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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-61000-06

Original Effective Date: 02/15/10

Reviewed: 01/24/13

Revised: 11/01/15

Subject: Occipital Nerve Stimulation

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates    

DESCRIPTION:

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.

Evidence of efficacy for occipital nerve stimulation (ONS) for treatment of chronic headache is limited to reports of small case series with short follow-up.

Randomized controlled trials (to account for potential placebo effect) with greater numbers of patients and longer follow-up are needed. In addition, these trials must compare outcomes of ONS with outcomes of other possible alternative treatments.

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. 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.

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 occurs mainly in women, and its true prevalence is not known. Indomethacin usually provides rapid relief of symptoms. Other non-steroidal 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. 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 women. 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.

As of October 2012, 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 has received approval in Europe for the treatment of chronic migraines. Medtronic and Boston Scientific Neuromodulation Systems are currently conducting clinical trials of devices.

POSITION STATEMENT:

The use of occipital nerve stimulation devices is considered experimental or investigational for all indications. There is insufficient clinical peer reviewed literature demonstrating the safety, efficacy, and the effects of occipital nerve stimulation on long-term health outcomes.

BILLING/CODING INFORMATION:

There is no specific CPT code for occipital nerve stimulation. The following codes may be used to describe occipital nerve stimulation.

CPT Coding:

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 electrode array; cranial nerve

64555

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

64575

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

64590

Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling

95970

Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple or complex brain, spinal cord, or peripheral (i.e. cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming

95971

Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spinal cord, or peripheral (i.e. peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming

HCPCS Coding:

L8679

Implantable neurostimulator pulse generator, any type

L8680

Implantable neurostimulator electrode, (with any number of contact points), 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

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 implanted neurostimulator, replacement only battery (internal) for use with implantable neurostimulator, replacement only

L8695

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

REIMBURSEMENT INFORMATION:

Refer to sections entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Spinal Cord Stimulation, 02-61000-05

OTHER

None.

REFERENCES:

  1. AHRQ National Guideline Clearinghouse. Guideline Summary NGC-8263. Diagnosis and treatment of headache. Institute for Clinical Systems Improvement (ICSI). Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2011 Jan. 84 p.
  2. American Academy of Physical Medicine and Rehabilitation. Knowledge NOW: Cervicogenic Headache. © 2011 Knowledge NOW. American Academy of Physical Medicine and Rehabilitation.
  3. Blue Cross Blue Shield Association Medical Policy Reference Manual. 7.01.125, Occipital Nerve Stimulation, November 2012.
  4. Burns et al. Treatment of intractable chronic cluster headache by occipital nerve stimulation in 14 patients. Neurology. 2009 Jan 27;72 (4):341-5.
  5. Burns et al. Treatment of medically intractable cluster headache by occipital nerve stimulation: long-term follow-up of eight patients. Lancet. 2007; 369: 1099-1106.
  6. Centers for Medicare and Medicaid Services (CMS) Manual System, Pub. 100-3, Manual Section 160.7.1. National Coverage Determination (NCD) for Assessing Patient's Suitability for ELECTRICAL NERVE STIMULATION Therapy, (06/19/06). Accessed 01/04/12.
  7. ClinicalTrials.gov. Bion® for Occipital Nerve Stimulation. NCT00205829. Last updated 10/28/08.
  8. ClinicalTrials.gov. Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache (ONSTIM). NCT00200109. Last updated 08/26/10.
  9. ClinicalTrials.gov. Occipital Nerve Stimulation in Medically Intractable Chronic Cluster Headache (ICON). NCT01151631. Last updated 07/11/11 (Accessed 01/02/13).
  10. ClinicalTrials.gov. Greater Occipital Nerve Block for Migraine Prophylaxis. NCT00915473. Last updated: September 13, 2012.
  11. Deshpande KK, Wininger KL. Case Report: Feasibility of Combined Epicranial Temporal and Occipital Neurostimulation: Treatment of a Challenging Case of Headache. Pain Physician 2011; 14:37-44.
  12. Falowski S, Wang D, Sabesan A, Sharan A. Occipital nerve stimulator systems: Review of complications and surgical techniques (2010). Department of Neurosurgery Faculty Papers. Paper 6. http://jdc.jefferson.edu/neurosurgeryfp/6.
  13. Gaul C, Diener HC, Müller OM. Cluster headache—clinical features and therapeutic options. Dtsch Arztebl Int 2011; 108(33): 543–9.
  14. Hayek SM, Jasper JF, Deer TR, Narouze SN. Occipital Neurostimulation-Induced Muscle Spasms: Implications for Lead Placement. Pain Physician 2009; 12:867-876.
  15. Interqual® 2010 Clinical Evidence Summary: Headache. Copyright ©2010 McKesson Corporation.
  16. Interqual® 2011 Clinical Evidence Summary: Headache. Copyright ©2011 McKesson Corporation.
  17. InterQual® 2012 Clinical Evidence Summary: Headache. Copyright ©2012 McKesson Corporation.
  18. Interventional Procedures Consultation: Occipital Nerve Stimulation for Intractable Headache. July 28, 2008. Last updated 03/30/10. Copyright © 2010 National Institute for Health and Clinical Excellence.
  19. Interventional Procedures Overview: Occipital Nerve Stimulation for Intractable Headache. July 28, 2008. Last updated 03/30/10. Copyright © 2010 National Institute for Health and Clinical Excellence.
  20. Jasper JF, Hayek SM. Implanted Occipital Nerve Stimulators. Systematic Review. Pain Physician. 2008 Mar-Apr; 11 (2):187-200. (Accessed 12/29/11).
  21. Jenkins B, Tepper SJ. Neurostimulation for Primary Headache Disorders, Part 1: Pathophysiology and Anatomy, History of Neuromodulation in Headache Treatment, and Review of Peripheral Neuromodulation in Primary Headaches. Headache 2011;51:1254-1266.
  22. Johnstone CSH Occipital nerve stimulation for the treatment of occipital neuralgia – eight case studies. Neuromodulation. 2006; 9:41-47.
  23. Kapural L, Mekhail N, Hayek SM, Stanton-Hicks M, Malak O. Occipital nerve electrical stimulation via the midline approach and subcutaneous surgical leads for treatment of severe occipital neuralgia: a pilot study. Anesth Analg. 2005 Jul; 101 (1):171-4.
  24. Lambru G, Matharu MS. Occipital nerve stimulation in primary headache syndromes. Ther Adv Neurol Disord. 2012 January; 5(1): 57–67.
  25. Mousavi SA, Mirbod SM, Khorvash F. Comparison between efficacy of imipramine and transcutaneous electrical nerve stimulation in the prophylaxis of chronic tension-type headache: a randomized controlled clinical trial. J Res Med Sci. 2011 July; 16(7): 923–927.
  26. National Institute for Health and Clinical Excellence (NICE). Occipital nerve stimulation for intractable headache. Interventional Procedures Consultation. London, UK: NICE; July 2008.
  27. Schwedt et al. Occipital nerve stimulation for chronic headache – long-term safety and efficacy. Cephalalgia. 2007; 26:1025-1027.
  28. Serra G, Marchioretto F. Occipital Nerve Stimulation for Chronic Migraine: A Randomized Trial. Pain Physician 2012; 15:245-253.
  29. Slavin et al. Peripheral neurostimulation for treatment of intractable occipital neuralgia. Neurosurgery. 2006 Jan;58(1):112-9.
  30. Strand NH, Trentman TL, Vargas BB, Dodick DW. Occipital Nerve Stimulation with the Bion® Microstimulator for the Treatment of Medically Refractory Chronic Cluster Headache. Pain Physician 2011; 14:435-440.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 01/24/13.

GUIDELINE UPDATE INFORMATION:

02/15/10

New Medical Coverage Guideline.

02/15/11

Scheduled review; position statement unchanged. Revised description section; added CPT codes 61885, 61886, and 64553; updated references.

01/01/12

Annual HCPCS coding update. Revised 64553, 64555, 64575, 95970 and 95971 descriptors.

02/15/12

Scheduled review; position statement unchanged. Revised description section and updated references.

02/15/13

Scheduled review. Position statement maintained. Revised description and updated references.

01/01/14

Annual HCPCS update. Added L8679. Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: August 23, 2017: 05:55 AM