Coverage Policy Manual
Policy #: 2010016
Category: Surgery
Initiated: March 2010
Last Review: November 2023
  Electrical Stimulation, Occipital and Transcutaneous Peripheral Nerve Stimulation for Treatment of Headaches

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.
  
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 consecutive 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 and other triptans are commonly used for relief of symptoms. Drugs used to prevent migraine include amitriptyline, propranolol and other β-blockers, topiramate and other antiepileptic drugs, and verapamil.
 
Hemicrania continua 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 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 to 1in 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.
 
The U.S. Food and Drug Administration (FDA) has not cleared or approved any occipital nerve stimulation device for treatment of headache. In 1999, the Synergy™ IPG device (Medtronic), an implantable pulse generator, was approved by the FDA through the premarket approval process 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) was 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.
 
The Omega Procedure is another name for the Reed Procedure ®, a registered and patented trademark procedure exclusively performed by Reed Migraine Centers’ trained and authorized physicians. The Omega procedure uses neurostimulation, including both occipital and supraorbital nerve stimulation, to treat chronic headaches and chronic migraines.
 
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
64555 peripheral nerve (excludes sacral nerve)
64578 Incision for implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator
64575 peripheral nerve (excludes sacral nerve)
64999 Unlisted procedure, nervous system

Policy/
Coverage:
Effective October 2021
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Occipital Nerve Stimulation for the treatment of headaches or any other indication does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, Occipital Nerve Stimulation for the treatment of headaches or any other indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Transcutaneous electrical nerve stimulation of peripheral nerves for the treatment of headaches does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, transcutaneous electrical nerve stimulation of peripheral nerves for the treatment of headaches Occipital Nerve Stimulation for the treatment of headaches is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to October 2021
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Occipital Nerve Stimulation for the treatment of headaches or any other indication does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, Occipital Nerve Stimulation for the treatment of headaches or any other indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:
Evidence of efficacy for occipital nerve (ONS) stimulation 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 9 patients who participated in a feasibility trial of the Bion microstimulator  (Trentman, 2009). One patient stopped using the device before one year because of the time required to recharge the device. At one year, 7 of the 8 remaining patients had fair or better results in terms of reduction of disability with 5 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 (Schwedt, 2007).  Eight patients had chronic migraine, 3 chronic cluster, 2 hemicrania continua, and 2 post-traumatic headache. Eight patients had bilateral and 7 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 paper, the same authors report on a retrospective review of the patients in the study reported above to determine if response to occipital nerve block (ONB) predicts response to ONS (Schwedt, 2007).  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 3 were ONB nonresponders. Of the 3 ONB nonresponders, 2 were ONS responders. Of the 2 patients who did not have ONB prior to ONS, one was an ONS responder and one was an ONS nonresponder. The authors conclude that ONB may not be predictive of the therapeutic effect of ONS.
 
Burns et al. report on 14 patients with cluster headache implanted with bilateral electrodes (Burns, 2009). 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, and 4 reported mild improvement. 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 cross-over study, also by Burns and colleagues, 6 patients with hemicrania continua received continuous unilateral ONS (Burns, 2008).  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 7 patients with chronic migraine by Reed and colleagues (Reed, 2009). 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 1-35 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 occipital nerve stimulation with outcomes of other possible alternative treatments. The available evidence, from small uncontrolled trials, is insufficient to permit conclusions concerning the impact of occipital nerve stimulation on health outcomes. In addition, no implanted occipital nerve stimulators have received FDA approval. Therefore, occipital nerve stimulation is considered investigational.
 
2012 Update
A search of the MEDLINE database was conducted through September 2012.  There was no new information identified that would prompt a change in the coverage statement. The following is a summary of the key literature identified.
 
A report of the Occipital Nerve Stimulation for the Treatment of Intractable Migraine (ONSTIM) trial, a multicenter, randomized feasibility study of occipital nerve stimulation for treatment of intractable chronic migraine headache, was published in September 2010 (Saper, 2010).  The trial was designed to evaluate the study design and not powered for a single primary endpoint. 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 of 1 minute per day (PS), and 17 to medical management (MM). Patients in the PS group did not have a controller. A fourth, ancillary, group of 8 patients received adjustable stimulators but did not have preoperative nerve blocks to test whether positive response to nerve block predicted response to stimulation. Patients in the AS, PS, and ancillary groups were required to keep medication regimens stable but were allowed to adjust the frequency and dose of acute medications. Patients in the MM group were allowed to change medications and dosage as directed by their physicians. At the end of the 3-month trial, 28 patients remained in the AS group, 16 in the PS group and 17 in the MM group. A number of outcome measures were used including responder rate (percentage of patients who achieve 50% or greater reduction in number of headache days per month or a 3-point or greater reduction in average overall pain intensity compared to baseline). At the 3-month evaluation, the responder rate 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. Three subjects required hospitalization for adverse events (infection, lead migration, and nausea). The authors concluded that further study is warranted noting that the 39% responder rate is comparable to response rates achieved by preventive chronic migraine treatments. Limitations of the study cited by the authors are short observation period and the inability to effectively blind subjects and investigators to treatment group.
 
Serra and colleagues reported on a prospective, randomized cross-over study assessing the use of occipital nerve stimulation for the treatment of chronic migraine (CM) and medication overuse headache (MOH) (Serra, 2012). Thirty eligible subjects were randomized to either a “Stimulation On” arm or “Stimulation Off” arm and were crossed over after one month. The authors report that headache intensity and frequency were significantly lower in the “ON” arm than in the “OFF” arm (P,0.05). Quality of Life as measured by the SF-36 Questionnaire was significantly improved (p,0.05). Two severe implantation site infections and three lead dislocations occurred during the study. Study limitations include small number of patients, no control group and it was a single-center study.  
 
In summary, larger, sham-controlled, multicenter trials are needed to assess the clinical utility of occipital nerve stimulation for the treatment of headaches.
 
Clinical Trials
A search of the clinicaltrials.gov website identified the following ongoing studies:
 
NCT01184222- A Phase III single blind, sham controlled, randomized trial assessing the safety and efficacy of occipital nerve stimulation in chronic cluster headaches. Estimated study completion date is January 2013. Primary endpoint will be the comparison of the rate of headache-free patients, fourteen days after medication withdrawal, in both groups. The estimated date of study completion is January 2014.
 
NCT01184222- Sham-controlled, single blind, randomized trial to assess the efficacy of occipital nerve stimulation versus sham for the treatment of rebound headache after medication withdrawal. The estimated study completion date is December 2012.
 
NCT00286078- (PRISM study) Phase III, double-blind, randomized controlled trial assessing the safety and efficacy of occipital nerve stimulation using the Precision device manufactured by Boston scientific, for the treatment of drug refractory migraine. This study is ongoing but not recruiting patients at this time.  The companion trial (PRISM-UK) was terminated as a result of the interim results of this trial.
 
2013 Update
A search of the MEDLINE database through October 2013 did not reveal any new information that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
 
Serra and Marchioretto conducted a 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 (ONS) and randomized to “Stimulation On” or “Stimulation Off” arms (Serra, 2012). After one month, or if headaches worsened during the off period, patients were crossed over to the other arm. The mean number of days when patients randomized to the off condition turned on the generators was 4.65 days (range, 1-12 days). Follow-up examinations were conducted at 1, 3, 6, and 12 months after nerve stimulator implantation, during which time the stimulation parameters were adjusted in order to optimize the perception of paresthesia. In addition, the patients were provided with remote controls to modify the stimulation amplitude. At baseline, the average frequency of migraines was 5.8 days per week and the median headache severity was 8 on an 11-point numerical rating scale. Headache intensity and/or frequency were significantly lower in the on arm compared to the off arm and decreased from baseline to each follow-up visit in all patients with Stimulation On. For example, 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. The median Migraine Disability Assessment (MIDAS) score decreased from 79 at baseline to 10 at 12-month follow-up. Quality of life measured by the SF-36 significantly improved from baseline throughout the follow-up period. Use of triptans decreased from a median of 20 to 3 doses/month and use of nonsteroidal anti-inflammatory drug (NSAIDs) use 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, although blinding of patients may be difficult due to paresthesia with this treatment.
 
Vadivelu et al. reported on a series of 22 patients with Chiari malformation and persistent occipital headaches (Vadivelu, 2011). 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.
 
Ongoing Clinical Trials
A search of online site ClinicalTrials.gov in October 2013 identified a number of clinical trials that are currently underway. Of particular note are the following:
 
  • NCT01151631 is a randomized double-blind multi-center 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 an expected completion date in 2014.
  • Recruitment (n=179) has been completed for an industry-sponsored Phase III trial from Boston Scientific (NCT00286078). The estimated study completion date is January 2015.
  • NCT01775735 is randomized double-blind study sponsored by Boston Scientific assessing the safety and efficacy of the BSC Precision™ System in the management of intractable chronic migraine when used in conjunction with anti-migraine medications. Estimated enrollment is 180 subjects with a study completion date of June 2016.
 
2014 Update  
 
A literature search conducted through December 2013 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2012 by an industry-sponsored FDA-regulated double-blind trial that randomized 157 patients in a 2:1 ratio to active or sham stimulation (Silberstein, 2012). Intention-to-treat analysis revealed no significant difference between the groups in the percentage of patients who achieved 50% or greater reduction in visual analog scores (VAS) 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.
 
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 (NICE, 2013). 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.
 
2014 Update
A literature search conducted through October 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
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 randomized clinical trials 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.  
 
2016 Update
A literature search conducted through September 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Migraine
Two systematic reviews of literature on occipital nerve stimulation (ONS) were published in 2015. Both included RCTs and observational studies. The study by Chen and colleagues identified 5 RCTs and 7 case series with at least 10 patients (Chen, 2015). Three of the RCTs were industry-sponsored, multicenter, parallel-group studies and 2 were single-center crossover trials. All 5 included a sham control group and 1 trial also included a medication management group. Risk of bias was judged to be high or unclear for all trials. Meta-analyses were performed on 2 outcomes. A pooled analysis of 2 studies did not find a significant difference in response rate between active and sham stimulation (risk ratio [RR], 2.08; 95% confidence interval [CI], 0.50 to 0.55; p=0.31) and a pooled analysis of 3 studies showed a significantly greater reduction in days with prolonged moderate to severe headache (mean difference [MD], 2.59; 95% CI, 0.91 to 4.27; p=0.003).
 
In their systematic review, Yang and colleagues identified the same 5 RCTs as Chen and colleagues (Yang, 2015). The Yang review was limited to studies conducted with patients with migraine of at least 6 months in duration who did not respond to oral medications. In addition to the RCTs, 5 case series met the inclusion criteria. Yang and colleagues did not pool study findings. Response rates in 3 case series with self-report of efficacy were 100% each, and response rates in the other 2 series were 50% and 89%, respectively. Complication rates in the series ranged from 40% to 100%. The authors noted that the series were subject to biases (eg, an inability to control for the placebo effect) and that RCT evidence was limited and complication rates were high.
 
Occipital Neuralgia
A systematic review by Sweet and colleagues identified 9 small case series (fewer than 15 patients each) on the efficacy of ONS for treating medically refractory occipital neuralgia ((Sweet, 2015). The authors did not pool study findings. Conclusions cannot be drawn about the impact of ONS on occipital neuralgia due to the lack of RCTs or other controlled studies.
 
2017 Update
A literature search conducted through October 2017 did not reveal any new information that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
Fontaine and colleagues published a prospective case series of 67 patients with chronic cluster headache (CCH) (Fontaine, 2016). Data were taken from a French database on ONS for treating refractory headache disorders. Sixty-seven patients with CCH were included in the database; data were available for 52 (78%) patients at 3 months and 44 (66%) patients at 12 months. The primary outcome was a composite score that incorporated patient’s global impression of change, reduction in the frequency of headache attacks, and changes in prophylactic medications. For patients with available data, at 3 months, 34 (65.4%) of 52 were considered to be excellent responders, 9 (17.3%) of 52 were mild responders, and 9 (17.3%) of 52 were nonresponders. At 12 months, 22 (48%) of 44 were excellent responders, 10 (21.7%) of 44 were mild responders, and 15 (32.6%) of 44 were nonresponders. The series had a large amount of missing data at follow-up.
 
Leone and colleagues published a case series of ONS in 35 patients with CCH (Leone, 2016).  This series had the longest follow-up (median, 6.1 years; range, 1.6-10.7 years). Selection criteria included daily or almost daily cluster headache attacks in the past year and resistance of prophylactic drugs. Twenty (66.7%) of the 30 patients in the per protocol analysis had 50% or more reduction in headache number per day and were considered responders. In 12 (40%) patients, improvement was considered stable (ie, 3 headache attacks per month). Limitations of the studies included lack of blinding and comparison groups.
 
2018 Update
A literature search was conducted through October 2018.  There was no new information identified that would prompt a change in the coverage statement.  
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2019. No new literature was identified that would prompt a change in the coverage statement.
 
 2020 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2020. No new literature was identified that would prompt a change in the coverage statement.
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A case series of 105 patients with refractory cluster headache in a French occipital nerve stimulation database was identified (Leplus, 2021). Mean follow-up was 3.7 years; the number of patients with follow-up data ranged from 60 to 93, depending on the outcome. The primary outcome was change in attack frequency. At last follow-up, 69% (64/93) of patients had a reduction of 50% in attack frequency, and 73% (68/93) reported at least a 30% reduction in frequency. Overall response rate was 77% (72/93); including 59% of patients who reported excellent response to treatment and 18% who reported mild response; 23% were nonresponders. Statistically significant improvements from baseline were also reported for quality of life measures. Adverse events were common, occurring in 64% (67/105) of patients, including need for reoperation in 28% (29/105).
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:
61885Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array
61886Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to 2 or more electrode arrays
61888Revision or removal of cranial neurostimulator pulse generator or receiver
64553Percutaneous implantation of neurostimulator electrode array; cranial nerve
64555Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve)
64568Open implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator
64575Open implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve)
64999Unlisted procedure, nervous system
A4540Distal transcutaneous electrical nerve stimulator, stimulates peripheral nerves of the upper arm
A4541Monthly supplies for use of device coded at e0733
A4542Supplies and accessories for external upper limb tremor stimulator of the peripheral nerves of the wrist
K1023Distal transcutaneous electrical nerve stimulator, stimulates peripheral nerves of the upper arm
L8678Electrical stimulator supplies (external) for use with implantable neurostimulator, per month
L8679Implantable neurostimulator, pulse generator, any type
L8680Implantable neurostimulator electrode, each
L8681Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only
L8682Implantable neurostimulator radiofrequency receiver
L8683Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver
L8684Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement
L8685Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8686Implantable neurostimulator pulse generator, single array, non rechargeable, includes extension
L8687Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688Implantable neurostimulator pulse generator, dual array, non rechargeable, includes extension
L8689External recharging system for battery (internal) for use with implantable neurostimulator, replacement only

References: Burns B, Watkins L, Goadsby P.(2008) 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.

Burns B, Watkins L, Goadsby P.(2009) Treatment of intractable chronic cluster headache by occipital nerve stimulation in 14 patients. Neurology 2009; 72(4):341-5.

Chen YF, Bramley G, Unwin G, et al.(2015) Occipital nerve stimulation for chronic migraine--a systematic review and meta-analysis. PLoS One. 2015;10(3):e0116786. PMID 25793740

Clinical Trials.gov. Accessible at http://clinicaltrials.gov

Dodick DW, Silberstein SD, Reed KL, et al.(2014) 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. Jul 30 2014. PMID 25078718

Fontaine D, Blond S, Lucas C, et al.(2016) Occipital nerve stimulation improves the quality of life in medically intractable chronic cluster headache: Results of an observational prospective study. Cephalalgia. Oct 03 2016. PMID 27697849

Leone M, Proietti Cecchini A, Messina G, et al.(2016) Long-term occipital nerve stimulation for drug-resistant chronic cluster headache. Cephalalgia. Jun 01 2016. PMID 27250232

Leplus A, Fontaine D, Donnet A, et al.(2021) Long-Term Efficacy of Occipital Nerve Stimulation for Medically Intractable Cluster Headache. Neurosurgery. Jan 13 2021; 88(2): 375-383. PMID 32985662

Lipton RB, Goadsby PJ, Cady RK, et al.(2009) PRISM study: occipital nerve stimulation for treatment-refractory migraine. Cephalalgia. 2009;29(30):Abstract PO47. PMID

Miller S, Watkins L, Matharu M.(2017) Treatment of intractable chronic cluster headache by occipital nerve stimulation: a cohort of 51 patients. Eur J Neurol. Feb 2017;24(2):381-390. PMID 27995704

National Institute for Health and Care Excellence. IPG452(2013) Occipital nerve stimulation for intractable chronic migraine. 2013. Available online at: http://publications.nice.org.uk/occipital-nerve-stimulation-for-intractable-chronic-migraine-ipg452. Last accessed September, 2013.

Reed KL, Black SB, Bant CJ 2nd et al.(2009) 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 ST et al.(2010) Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalgia 2010 [Epub ahead of print]. Accessible online at http://cep.sagepub.com/content/early/2010/09/29/0333102410381142.full.pdf+html.

Schwedt TJ, Dodick DW, Trentman TL et al.(2007) 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.(2007) Response to occipital nerve block is not useful in predicting efficacy of occipital nerve stimulation. Cephalalgia 2007; 27(3):271-4.

Serra G, Marchioretto F.(2012) Occipital nerve stimulation for chronic migraine: a randomized trial. Pain Physician 2012; 15(3):245-53.

Serra G. Marchioretto F.(2012) Occipital nerve stimulation for chronic migraine: a randomized trial. Pain Physician 2012; 15:245-253.

Silberstein SD, Dodick DW, Saper J et al.(2012) 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; 32(16):1165-79.

Sweet JA, Mitchell LS, Narouze S, et al.(2015) 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

Trentman TL, Rosenfeld DM, Vargas BB et al.(2009) Greater occipital nerve stimulation via the Bion Microstimulatro; implantation technique and stimulation parameters Clinical Trial: NCT00205894. Pain Physician 2009; 12(3):621-8.

Vadivelu S, Bolognese P, Milhorat TH et al.(2012) Occipital nerve stimulation for refractory headache in the Chiari malformation population. Neurosurgery 2012; 70(6):1430-6; discussion 36-7.

Yang Y, Song M, Fan Y, et al.(2015) Occipital Nerve Stimulation for Migraine: A Systematic Review. Pain Pract. Apr 11 2015. PMID 25865962

Young WB.(2014) Occipital nerve stimulation for chronic migraine Curr Pain Headache Rep. Feb 2014;18(2):396. PMID 24474153


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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