When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin 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 Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
Deep brain stimulation (DBS) may be used for individuals who become less responsive to medical treatments for essential tremor (ET), tremor associated with Parkinson's disease (PD), primary dystonia, and obsessive compulsive disorder (OCD), or for those who cannot tolerate the side effects from medications that are commonly used to treat these conditions. DBS has several potential advantages over ablative procedures (e.g., pallidotomy) because it is nondestructive and reversible. DBS may also provide better long-term results than can be achieved by a single ablative procedure. PD and ET are progressive diseases, and different neurostimulator parameters may be needed for these conditions over time to achieve optimal symptom control.
DBS is a high-frequency electrical stimulation of targeted nuclei deep within the brain that controls movement and muscle function. DBS is a neurosurgical procedure that involves stereotactic placement of implantable electrodes within targeted nuclei on one (unilateral) or both (bilateral) sides of the brain. There are currently three targeted sites for DBS: the thalamic ventralis intermedius nucleus (VIM), subthalamic nucleus (STN), and globus pallidus interna (GPi). Once effectiveness has been demonstrated by temporary stimulation, the individual returns to surgery, usually within several days, for subcutaneous placement of the pulse generator (neurostimulator) in the chest and subcutaneous placement of the cable that connects the pulse generator to the implanted electrodes. Following implantation, noninvasive programming of the neurostimulator can be adjusted according to the individual's symptoms. The system can also be independently activated by the individual as needed.
ESSENTIAL TREMOR (ET)
ET is a progressive, disabling disorder most often affecting the hands, but it may also affect the head, voice, or legs. The exact etiology of ET is unknown. It may start at any age but peaks within the second and sixth decades of life. Beta-adrenergic blockers and anticonvulsant medications are usually first-line treatments for reducing the severity of tremors. However, many individuals do not adequately respond to or cannot tolerate these medications.
One of the earlier tremor scales developed that is still widely used today is the Fahn–Tolosa–Marin Tremor Rating Scale (TRS). This five-point scale rates tremor severity based on tremor amplitude, from zero (no tremor) to four (severe tremor) in each part of the body, and includes assessments of specific abilities and functional disability.
PARKINSON'S DISEASE (PD)
PD is a chronic and progressive neurodegenerative disease of unknown etiology. The disorder involves the loss of dopaminergic cells in the substantia nigra of the midbrain, which leads to the depletion of dopamine, a neurotransmitter that is essential for the regulation of motor function throughout the body. PD is characterized by tremor, rigidity (a stiffness of the limbs), bradykinesia/akinesia (slowness of motor movements/inability to initiate movement), and progressive postural instability. There are also many non-motor symptoms, including depression, anxiety, apathy, fatigue, and sexual dysfunction. Dopaminergic medication is typically used as a first-line treatment for reducing the primary symptoms of PD. However, after prolonged use, medication can become less effective and can produce significant adverse events such as dyskinesias (abnormality with voluntary muscle movements).
PD staging is accomplished through various rating tools, including the Hoehn and Yahr Staging of Parkinson's Disease, Unified Parkinson's Disease Rating Scale [UPDRS], and the Schwab and England Activities of Daily Living. The UPDRS is a rating tool to follow the longitudinal course of PD. It is made up of three sections: 1) Mentation, Behavior, and Mood; 2) Activities of Daily Living (ADL); and 3) Motor. These sections are evaluated by individual interviews. Some sections require multiple grades assigned to each extremity. A total of 199 points are possible. A score of 199 represents the worst (total) disability, and a score of zero represents no disability.
Primary dystonia is a neurological movement disorder of unknown etiology characterized by involuntary muscle contractions that force parts of the body into abnormal, contorted, and painful movements or postures. Primary dystonia is classified as focal (limited to one area [e.g., torticollis]), multifocal (affecting many areas [e.g., eyes, jaw, and tongue]), or generalized (affecting the entire body [e.g., arms, legs, and trunk]). When conservative therapy, such as oral or injectable medications (e.g., benztropine, diazepam, botulinum toxin) has failed, treatment options have included destructive neurosurgical interventions (e.g., thalamotomy, pallidotomy).
The US Food and Drug Administration (FDA) approved the Medtronic Activa® Dystonia Therapy (Medtronic Inc.; Minneapolis, MN) on April 15, 2003, as a Humanitarian Drug Exemption (HDE). It is indicated for the management of long-term primary dystonia in individuals seven years of age and older who are not responsive to drug therapy. The device may improve some symptoms associated with primary dystonia.
OBSESSIVE COMPULSIVE DISORDER (OCD)
OCD is an anxiety disorder and is characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions). Repetitive behaviors such as hand-washing, counting, checking, or cleaning are often performed with the hope of preventing obsessive thoughts or making them go away. Performing these behaviors, however, provides only temporary relief, and not performing them markedly increases anxiety.
The FDA approved the Medtronic Reclaim® DBS Therapy for OCD (Medtronic Inc.; Minneapolis, MN) on February 19, 2009 (as a humanitarian device exemption [HDE]) for the treatment of chronic, severe, treatment-resistant OCD in adult individuals having failed three selective serotonin reuptake inhibitors (SSRIs). This device is indicated for bilateral stimulation of the anterior limb of the internal capsule (AIC), as adjunctive to medications, and as an alternative to anterior capsulotomy for the treatment of OCD. The generic name for the Medtronic Reclaim® is Implantable Multi-Programmable Quadripolar Deep Brain Stimulation System.
HUMANITARIAN DEVICE EXEMPTION (HDE)
In rare instances, certain medical devices intended to be used for humanitarian purposes are evaluated by the FDA through the HDE process. The FDA’s humanitarian use device (HUD) designation permits the use of certain medical devices when there is no comparable device available to treat or diagnose a disease or condition affecting fewer than 4,000 individuals annually. Because clinical investigation demonstrating the efficacy of the device is not feasible (given the low prevalence of the disease in the population), an HDE grants manufacturers an exemption to the usual premarket approval process and allows marketing of the device only for the FDA-labeled HDE indication(s).
Under FDA requirements, an HUD may only be used after institutional review board (IRB) approval has been obtained for the use of the device in accordance with the FDA-labeled indication(s) under the HDE.
OTHER PROPOSED APPLICATIONS FOR DBS
Deep brain stimulation is also being investigated for the treatment of disorders such as treatment resistant depression, chronic cluster headaches, chronic pain syndromes, Tourette syndrome, multiple sclerosis tremor, and refractory epilepsy. Available published peer-reviewed literature demonstrates insufficient evidence upon which to support its effectiveness of these and other proposed indications. Additional controlled studies with larger number of subjects are required to evaluate the role of DBS for these proposed conditions.
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F42.9 Obsessive-compulsive disorder, unspecified
G20 Parkinson's disease
G24.1 Genetic torsion dystonia
G24.2 Idiopathic nonfamilial dystonia
G24.3 Spasmodic torticollis
G24.8 Other dystonia
G24.9 Dystonia, unspecified
G25.0 Essential tremor
G25.2 Other specified forms of tremor
C1767 Generator, neurostimulator (implantable), nonrechargeable
C1778 Lead, neurostimulator (implantable)
C1787 Patient programmer, neurostimulator
C1816 Receiver and/or transmitter, neurostimulator (implantable)
C1820 Generator, neurostimulator (implantable), with rechargeable battery and charging system
C1823 Generator, neurostimulator (implantable), non-rechargeable, with transvenous sensing and stimulation leads
C1883 Adaptor/extension, pacing lead or neurostimulator lead (implantable)
L8679 Implantable neurostimulator, pulse generator, any type
L8680 Implantable neurostimulator electrode, each
L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only
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 battery (internal) for use with implantable neurostimulator, replacement only
L8695 External recharging system for battery (external) for use with implantable neurostimulator, replacement only