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Occipital Nerve Stimulation

Policy Number: MP-411

Latest Review Date: April 2021

Category: Surgery                                                                  

Policy Grade: B

POLICY:

Occipital nerve stimulation is considered investigational for all indications.

DESCRIPTION OF PROCEDURE OR SERVICE:

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.

Headache

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 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

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.

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 methysergide maleate, propranolol hydrochloride, ergotamine tartrate; amitriptyline, valproic acid, and verapamil.

Hemicrania Continua

Hemicrania continua, also a vascular headache, cause 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 woman, and its true prevalence is not known.

Treatment

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

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. At least one of the following autonomic symptoms accompanies the headache: ptosis (drooping eyelid), conjunctival injection, lacrimation, rhinorrhea, and, less commonly, facial blushing, swelling, or sweating. Bouts of one headache every other day to eight attacks per day may last from weeks to months, usually followed by remission periods when the headache attacks stop completely. The pattern varies from one person to another, but most people have one or two cluster periods a year. During remission, no headaches occur for months, and sometimes even years. The intense pain is caused by the dilation of blood vessels, which creates pressure on the trigeminal nerve. While this process is the immediate cause of the pain, the etiology is not fully understood. It is more common in men than in woman. One-year prevalence is estimated to be 0.5 to 1.0 in 1,000.

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. Varieties 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.

KEY POINTS:

The most recent literature search was performed using the MEDLINE database for the period through March 10, 2021.

Summary of Evidence

For individuals who have migraine headaches refractory to preventive medical management who receive occipital nerve stimulation, 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 five sham-controlled randomized trials. Findings from pooled analyses of these RCTs were mixed. For example, compared to placebo, response rates to occipital nerve stimulation did not differ significantly but did reduce the number of days with prolonged moderate-to-severe headache. Occipital nerve stimulation was also associated with a substantial number of minor and serious adverse events. The evidence is insufficient to determine that the technology results in an Improvement in the net health outcome.

For individuals who have non-migraine headaches (e.g., hemicrania continua, cluster headaches) who receive occipital nerve stimulation, the evidence includes case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Many 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 occipital nerve stimulation, these studies lacked blinding and comparison groups. RCTs are needed to compare outcomes between occipital nerve stimulation and comparators (e.g., to control for a potential placebo effect). The evidence is insufficient to determine that the technology results in an Improvement in the net health outcome.

Practice Guidelines and Position Statements

Congress of Neurological Surgeons

A 2015 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.” The statement had a level III recommendation based on a systematic review of literature, discussed in the Key Points that identified only case series.

National Institute for Health and Care Excellence

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. With regard to safety, there is a risk of complications, needing further surgery.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Occipital neurostimulation, Headache, ONSTIM, Migraine, Neuromodulation, implantable pulse generator, Synergy™ IPG, Genesis™ neuromodulation system, Eon™ stimulator, Precision™, Omega Procedure, Reed Procedure®

APPROVED BY GOVERNING BODIES:

To date, the U.S. Food and Drug Administration (FDA) has not cleared or approved any occipital nerve stimulation (ONS) device for treatment of headache.  In 1999, the Synergy™ IPG device (Medtronic), an implantable pulse generator, was approved by 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 FDA for spinal cord stimulation approved The Genesis™ neuromodulation system (St. Jude Medical). The Eon™ stimulator has received CE mark approval in Europe for the treatment of chronic migraines.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING: 

CPT Codes:

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 array; cranial nerve

64555           

Percutaneous implantation of neurostimulator electrodes; peripheral nerve (excludes sacral nerve)

64568

Open 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 nerve (excludes sacral nerve)

64575

Open implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve)

64999

Unlisted procedure, nervous system

 

 

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, non-rechargeable, includes extension

L8687

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

L8688

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

L8689

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

REFERENCES:

  1. Burns B, Watkins L and Goadsby P. 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):1001-1012.

  2. Burns B, Watkins L and Goadsby P. Treatment of intractable chronic cluster headache by occipital nerve stimulation in 14 patients. Neurology 2009; 72(4):341-345.

  3. 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.

  4. 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. 

  5. 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.

  6. 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.

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

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

  9.  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.

  10. 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.

  11. 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. 

  12. National Institute for Health and Care Excellence. IPG452 Occipital nerve stimulation for intractable chronic migraine. 2013. Available online at:  publications.nice.org.uk/occipital-nerve-stimulation-for-intractable-chronic-migraine-ipg452. Accessed March 4, 2020.

  13. Reed KL, Black SB, Bant CJ II, et al. Combined occipital and supraorbital neurostimulation for the treatment of chronic migraine headaches: initial experience. Cephalalgia 2009 Sep 3 2010; 30(3):260-71.

  14. Saper JR, Dodick DW, Silberstein ST et al. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalgia 2011; 31(3): 271-85.

  15. Schwedt TJ, Dodick DW, Trentman TL, et al. Occipital nerve stimulation for chronic headache--long-term safety and efficacy. Cephalalgia 2007; 27(2):153-7.

  16. 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.

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

  18. 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. Cephalagia 2012; 32(16):1165-1179.

  19. 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.

  20. 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.

  21. Yang Y, Song M, Fan Y, et al. Occipital nerve stimulation for migraine: a systematic review. Pain Pract. Apr 2016; 16(4):509-517.

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

POLICY HISTORY:

Medical Policy Group, February 2010 (3)

Medical Policy Administration Committee, February 2010

Available for comment February 23-April 8, 2010

Medical Policy Group, December 2010: 2011 code update

Medical Policy Group, April 2011; Updated Key Points and References (3)

Medical Policy Group, December 2011 (3): Updated Key Points and References; Updated 2012 Codes 64553 & 64575

Medical Policy Group, December 2012 (3): 2012 update to Description, Key Points and References

Medical Policy Panel, November 2013

Medical Policy Group, January 2014 (2): Policy updated with literature review through September 2013.  Policy statement unchanged.  Information added to Approved by Governing Body.  Key Points and References updated. 

Medical Policy Group, May 2014 (5):  2014 Coding Update:  Deleted code L8680 effective July 1, 2014.

Medical Policy Group, June 2014 (5):  Quarterly 2014 Coding Update:  Code L8680 did not delete added back to policy under current codes.

Medical Policy Panel, November 2014

Medical Policy Group, November 2014 (4): Updates to Key Points and References.  No change to policy statement.

Medical Policy Panel, April 2016

Medical Policy Group, April 2016 (6):  Updates to Key Points, Approved by Governing Bodies, Coding and References; no change to policy statement.

Medical Policy Panel, April 2017

Medical Policy Group, May 2017 (6): Updates to Description, Key Points and References. No change in policy statement.

Medical Policy Panel, April 2018

Medical Policy Group, May 2018 (6): Updates to Description and Key Points.

Medical Policy Panel, April 2019

Medical Policy Group, May 2019 (3): 2019 Updates to Key Points, References and Key Words: added: Omega Procedure and Reed Procedure®. No changes to policy statement or intent.

Medical Policy Panel, April 2020

Medical Policy Group, May 2020 (3): 2020 Updates Key Points, Practice Guidelines and Position Statements, and References. No changes to policy statement or intent.

Medical Policy Panel, April 2021

Medical Policy Group, April 2021 (3): 2021 Updates to Key Points and References. Policy statement updated to remove “not medically necessary,” no change to policy statement or intent.

Medical Policy Group, December 2021: 2022 Annual Coding Update.  Revised CPT codes 64568 and 64575 “Open” added to descriptor and “incision for” was removed.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.