective percent change in pain was 52%.  Sixty percent of patients required lead revision within one year.  The authors conclude that ONS may be effective in some patients with intractable headache.  In a separate report, the same authors describe a retrospective review of the patients in the study reported above to determine if response to occipital nerve block (ONB) predicts response to ONS. Thirteen patients in the study had ONB; 10 of them were responders (50% or more reduction in frequency or severity).  Ten of 13 who had ONB had significant relief of pain lasting at least 24 hours, and three were ONB nonresponders.  Of the three ONB nonresponders, two were ONS responders.  Of the two patients who did not have ONB prior to ONS, one was an ONS responder and one was an ONS non-responder.  The authors conclude that ONB may not be predictive of the therapeutic effect of ONS.

Burns et al. reported on 14 patients with cluster headache implanted with bilateral electrodes.  At a median follow-up of 17.5 months (range 4–35 months), 10 of 14 patients reported improvement. Three reported improvement of 90% or better; three reported moderate improvement (30%–60%), and four reported mild improvement (20%–30%). Four patients required new electrode leads.  A wide range of stimulation was used.  Six patients required battery replacement.  Muscle recruitment, neck stiffness, skin discomfort, superficial infections, and painful overstimulation were also reported in a crossover study, also by Burns and colleagues; six patients with hemicrania continua received continuous unilateral ONS.  Pain on a 10-point scale was recorded hourly in patient diaries and the Migraine Disability Assessment Scale was administered at each follow-up visit.  Four of six patients reported substantial improvement (80%–95%), one reported a 30% improvement, and one reported that pain was worse by 20%. Adverse events were mild and associated with transient overstimulation.

Combined occipital and supraorbital neurostimulation was evaluated in seven patients with chronic migraine by Reed and colleagues.  Responses to two stimulation programs were evaluated: one that stimulated only the occipital leads and one that stimulated both the occipital and supraorbital leads together.  With follow-up ranging from 1–35 months, all patients reported a full therapeutic response but only to combined supraorbital-occipital neurostimulation.

Industry-sponsored clinical trials are currently underway. 

In summary, randomized controlled trials (to account for potential placebo effect) with greater numbers of patients and longer follow-up are needed.  In addition, these trials must compare outcomes of ONS with outcomes of other possible alternative treatments.  The available evidence, from small uncontrolled trials, is insufficient to permit conclusions concerning the impact of ONS on health outcomes.  In addition, no implanted occipital nerve stimulators have received U.S. Food and Drug Administration (FDA) approval.  Therefore, ONS is considered investigational.

ICD-9 Codes

339.0-339.89, 346.00-346.93, 723.8, 784.0

ICD-10 Codes

 Investigational for all diagnoses.

Procedural Codes: 64555, 64575, 64585, 64590, 64595, 64999, 95970, 95971, 95972, 95973, L8680, L8681, L8682, L8685, L8686, L8687, L8688, L8689, L8695
References
  1. Schwedt, T.J., Dodick, D.W., et al.  Occipital nerve stimulation for chronic headache--long-term safety and efficacy.  Cephalalgia (2007) 27(2):153-7.
  2. Schwedt, T.J., Dodick, D.W., et al.  Response to occipital nerve block is not useful in predicting efficacy of occipital nerve stimulation. Cephalalgia (2007) 27(3):271-4.
  3. Burns, B., Watkins, L., et al. 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.
  4. Trentman, T.L., Rosenfeld, D.M., 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.
  5. Burns, B., Watkins, L., et al.  Treatment of intractable chronic cluster headache by occipital nerve stimulation in 14 patients.  Neurology (2009) 72(4):341-5.
  6. Reed, K.L., Black, S.B., et al.  Combined occipital and supraorbital neurostimulation for the treatment of chronic migraine headaches: initial experience.  Cephalalgia (2009) Sep 3 [Epub ahead of print]. 
  7. Clinical Trials.gov. Accessible at http://clinicaltrials.gov.
  8. Occipital Nerve Stimulation.  Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Reference Manual (2010 February) Surgery 7.01.125.
History
June 2010 Medical Policy Development Meeting
July 2010 Medical Policy Physician's Committee Meeting/approved
February 2012 Policy updated with literature search through August 2011; references 7 and 8 added and references reordered; policy statement unchanged 
April 2013 Policy formatting and language revised.  Policy statement unchanged.
BCBSMT Home
®Registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. ®LIVE SMART. LIVE HEALTHY. is a registered mark of BCBSMT, an independent licensee of the Blue Cross and Blue Shield Association, serving the residents and businesses of Montana.
CPT codes, descriptions and material only are copyrighted by the American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS Restrictions Apply to Government Use. CPT only © American Medical Association.
Occipital Nerve Stimulation