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Deep brain stimulation (DBS) involves the stereotactic placement of an electrode into the brain (ie, hypothalamus, thalamus, globus pallidus, subthalamic nucleus). DBS is used as an alternative to permanent neuroablative procedures for control of essential tremor and Parkinson disease. DBS is also being evaluated for the treatment of a variety of other neurologic and psychiatric disorders.
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 (ET) and tremor associated with Parkinson 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 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 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 and secondary dystonia, defined as a neurologic 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. Secondary dystonia is a dystonia brought on by an inciting event, such as a stroke, trauma, or drugs. Tardive dystonia is a form of drug-induced secondary dystonia.
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 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.
The role of DBS in treatment of other treatment-resistant neurologic and psychiatric disorders, particularly Tourette syndrome, epilepsy, obsessive-compulsive disorder, and major depressive disorders, is also being investigated. Ablative procedures are irreversible and, though they have been refined, remain controversial treatments for intractable illness. Interest has shifted to neuromodulation through DBS of nodes or targets within neural circuits involved in these disorders. Currently, a variety of target areas are being studied.
DBS involves the stereotactic placement of an electrode into the brain (i.e., hypothalamus, 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 adverse effects of neurostimulation, such as dysarthria, disequilibrium, or involuntary movements.
In 1997, the Activa® Tremor Control System (Medtronic) was cleared for marketing by the U.S. Food and Drug Administration (FDA) for deep brain stimulation. The original FDA-labeled indications were limited to unilateral implantation of the device for the treatment of tremor, but, in January 2002, the FDA-labeled indications were expanded to include bilateral implantation as a treatment to decrease the symptoms of advanced Parkinson disease 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 neurostimulator, 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 neurostimulator on and off, or change between high and low settings.
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 February 2009, the Reclaim® device (Medtronic), a deep brain stimulatory, was cleared for marketing by FDA through 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.
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.
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 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, Alzheimer disease, 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Disabling, medically unresponsive tremor is defined as all of the following:
Contraindications to deep brain stimulation include:
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.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
12/31/2014: Code Reference section updated to revise the description of the following CPT code: 95972.
01/12/2015: Policy description updated regarding secondary dystonia and devices. Added the following policy statement: Bilateral deep brain stimulation of the thalamus may be considered medically necessary in patients with disabling, medically unresponsive tremor in both limbs due to essential tremor or Parkinson disease. Added Alzheimer disease as an investigational indication for deep brain stimulation.
08/25/2015: Code Reference section updated to add ICD-10 codes. Removed ICD-9 procedure code 01.24. Updated the code descriptions for 01.22, 02.93, 61885, and 61886. Removed deleted code 64573 from the policy and replaced with 64568.
12/31/2015: Policy guidelines updated to add medically necessary and investigative definitions. Code Reference section updated to revise the description for CPT code 95972.
05/31/2016: Policy number added. Removed deleted CPT code 61875 from the Code Reference section.
07/06/2016: Policy description updated. Medically necessary statement regarding bilateral deep brain stimulation updated to add "upper" to clarify that the statement refers to both upper limbs.
09/30/2016: Code Reference section updated to add new ICD-10 procedure code 05P002Z.
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.