|
Medical Policy: 07.01.51
Original Effective Date: August 2010
Reviewed: October 2011
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
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.
Implanted peripheral nerve stimulators have been used for treatment of refractory pain for many years but only recently proposed for management of craniofacial pain. Occipital, supraorbital, and infraorbital stimulation have been reported in the literature.
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 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. 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 woman, and its true prevalence is not known. 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 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. 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 1.0/1,000. 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.
Currently, there are no occipital nerve stimulation devices approved or cleared for marketing by the U.S. Food and Drug Administration (FDA).
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.
Trentman and colleagues (2009) reported outcome measures at 1 year post-implant in 9 patients who participated in a feasibility trial of the Bion micro stimulator. One patient stopped using the device before 1 year because of the time required to recharge the device. At 1 year, 7 of the 8 remaining patients had fair or better results in terms of reduction of disability with 5 having greater than 90% reduction in disability.
Schwedt and colleagues (2007) published a retrospective analysis of pre- and post-implant data from 15 patients with chronic, intractable headache implanted with the Synergy implantable pulse generator. Eight patients had chronic migraine, 3 chronic cluster, 2 hemicrania continua, and 2 post-traumatic headache. Eight patients had bilateral and 7 had unilateral lead placement. Data were collected on headache frequency, severity, disability, depression, and post-stimulator complications. Nine patients reported at least a 50% reduction in headache pain, and none reported worsening of pain. The mean subjective percent change in pain was 52%. Sixty percent of patients required lead revision within 1 year. The authors conclude that ONS may be effective in some patients with intractable headache. In a separate report (2007), the same authors describe a retrospective review of the patients in the study reported above to determine if response to occipital nerve block (ONB) predicts response to ONS. Thirteen patients in the study had ONB; 10 of them were responders (50% or more reduction in frequency or severity). Ten of 13 who had ONB had significant relief of pain lasting at least 24 hours, and 3 were ONB nonresponders. Of the 3 ONB nonresponders, 2 were ONS responders. Of the 2 patients who did not have ONB prior to ONS, one was an ONS responder and one was an ONS nonresponder. The authors conclude that ONB may not be predictive of the therapeutic effect of ONS.
Burns et al (2009) report on 14 patients with cluster headache implanted with bilateral electrodes. At a median follow-up of 17.5 months (range 4–35 months), 10 of 14 patients reported improvement. Three reported improvement of 90% or better; 3 reported moderate improvement (30%–60%), and 4 reported mild improvement (20%–30%). Four patients required new electrode leads. A wide range of stimulation was used. Six patients required battery replacement. Muscle recruitment, neck stiffness, skin discomfort, superficial infections, and painful overstimulation were also reported in a crossover study, also by Burns and colleagues (2008); 6 patients with hemicrania continua received continuous unilateral ONS. Pain on a 10-point scale was recorded hourly in patient diaries and the Migraine Disability Assessment Scale was administered at each follow-up visit. Four of 6 patients reported substantial improvement (80%–95%), 1 reported a 30% improvement, and 1 reported that pain was worse by 20%. Adverse events were mild and associated with transient overstimulation.
Combined occipital and supraorbital neurostimulation was evaluated in 7 patients with chronic migraine by Reed and colleagues (2009). Responses to two stimulation programs were evaluated: one that stimulated only the occipital leads and one that stimulated both the occipital and supraorbital leads together. With follow-up ranging from 1–35 months, all patients reported a full therapeutic response but only to combined supraorbital-occipital neurostimulation.
In summary, 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. The available evidence, from small uncontrolled trials, is insufficient to permit conclusions concerning the impact of ONS on health outcomes.
 Top
Prior Approval:
Not applicable
Top
Policy:
Occipital nerve stimulation is considered investigational for all indications.
Randomized controlled trials with greater numbers of patients and longer follow-up are needed. These trials must also compare outcomes of ONS with outcomes of other possible alternative treatments. The available evidence is insufficient to permit conclusions concerning the impact of ONS on net health outcome, In addition, no implanted occipital nerve stimulators have received FDA approval.
Top
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- There is no specific code for this procedure. 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 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to 2 or more electrode arrays
- 64553 Percutaneous implantation of neurostimulator electrodes; cranial nerve
- 64555 Percutaneous implantation of neurostimulator electrodes; peripheral nerve (excludes sacral nerve)
- 64573 Incision for implantation of neurostimulator electrodes; cranial nerve
- 64575 Incision for implantation of neurostimulator electrodes; peripheral nerve (excludes sacral nerve)
- 64999 Unlisted procedure, nervous system
Top
Selected References:
- Trentman TL, Rosenfeld DM, Vargas BB et al. Greater occipital nerve stimulation via the Bion Microstimulatro; implantation technique and stimulation parameters Clinical Trial: NCT00205894. Pain Physician 2009; 12(3):621-8.
- 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.
- 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.
- Burns B, Watkins L, Goadsby P. Treatment of intractable chronic cluster headache by occipital nerve stimulation in 14 patients. Neurology 2009; 72(4):341-5.
- Burns B, Watkins L, 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):1001-12.
- Reed KL, Black SB, Bant CJ 2 nd et al. Combined occipital and supraorbital neurostimulation for the treatment of chronic migraine headaches: initial experience. Cephalalgia 2009 Sep 3 [Epub ahead of print].
- Saper JR, Dodick DW, Silberstein SD, et al. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia. 2011 Feb;31(3):271-85.
- Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2000 Sep 26;55(6):754-62.
Top
Policy History:
Date Reason Action
August 2010 Inquiry New policy
October 2011 Annual review Policy renewed
Top
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
|
 |
