Medical Policy: 07.01.59 

Original Effective Date: November 2000 

Reviewed: August 2017 

Revised: August 2017 

 

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:

 Deep brain stimulation (DBS) may be used for individuals who become less responsive to medical treatments for essential tremor, tremor associated with Parkinson’s disease (PD) and primary dystonia, 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. thalamotomy or pallidotomy) because it is nondestructive and reversible. DBS may also provide better long term results than can be achieved by a single ablative procedure.  Deep brain stimulation is also being evaluated for the treatment of variety of other neurological and psychiatric disorders, including but not limited to refractory epilepsy, dystonia, other movement disorder, cluster headache, Tourette syndrome, treatment resistant depression, and obsessive compulsive disorder (OCD).

 

Deep brain stimulation (DBS) is a high frequency electrical stimulation of targeted nuclei deep within the brain that controls movement and muscle function. DBS is a neurological procedure that involves the stereotactic placement of implantable electrodes within the targeted nuclei on one (unilateral) or both (bilateral) sides of the brain.  there are currently three targeted sites for DBS: the thalmic ventral intermediate nucleus (VIM), globus pallidus interna (GPi), and subthalamic nucleus (STN). Once effectiveness has been demonstrated by temporary stimulation (electrode is initially attached to a temporary transcutaneous cable for short-term stimulation to validate treatment  effectiveness), the patient will return for surgery usually several days later for permanent subcutaneous implantation (placement) of the cable that connects the pulse generator to the implanted electrodes. Following implantation (placement), 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.

 

Parkinson's Disease and Essential Tremor

Parkinson's Disease (PD)  (H4)

Parkinson’s disease (PD) is a chronic neurodegenerative disease of unknown etiology. The primary underlying abnormality in PD is the progressive loss of dopamine producing cells in the brain, leading to an imbalance of dopamine and acetylcholine, the normal neurotransmitters in the corpus straitum. Dopamine is 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. The most common form, idiopathic Parkinson’s disease (PD) begins most often between the ages of 45-65, with an average onset at age 58. The cause of PD remains unknown, although proposed theories include a role of genetic and certain environmental factors.  

 

Parkinson’s disease (PD) staging is accomplished through various rating tools, including the Hoehn and Yahr Staging of Parkinson 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.

 

Treatments for PD include those to alleviate symptoms (symptomatic therapy), with medications. Dopaminergic medication (Levodopa) 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). After 5 to 10 years of drug therapy it is often increasingly difficult to balance the control of PD symptoms with the adverse effects of dopaminergic medications. For patients who become unresponsive to pharmacological treatments and/or have intolerable drug side effects, deep brain stimulation may be helpful in carefully selected patients. 

 

Essential Tremor (ET)

Essential tremor (ET) is a progressive, disabling disorder most often affecting the hands, but it may also effect the head, voice and legs. The exact etiology of ET is unknown. Essential tremor (ET) may start at an early age but peaks within the second and sixth decades of life. Pharmacotherapy with beta-adrenergic blockers (propranolol) and anticonvulsant medications are usually first line treatments for reducing the severity of tremors. However, certain patients do not adequately respond to or cannot tolerate these medications. For patients who become unresponsive to pharmacological treatments and/or have intolerable drug side effects, deep brain stimulation (DBS) may be helpful for carefully selected patients.

 

One of the early 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.

 

 

Deep brain stimulation (DBS) has been investigated as an alternative to to permanent neuroablative procedures, such as thalamotomy  and pallidotomy.  DBS has been thoroughly investigated as an alternative thalamotomy for unilateral control of essential tremor (ET) and tremor associated with Parkinson disease (PD). More recently, there has been research interest in the use of DBS of the globus pallidus or subthalamic nucleus as a treatment of other parkinsonian symptoms, such as rigidity, bradykinesia, or akinesia. Another common morbidity associated with PD is the occurrence of motor fluctuations, referred to as "on and off" phenomena, related to the maximum effectiveness of drugs (i.e., “on” state) and the nadir response during drug troughs (i.e., “off”state). In addition, levodopa, the most commonly used anti-Parkinson drug, may be associated with disabling drug-induced dyskinesias. Therefore, the optimal pharmacologic treatment of PD may involve a balance between optimal effects on PD symptoms andthe appearance of drug-induced dyskinesias. The effect of DBS on both PD symptoms and drug-induced dyskinesias has also been studied.

 

Blue Cross and Blue Shield Association (BCBSA) TEC assessment completed in 1997 focused on unilateral deep brain stimulation (DBS) of the thalamus as a treatment of tremor. The assessment concluded:

  • Tremor suppression was total or clinically significant in 82% to 91% of operated sides in 179 patients who underwent implantation of thalamic stimulation devices. Results were durable for up to 8 years, and adverse effects of stimulation were reported as mild and largely reversible.
  • These results were at least as good as those associated with thalamotomy. An additional benefit of DBS is that recurrence of tremor may be managed by changes in stimulation parameters.

BCBSA TEC assessment found that unilateral DBS of the thalamus for patients with disabling, medically unresponsive tremor due to essential tremor or Parkinson’s disease met the BCBSA Technology Evaluation Center (TEC) criteria. Subsequent studies reporting long term follow up have supported the conclusions of the TEC assessment and found that tremors were effectively controlled 5 to 6 years after DBS.

 

Blue Cross and Blue Shield Association (BCBSA) TEC assessment completed in 2001 focused on the use of deep brain stimulation (DBS) of the internal segment of the globus pallidus interna (GPi) and subthalmic nucleus (STN) for a broader range of Parkinson’s disease (PD) symptoms. The assessment concluded:

  • A wide variety of studies have consistently demonstrated that DBS of the GPi or STN results in significant improvements, as measured by standardized rating scales of neurologic function. The most frequently observed improvements consist of increased waking hours spent in a state of mobility without dyskinesia, improved motor function during “off” periods when levodopa is not effective, reduction in frequency and severity of levodopa-induced dyskinesia during periods when medication is not working, and, in the case of bilateral DBS of the STN, reduction in the required dosage of levodopa and/or its equivalents. The magnitude of these changes were both statistically significant and clinically meaningful.
  • The beneficial treatment effect lasted at least for the 6 to 12 months observed in most trials. While there was not a great deal of long-term follow up, the available data were generally positive.
  • Adverse effects and morbidity were similar to those known to occur with thalamic stimulation.
  • DBS possesses advantages to other treatment options. Compared to pallidotomy, DBS can be performed bilaterally. The procedure is non-ablative and reversible.        

BCBSA TEC assessment found that bilateral deep brain stimulation (DBS) of the subthalmic nucleus (STN) or the globus pallidus interna (GPi) for patients with advanced Parkinson’s disease meets the BCBSA Technology Evaluation Center (TEC) criteria.Based on review of the peer reviewed medical literature a number of randomized controlled trials (RCTs) and systematic reviews of the literature have also been published, that have found significantly better outcomes after DBS than with a control intervention. Meta-analyses of RCTs comparing GPi and STN have had mixed findings and did not how that one type of stimulation was clearly superior over the other.   
  
Summary

For individuals who have essential tremor or tremor in Parkinson’s disease who receive deep brain stimulation (DBS) of the thalamus, the evidence includes systematic review and case series. The systematic review (BCBSA TEC Assessment) concluded that there was sufficient evidence that DBS of the thalamus resulted in clinically significant tremor suppression and that outcomes after DBS were at least as good as thalamotomy. Subsequent studies reporting long-term follow up have supported the conclusions of the TEC assessment and found that tremors were effectively controlled 5 to 6 years after DBS. The evidence is sufficient to determine that the use of deep brain stimulation (DBS) results in meaningful improvement in the net health outcome in the treatment of essential tremor or tremor in Parkinson's disease.

 

For individuals who have symptoms (e.g. speech, motor fluctuations) associated with Parkinson’s disease (advanced or > 4 years in duration with early motor symptoms) who receive deep brain stimulation (DBS) of the globus pallidus interna (GPi) or subthalmic nucleus (STN), the evidence includes randomized clinical trials (RCTs) and systematic reviews. One of the systematic reviews (BCBSA TEC Assessment) concluded that studies of  DBS of the GPi or STN have consistently demonstrated clinically significant improvements in outcomes (e.g. neurologic function). Other systematic reviews have also found significantly better outcomes after DBS than after a control intervention. An RCT in patients with levodopa-responsive Parkinson’s disease of at least 4 years in duration and uncontrolled motor symptoms found that quality of life (QOL) at 2 years was significantly higher when DBS was provided in addition to medical therapy. Meta-analyses of RCTs comparing GPi and STN have had mixed findings and did not how that one type of stimulation was clearly superior over the other. The evidence is sufficient to determine that the use of deep brain stimulation (DBS) results in a meaningful improvement in the net health outcome and is an effective therapeutic option for medically intractable symptoms of Parkinson’s disease.  

 

Primary Dystonia

Primary dystonia is a neurological movement disorder of unknown etiology characterized by involuntary muscle contractions that force parts of the body into abnormal, contorted, painful movements or postures. Primary dystonia is classified as focal (limited to one area e.g. torticollis), multifocal (affecting many areas), 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 nonsurgical interventions (e.g. thalamotomy, pallidotomy).  Deep brain stimulation (DBS) has also been investigated in patients with primary dystonia.

 

Summary

For individuals who have primary dystonia who receive deep brain stimulation (DBS) of the globus pallidus (GPi) or subthalamic nucleus (STN), the evidence includes systematic reviews, randomized controlled trial and case series. A pooled analysis of 24 studies, mainly uncontrolled, found improvements in motor scores and disability scores after 6 months and at last follow up (mean 32 months). A double-blind randomized controlled study found significantly better outcomes with active stimulation. The evidence is sufficient to determine that deep brain stimulation (DBS) results in a meaningful improvement in net health outcomes for children and adults with disabiling primary dystonia who do not respond to pharmacologic therapy or chemodenervation with botulinum toxin or other conservative therapies.

 

Cluster Headaches

Deep brain stimulation (DBS) has been investigated in patients with chronic cluster headaches. Cluster headaches occur as episodic attacks of severe pain lasting from 30 minutes to several hours. The pain is usually unilateral and localized to the eye, temple, forehead, and side of the face. Autonomic symptoms that occur with cluster headaches include ipsilateral facial sweating, flushing, tearing, and rhinorrhea. Cluster headaches have been classified as vascular headaches that have been associated with high blood pressure, smoking, alcohol use, etc. However, the exact pathogenesis of cluster headaches is uncertain. Positron emission tomography (PET) scanning and magnetic resonance imaging (MRI) have shown the hypothalamic region may be important in the pathogenesis of cluster headaches. Alterations in hormonal/serotonergic function may also play a role. Treatment of cluster headaches includes pharmacologic interventions for acute episodes and prophylaxis and surgical procedures such gamma knife radiosurgery of the trigeminal nerve.  Deep brain stimulation (DBS) of the posterior hypothalamus for the treatment of chronic cluster headaches has been investigated because functional studies have suggested cluster headaches have a central hypothalamic pathogenesis.

 

Summary

Based on review of the peer reviewed medical literature regarding deep brain stimulation (DBS) and treatment of cluster headaches, the evidence includes a randomized cross over study and case series. Only a small number of patients have been studied and there was no significant differences between groups receiving active and sham stimulation. Additional randomized controlled trials (RCTs) are needed. The evidence is insufficient to determine the safety and efficacy on net health outcomes of DBS for the treatment of cluster headaches and therefore, is considered investigational.

 

Obsessive Compulsive Disorder

Deep brain stimulation (DBS) has been investigated in patients with treatment resistant obsessive compulsive disorder (OCD). Obsessive compulsive disorder (OCD) is an anxiety disorder and is characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions). For individuals who have obsessive-compulsive disorder who receive DBS, the evidence includes RCTs (randomized controlled trials) and systematic reviews. Most studies have small sample sizes. Among the RCTs on DBS for OCD, one study may suggest that DBS may reduce symptoms for OCD, but larger trials are needed to confirm these preliminary findings and the impact of DBS on net health outcomes. The evidence is insufficient to determine the effects on net health outcomes and therefore, deep brain stimulation (DBS) for the treatment of obsessive-compulsive disorder (OCD) is considered investigational. 

 

In February of 2009, the FDA approved deep brain stimulation with the Reclaim® device (Medtronic, Inc.) via the Humanitarian Device Exemption (HDE) process for the treatment of severe treatment resistant obsessive-compulsive disorder (OCD). This device is indicated for bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medication and as an alternative to anterior capsulotomy for the treatment of chronic, severe treatment resistant obsessive compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs). See medical policy 10.01.14 Humanitarian Use Devices if DBS is being utilized for this indication. 

 

Treatment Resistant Depression

Deep brain stimulation (DBS) is being investigated in patients with treatment resistant depression.  The regions targeted for stimulation for this indication are also still being investigated.  A number of case series and several RCTs (randomized controlled trials) evaluating deep brain stimulation (DBS) in patients with treatment resistant depression have been published.  There is no compelling data that DBS is efficacious for the treatment of treatment resistant depression.  Neuropsychological functioning does not appear to be adversely affected by deep brain stimulation, based upon prospective open label studies.  Further randomized controlled trials are needed.  The evidence is insufficient to determine the effects on net health outcomes and therefore, deep brain stimulation (DBS) for the treatmenttreatment resistant depression is considered investigational.  

 

Tourette Syndrome

Tourette syndrome (TS) is a neurological disorder manifested by motor and phonic tics with onset during childhood. Deep brain stimulation (DBS) has been investigated in patients who have disabling tics that are refractory to optimal medical management. The available evidence includes crossover RCTs (randomized clinical trials), systematic reviews and meta-analysis. A meta-analysis in 2015 suggested that DBS may improve outcomes in patients with Tourette syndrome. However, the optimal target for DBS is unknown and additional randomized controlled trials in a larger number of patients are needed to determine whether DBS is beneficial for controlling tics in patients with TS.  The evidence is insufficient to determine the effects on net health outcomes and therefore, is considered investigational.

 

Tardive Dyskinesia

Tardive dyskinesia (TD) is a hyperkinetic movement disorder that appears with delayed onset, usually after prolonged receptor blocking agents, mainly the antipsychotic drugs (also called neuroleptics) and the antiemetic drug metoclopramide. TD has numerous clinical manifestations that include chorea, dystonia, akathisia, stereotyped behaviors and rarely tremor. Deep brain stimulation (DBS) is being investigated in patients who have permanent disabling TD that is unresponsive to pharmacologic treatment modalities. The evidence for DBS includes case series. Few studies were identified and they had small sample sizes (≤ 10 patients). Additional studies, especially randomized controlled trials (RCTs) are needed. The evidence is insufficient to determine the effects on net health outcomes and therefore, deep brain stimulation (DBS) for the treatment of tardive dyskinesia is considered investigational.

 

Multiple Sclerosis

Multiple sclerosis (MS) is an autoimmune inflammatory demyelinating disease of the central nervous system (CNS) that is leading cause of disability in young adults. The course of MS is variable. For some, MS is a disease with one or two acute neurologic episodes and no further evidence of disease activity. In others, it is a chronic, relapsing, or progressive disease with an unpredictable clinical course that may span 10 to 20 years, during which time neurologic disability accumulates. Treatment directed at the progressive phase of MS is typically more difficult than treatment of relapsing forms of MS. Deep brain stimulation (DBS) is being investigated in patients who have multiple sclerosis (MS). ). For individuals who have MS who receive DBS, the evidence includes one RCT (randomized controlled trial) with small number of patients (10), there is insufficient evidence on which to draw conclusions about the impact of DBS on net health outcomes in this population.  Additional studies are needed. The evidence is insufficient to determine the effects on net health outcomes and therefore, deep brain stimulation (DBS) for the treatment of multiple sclerosis and is considered investigational.      

 

Refractory Epilepsy

Deep brain stimulation (DBS) has been investigated in patients who have refractory epilepsy. Patients with epilepsy whose seizures do not successfully respond to anti-seizure drug therapy are considered to have drug resistant epilepsy (DRE). This condition is also referred to as intractable, medically refractory or pharmacoresistant epilepsy. Based on review of the peer reviewed medical literature there was one randomized controlled trial (RCT) identified that evaluated DBS for treatment of epilepsy; in it, DBS had a positive impact on some parts of the blinded trial phase, but not others, and a substantial number of adverse events were reported. Additional RTCs are needed. The evidence is insufficient to determine the effects of deep brain stimulation (DBS) on net health outcomes for the treatment of refractory epilepsy and therefore, is considered investigational.

 

Other Indications

Deep brain stimulation (DBS) is also being investigated for the treatment of disorders such as anorexia nervosa/eating disorders, Alzheimer disease/dementia, Huntington disease, head or voice tremor, traumatic brain injury (TBI) and chronic pain. Available published peer reviewed medical literature (includes case series and observational studies) demonstrate insufficient evidence to support its effectiveness of these indications. Additional controlled studies with larger number of subjects are needed to evaluate the role of deep brain stimulation (DBS) for these proposed conditions. The evidence is insufficient to determine the effects of deep brain stimulation (DBS) on net health outcomes and therefore, is considered investigational. 

 

Cerebellar Stimulation

Cerebellar stimulation or pacing is a similar technique to deep brain stimulation (DBS), but works in the cerebellar portion of the brain.  Cerebellar stimulation/pacing is electrical stimulation using surgically implanted electrodes on the surface of the cerebellum and has been proposed as on way to treat some neurological disorders. At this time, there is lilttle information available about this technology to make an assessment of the clinical usefulness.  The evidence is insufficient to determine the effects on net health outcomes related to this technology and therefore, is considered investigational.

 

Practice Guidelines and Position Statements

American Academy of Neurology (AAN)

In 2006, the American Academy of Neurology (AAN) issued a guideline on the treatment of Parkinson disease (PD) with motor fluctuations and dyskinesia found that, although criteria are evolving, patients with PD considered candidates for DBS include those who are levodopa responsive, nondemented, and neuropsychiatrically intact patients who have intractable motor fluctuations, dyskinesia or tremor. AAN concluded that deep brain stimulation (DBS) of the subthalamic nucleus (STN) may be considered a treatment option in PD patients to improve motor function and to reduce motor fluctuations, dyskinesia and medication usage (Level C, possibly effective), but found evidence  insufficient to make any recommendations about the effectiveness of DBS of the global pallidus interna (GPi) or the ventral intermediate nucleus of the thalamus (VIM) in reducing motor complications or medication usage, or in improving motor function in PD patients.

 

In 2011, the American Academy of Neurology (AAN) published an updated guideline on the treatment of essential tremor (ET). There were no changes from the conclusions and recommendations of the 2005 practice parameters regarding DBS for ET. The guidelines stated bilateral DBS of the thalamic nucleus may be used to treat medically refractory limb tremor in both upper limbs (level C possibly effective), but there were insufficient data regarding the risk/benefit ratio of bilateral versus unilateral DBS in the treatment of limb tremor. There was insufficient evidence to make recommendation regarding the use of thalamic for head or voice tremor (Level U, treatment is unproven).  (This guideline was reaffirmed on April 30, 2014)

      

In 2013, the American Academy of Neurology (AAN) published an evidence based guideline on the treatment of tardive syndromes which indicated: The available evidence which consists of class IV studies comprising of case reports or small case series, is insufficient to support or refute pallidal deep brain stimulation (DBS) for tardive syndromes.  (This guideline was reaffirmed on July 16, 2016)

 

American Psychiatric Association

In 2007, the American Psychiatric Association practice guideline for the treatment of patients with obsessive compulsive disorder states DBS may be recommended on the basis of individual circumstances.

 

In 2013, the American Psychiatric Association guideline watch practice parameter for the treatment of patients with obsessive-compulsive disorder states DBS and ablative neurosurgical treatment for OCD should be performed only at sites with expertise in both OCD and these treatment approaches.

 

In 2010, the American Psychiatric Association guideline on the treatment of major depressive disorder and the 2014 guideline watch, did not mention the use of deep brain stimulation (DBS) for the treatment of major depressive disorder. 

 

National Institute of Health and Care Excellence (NICE)

The National Institute of Health and Care Excellence (NICE) has published Interventional Procedure Guidance documents on deep brain stimulation (DBS):

 

Parkinson Disease: In 2003, NICE guidance states current evidence on the safety and efficacy of DBS for treatment of PD appears adequate to support the use of the procedure, provided that normal arrangements are in place for consent, audit, and clinical governance.

 

Tremor and Dystonia (Excluding Parkinson's Disease):  (H5)

In 2006, NICE made the same statement for use of DBS for treatment of tremor and dystonia. Unilateral and bilateral stimulation of structures responsible for modifying movements, such as the thalamus, globus pallidus, and the subthalamic nucleus, which interact functionally with the substantia nigra, are included in both guidance statements.  The guidance stated: “Current evidence on the safety and efficacy of deep brain stimulation for tremor and dystonia (exclluding Parkinson’s disease) appears adequate to support the use of this procedure, provided that normal arrangements are in place for consent, audit and clinical governance."

 

Refractory Chronic Pain Syndromes (Excluding Headache):

In 2011 guidance from NICE indicated there is evidence that DBS for refractory chronic pain (excluding headaches) is associated with serious risks. However, the procedure "is efficacious in some patients who are refractory to other forms of pain control and, therefore, this procedure may be used provided normal arrangements are in place for clinical governance, consent and audit. Patients should be informed that DBS may not control their chronic pain symptoms and that possible risk associated with this procedure include small risk of death."

 

Intractable Trigeminal Autonomic Cephalalgias:

In 2011 guidance from NICE indicated the evidence on the efficacy of DBS for intractable trigeminal autonomic cephalalgias (e.g. cluster headaches) was limited and inconsistent, and the evidence on safety shows that there are serious but well-known adverse effects. Therefore, "this procedure should only be used with special arrangements for clinical governance, consent, and audit or research."

 

Refractory Epilepsy:

In 2012 guidance from NICE indicated that the evidence on the efficacy of the DBS for refractory epilepsy was limited in both quantity and quality. The evidence on safety shows that there are serious but well-known adverse effects. Therefore, "this procedure should only be used with special arrangements for clinical governance, consent and audit or research."

 

Regulatory Status

The U.S. Food and Drug Administration (FDA) has approved the Activa® Tremor Control System, manufactured by Medtronic Corp, MN, for deep brain stimulation. While the original 1997 FDA-labeled indications were limited to unilateral implantation of the device for the treatment of tremor, in January 2002, the FDA-labeled indications were expanded to include bilateral implantation as a treatment to decrease the symptoms of advanced Parkinson’s disease that are not controlled by medication.

 

In April 2003, the FDA labeled indications for Activa® Tremor Control System, manufactured by Medtronic Corp, MN for deep brain stimulation were expanded to include “unilateral or bilateral stimulation of the internal globus pallidus or subthalamic nucleus to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients seven years of age or above.” This latter indication received FDA approval through the Humanitarian Device Exemption process. The Activa Tremor Control System consists of the following components: the implantable pulse generator, the deep brain stimulator lead, an extension that connects the lead to the power source, a console programmer, a software cartridge to set electrical parameters for simulation, and a patient control magnet, which allows the patient to turn the pulse generator on and off, or change between high and low settings.

 

In 2017 the FDA labeled indications for Activa® Tremor Control System, manufactured by Medtronic Corp, MN for deep brain stimulation regarding Parkinson’s disease was modified to include “adjunctive therapy in reducing some of the symptoms in individuals with levodopa-responsive Parkinson’s disease of at least 4 years duration that are not adequately controlled with medication.”

 

In February 2009, the FDA approved deep brain stimulation with the Reclaim® device (Medtronic, Inc.) via the Humanitarian Device Exemption (HDE) process for the treatment of severe treatment resistant obsessive-compulsive disorder (OCD).  This device is indicated for bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medication and as an alternative to anterior capsulotomy for the treatment of chronic, severe treatment resistant obsessive compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs).

 

The Vercise™ Deep Brain Stimulation system (Boston Scientific) is currently available in Europe, Israel,and Australia. Completion of a large U.S. multicenter trial (INTREPID) is expected in 2021.

 

In June 2015, the U.S. Food and Drug Administration approved the Brio Neurostimulation System (now called Infinity; St. Jude Medical Neuromodulation) as a PMA (premarket approval)  device for the following indications: 1) bilateral stimulation of the subthalmic nucleus (STN) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson’s disease that are not adequately controlled by medications; 2) unilateral or bilateral stimulation of the ventral intermediate (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability. This is a rechargeable system.

 

Prior Approval:

Not applicable

 

Policy:

Primary Dystonia

Unilateral or bilateral deep brain stimulation (DBS) of the globus pallidus (GPi) or the subthalmic nucleus (STN) may be considered medically necessary in patients 7 years of age or older with chronic intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia and cervical dystonia (torticollis).

 

Parkinson's Disease and Essential Tremor

Unilateral or bilateral deep brain stimulation (DBS) of the globus pallidus (GPi) or subthalmic nucleus (STN) may be considered medically necessary for an individual with Parkinson's disease when ALL of the following are met:

  • The individual meets a minimal score of 30 points on the motor portion of the United Parkinson’s Disease Rating Scale (UPDRS) following dthe discontinuation of medications for approximately 12 hours; and
  • A good response to levodopa (levodopa responsive Parkinson's disease); and
  • Motor complications that can not be managed with medication

Unilateral deep brain stimulation (DBS) of the thalamus may be considered medically necessary in patients with disabling medically unresponsive tremor due to essential tremor (ET) or Parkinson's disease (PD).

 

Bilateral deep brain stimulation of the thalamus may be considered medically necessary in patients with disabling, medically unresponsive tremor in both upper limbs due to essential tremor or Parkinson's disease (PD).

 

Disabling, medically unresponsive tremor is defined as all of the following:

  • Tremor causing significant limitation in daily activities
  • inadequate control by maximal dosage of medication for at least 3 month before implant

 

Replacement or Revision

Replacement or revision of deep brain stimulator generator and/or lead/electrode(s) and/or programmer may be considered medically necessary for an individual that meets  the above criteria and the existing generator/lead/electrode(s)/programmer is no longer under warranty and cannot be repaired. 

 

Deep brain Stimulation (DBS) is considered investigational including but not limited to the following indications, based on peer reviewed literature there is insufficient evidence to support the safety and effectiveness of deep brain stimulation (DBS), additional randomized controlled trials with larger number of subjects are required to evaluate the role of DBS.  The evidence is insufficient to determine the effects of this technology on net health outcomes:

  • Depression/treatment resistant depression
  • Alzheimer’s Disease/dementias
  • Chronic pain/Chronic pain syndromes
  • Obsessive-compulsive disorder (OCD) (Deep brain stimulation using the Reclaim device for the treatment of severe treatment resistant obsessive compulsive disorder (OCD) in an adult patient, see also Medical Policy 10.01.14 Humanitarian Use Devices – FDA website)
  • Cluster headache/headaches
  • Tourette Syndrome
  • Tardive Dyskinesia
  • Multiple sclerosis
  • Anorexia nervosa/eating disorders
  • Refractory epilepsy
  • Head or voice tremor
  • Huntington’s disease
  • Traumatic brain injury (TBI)

 

Cerebellar Stimulation/Pacing

The use of cerebellar stimulation/pacing is considered investigational for all indications. Based on peer reviewed literature there is little information available about this technology.  The evidence is insufficient to determine the safety and effectiveness of cerebellar stimulation/pacing for any indication and therefore is considered investigational.

 

Definitions

 

United Parkinson’s Disease Rating Scale (UPDRS):

UPDRS is a universal scale of Parkinson’s disease (PD) symptoms and it was created to comprehensively assess and document the exam of the patient with PD and be able to compare it with patient’s future follow up visits, or to communicate about the progression of the PD symptoms in each patient with other neurologists.

 

The UPDRS is made up of the 1) Mentation, Behavior, and Mood, 2) ADL and 3) Motor sections. These are evaluated by interview. Some sections require multiple grades assigned to each extremity. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability.

 

Essential Tremor:

Uncontrolled shaking or trembling, usually of one or both hands or arms, that worsens when basic movements are attempted. It is caused by abnormalities in areas of the brain that control movement and is not tied to an underlying disease (e.g. Parkinson’s disease).

 

Dystonia:

Highly variable neurological movement disorder characterized by involuntary muscle contractions. Dystonia results from abnormal functioning of the basal ganglia, a deep part of the brain which helps control coordination of movement. These regions of the brain control the speed and fluidity of movement and prevent unwanted movements. Patients with dystonia may experience uncontrollable twisting, repetitive movements, or abnormal postures and positions. These can affect any part of the body, including the arms, legs, trunk, face and vocal cords. Dystonia can affect young children to older adults of all races and ethnicities.

 

Primary (Idiopathic)  Dystonia:

Dystonia is the only sign, and secondary causes have been ruled out. Most primary dystonias are variable, have adult onset, and are focal or segmental in nature. However, there are specific primary dystonias with childhood or adolescent onset that have been linked to genetic mutations.

  • Focal Dystonia: Is limited to one area of the body.
  • Segmental Dystonia: Affects two or more parts of the body that are adjacent or close to one another.

 

Parkinson’s Disease:

 

Idopathic Parkinson’s Disease:

Most common form of Parkinson’s disease, and the cause essentially remains unknown. Parkinson’s disease is a progressive disorder that is caused by a degeneration of nerve cells in the part of the brain called the substantia nigra, which controls movement. These nerve cells die or become impaired, losing the ability to produce an important chemical called dopamine.

 

Secondary Parkinsonism:

This is a disorder with symptoms similar to Parkinson’s, but is caused by medication side effects, different neurodegenerative disorders, Illness, or brain damage. 

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 61863 Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (eg, thalamus, globus pallidus, subthalmic nucleus, periventricular, periaqueductal gray), without use of intraoperative microelectrode recording; first array
  • 61864 each additional array
  • 61867 Twist drill, burr hole, craniotomy, or cranietctomy with stereotactic implantation of neurostimulator electrode array in subcortical site (eg, thalamus, globus pallidus, subthalmic nucleus, periventricular, periaqueductal gray), with use of intraoperative microelectrode recording; first array
  • 61868 each additional array
  • 61870 Craniectomy for implantation of neurostimulator electrodes, cerebellar, cortical
  • 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
  • C1767 Generator neurostimulator (implantable) non-rechargeable
  • C1778 Lead, nuerostimulator
  • C1787 Patient programmer, neurostimulator
  • C1816 Receiver and/or transmitter neurostimulator (implantable)
  • C1820 Generator, neurostimulator (implantable), non high-frequency with rechargeable battery and charging system
  • C1822 Generator, neurostimulator (implantable), high frequency, with rechargeable battery and charging system
  • C1897 Lead neurostimulator test kit (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
  • 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, nonrechargeable, includes extension
  • L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
  • L8688 Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension
  • L8689 External recharging system for battery (internal)for use with implantable neurostimulator, replacement only
  • 95970 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode slectability, 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
  •  95978 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and duration, battery status, electrode selectability and polatiry, impedance and patient compliance measurements), complex deep brain neurostimulator pulse generator/transmitter, with initial or subsequent programming; first hour
  • 95979 each additional 30 minutes after first house (list separately in addition to code for primary procedure

 

Selected References:

  • ECRI Institute. Deep Brain Stimulation for Treating Non-Parkinsonian Neurologic and Psychiatric Disorders. Plymouth Meeting (PA): ECRI 2012 November. [Hotline Response].
  • Department of Health and Human Services Food and Drug Administration, Humanitarian Device Exemption for Medtronic Activa Dystonia Therapy, for the management of chronic, intractable (drug refractory) primary dystonia. April 2003. 
  • American Academy of Neurology Practice Parameter: Therapies for Essential Tremor: Report of the Quality Standards Subcommittee of the American Academy of Neurology. T.A. Zesiewicz, R. Elble, E.D. Louis, et. Al. Neurology 2005; 64; 2008-2020. Published online before print June 22, 2005. DOI 10.1212/01.WNL.0000163769.28552.CD.
  • American Academy of Neurology Practice Parameter of Parkinson Disease with Motor Fluctuations and Dyskinesia (an evidence based review): Report of the Quality Standards Subcommittee of the American Academy of Neurology. R. Pahwa, S.A. Factor, K. E. Lyons, et al. Neurology 2006; 66;983-995 Published online before print April 2, 2006. DOI 10.1212/01. WNL.0000215250.82576.87
  • American Academy of Neurology Evidence Based Guideline: Treatment of Tadive Syndromes: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Roongroj Bhidayasiri, Stanley Fahn, William J. Weinter, et al. Neurology 2013; 81; 463-469. DOI 10.1212/WNL.0b013e31829d86b6.
  • Deep Brain Stimulation for Primary Generalized Dystonia. Ioaanis U. Isaias, M.D., Ron L. Alterman, M.D., Michele Tagliati, M.D. Jama Neurology Vol 66 (NO4), April 2009.
  • American Association of Neurological Surgeons (AANS). Patient Information. Deep Brain Stimulation. April 2007.
  • American Association of Neurological Surgeons (AANS) Patient Information. Dystonia. October 2005.
  • American Association of Neurological Surgeons (AANS) Patient Information. Movement Disorders. January 2013.
  • American Association of Neurological Surgeons (AANS) Patient Information. Parkinson's Disease. December 2005.
  • American Society for Stereotactic and Functional Neurosurgery Deep Brain Stimulation: Indications, Techniques, and Practice Parameters.
  • Medtronic Deep Brain Stimulation.
  • PubMed. Deep Brain Stimulation for Psychiatric Disorders 2010 Feb; 107(7):105-13. Kuhn J, Grundler TO, Lenartz D, Sturm V,  Klosterkotter J, Huff W.
  • PubMed. Pallidal Deep Brain Stimulation for Primary Dystonia in Children Neurosurgery 2011 Mar; 68(3): 738-43. Haridas A, Tagliati M, Osborn I, Isaias I, Gologorsky Y, Bressman SB, Weisz D, Alterman RL.
  • MedScape. Deep Brain Stimulation for Parkinson's Disease and Other Movement Disorders. Curr Opin Neurol. 2013; 26 (4): 374-380. Suneil K. Kalia, Tejas Sankar, Andres M. Lazano.
  • The Medical Letter, On Drugs and Therapeutics. Volume 55 (Issue 1427), October 14, 2013. Deep Brain Stimulation for Parkson's Disease with Early Motor Complications. 
  • ECRI. Health Technology Forecast. Deep Brain Stimulation for Treatment-Resistant Depression. May 2011.
  • ECRI. Health Technology Forecast. Deep Brain Stimulation for Treatment Resistant Obsessive Compulsive Disorder. September 2013.
  • ECRI. Deep Brain Stimulation for Primary Dystonia. September 2010.
  • UpToDate. Surgical Treatment of Essential Tremor. Daniel Tarsy, M.D.. Topic Last Updated: January11, 2016.
  • UpToDate. Cluster Headache: Treatment and Prognosis. Arne May, M.D.. Topic Last Updated May10, 2016.
  • UpToDate. Deep Brain Stimulation for Treatment of Obsessive Compulsive Disorder. Damiaan Denys, M.D., PhD, Pelle P. de Koning, M.D.. Topic Last Updated May 15, 2015.
  • UpToDate. Tourette Syndrome. Joseph Jankovic, M.D.. Topic Last Updated October 6, 2015.
  • UpToDate. Tardive Dyskinesia: Preventative and Treatment. Daniel Tarsy, M.D.. Topic Last Updated June 6, 2016
  • UpToDate. Unipolar Depression in Adults: Treatment with Surgical Appraches. Paul E. Holtzheimer, M.D.. Topic Last Updated August 13, 2015.
  • American Psychiatric Association. Practice Guideline for the Treatment of Patients with Obsessive Compulsive Disorder. Approved October 2006 and published July 2007.
  • CMS. National Coverage Determination (NCD) for Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease. (160.24)
  • UpToDate. Surgical Treatment of Parkinson Disease. Daniel Tarsey M.D.. Topic last updated May 9, 2014.
  • UpToDate. Treatment of Dystonia. Cynthia Comella, M.D.. Topic last updated June 21, 2016.
  • UpToDate. Overview of Chronic Daily Headache.
  • UpToDate. Short Lasting Unilateral Neuralgiform Headache Attacks. Treatment. Manjit S. Matharu, M.D., Anna S. Cohen, M.D.. Topic last updated December 5, 2013.
  • UpToDate. Eating Disorders. Overview and Treatment. Sara F. Foreman, M.D.. Topic last updated July 28, 2016.
  • UpToDate. Evaluation and Management of Drug Resistant Epilepsy. Joseph I Sirven, M.D.. Topic last updated May 15, 2014.
  • UpToDate. Huntington Disease: Management. Oksana Suchowersky, M.D., FRCPC, FCCMG. Topic last updated September 28 2015.
  • UpToDate. Overview of the Treatment of Chronic Pain. Ellen WK Rosenquist M.D.. Topic last updated February16, 2016.
  • Medscape. Deep Brain Stimulation in Treatment Resistant Depression.
  • UpToDate. Depression in Adults Overview of Neuromodulation Procedures, Paul E. Holtzheimer, M.D.. Topic last updated August 25, 2015.
  • Koran Lorrin and Simpson Blair H, American Psychiatric Association Guideline Watch (March 2013) Practice Guideline for the Treatment of Patients with Obsessive Compulsive Disorder. Psychiatry Online
  • Bhidayasiri Roongroj, Fahn Stanley, et. al. Evidence Based Guideline: Treatment of Tardive Syndromes, American Academy of Neurology, Neurology July 320, 2013 Vol 81 No 5 463-469
  • National Institute for Health and Care Excellence (NICE) Interventional Procedure Guidance 19. Deep Brain Stimulation for Parkinsons Disease 2003.
  • National Institute for Health and Care Excellence (NICE) Interventional Procedure Guidance 188. Deep Brain Stimulation for Tremor and Dystonia (excluding Parkinson Disease). 2006.
  • National Institute for Health and Care Excellence (NICE) Interventional Procedure Guidance 382. Deep Brain Stimulation for Refractory Chronic Pain Syndromes (excluding headache) 2011.
  • National Institute for Health and Care Excellence (NICE) Interventional Procedure Guidance 381. Deep Brain Stimulation for Intractable Trigeminal Autonomic Cephalalgias 2011.
  • UpToDate. Treatment of Progressive Multiple Sclerosis in Adults. Michael J. Olek D.O. Topic last updated May 27, 2016.
  • UpToDate. Disease Modifying treatment of Relapsing Remitting Multiple Sclerosis in Adults. Michael J. Olek, M.D., Topic last updated July 15, 2016.
  • UpToDate. Treatment of Dementia. Daniel Press M.D., Michael Alexander M.D., Topic last updated June 20, 2016.  
  • National Institute for Health and Care Excellence (NICE) Parkinson’s Disease in Over 20s: Diagnosis and Management. Clinical Guidelinne 35. 2006.
  • National Institute for Health and Care Excellence (NICE) Deep Brain Stimulation for Refractory Epilepsy. Clinical Guideline 416. 2012  
  • Perestelo-Perez L, Rivero-Santana A, Perez-Ramos J, et al. Deep brain stimulation in Parkinson's disease: meta-analysis of randomized controlled trials. J Neurol. Nov 2014;261(11):2051-2060. PMID 24487826
  • Sako W, Miyazaki Y, Izumi Y, et al. Which target is best for patients with Parkinson's disease? A meta-analysis of pallidal and subthalamic stimulation. J Neurol Neurosurg Psychiatry. Sep 2014;85(9):982-986. PMID 24444854
  • Combs HL, Folley BS, Berry DT, et al. Cognition and Depression Following Deep Brain Stimulation of the Subthalamic Nucleus and Globus Pallidus Pars Internus in Parkinson's Disease: A Meta-Analysis. Neuropsychol Rev. Dec 2015;25(4):439-454. PMID 26459361
  • Volkmann J, Mueller J, Deuschl G, et al. Pallidal neurostimulation in patients with medication-refractory cervical dystonia: a randomised, sham-controlled trial. Lancet Neurol. Sep 2014;13(9):875-884. PMID 25127231
  • Salanova V, Witt T, Worth R, et al. Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy. Neurology. Mar 10 2015;84(10):1017-1025. PMID 25663221
  • Baldermann JC, Schuller T, Huys D, et al. Deep brain stimulation for tourette-syndrome: a systematic review and meta-analysis. Brain Stimul. Mar-Apr 2016;9(2):296-304. PMID 26827109
  • Fraint A, Pal G. Deep Brain Stimulation in Tourette's Syndrome. Front Neurol. 2015;6:170. PMID 26300844
  • Schrock LE, Mink JW, Woods DW, et al. Tourette syndrome deep brain stimulation: a review and updated recommendations. Mov Disord. Apr 2015;30(4):448-471. PMID 25476818
  • Servello D, Zekaj E, Saleh C, et al. 16 years of Deep Brain Stimulation in Tourette's Syndrome: a critical review. J Neurosurg Sci. Jan 20 2016. PMID 26788742
  • Kefalopoulou Z, Zrinzo L, Jahanshahi M, et al. Bilateral globus pallidus stimulation for severe Tourette's syndrome: a double-blind, randomised crossover trial. Lancet Neurol. Jun 2015;14(6):595-605. PMID 25882029
  • Morishita T, Fayad SM, Higuchi MA, et al. Deep brain stimulation for treatment-resistant depression: systematic review of clinical outcomes. Neurotherapeutics. Jul 2014;11(3):475-484. PMID 24867326
  • Mosley PE, Marsh R, Carter A. Deep brain stimulation for depression: Scientific issues and future directions. Aust N Z J Psychiatry. Nov 2015;49(11):967-978. PMID 26276049
  • Dougherty DD, Rezai AR, Carpenter LL, et al. A Randomized Sham-Controlled Trial of Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Chronic Treatment-Resistant Depression. Biol Psychiatry. Aug 15 2015;78(4):240-248. PMID 25726497
  • Hamani C, Pilitsis J, Rughani AI, et al. Deep brain stimulation for obsessive-compulsive disorder: systematic review and evidence-based guideline sponsored by the American Society for Stereotactic and Functional Neurosurgery and the Congress of Neurological Surgeons (CNS) and endorsed by the CNS and American Association of Neurological Surgeons. Neurosurgery. Oct 2014;75(4):327-333; quiz 333. PMID 25050579
  • Alonso P, Cuadras D, Gabriels L, et al. Deep Brain Stimulation for Obsessive-Compulsive Disorder: A Meta-Analysis of Treatment Outcome and Predictors of Response. PLoS One. 2015;10(7):e0133591. PMID 26208305
  • Kisely S, Hall K, Siskind D, et al. Deep brain stimulation for obsessive-compulsive disorder: a systematic review and meta-analysis. Psychol Med. Dec 2014;44(16):3533-3542. PMID 25066053
  • ECRI. Technology News. Implantable Neurostimulation System gets FDA Premarket Approval for Parkinson’s Essential Tremor Symptoms, Published June 19, 2015. 
  • Blue Cross and Blue Shield Association Technology Evaluation Center. Deep brain Stimulation of the thalamus for tremor TEC Assessment 1997;Volume 12:Tab 20
  • Blue Cross and Blue Shield Association Technology Evaluation Center. Bilateral deep brain stimulation of the subthalamic nucleus or the globus pallidus interna for treatment of advanced Parkinson’s disease. TEC Assessment 2001. Volume 16; Tab 16
  • CMS Decision Memo for Deep Brain Stimulation for Parkinson’s Disease (CAG-00124N).
  • Tan ZG, Zhou Q, Huang T, et. al. Efficacies of globus pallidus stimulation and subthalamic nucleus stimulation for advanced Parkinson’s disease: a meta-analysis of randomized controlled trials. Clin Interv Agin. 2016;11:777-786. PMID 27382262
  • Wang JW, Zhang YQ, Zhang XH, et. al. Cognitive and psychiatric effects of STN versus GPi deep brain stimulation in Parkinson’s disease: a meta-analysis of randomized controlled trials. PLoS One. 2016;11(6):e0156721. PMID 27248139
  • Xie CL, Shao B, Chen J, et. al. Effects of neurostimulation for advanced Parkinson’s disease patients on motor symptoms: A multiple treatments meta-analysis of randomized controlled trials. Sci Rep May 4 2016;6:25285. PMID 27142183
  • Xu F, Ma W, Huang Y, et. al. Deep brain stimulation of pallidal versus subthalamic for patients with Parkinson’s disease: a meta-analysis of controlled clinical trials. Neuropsychiatr Dis Treat. 2016;12:1435-1444. PMID 27382286
  • Moro E, LeReun C, Krauss JK, et. al. Efficacy of pallidal stimulation in isolated dystonia: a systematic review and meta-analysis. Eur J Neurol Apr 2017;24(4):552-560. PMID 28186378
  • Baldermann JC, Schuller T, Huys D, et. al. Deep brain stimulation for Tourette syndrome: a systematic review and meta-analysis. Brain Stimul. Mar-Apr 2016;9(2):296-304. PMID 26827109
  • Servello D, Zekaj E, Saleh C, et. al. Sixteen years of deep brain stimulation in Tourette’s Syndrome: a critical review. J Neurosurg Sci. Jun 2016;60(2):218-229. PMID 26788742
  • Bergfeld IO, Mantione M, Hoogendoorn ML, et. al. Deep brain stimulation of the ventral anterior limb of the internal capsule for treatment-resistant depression: a randomized clinical trial. JAMA Psychiatry May 1, 2016;73(5):456-464. PMID 27049915
  • Naesstrom M, Blomstedt P, Bodlund O. A systematic review of psychiatric indications for deep brain stimulation, with focus on major depressive and obsessive-compulsive disorder. Nord J Psychiatry. Oct 2016;70(7):483-491. PMID 27103550
  • Cruccu G, Garcia-Lerrea L, Hansson P, et. al. EAN guidelines on central neurostimulation therapy in chronic pain conditions. Eur J Neurol. Oct 2016;23(10):1489-1499. PMID 27511815  
  • Muller-Vahl KR, Cath DC, Cavanna AE, et. al. European Clinical Guidelines for Tourette syndrome and other tic disorders. Part IV: deep brain stimulation. Eur Child Adolesc Psychiatry 2011 Apr 2011;20(4):209-217. PMID 21445726
  • ECRI. FDA Approvals and Clearances. Infinity Deep Brain Stimulation System. Published October 12, 2016. 

 

Policy History:

  • August 2017 - Annual Review, Policy Revised

  • August 2016 - Annual Review, Policy Revised

  • September 2015 - Annual Review, Policy Revised

  • February 2015 - Policy Revised

  • October 2014 - Annual Review, Policy Revised

  • January 2014 - Annual Review, Revised and New Policy Created

  • January 2013 - Annual Review, Policy Renewed

  • January 2012 - Annual Review, Policy Renewed

  • February 2011 - Interim Review, Policy Revised

  • October 2010 - Annual Review, Policy Renewed

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.

 

*CPT® is a registered trademark of the American Medical Association.