Occipital Nerve Stimulation - Insertion Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 06|01|2015 POLICY LAST REVIEWED: 05|21|2025 OVERVIEW 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. This policy is intended to document the insertion or implantation of the device as not medically necessary. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION Not applicable POLICY STATEMENT Medicare Advantage Plans Occipital nerve stimulation is not covered as the evidence is insufficient to determine the effects of the technology on health outcomes. Revision or replacement of an occipital nerve stimulator is not covered as the initial implantation procedure is also not covered.
Commercial Products Occipital nerve stimulation is considered not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes. Revision or replacement of an occipital nerve stimulator is considered not medically necessary as the initial implantation procedure is also not medically necessary.
COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for not covered/not medically necessary benefits/coverage. BACKGROUND The ONS 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, we only discuss types of vascular headache, 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. Medical Coverage Policy | Occipital Nerve Stimulation - Insertion

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

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 of Migraine Drug therapy for migraine is often combined with biofeedback and relaxation training. Sumatriptan and other triptans are commonly used for relief of symptoms. Drugs used to prevent migraine include amitriptyline, propranolol and other β-blockers, topiramate and other antiepileptic drugs, and verapamil.

Hemicrania Continua 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 of Hemicrania Continua Indomethacin usually provides rapid relief of symptoms. Other nonsteroidal anti-inflammatory drugs, including ibuprofen, celecoxib, and naproxen, can provide some relief of 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 1 headache every other day up 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 to 1 in 1000.

Treatment of Cluster Headache 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.

The U.S. Food and Drug Administration (FDA) has not cleared or approved any occipital nerve stimulation device for treatment of headache.

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 5 sham-controlled randomized trials. Findings from pooled analyses of these RCTs were mixed. For example, compared with 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

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

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 (eg, hemicrania continua, cluster headaches) who receive occipital nerve stimulation, the evidence includes 1 RCT and 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 (eg, to control for a potential placebo effect). One blinded RCT assessing electrical dose-controlled stimulation did not find a significant difference between 100% and 30% (sham) stimulation in individuals with refractory chronic cluster headache. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

CODING Medicare Advantage Plans and Commercial Products There is no specific CPT or HCPCS code(s) for occipital nerve stimulation, therefore providers should report this service with an unlisted procedure code. 64999 Unlisted procedure, nervous system

RELATED POLICIES Not applicable.

PUBLISHED Provider Update, July 2025 Provider Update, July 2024 Provider Update, June 2023 Provider Update February/September 2022 Provider Update, July 2020

REFERENCES

1. Chen YF, Bramley G, Unwin G, et al. Occipital nerve stimulation for chronic migraine--a systematic review and meta-analysis. PLoS One. Mar 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 2016;16(4):509-517. 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. Wilbrink LA, de Coo IF, Doesborg PGG, et al. Safety and efficacy of occipital nerve stimulation for attack prevention in medically intractable chronic cluster headache (ICON): a randomised, double- blind, multicentre, phase 3, electrical dose-controlled trial. Lancet Neurol. Jul 2021; 20(7): 515-525. PMID 34146510
7. Brandt RB, Wilbrink LA, de Coo IF, et al. A prospective open label 2-8 year extension of the randomised controlled ICONtrial on the long-term efficacy and safety of occipital nerve stimulation in medically intractable chronic cluster headache. EBioMedicine. Dec 2023; 98: 104895. PMID 38007947
8. Burns B, Watkins L, Goadsby PJ. Treatment of hemicrania continua by occipital nerve stimulation with a bion device: long-term followup of a crossover study. Lancet Neurol. Nov 2008;7(11):1001-1012. PMID 18845482

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

9. 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
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. PMID 21848953
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-
12. PMID 21448856
13. 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
14. 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
15. 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
16. 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. PMID 32985662
17. 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): 1001-12. PMID 18845482
18. 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
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): 332-41. PMID 26125672
20. Strand N, D'Souza RS, Hagedorn JM, et al. Evidence-Based Clinical Guidelines from the American Society of Pain and Neuroscience for the Use of Implantable Peripheral Nerve Stimulation in the Treatment of Chronic Pain. J Pain Res. 2022;15: 2483-2504. PMID 36039168
21. Staudt MD, Hayek SM, Rosenow JM, et al. Congress of Neurological Surgeons Systematic Review and Evidence-Based Guidelines for Occipital Nerve Stimulation for the Treatment of Patients With Medically Refractory Occipital Neuralgia: Update. Neurosurgery. Sep 01 2023; 93(3): 493-495. PMID 37458729
22. VA/DoD Clinical Practice Guideline. (2023). Management of Headache Work Group. Washington, DC:U.S. Government Printing Office. https://www.healthquality.va.gov/guidelines/pain/headache/VA-DoD-CPG-Headache-Full- CPG.pdf. Accessed April 18, 2025.
23. 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

24. National Institute for Health and Care Excellence. Occipital nerve stimulation for intractable chronic migraine [IPG452]. 2013; https://www.nice.org.uk/guidance/ipg452. Accessed April 18, 2025.

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    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS