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MP 7.01.125

Occipital Nerve Stimulation


Medical Policy    
Section
Surgery 
Original Policy Date
2:2010
Last Review Status/Date
Reviewed with literature search/11:2014
Issue
11:2014
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. 


Description

 

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

There are 4 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 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 1 or both sides of the head, an upset stomach, and, at times, disturbed vision. One-year prevalence of migraine ranges from 6% to 15% in adult men and from 14% to 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 women, and its true prevalence is not known. Indomethacin usually provides rapid relief of symptoms. Other nonsteroidal antiinflammatory drugs, 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 1 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 1 person to another, but most people have 1 or 2 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 in 1000. 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.

Regulatory Status

As of September 2014, FDA has not cleared any 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 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.


Policy

 

Occipital nerve stimulation is considered investigational for all indications. 


Policy Guidelines

 

There is no specific CPT code for occipital nerve stimulation. 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 with connection to 2 or more electrode arrays

64553 Percutaneous implantation of neurostimulator electrodes; cranial 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

64570 Removal of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator

64999 Unlisted procedure, nervous system

 


Benefit Application

 

BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity. 


Rationale
 

 

Assessment of efficacy for therapeutic interventions involves a determination of whether the intervention improves health outcomes. The optimal study design for a therapeutic intervention is a randomized controlled trial (RCT) that includes clinically relevant measures of health outcomes. It is recognized that RCTs are particularly important to assess treatments of painful conditions, due to the expected placebo effect and the subjective nature of pain assessment in general. Intermediate outcome measures, also known as surrogate outcome measures, may also be adequate if there is an established link between the intermediate outcome and true health outcomes. Nonrandomized comparative studies and uncontrolled studies can sometimes provide useful information on health outcomes but are prone to biases such as noncomparability of treatment groups, the placebo effect, and variable natural history of the condition.

Controlled Trials

Migraine

Three randomized trials with over 100 patients and a smaller randomized crossover study have been identified.

The Occipital Nerve Stimulation for the Treatment of Intractable Chronic Migraine Headache (ONSTIM) trial, was a multicenter, randomized feasibility study of occipital nerve stimulation (ONS) for treatment of intractable chronic migraine headache that was published in 2011.(1) The trial was designed to evaluate the study design and did not have a single primary end point. One hundred ten patients were enrolled, and patients who had a positive response to a short-acting occipital nerve block were randomized as follows: 33 to adjustable stimulation (AS), 17 to preset stimulation (PS) of 1 min/d, and 17 to medical management (MM). At the 3-month evaluation, the responder rate (percentage of patients who achieve 50% or more reduction in number of headache days per month or a 3-point or greater reduction in average overall pain intensity compared with baseline) was 39% in the AS group, 6% in the PS group, and 0% in the MM group. Lead migration occurred in 12 of 51 (24%) of subjects and 3 subjects required hospitalization for adverse events (infection, lead migration, nausea). Limitations of the study  include a short observation period and the inability to effectively blind subjects and investigators to treatment group.

This report was followed in 2012 by an industry-sponsored U.S. Food and Drug Administration (FDA) regulated double-blind trial that randomized 157 patients in a 2:1 ratio to active or sham stimulation.(2) Intention-to-treat (ITT) analysis revealed no significant difference between the groups in the percentage of patients who achieved 50% or greater reduction in visual analog scale scores for pain at 12 weeks (active, 17.1%; control, 13.5%). More patients in the ONS group improved in the number of headache days, migraine-related disability, and direct reports of pain, although the benefits were modest. The most common adverse event was persistent implant site pain. Results from the 52-week open-label extension of this study were published in 2014.(3) Results were reported for the ITT population and for the 125 patients who met criteria for intractable chronic migraine. Twenty-four patients were excluded from analysis due to explantation of the system (n=18) or other loss to follow-up. Mean headache days at baseline were 21.6 for the ITT population and 24.2 for the intractable chronic migraine group. In the ITT population, headache days were reduced by 6.7 days, and a 50% or greater reduction in headache days and/or pain intensity was observed in 47.8% of patients. Sixty-eight percent of patients were satisfied with the headache relief provided by the device. Seventy percent experienced at least 1 of 183 device-related adverse events, of which 8.6% required hospitalization and 40.7% required surgical intervention. Eighteen percent of patients had persistent pain and/or numbness with the device.

A third multicenter double-blind, randomized, sham-controlled trial with 140 patients was reported in abstract form in 2009; results were negative and a full report has not been published.(4,5) Serra and Marchioretto conducted a randomized crossover study in which 30 patients with chronic migraine (100% of patients) and medication overuse headache (85% of patients) were implanted with an occipital nerve stimulator and randomized to “stimulation on” or “stimulation off” arms.(6) After 1 month, or if headaches worsened during the off period, patients were crossed over to the other arm. At baseline, the average frequency of migraines was 5.8 days per week and the median  headache severity was 8 on an 11-point numeric rating scale. The number of headaches decreased from a median of 6.3 days per week in the off phase to 2.1 days per week in the on phase (p<0.05). The median Migraine Disability Assessment score decreased from 79 at baseline to 10 at 12-month follow-up (p<0.001). Quality of life measured by the 36-Item Short-Form Health Survey (SF-36) was significantly improved, use of triptans decreased from a median of 20 to 3 doses/month, and use of nonsteroidal anti-inflammatory drugs decreased from a median of 25.5 to 2 doses/month. There were 2 infections (6.7%) and 3 lead migrations (10%) during the study. This study is limited by the lack of a control group during follow-up and lack of blinding.

Hemicrania Continua

Six patients with hemicrania continua received continuous unilateral ONS in a crossover study by Burns et al. in 2008.7 Pain on a 10-point scale was recorded hourly in patient diaries, and the Migraine Disability Assessment was administered at each follow-up visit. Four of 6 patients reported substantial improvement (80%-95%), 1 reported a 30% improvement, and 1 reported that pain was worse by 20%. Adverse events were mild and associated with transient overstimulation.

Cluster Headache

Burns et al reported on 14 patients with cluster headache in 2009.(8) 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, 3 reported moderate improvement (30%-60%), and 4 reported mild improvement (20%-30%). Four patients required new electrode leads. A wide range of stimulation was used. Six patients required battery replacement. In 2011, Mueller et al reported a prospective study of 10 patients with refractory chronic cluster headache who had been treated with bilateral ONS.(9) At a mean follow-up of 12 months (range, 3-18 months), the frequency of the attacks were reduced by a mean of 44% (range, 20%-90%) in 90% of the patients. The daily frequency of the attacks dropped from a mean of 6 to 3. Seventy percent of the patients required less medication during attacks. There was a nonsignificant tendency for improvement on the SF-36 in this small study.

Another publication from 2011 reported mean 37-month follow-up (range, 11-64 months) on 15 patients with intractable chronic cluster headache.(10) The mean duration of cluster headache was 7 years, with a mean 2.5 attacks per day. One patient had an immediate postoperative infection and was explanted. For the remaining 14 patients, the mean attack frequency decreased from 2.24 to 0.12 per day. Twelve patients reported total or partial relief and 2 had no or minimal improvement. Two patients found the ONS-related paresthesias to be unbearable. In some patients contralateral attacks occurred. Technical problems included battery depletion (64%) and infection (20%). Five patients (33%) had the stimulators removed due to discomfort or infection, and 9 patients (60%) were reported to be pain-free for extended
periods.

Headache Associated With Chiari Malformation

Vadivelu et al reported on a series of 22 patients with Chiari malformation and persistent occipitalheadaches.(11) Of the 22, 15 (68%) had a successful occipital neurostimulator trial and underwent permanent implantation. At a mean follow-up of 18.9 months (range, 6-51 months), 13 of the 15 patients (87%) reported pain relief of greater than 50%. Device-related complications requiring additional surgeries (lead migration, uncomfortable position of generator, wound infection) occurred in 40% of patients during the follow-up period.

Combined Occipital and Supraorbital Stimulation

Combined occipital and supraorbital neurostimulation was evaluated in 7 patients with chronic migraine by Reed et al.(12) Responses to 2 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 to 35 months, all patients reported a full therapeutic response but only to combined supraorbital-occipital neurostimulation.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in September 2013 identified a number of clinical trials that are currently underway. Of particular note are the following:

  • NCT01151631 is a randomized double-blind multicenter trial sponsored by Leiden University Medical Center that will compare low (30%) and high (100%) stimulation parameters in patients with medically intractable chronic cluster headache. Enrollment of 144 patients is anticipated with a targeted completion date in January 2014. The status of this study is unknown.
  • Boston Scientific began a randomized trial (OPTIMIZE) in 2013 to evaluate the Precision™ system for ONS for migraine (NCT01775735). The study lists an estimated enrollment of 180 patients with completion expected June 2016.
  • NCT01842763 is a French database of patients suffering from refractory chronic headache disorders (chronic migraine, cluster headache, chronic paroxysmal hemicranias, SUNCT syndrome, hemicrania continua, cervicogenic headache disorders), and treated by ONS. The study has an estimated enrollment of 50 and an expected completion date of December 2016.
  • ONS is also being studied for the treatment of fibromyalgia (NCT01298609). This study had an enrollment of 40 and is listed as completed. As of October 2014, no results have been posted.

Summary of Evidence

The literature to date on the use of occipital nerve stimulation (ONS) consists primarily of small case series, small randomized trials and 2 small crossover studies. While the case series report substantial benefit, treatment-related improvements in the randomized controlled trials (RCTs) were modest. RCTs (to account for potential placebo effect) with greater numbers of patients and longer follow-up are needed. It is noted that a number of trials are in progress. At this time, the available evidence is insufficient to permit conclusions concerning the impact of ONS on net health outcome. In addition, no implanted occipital nerve stimulators have received U.S. Food and Drug Administration approval. Therefore, ONS is considered investigational.

Practice Guidelines and Position Statements

The 2013 Guidance from the United Kingdom’s National Institute for Health and Care Excellence (NICE) states that the evidence on ONS for intractable chronic migraine shows some efficacy in the short term but there is very little evidence about long-term outcomes.(13) 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. NICE recommends that clinicians wishing to undertake ONS for intractable chronic migraine should ensure that patients understand the uncertainty about the procedure's safety and efficacy, and provide them with clear written information.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

References:

  1. Saper JR, Dodick DW, Silberstein SD, et al. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia. Feb 2011;31(3):271-285. PMID 20861241
  2. 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
  3. 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, doubleblinded, controlled study. Cephalalgia. Jul 30 2014. PMID 25078718
  4. Lipton RB, Goadsby PJ, Cady RK, et al. PRISM study: occipital nerve stimulation for treatment-refractory migraine. Cephalalgia. 2009;29(30):Abstract PO47. PMID
  5. Young WB. Occipital nerve stimulation for chronic migraine. Curr Pain Headache Rep. Feb 2014;18(2):396. PMID 24474153
  6. Serra G, Marchioretto F. Occipital nerve stimulation for chronic migraine: a randomized trial. Pain Physician. May-Jun 2012;15(3):245-253. PMID 22622909
  7. Burns B, Watkins L, Goadsby PJ. Treatment of hemicrania continua by occipital nerve stimulation with a bion device: long-term follow-up of a crossover study. Lancet Neurol. Nov 2008;7(11):1001-1012. PMID 18845482
  8. Burns B, Watkins L, Goadsby PJ. Treatment of intractable chronic cluster headache by occipital nerve stimulation in 14 patients. Neurology. Jan 27 2009;72(4):341-345. PMID 19171831
  9. 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
  10. 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
  11. 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
  12. Reed KL, Black SB, Banta CJ, 2nd, et al. Combined occipital and supraorbital neurostimulation for the treatment of chronic migraine headaches: initial experience. Cephalalgia. Mar 2010;30(3):260-271. PMID 19732075
  13. National Institute for Health and Care Excellence. IPG452 Occipital nerve stimulation for intractable chronic migraine. 2013; http://publications.nice.org.uk/occipital-nerve-stimulation-for-intractable-chronic-migraine-ipg452. Accessed September 9, 2014.

Codes

Number

Description

CPT   See Policy Guidelines 
ICD-9 Diagnosis    Investigational for all diagnoses
HCPCS  L8680 Implantable neurostimulator electrode, each
  L8681, L8682, L8683, L8684, L8685, L8686, L8687, L8688, L8689 Implantable neurostimulator programmer and pulse generator code range
ICD-10-CM (effective 10/1/15)    Investigational for all diagnoses
   G43.00-G43.919 Migraine code range
   G44.00-G44.89 Other headache syndromes code range
ICD-10-PCS (effective 10/1/15)    ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for the initiation of this therapy.
  00HE0MZ, 00HE3MZ, 00HE4MZ Surgical, central nervous system, insertion, cranial nerve, neurostimulator lead, code by approach
   00PE0MZ, 00PE3MZ, 00PE4MZ Surgical, central nervous system, removal, cranial nerve, neurostimulator lead, code by approach
   0JH60M6, 0JH60M7, 0JH60M8, 0JH60M9, 0JH63M6, 0JH63M7,
0JH63M8, 0JH63M9, 0JH80M6, 0JH80M7, 0JH80M8, 0JH80M9, 0JH83M6, 0JH83M7, 0JH83M8, 0JH83M9
Surgical, subcutaneous tissue and fascia, insertion, stimulator generator, code by body part (chest or abdomen), approach, number of arrays and whether rechargeable or not
   0JPT0MZ, 0JPT3MZ Surgical, subcutaneous tissue and fascia, removal, subcutaneous tissue and fascia, trunk, stimulator generator, code by approach

 


Index

 Occipital neurostimulation 


Policy History

 

Date Action Reason
02/11/2010 Add policy to Surgery section New policy
2/10/11 Replace policy Policy updated with literature search, reference 6 updated, reference 7 added; policy statement unchanged. CPT coding updated in Policy Guidelines.
11/10/11 Replace policy Policy updated with literature search through August 2011; references 7 and 8 added and references reordered; policy statement unchanged
11/08/12 Replace Policy Policy updated with literature search through August 2012; references 2 and 10 added and references reordered; policy statement unchanged
11/14/13 Replace policy Policy updated with literature review through September 27, 2013; references 2 and 13 added; policy statement unchanged
11/13/14 Replace policy Policy updated with literature review through October 7, 2014; reference 3 added; some references removed; policy statement unchanged