Medical Policies - Surgery


Occipital Nerve Stimulation

Number:SUR712.033

Effective Date:07-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Occipital nerve stimulation is considered experimental, investigational and/or unproven for all indications.

Description:

Occipital nerve stimulation (ONS) delivers a small electrical charge to the occipital nerve intended 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.

Headache

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 consecutive months. An estimated 45 million Americans experience chronic headaches. For at least half of these people, the problem is severe and sometimes disabling. Herein, only types of vascular headaches are discussed, including migraine, hemicrania continua, and cluster.

Migraine

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 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.

Treatment

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 amitriptyline, propranolol and other β-blockers, topiramate and other antiepileptic drugs, and verapamil.

Hemicrania Continua

Hemicrania continua causes moderate and occasionally 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.

Treatment

Indomethacin usually provides rapid relief of symptoms. Other nonsteroidal anti-inflammatory drugs, including ibuprofen, celecoxib, and naproxen, can provide some relief from symptoms. Amitriptyline and other tricyclic antidepressants are effective in some patients.

Cluster Headache

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, 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 by person, 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 1.0/1000.

Treatment

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.

Peripheral Nerve Stimulators

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

Regulatory Status

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.

Rationale:

This policy was created in February 2010 and has been updated periodically with searches of the MEDLINE database. The most recent literature update was performed for through February 5, 2018.

Medical policies assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function--including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Migraine Headache

Two systematic reviews of the literature on occipital nerve stimulation (ONS) have been published, both included RCTs and observational studies. The review by Chen et al. (2015) identified 5 RCTs and 7 case series with at least 10 patients. (1) Three of the RCTs were industry-sponsored, multicenter, parallel-group trials and 2 were single-center crossover trials. All 5 included a sham control group and 1 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 trials did not find a significant difference in response rate between active and sham stimulation (relative risk [RR], 2.07; 95% confidence interval [CI], 0.50 to 8.55; p=0.31) and a pooled analysis of 3 trials showed a significantly greater reduction in the number of days with prolonged moderate-to-severe headache (mean difference, 2.59; 95% CI, 0.91 to 4.27; p=0.003).

In their systematic review, Yang et al. (2016) (2) identified the same 5 RCTs as Chen. The Yang review only included 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 did not pool study findings. The definition of response rate varied across studies and could include frequency and/or severity of headaches. Response rates in 3 case series with self-reported 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%. Reviewers noted that the case series were subject to biases (e.g., inability to control for the placebo effect), that RCT evidence was limited, and that complication rates were high. The most common complications were lead migration (21% of patients) and infection (7% of patients).

The 2 parallel-group RCTs published as full-text journal articles are detailed next. The Occipital Nerve Stimulation for the Treatment of Intractable Chronic Migraine Headache (ONSTIM) trial, was a multicenter, randomized feasibility study of ONS for treatment of intractable chronic migraine headache refractory to preventive medical management. (3) The trial, reported by Saper et al. (2011), evaluated study design and had no 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, 17 to preset stimulation of 1 min/d, and 17 to medical management. At the 3-month evaluation, the response rate (percentage of patients who achieve ≥50% reduction in number of headache days per month or a ≥3-point reduction in average overall pain intensity vs baseline) was 39% in the adjustable stimulation group, 6% in the preset stimulation group, and 0% in the medical management group. Twelve (24%) of 51 subjects who had successful ONS device implantation experienced lead migration and 3 of the 51 subjects were hospitalized for adverse events (infection, lead migration, nausea). Study limitations included a short observation period and ineffective blinding of subjects and investigators to treatment groups.

An industry-sponsored, double-blind trial, regulated by the U.S. Food and Drug Administration, and reported by Silberstein et al. (2012), randomized 157 patients with chronic migraine refractory to preventive medical management in a 2:1 ratio to active or sham stimulation. (4) Intention-to-treat (ITT) analysis revealed no significant difference between 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 had fewer days with headache, less migraine-related disability, and greater pain relief, although 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 2015. (5) Results were reported for the ITT population and for the 125 patients who met selection criteria for intractable chronic migraine. Twenty-four patients were excluded from analysis due to explantation of the ONS system (n=18) or 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 reduction of 50% or more in the number of headache days and/or pain intensity was observed in 47.8% of this group. Seventy percent of patients experienced at least 1 of 183 device-related adverse events, of which 8.6% of events required hospitalization and 40.7% of events required surgical intervention. Eighteen percent of patients had persistent pain and/or numbness with the device.

Section Summary: Migraine Headache

Two systematic reviews (2015, 2016) each identified 5 sham-controlled randomized trials. One of the systematic reviews also identified 5 case series. Findings from pooled analyses of RCTs were mixed. For example, compared with sham stimulation, response rates (i.e., ≥50% reduction in VAS score) for ONS did not differ significantly, but the number of days with prolonged moderate-to-severe headache was reduced. ONS was also associated with a substantial number of minor and serious adverse events.

Non-Migraine Headaches

Hemicrania Continua

The evidence evaluating the use of ONS for hemicrania continua consists of a small crossover study by Burns et al. (2008) who reported on the efficacy of continuous unilateral ONS in 6 patients. (6) 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 substantially less pain (80%-95%), 1 reported a 30% less pain, and 1 reported 20% worse pain. Adverse events were mild and associated with transient overstimulation.

Cluster Headache

Several case series assessing cluster headache were identified, with sample sizes ranging from 10 to 67 patients. (7-12) Fontaine et al. (2017) published a prospective case series of 67 patients with chronic cluster headache. (10) Data were taken from a French ONS database on treatment of refractory headache disorders. Sixty-seven patients with chronic cluster headache 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 et al. (2017) published a case series on use of ONS in 35 patients with chronic cluster headache. (11) 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 number of headaches per day and were considered responders. In 12 (40%) patients, improvement was considered stable (i.e., ≤3 headache attacks per month).

Limitations of the series reporting on cluster headaches included lack of blinding and comparison groups.

Headache Associated With Chiari Malformation

Vadivelu et al. (2012) reported on a series of 22 patients with Chiari malformation and persistent occipital headaches. (13) 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 (87%) of the 15 patients reported pain relief greater than 50%. Forty percent of patients reported device-related complications requiring additional surgery (lead migration, uncomfortable position of generator, wound infection) during follow-up.

Occipital Neuralgia

A systematic review by Sweet et al. (2015) identified 9 small case series (<15 patients each) assessing the efficacy of ONS for treating medically refractory occipital neuralgia. (14) Reviewers did not pool study findings. Conclusions cannot be drawn on the impact of ONS on occipital neuralgia due to the lack of RCTs or other controlled studies.

Section Summary: Non-Migraine Headaches

The evidence on ONS for treatment of non-migraine headaches consists of case series; no RCTs or nonrandomized comparative studies were identified. Many of the case series were small; series with over 25 patients were available only for treatment of cluster headache. Although case series tended to find that a substantial number of patients improved after ONS, the studies lacked blinding and comparison groups. RCTs are needed to assess outcomes between ONS and comparators (e.g., to control for a potential placebo effect).

Summary of Evidence

For individuals who have migraine headaches refractory to preventive medical management who receive occipital nerve stimulation (ONS), the evidence includes randomized controlled trials (RCTs), systematic reviews of RCTs, and observational studies. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Systematic reviews identified 5 sham-controlled randomized trials. Findings from pooled analyses of RCTs were mixed. For example, compared to placebo, response rates to ONS did not differ significantly but did reduce the number of days with prolonged moderate-to-severe headache. ONS was associated with a substantial number of minor and serious adverse events. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have non-migraine headache (e.g., hemicrania continua, cluster headaches) who receive ONS, the evidence includes case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Most of the case series had small sample sizes; series with over 25 patients were available only for treatment of cluster headache. Although the case series tended to find that a substantial number of patients improved after ONS, these studies lacked blinding and comparison groups. RCTs are needed to compare outcomes between ONS and comparators (e.g., to control for a potential placebo effect). The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

Congress of Neurological Surgeons

A 2015 evidence-based guideline from the Congress of Neurological Surgeons states: “the use of occipital nerve stimulation is a treatment option for patients with medically refractory occipital neuralgia.” (14) The statement had a level III recommendation based on a systematic review of literature (see Rationale section) that only identified case series.

National Institute for Health and Care Excellence

Guidance from the National Institute for Health and Care Excellence (NICE) (2013) noted that the evidence on ONS for intractable chronic migraine showed “some efficacy for short-term but very little evidence about long-term outcomes. With regard to safety, there is a risk of complications, needing further surgery.” (15)

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No.

Name

Planned Enrollment

Completion Date

Ongoing

NCT01775735a

Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE

180

Jun 2017 (ongoing)

Unpublished

NCT01842763

French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders

50

Dec 2016

(unknown)

NCT: national clinical trial.

a Denotes industry-sponsored or cosponsored trial.

Contract:

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.

Coding:

There is no specific CPT code for occipital nerve stimulation. The following CPT codes may be used: 61885, 61886, 64553, 64568, 64569, 64570, and 64999.

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

64999

HCPCS Codes

C1767, L8679, L8680, L8681, L8682, L8683, L8684, L8685, L8686, L8687, L8688, L8689

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

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

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

3. 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

4. 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

5. 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, double-blinded, controlled study. Cephalalgia. Apr 2015; 35(4):344-358. PMID 25078718

6. 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

7. 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

8. 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

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. Fontaine D, Blond S, Lucas C, et al. Occipital nerve stimulation improves the quality of life in medically- intractable chronic cluster headache: Results of an observational prospective study. Cephalalgia. Oct 2017; 37(12):1173-1179. PMID 27697849

11. Leone M, Proietti Cecchini A, Messina G, et al. Long-term occipital nerve stimulation for drug-resistant chronic cluster headache. Cephalalgia. Jul 2017; 37(8):756-763. PMID 27250232

12. Miller S, Watkins L, Matharu M. 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

13. 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

14. Sweet JA, Mitchell LS, Narouze S, et al. 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

15. National Institute for Health and Care Excellence. IPG452 Occipital nerve stimulation for intractable chronic migraine. 2013; Available at: <http://publications.nice.org> (accessed March 8, 2018).

16. Occipital Nerve Stimulation. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2018 April) Surgery 7.01.125.

Policy History:

Date Reason
7/15/2018 Document updated with literature review. Coverage unchanged. References 10-12 added.
7/15/2017 Reviewed. No changes.
10/1/2016 Document updated with literature review. Coverage unchanged.
5/15/2015 Reviewed. No changes.
8/15/2014 Document updated with literature review. Coverage unchanged
6/1/2011 CPT/HCPCS code(s) updated
12/1/2010 New medical document. Occipital nerve stimulation is considered experimental, investigational and unproven for all indications

Archived Document(s):

Title:Effective Date:End Date:
Occipital Nerve Stimulation07-15-201707-14-2018
Occipital Nerve Stimulation10-01-201607-14-2017
Occipital Nerve Stimulation05-15-201509-30-2016
Occipital Nerve Stimulation08-15-201405-14-2015
Occipital Nerve Stimulation06-01-201108-14-2014
Occipital Nerve Stimulation12-01-201005-31-2011
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