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DESCRIPTIONDeep 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 unassociated 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 2 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.
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 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: 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 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 obsessive-compulsive disorder (OCD).
Note: The use of spinal cord stimulation as a treatment of chronic pain is addressed in a separate policy, Spinal Cord Stimulation.
POLICYUnilateral 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 nucleus may be considered medically necessary in the following patients:
Deep brain stimulation for other movement disorders, including but not limited to multiple sclerosis, post-traumatic dyskinesia, and tardive dyskinesia, is considered investigational.
Deep brain stimulation for the treatment of chronic cluster headaches is considered investigational.
Deep brain stimulation for the treatment of other psychiatric or neurologic disorders, including but not limited to Tourette syndrome, depression, obsessive-compulsive disorder, anorexia nervosa, alcohol addiction, chronic pain, and epilepsy, is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESDisabling, medically unresponsive tremor is defined as all of the following:
Contraindications to deep brain stimulation include:
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
At the present time, there is only one device that has been approved by the U.S. Food and Drug Administration (FDA) for deep brain stimulation: the Activa Tremor Control SystemTM, manufactured by Medtronic Corp., MN. This system consists of the following components: the implantable pulse generator (Itrel7 II), the deep brain stimulator lead (DBSJ Lead), an extension that connects the lead to the power source (Model 7495 Extension), a console programmer (Model 7432 Console Programmer), a software cartridge to set electrical parameters for simulation (MemoryMod7), and a patient control magnet, which allows the patient to turn the pulse generator on and off or change between high and low settings.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY5/1998: Issued
12/4/2000: Code reference section updated
5/2001: Reviewed by Medical Policy Advisory Committee (MPAC); DBS for treatment of dystonia considered investigational.
2/13/2002: Investigational definition added
3/6/2002: "The procedure must be performed in a BCBSMS approved center" deleted
4/18/2002: Type of Service and Place of Service deleted
5/6/2002: Code Reference section updated, CPT code 61855 deleted
5/2002: Reviewed by MPAC; broader indications for otherwise untreatable Parkinsonism is medically necessary, Sources updated
5/29/2002: Code Reference section updated, HCPCS C1767, C1816 added
3/11/2004: Code Reference section updated, CPT code range 61850-61888 listed separately, HCPCS C1767, C1816, E0751, E0753 deleted, non-covered ICD-9 diagnosis codes 333.0, 333.6, 333.7, 340 deleted
7/21/2005: Reviewed by MPAC, added "DBS for obsessive compulsive disorder is considered investigational."
10/17/2005: Code Reference table updated, codes 95978, 95979 added. Change description of 95970, 95971, 95972, 95973, 95974, 95975.
11/15/2005: ICD9 procedure codes 86.97, 86.98 added
3/13/2006: Policy reviewed, no changes
03/22/2006: Coding updated. HCPCS 2006 revisions added to policy
9/18/2007: Policy reviewed, no changes
12/31/2008: Code reference section updated per 2009 CPT/HCPCS revisions
8/18/2010: Policy description section updated, medically necessary indications for globus pallidus or subthalamic nucleus, primary dystonia, including generalized and segmental dystonia, hemidystonia and cervical dystonia (torticollis) added to policy statment section. FEP verbiage added to the Policy Exceptions section. Detailed information regarding disabling, medically unresponsive tremor and contraindications of deep brain stimulation added to policy guidelines. Added ICD-9 codes 333.6, 333.79, 333.83 and 333.89.
08/11/2011: Policy reviewed; policy statement unchanged. Deleted outdated references from the Sources section.
07/17/2012: Policy reviewed; no changes.
11/15/2013: Added anorexia nervosa, alcohol addiction, and chronic pain as investigational indications for deep brain stimulation.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.63
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.