Medical Policy: 07.01.59
Original Effective Date: November 2000
Reviewed: October 2014
Revised: February 2015
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.
Deep brain stimulation (DBS) is presumed to help modulate dysfunctional circuits in the brain so that the brain can function more effectively. This is accomplished by sending continuous electrical signals to specific target areas of the brain, which block the impulses that cause neurologic dysfunctions. These targets are the ventralis intermediate nucleus of the thalamus (Vim), the globus pallidus pars interna (GPi), and the subthalmic nucleus (STN).
The DBS system consists of three components:
- The lead (also called an electrode) is thin, insulated wire inserted through a small opening in the skull and implanted in the brain.
- The extension is an insulated wire that is passed under the skin of the head, neck and shoulder, connecting the lead to an internal pulse generator (IPG)
- The IPG or neurostimulator is the third component and is usually implanted under the skin near the collarbone. In some cases it may be implanted in the chest or under the skin over the abdomen.
A magnet is used with the IPG to adjust the stimulation parameters so the appropriate level of stimulation is applied at the electrode tip. The patient is provided with an access control device or handheld magnet to turn the IPG on and off at home. Depending on the application, the battery can last three to five years. When the battery needs to be replaced, the IPG is also replaced, usually under local anesthesia as an outpatient procedure.
DBS Surgery Advantages
- Surgery can be performed on both sides of the brain for control of symptoms affecting both sides of the body.
- The effects are reversible and can be tailored to a patient's clinical status.
- Stimulation parameters can be adjusted to minimize potential side effects and improve efficacy over time.
- The device can provide continuous symptom control 24 hours per day.
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 inadequate information available to make an assessment of the clinical usefulness of this procedure.
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 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).
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 intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia and cervical dystonia (torticollis)
Unilateral or bilateral deep brain stimulation (DBS) of the globus pallidus (GPi) or subthalmic nucleus (STN) may be considered medically necessary in individuals that have moderate to severe medically intractable idiopathic Parkinson’s disease with the following:
- A minimal score of 30 points on the motor portion of the United Parkinson’s Disease Rating Scale (UPDRS) when the individual has been off medication for about 12 hours; and
- A good response to Levodopa; and
- Motor complications that can not be managed with medication; and
- The presence of at least 2 major symptoms of Parkinson’s disease (tremor, rigidity, slowness or movement or impaired balance and coordination)
Unilateral deep brain stimulation (DBS) of the ventral intermediate nucleus of the thalmus (Vim) may be considered medically necessary for severely disabling, medication resistant essential tremor or tremor due to Parkinson disease.
Based on peer reviewed literature there is insufficient evidence to support the safety and effectiveness of deep brain stimulation (DBS), and is therefore considered investigational for the following indications, including but not limited to:
- Alzheimer’s Disease/dementias
- Chronic pain/Chronic pain syndromes
- Obsessive-compulsive disorder (OCD)
- Cluster headache/headaches
- Tourette Syndrome
- Tardive Dyskinesia
- Multiple sclerosis
- Anorexia nervosa/eating disorders
- Head or voice tremor
- Huntington’s disease
The use of cerebellar stimulation/pacing is considered investigational. Based on peer reviewed literature there is insufficient evidence to support the effectiveness of cerebellar stimulation/pacing on health outcomes and is therefore considered investigational.
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.
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, 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
Wellmark's policy is based on:
- ECRI Institute. Deep Brain Stimulation for Treating Non-Parkinsonian Neurologic and Psychiatric Disorders. Plymouth Meeting (PA): ECRI Health Technology Information Service; 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. Available at: www.archneur.jamanetwork.com
- 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 Institute. Deep Brain Stimulation for Primary Dystonia. September 2010.
- UpToDate. Surgical Treatment of Parkinson Disease. Daniel Tarsy, M.D.. Topic Last Updated: August 20, 2013.
- UpToDate. Surgical Treatment of Essential Tremor. Daniel Tarsy, M.D.. Topic Last Updated: August 28, 2013.
- UpToDate. Treatment of Dystonia. Cynthia Comella, M.D.. Topic Last Updated July 16, 2013.
- UpToDate. Cluster Headache: Acute and Preventative Treatment. Arne May, M.D.. Topic Last Updated August 19, 2013.
- 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 29, 2012.
- UpToDate. Tourette Syndrome. Joseph Jankovic, M.D.. Topic Last Updated September 3, 2013.
- UpToDate.Tardive Dyskinesia: Preventative and Treatment. Daniel Tarsy, M.D.. Topic Last Updated October 3, 2013.
- UpToDate. Unipolar Depression in Adults: Treatment with Surgical Appraches. Paul E. Holtzheimer, M.D.. Topic Last Updated September 23, 2013.
- 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. Available at www.cms.gov
- National Institute of Health and Clinical Excellence (NICE), Deep Brain Stimulation for Refractory Epilepsy: Clinical Audit Tool.
- UpToDate. Surgical Treatment of Parkinson Disease. Daniel Tarsey M.D.. Topic last updated May 9, 2014. Also available www.uptodate.com
- UpToDate. Treatment of Dystonia. Cynthia Comella, M.D.. Topic last updated December 20, 2013. Also available www.uptodate.com
- UpToDate. Cluster Headache Treatment and Prognosis. Arne May, M.D.. Topic last updated October 16, 2014. Also available at www.uptodate.com
- UpToDate. Overview of Chronic Daily Headache. Also available at www.uptodate.com
- UpToDate. Short Lasting Unilateral Neuralgiform Headache Attacks. Treatment. Manjit S. Matharu, M.D., Anna S. Cohen, M.D.. Topic last updated December 5, 2013. Also available at www.uptodate.com
- UpToDate. Eating Disorders. Overview and Treatment. Sara F. Foreman, M.D.. Topic last updated September 21, 2014. Also available at www.uptodate.com
- UpToDate. Unipolar Depression in Adults: Treatment with Surgical Approaches. Paul E. Holtzheimer, M.D.. Topic last updated October 1, 2014. Also available at www.uptodate.com
- UpToDate. Tourette Syndrome. Joseph Jankovic, M.D.. Topic last updated December 12, 2013. Also available at www.uptodate.com
- UpToDate. Evaluation and Management of Drug Resistant Epilepsy. Joseph I Sirven, M.D.. Topic last updated May 15, 2014. Also available at www.uptodate.com
- UpToDate. Huntington Disease: Management. Also available at www.uptodate.com
- UpToDate. Overview of the Treatment of Chronic Pain. Ellen WK Rosenquist M.D.. Topic last updated September 19, 2014. Also available at www.uptodate.com
- Medscape. Deep Brain Stimulation in Treatment Resistant Depression. www.medscape.com
Date Reason Action
October 2010 Annual review Policy renewed
February 2011 Interim review Policy revised
January 2012 Annual review Policy renewed
January 2013 Annual review Policy renewed
January 2014 Annual eeview Revised and New Policy Created
October 2014 Annual review Policy revised
February 2015 Policy revised
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.