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Occipital Nerve Stimulation

Number 7.01.125

Effective Date January 21, 2014

Revision Date(s) 01/13/14; 01/14/13; 01/06/12

Replaces N/A

Policy

Occipital nerve stimulation is considered investigational for all indications.

Related Policies

1.01.507

Electrical Stimulation Devices

7.01.63

Deep Brain Stimulation

7.01.135

Surgical Deactivation of Headache Trigger Sites

7.01.546

Spinal Cord Stimulation

Policy Guidelines

Coding

CPT

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 (e.g., vagus nerve) neurostimulator electrode array and pulse generator

64569

Revision or replacement of cranial nerve (e.g., vagus nerve) neurostimulator electrode array, including connection to existing pulse generator

64570

Removal of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator

64999

Unlisted procedure, nervous system

Some of the occipital nerve stimulation (ONS) devices commercially available are the Eon™ stimulator, the Genesis™ neuromodulation system, Precision™ neuromodulation, the Synergy™IPG. This list is not all inclusive. As of September 2013 no occipital nerve stimulation (ONS) device for the treatment of headaches has been cleared for marketing by the U.S. Food and Drug Administration (FDA). (See Regulatory Status and the FDA website).

Description

Occipital nerve stimulation (ONS) devices deliver 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.

Background

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 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. 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.

A 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 occur mainly in women, and its true prevalence is not known. Indomethacin usually provides rapid relief of symptoms. Other nonsteroidal anti-inflammatory drugs (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 (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 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 1.0/1000. 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.

As of September 2013, the U.S. Food and Drug Administration (FDA) has not cleared any occipital nerve stimulation (ONS) device for treatment of headache. The Synergy™ IPG (implantable pulse generator) device from Medtronic received marketing clearance in 1999 for management of chronic, intractable pain of the trunk or limbs, and off-label use for headache is described in the literature. The Genesis™ neuromodulation system (St. Jude Medical) is approved by the FDA for spinal cord stimulation and the Eon™ stimulator has received CE mark approval in Europe for the treatment of chronic migraines. Medtronic and Boston Scientific Neuromodulation Systems (Precision™) are currently conducting clinical trials of devices.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply.

Benefit Application

N/A

Rationale

This policy was created in February 2010. Since that time the policy has been reviewed on a regular basis and updated as needed. The most recent literature search was performed through September 27, 2013. Following is a summary of the key literature.

Controlled Trials

Migraine

A report of the Occipital Nerve Stimulation for the Treatment of Intractable Chronic Migraine Headache (ONSTIM) trial, a multicenter, randomized feasibility study of occipital nerve stimulation (ONS) for treatment of intractable chronic migraine headache, was published in 2011. (1) The trial was designed to evaluate the study design and not powered for 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 minute per day, and 17 to medical management (MM). 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). 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 FDA-regulated double-blind trial that randomized 157 patients in a 2:1 ratio to active or sham stimulation. (2) 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.

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 and randomized to “Stimulation On” or “Stimulation Off” arms. (3) After 1 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). 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 non-steroidal 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.

Hemicrania Continua

Six patients with hemicrania continua received continuous unilateral ONS in a crossover study by Burns et al. in 2008. (4) Pain on a 10-point scale was recorded hourly in patient diaries, and the Migraine Disability Assessment Scale (MIDAS) 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.

Observational Studies

Aside from the 2 randomized studies and small cross-over study discussed above, evidence on ONS for treatment of headache is limited to small case series.

For example, in 2007, Schwedt et al. published a retrospective analysis of pre- and post-implant data from 15 patients with chronic, intractable headache implanted with the Synergy implantable pulse generator. (5) Eight patients had chronic migraine, 3 chronic cluster, 2 hemicrania continua, and 2 post-traumatic headaches. Eight patients had bilateral and 7 had unilateral lead placement. Nine patients reported at least a 50% reduction in headache pain, and none reported worsening of pain. Sixty percent of patients required lead revision within 1 year. The same authors conducted a retrospective review of the patients in the study reported above to determine if response to occipital nerve block (ONB) predicts response to ONS. (6) Ten of 13 patients who had ONB had significant relief of pain (50% or more reduction in frequency or severity), and 3 were ONB nonresponders. Of the 3 ONB nonresponders, 2 were ONS responders. Thus, ONB may not be predictive of the therapeutic effect of ONS.

In 2009 Trentman et al. reported outcome measures at 1 year post-implant in 9 patients who participated in a feasibility trial of the Bion microstimulator. (7) One patient stopped using the device before 1 year because of the time required to recharge the device. At 1 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.

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 improvements (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 non-significant 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 post-operative 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 paresthesisas 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 occipital headaches. (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) occurring 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 Clinical Trials

A search of online site 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 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 January 2014.
  • NCT00286078 an industry-sponsored Phase III trial from Boston Scientific titled Precision Implantable Stimulator for Migraine (PRISM) Study: Occipital Nerve Stimulation (ONS) for Migraine (Recruitment n=179) is completed. The original estimated study completion date is listed as January 2015. However, the posting for NCT00747812 (PRISM UK) states that Boston Scientific closed enrollment and terminated the study early based on interim data from the PRISM US Pivotal Study, while the background section of a recent publication(2) reports no significant difference in the PRISM trial between active treatment and sham controls for the number of migraine days/month.
  • NCT01775735 Boston Scientific began a randomized trial (OPTIMIZE) in 2013 to evaluate the Precision™ system for occipital nerve stimulation for migraine. The study lists an estimated enrollment of 180 patients with completion expected June 2016.
  • NCT01151631 is a study of occipital nerve stimulation in medically intractable chronic cluster headache sponsored by Leiden University Medical Center. The study has an estimated enrollment of 144 patients with completion expected January 2014.
  • 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 occipital nerve stimulation. The study began January 2013.
  • NCT01298609 is a study of occipital nerve stimulation for the treatment of fibromyalgia. This study shows no updates since October 2011.

Summary

The literature to date on the use of occipital nerve stimulation (ONS) consists primarily of small case series, small randomized trials and two small crossover studies. While the case series report substantial benefit, treatment-related improvements in the randomized controlled trials were modest. Randomized controlled trials (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. Available evidence, at this time, 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 (FDA) approval. Therefore, ONS is considered investigational.

Practice Guidelines and Position Statements

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.

Medicare National Coverage

There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of the 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 2011; 31(3):271-85.
  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 2012; 32(16):1165-79.
  3. Serra G, Marchioretto F. Occipital nerve stimulation for chronic migraine: a randomized trial. Pain Physician 2012; 15(3):245-53.
  4. 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 2008; 7(11):1001-12.
  5. Schwedt TJ, Dodick DW, Hentz J et al. Occipital nerve stimulation for chronic headache--long-term safety and efficacy. Cephalalgia 2007; 27(2):153-7.
  6. Schwedt TJ, Dodick DW, Trentman TL et al. Response to occipital nerve block is not useful in predicting efficacy of occipital nerve stimulation. Cephalalgia 2007; 27(3):271-4.
  7. Trentman TL, Rosenfeld DM, Vargas BB et al. Greater occipital nerve stimulation via the Bion Microstimulator: implantation technique and stimulation parameters. Clinical Trial: NCT00205894. Pain Physician 2009; 12(3):621-8.
  8. Burns B, Watkins L, Goadsby PJ. Treatment of intractable chronic cluster headache by occipital nerve stimulation in 14 patients. Neurology 2009; 72(4):341-5.
  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 2011; 72(2):84-9.
  10. Magis D, Gerardy PY, Remacle JM et al. Sustained effectiveness of occipital nerve stimulation in drug-resistant chronic cluster headache. Headache 2011; 51(8):1191-201.
  11. Vadivelu S, Bolognese P, Milhorat TH et al. Occipital nerve stimulation for refractory headache in the Chiari malformation population. Neurosurgery 2012; 70(6):1430-6; discussion 36-7.
  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 2010; 30(3):260-71.
  13. National Institute for Health and Care Excellence. IPG452 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 December 11, 2013.
  14. Blue Cross and Blue Shield Association (BCBSA) Medical Policy Reference Manual. Occipital Nerve Stimulation. Medical Policy Reference Manual, Policy 7.01.125, 2013.

Coding

Codes

Number

Description

CPT

61885

Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array

 

61886

Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to 2 or more electrode arrays

 

64553

Percutaneous implantation of neurostimulator electrodes; cranial nerve

 

64568

Incision for implantation of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator

 

64569

Revision or replacement of cranial nerve (e.g., vagus nerve) neurostimulator electrode array, including connection to existing pulse generator

 

64570

Removal of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator

     
 

64999

Unlisted procedure, nervous system

ICD-9 Procedure

   

ICD-9 Diagnosis

   

ICD-10-CM
(effective 10/01/14)

G43.00-G43.919

Migraine code range

 

G44.00-G44.89

Other headache syndromes code range

ICD-10-PCS
(effective 10/01/14)

   
 

0JPT0MZ, 0JPT3MZ

Surgical, subcutaneous tissue and fascia, removal, subcutaneous tissue and fascia, trunk, stimulator generator, code by approach

HCPCS

L8680

Implantable neurostimulator electrode, each

 

L8681

Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only

 

L8682

Implantable neurostimulator radiofrequency receiver

 

L8683

Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver

 

L8684

Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement

 

L8685

Implantable neurostimulator pulse generator, single array, rechargeable, includes extension

 

L8686

Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension

 

L8687

Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension

 

L8688

Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension

 

L8689

External recharging system for battery (internal) for use with implantable neurostimulator, replacement only

Type of Service

Surgery

 

Place of Service

Inpatient

 

Appendix

N/A

History

Date

Reason

04/13/10

Add to Surgery Section - New Policy

05/10/11

Replace Policy - Policy updated with literature search, reference 6 updated, reference 7 added; policy statement unchanged. CPT coding updated in Policy Guidelines. ICD-10 codes added to policy.

01/06/12

Replace Policy – Policy updated with literature search through August 2011; references 7 and 8 added and references reordered; policy statement unchanged.

04/17/12

Related Policies updated: 7.01.546 added to replace 7.01.25 which has been deleted.

09/26/12

Update Coding Section – ICD-10 codes are now effective 10/01/2014.

10/17/12

Update Related Policies – Add 7.01.135.

01/29/13

Replace policy. Policy updated with literature search through August 2012; references 2 and 10 added and references reordered; policy statement unchanged.

10/16/13

Update Related Policies. Change title to policy 7.01.135.

01/21/14

Replace policy. Policy updated with literature review through September 27, 2013. References 2, 13 added; others renumbered/removed. Policy statement unchanged. ICD-10-PCS codes removed; this is an outpatient procedure and they would not apply.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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