|Subject:||Occipital Nerve Stimulation|
|Policy #:||SURG.00112||Current Effective Date:||07/09/2013|
|Status:||Reviewed||Last Review Date:||05/09/2013|
Occipital Nerve Stimulation (ONS) involves delivering small electrical impulses to the occipital nerve. Insulated lead wires are advanced through a needle until they are adjacent to the nerve. The leads are then tunneled to a site, usually under the collarbone, and connected to a small implanted pulse generator. It is theorized that ONS interferes with pain transmission to the brain.
This therapy is being researched for occipital neuralgia, chronic headaches and migraines that are refractory to medical treatments.
Investigational and Not Medically Necessary:
Occipital nerve stimulation is considered investigational and not medically necessary for all indications.
ONS is accomplished via a modified device that is related to the spinal cord stimulator and is one type of implantable pulse generators (IPG). Electrical stimulation is applied to the occipital nerve, which arises from the second cervical vertebral area and then branches out across the back of the head carrying sensory signals from that region to the brain. Pain conditions (for example, migraines and chronic headaches) are currently treated with medications and anesthetic blocks. While this type of treatment may work in some instances, pain relief is short lived or not relieved in some individuals. For this group, research using electrical stimulation is being conducted to establish whether this application is efficacious and safe.
Serra and Marchioretto (2012) conducted a randomized crossover study to investigate the safety and efficacy of ONS for chronic migraine (CM) and medication overuse headache (MOH) in individuals and to evaluate changes in disability, quality of life, and drug intake in implanted subjects. The study included 30 participants with chronic migraine (100% of participants) and medication overuse headache (85% of participants) who were implanted with an occipital nerve stimulator (ONS) and randomized to one of two arms: (1) "Stimulation On" or (2) "Stimulation Off". The participants crossed over after one month, or when their headaches worsened. The participants were provided with remote controls to modify the stimulation amplitude. Follow-up examinations were conducted at 1, 3, 6, and 12 months after stimulator implantation, during which time the stimulation parameters were adjusted. During this one-year follow-up period, degree of disability (using the Migraine Disability Assessment [MIDAS]), quality of life (using SF-36) and drug intake (using a participant's diary) were assessed. Twenty-nine (29) participants completed the study. The intensity and/or frequency of headache were significantly lower in the "On" arm of the study compared to the "Off" arm and decreased from baseline to each follow-up visit in all participants with stimulation on. The degree of disability improved during the study as reflected by the median MIDAS score decreasing from 79 at baseline to 10 at 12-month follow-up. With regards to medication usage, Triptans and nonsteroidal anti-inflammatory drug use decreased from the baseline (20 and 25.5 doses/month) at each follow-up visit, to 3 and 2 doses/month at one year, P < 0.001). A total of 5 adverse events occurred: 2 infections (6.7%) and 3 lead migrations (10%). The authors concluded that ONS appears to be a safe and effective treatment for carefully selected individuals with CM and MOH. The small number of participants is one of the limitations of this study.
Burns and colleagues (2008) studied fourteen individuals with medically intractable chronic cluster headaches (CCH). Participants were implanted with bilateral electrodes in the suboccipital region for occipital nerve stimulation (ONS). Twelve individuals used the stimulation continuously while two used it intermittently. A retrospective assessment of their clinical outcome was obtained. At a median follow-up of 17.5 months (range 4–35 months), 10 of 14 participants reported improvement and 9 of these recommend ONS. Three participants noticed a marked improvement of 90% or better (90%, 90%, and 95%), 3 a moderate improvement of 40% or better (40%, 50%, and 60%), and 4 a mild improvement of 20–30% (20%, 20%, 25%, and 30%). Improvement occurred within days to weeks for those who responded most and participants consistently reported their attacks returned within hours to days when the device was off. One participant found that ONS helped abort acute attacks. Adverse events of concern were lead migrations and battery depletion. The authors concluded that ONS offers a safe, effective option for some individuals with CCH, however more research is required to evaluate safety and efficacy of this therapy.
Schwedt and colleagues (2007) performed a retrospective analysis of 15 individuals with medically refractory headache treated with occipital nerve stimulation. Pre- and post implant data regarding headache frequency, severity, disability, depression and poststimulator complications were collected. Twelve individuals were female and three male. Ages ranged from 21 to 52 years (mean 39 years). Eight individuals had chronic migraine, three chronic cluster, two hemicrania continua and two had post-traumatic headache. Eight individuals underwent bilateral and seven had unilateral lead placement. Individuals were measured after 5-42 months (mean 19). All six mean headache measures improved significantly from baseline (P < 0.03). Headache frequency per 90 days improved by 25 days from a baseline of 89 days; headache severity (0-10) improved 2.4 points from a baseline of 7.1 points; migraine disability assessment (MIDAS) improved 70 points from a baseline of 179 points; Headache Impact Test™ HIT-6 scores improved 11 points from a baseline of 71 points; Beck Depression Inventory (BDI-II) improved eight points from a baseline of 20 points; and the mean subjective percent change in pain was 52%. Most individuals (60%) required lead revision within 1 year. One individual required generator revision. Occipital nerve stimulation may be effective in some individuals with intractable headache. The authors determined that further well-designed clinical studies are necessary for individuals with medically refractory headache.
The ONS device does not have U.S. Food and Drug Administration (FDA) approval at this time. Currently, clinical trials are underway for two ONS devices: ONSTIM® (Medtronic Neuro) and PRISM® (Boston Scientific Corporation) to establish safety and efficacy of ONS for migraine headaches.
Occipital nerve stimulation may be effective for the treatment of medically intractable headache, because electrical stimulation of large sensory afferents generally has an antinociceptive effect. The electrical stimulus interferes with the neural transmission of the pain sensations back to the brain. Neural electrical stimulation has been used in other modalities for treatment of pain that includes implanted and non implanted lead wires/devices. The ONS device is implanted and requires surgery for placement of the lead wires that deliver the electrical stimulus and placement of the pulse generator. The therapy is not without difficulties. Lead migration is the most frequent problem, requiring removal and replacement. Power depletion in the pulse generator also needs to be addressed. As with all surgery, the possibility of infection has to be considered.
Afferent: A nerve that carries impulses toward the central nervous system (CNS); the opposite of an afferent nerve is an efferent nerve that carries impulses away from the CNS.
Cluster Headaches: Sudden, intensely painful headaches that occur repeatedly in groups or clusters.
Intractable: Having no relief, such as a symptom or a disease that is not relieved by the therapeutic measures.
Migraine: A vascular headache believed to be caused by blood flow changes and certain chemical changes in the brain leading to a cascade of events that include constriction of arteries supplying blood to the brain that result in severe head pain, stomach upset, and visual disturbances.
Nociceptive: Causing pain.
The following codes for treatments and procedures applicable to this document are included below for informational purposes. A draft of future ICD-10 Coding (effective 10/01/2014) related to this document, as it might look today, is included below for your reference. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services are Investigational and Not Medically Necessary:
For the following codes when describing an occipital nerve stimulator, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
|64555||Percutaneous implantation of neurostimulator electrodes; peripheral nerve (excludes sacral nerve) [when specified as occipital nerve stimulator]|
|64575||Incision for implantation of neurostimulator electrodes; peripheral nerve (excludes sacral nerve) [when specified as occipital nerve stimulator]|
|64590||Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling [when specified as occipital nerve stimulator]|
|04.92||Implantation or replacement of peripheral neurostimulator lead(s) [when specified as occipital nerve stimulator]|
|All diagnoses, including but not limited to, the following:|
|339.00-339.89||Other headache syndromes (cluster headaches, tension type headache, post-traumatic headache, etc)|
|723.8||Other syndromes affecting cervical region (occipital neuralgia)|
|ICD-10 Procedure||ICD-10-PCS draft codes; effective 10/01/2014:|
|For the following codes when specified as an occipital nerve stimulator:|
|01HY0MZ||Insertion of neurostimulator lead into peripheral nerve, open approach|
|01HY3MZ||Insertion of neurostimulator lead into peripheral nerve, percutaneous approach|
|01HY4MZ||Insertion of neurostimulator lead into peripheral nerve, percutaneous endoscopic approach|
|ICD-10 Diagnosis||ICD-10-CM draft codes; effective 10/01/2014:|
|All diagnoses, including but not limited to, the following:|
|G44.001-G44.89||Other headache syndromes|
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
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.
|Reviewed||05/09/2013||Medical Policy and Technology Assessment Committee (MPTAC) review. Updated review date, Rationale and References sections.|
|Reviewed||05/10/2012||MPTAC review. Updated review date, References and History sections.|
|Reviewed||05/19/2011||MPTAC review. Updated review date, References and History sections.|
|Reviewed||05/13/2010||MPTAC review. Updated review date, References and History sections.|
|New||05/21/2009||MPTAC review. Initial document development.|