Archived Policies - Surgery
Deep Brain Stimulation for Tremor
Unilateral deep brain stimulation of the thalamus may be considered medically necessary in patients with disabling, medically unresponsive tremor due to essential tremor or Parkinson’s disease.
Unilateral or bilateral deep brain stimulation of the globus pallidus or subthalamic nuclei may be considered medically necessary in patients with Parkinson’s disease with all of the following:
Unilateral or bilateral deep brain stimulation of the globus pallidus or subthalamic nuclei may be considered medically necessary in patients aged seven years or greater with chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia or cervical dystonia (torticollis).
Deep brain stimulation for other movement disorders, including but not limited to multiple sclerosis and post-traumatic dyskinesia, is considered experimental, investigational and unproven.
Deep brain stimulation for the treatment of chronic cluster headaches is considered experimental, investigational and unproven.
NOTE: Replacement, revision or removal of electrodes and/or pulse generator for deep brain stimulation will not require additional medical necessity review.
Deep brain stimulation has been investigated as an alternative to permanent neuroablative procedures, such as thalamotomy and pallidotomy. The technique has been most thoroughly investigated as an alternative to thalamotomy for unilateral control of essential tremor and tremor associated with Parkinson's disease (PD). More recently, there has been research interest in the use of deep brain stimulation 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., the on state) and the nadir response during drug troughs (i.e., the off state). In addition, levodopa, the most commonly used anti-Parkinson's drug, may be associated with disabling drug-induced dyskinesias. Therefore, the optimal pharmacologic treatment of PD may involve a balance between optimal effects on Parkinson's symptoms versus the appearance of drug-induced dyskinesias. The effect of deep brain stimulation (DBS) on both Parkinson's symptoms and drug-induced dyskinesias has also been studied.
DBS has also been investigated in patients with primary dystonia, defined as a neurological movement disorder characterized by involuntary muscle contractions, which force certain parts of the body into abnormal, contorted, and painful movements or postures. Dystonia can be classified according to age of onset, bodily distribution of symptoms, and cause. Age of onset can occur during childhood or during adulthood. Dystonia can affect certain portions of the body (focal dystonia and multifocal dystonia) or the entire body (generalized dystonia). Torticollis is an example of a focal dystonia. Primary dystonia is defined when dystonia is the only symptom not associated with other pathology. Treatment options for dystonia include oral or injectable medications (i.e., botulinum toxin) and destructive surgical or neurosurgical interventions (i.e., thalamotomies or pallidotomies) when conservative therapies fail.
In addition, DBS has been recently 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 occur primarily in men and 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, sphenopalatine ganglion (SPG) blockade, and surgical procedures such as percutaneous SPG radiofrequency rhizotomy and gamma knife radiosurgery of the trigeminal nerve.
DBS involves the stereotactic placement of an electrode into the brain (i.e., thalamus, globus pallidus, or subthalamic nucleus). The electrode is initially attached to a temporary transcutaneous cable for short-term stimulation to validate treatment effectiveness. Several days later, the patient returns to surgery for permanent subcutaneous implantation of the cable and a radiofrequency-coupled or battery-powered programmable stimulator. The electrode is typically implanted unilaterally on the side corresponding to the most severe symptoms. However, the use of bilateral stimulation using two electrode arrays has also been investigated in patients with bilateral, severe symptoms.
After implantation, noninvasive programming of the neurostimulator can be adjusted to the patient's symptoms. This feature may be important for patients with PD, whose disease may progress over time, requiring different neurostimulation parameters. Setting the optimal neurostimulation parameters may involve the balance between optimal symptom control and appearance of side effects of neurostimulation, such as dysarthria, disequilibrium, or involuntary movements.
At the present time, only one device has been approved by the U.S. Food and Drug Administration (FDA) for deep brain stimulation: the Activa Tremor Control System, manufactured by Medtronic Corp, MN. 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 that are not controlled by medication. In April 2003, the labeled indications 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:
This policy on unilateral DBS as a treatment for tremor is based on a 1997 Blue Cross Blue Shield Association Technology Evaluation Center (TEC) assessment, and a 2001 TEC Assessment that focused on the use of deep brain stimulation of the globus pallidus and subthalamic nucleus for a broader range of Parkinson symptoms. The observations and conclusions of the TEC assessment are summarized here. Articles published since these two assessments continue to report positive outcomes for deep brain stimulation for tremor and Parkinson disease.
A wide variety of studies consistently demonstrate that deep brain stimulation of the globus pallidus or subthalamic nucleus 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 levodopa is working, improvement in cardinal symptoms of Parkinson’s disease during periods when medication is not working, and in the case of bilateral deep brain stimulation of the subthalamic nucleus, reduction in the required daily dosage of levodopa and/or its equivalents. The magnitude of these changes is both statistically significant and clinically meaningful. The beneficial treatment effect lasts at least for the six to twelve months observed in most trials. While there is not a great deal of long-term follow-up, the available data are generally positive. Adverse effects and morbidity are similar to those known to occur with thalamic stimulation. Deep brain stimulation possesses advantages to other treatment options. In comparison to pallidotomy, deep brain stimulation can be performed bilaterally. The procedure is non-ablative and reversible.
Deep Brain Stimulation for the Treatment of Dystonia
Deep brain stimulation for the treatment of primary dystonia received FDA approval through the Humanitarian Device Exemption (HDE) process. The HDE approval process is available for conditions that affect less than 4,000 Americans per year. According to this approval process, the manufacturer is not required to provide definitive evidence of efficacy, but only probable benefit. The approval was based on the results of DBS in 201 patients represented in 34 manuscripts. There were three studies that reported at least ten cases of primary dystonia. In these studies, clinical improvement ranged from 50% to 88%. A total of 21 pediatric patients were studied; 81% were older than seven years. Among these patients there was about a 60% improvement in clinical scores. As noted in the analysis of risk and probably benefit, the only other treatment options for chronic refractory primary dystonia are neuro destructive procedures. Deep brain stimulation provides a reversible alternative. The FDA Summary of Safety and Probable Benefit states, “Although there are a number of serious adverse events experienced by patients treated with deep brain stimulation, in the absence of therapy, chronic intractable dystonia can be very disabling and, in some cases, progress to a life-threatening stage or constitute a major fixed handicap. When the age of dystonia occurs prior to the individual reaching their full adult size, the disease not only can affect normal psychosocial development but also cause irreparable damage to the skeletal system. As the body of the individual is contorted by the disease, the skeleton may be placed under constant severe stresses that may cause permanent disfigurement. Risks associated with deep brain stimulation for dystonia appear to be similar to the risk associated with the performance of stereotactic surgery and the implantation of deep brain stimulation systems for currently approved indications, except when used in either child or adolescent patient groups.”
Since the FDA approval, there have been additional published trials of deep brain stimulation for dystonia, which continue to report positive results. Vidailhet and colleagues reported the results of a prospective multi-institutional case series of 22 patients with primary generalized dystonia. Symptoms were evaluated prior to surgery and at several points up to one year of follow-up, in a double-blind fashion with the stimulator turned on and off. Dystonia scores were significantly better with the neurostimulator turned on.
Deep Brain Stimulation for the Treatment of Headaches
Deep brain stimulation of the posterior hypothalamus for the treatment of chronic cluster headaches has been investigated. Recent functional studies have suggested cluster headaches have a central hypothalamic pathogenesis. Franzini and colleagues and Leone et al, reported deep brain stimulation with long-term, high-frequency, electrical stimulation of the ipsilateral posterior hypothalamus resulted in long-term pain relief without significant adverse effects in those patients with chronic cluster headaches. The results from these reports seem promising; however, the authors note further studies are needed to determine the long-term safety and effectiveness of this treatment.
Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.
The coding for deep brain stimulation consists of a series of codes describing the various steps of the procedure;
Implantation of Electrodes: If a patient is undergoing a bilateral electrode arrays, this code may be used twice. In some instances, patients undergo bilateral implantation in a staged procedure.
Electronic Analysis: Over time, patients may undergo several sessions of electronic analysis and programming to find the optimal programming parameters.
The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.
Medicare (CMS) does have a national coverage position.
A national coverage position for Medicare may have been developed or changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
Deep Brain Stimulation of the Thalamus for Tremor. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program. (1997 December) 12(20):1-29.
Bilateral DBS of the Subthalamic Nucleus or the Globus Pallidus Interna for Treatment of Advanced Parkinson’s Disease. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Assessment Program. (2002 February) 16(16):1-72.
FDA – Summary of Safety and Probably Benefit, Medtronic Activa Dystonia Therapy™. Federal Drug Administration – Center for Devices and Radiologic Health (2003 April 15) Available at <http://www.fda.gov>.
Franzini, A., Ferroli, P., et al. Stimulation of the posterior hypothalamus for treatment of chronic intractable cluster headaches: first reported series. Neurosurgery (2003) 52(5):1095-101.
Leone, M., May, A., et al. Deep brain stimulation for intractable chronic cluster headache: proposals for patient selection. Cephalalgia (2004) 24(11):934-7.
Franzini, A., Ferroli, P., et al. Hypothalamic deep brain stimulation for the treatment of chronic cluster headaches: a series report. Neuromodulation (2004) 7(1):1-8.
Halbig, T.D., Gruber, D., et al. Pallidal stimulation in dystonia: effects on cognition, mood, and quality of life. Journal of Neurology, Neurosurgery and Psychiatry (2005) 76(12):1713-6.
Vidailhet, M., Vercueil, L., et al. Bilateral deep-brain stimulation of the globus pallidus in primary generalized dystonia. New England Journal of Medicine (2005) 352(5):459-67.
Deep Brain Stimulation. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Manual (2006 March) Surgery 7.01.63.
|Title:||Effective Date:||End Date:|
|Deep Brain Stimulation (DBS)||08-15-2017||06-14-2018|
|Deep Brain Stimulation (DBS)||12-01-2016||08-14-2017|
|Deep Brain Stimulation||06-01-2015||11-30-2016|
|Deep Brain Stimulation for Tremor||06-01-2011||05-31-2015|
|Deep Brain Stimulation for Tremor||08-15-2009||05-31-2011|
|Deep Brain Stimulation for Tremor||05-01-2008||08-14-2009|
|Deep Brain Stimulation for Tremor||09-01-2007||04-30-2008|
|Deep Brain Stimulation for Tremor||05-15-2005||08-31-2007|
|Deep Brain Stimulation for Tremor||11-01-2000||05-14-2005|