Latest Review Date: May 2023

Category: Surgery                                                                 

POLICY:

Occipital nerve stimulation is considered investigational for all indications.

Infraorbital/Supraorbital nerve stimulation is considered investigational for all indications.

Trigeminal nerve stimulation is considered investigational for all indications.

DESCRIPTION OF PROCEDURE OR SERVICE:

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.

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.

Peripheral Nerve Stimulators

Peripheral (occipital and supraorbital) and cranial (trigeminal) nerve stimulation using an implantable device has been explored as an approach to treat numerous chronic pain conditions. The surgical procedure involves the surgical implantation of a small electrical device (a wire-like electrode) adjacent to the selected nerve(s). The electrode delivers rapid electrical pulses near the selected nerve, regardless of the specific nerve targeted. During the trial stimulation, the electrode is connected to an external device, and if the trial is successful, a small generator is implanted into the patient’s body. An electrical current is delivered from the generator to the nerve or nerves using one or several electrodes. The subject is able to control the intensity of the stimulation by turning the device on and off and adjusting stimulation parameters as needed.

Use of an implantable nerve stimulation device may be referred to as occipital, supraorbital or trigeminal nerve stimulation, depending upon the nerves that are being targeted for stimulation.

The implantation of an occipital, supraorbital or trigeminal nerve stimulation device may cause some complications.

Lead migration, power depletion in the pulse generator, and the possibility of infection are the most frequent problems requiring removal and replacement of the implantable nerve stimulation device.

Occipital Nerve Stimulation

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.

Supraorbital Nerve Stimulation

Supraorbital nerve stimulation includes the neurostimulation of both occipital and supraorbital nerves. Researchers have been exploring the utilization of supraorbital nerve stimulation as a treatment for chronic migraine. Participants were evaluated with the migraine disability assessment scale (MIDAS) and the Beck Depression Inventory (BDI) both preoperatively and postoperatively.

Trigeminal Nerve Stimulation for Trigeminal Neuralgia

Trigeminal neuralgia (TN) is a chronic pain condition that affects the trigeminal (5th cranial) nerve, one of the most widely distributed nerves in the head. Treatment options may include pharmacologic therapy, surgical interventions (including but not limited to rhizotomy), and other complementary approaches.

Treatment

Trigeminal nerve stimulation has been explored as a treatment for trigeminal neuralgia. Similar to occipital nerve stimulation and supraorbital nerve stimulation, trigeminal nerve stimulation involves the implantation of a pulse generator and electrodes to deliver mild electrical signals to branches of the trigeminal nerve in order to provide neuromodulation of pain. Implantation of the electrodes is considered a minimally invasive procedure. Postoperative complications may include nerve damage, pain, infection, electrode migration, mechanical failure (e.g., disconnection of hardware and failure to provide adequate pain relief) and cosmetic concerns.

KEY POINTS:

The most recent literature update was performed through January 16, 2023.

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.

For individuals who have headaches or facial pain there is a paucity of studies evaluating peripheral nerve stimulation therapy. Relevant outcomes are quality of life, productivity, and psychosocial aspects. Patients with an encouraging response to supraorbital nerve stimulation and occipital nerve stimulation also reported overall improvement in their functional status as reflected by the migraine disability assessment scale (MIDAS) and the Beck Depression Inventory (BDI) in the perioperative period. However, this effect diminished over the long-term follow-up. 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® Facial pain; Infraorbital nerve; Neuropathic pain; Stimulation; Supraorbital nerve; Trigeminal neuralgia, PRISM®Supraorbital nerve stimulation; trigeminal nerve stimulation

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:  Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING: 

CPT Codes:

There is are no specific CPT codes for infraorbital, occipital, supraorbital, or trigeminal nerve stimulation. The following CPT codes may be used:

HCPCS:

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. Clark SW, Wu C, Boorman DW, et al. Long-term pain reduction does not imply improved functional outcome in patients treated with combined supraorbital and occipital nerve stimulation for chronic migraine. Neuromodulation. 2016; 19(5):507-514.
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. 
6. 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.
7. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
8. 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.
9. 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.
10.  Magis D, Gerardy PY, Remacle JM, et al. Sustained effectiveness of occipital nerve stimulation in drug-resistant chronic cluster headache. Headache. Sep 2011; 51(8):1191-1201.
11. Mercieri M, Negro A, Silvestri B, et al. O065. Drug-resistant chronic cluster headache successfully treated with supraorbital plus occipital nerve stimulation. A rare case report. J Headache Pain. 2015; 16(Suppl 1):A97.
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.
13. 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. 
14. National Institute for Health and Care Excellence. IPG452 Occipital nerve stimulation for intractable chronic migraine. 2013.
15. 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.
16. Reed KL, Will KR, Conidi F, Bulger R. Concordant occipital and supraorbital neurostimulation therapy for hemiplegic migraine; Initial experience; a case series. Neuromodulation. 2015; 18(4):297-303.
17. 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.
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.

Medical Policy Panel, April 2022

Medical Policy Group, June 2022 (3): 2022 Updates to policy statement: added non-coverage of trigeminal and supra- and infraorbital nerve stimulation to policy. Updates to Key Points, References, and Key words: added: Facial pain; Infraorbital nerve stimulation; Neuropathic pain; supraorbital nerve; Trigeminal neuralgia, PRISM® supraorbital nerve stimulation; trigeminal nerve stimulation. No other changes to policy statement or intent. Title changed to: Peripheral Nerve Stimulation of the Head and Neck for Treatment of Pain from Occipital Nerve Stimulation.

Available for comment July 1, 2022 through August 15, 2022.

Medical Policy Administration Committee, July 2022

Medical Policy Panel, April 2023

Medical Policy Group, May 2023 (3): 2023 Updates to Key Points, Benefit Applications, and References. No changes to policy statement or intent.

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.