Archived Policies - Surgery


Deep Brain Stimulation for Tremor

Number:SUR712.025

Effective Date:05-15-2005

End Date:08-31-2007

Coverage:

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

  • A documented good response to levodopa; AND
  • A score of 30 points on the Unified Parkinson Disease Rating Scale when the patient has been without medication for approximately 12 hours;   AND
  • Motor complications not controlled by pharmacologic therapy,

Patients aged 7 years or greater with chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia or cervical dystonia (torticollis) may be considered medically necessary..

Deep brain stimulation for other movement disorders, including but not limited to multiple sclerosis and post-traumatic dyskinesia, is considered experimental, investigational and unproven.

The plan may request medical records for determination of medical necessity. When medical records are requested, a letter of support and/or explanation is helpful, but alone will not be considered sufficient documentation to make a medical necessity determination.

Description:

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 condition 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) has also been investigated in patients with primary dystonia defined as 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) or the entire body (generalized dystonia).  Torticollis is an example of a focal dystonia.  Primary dystonia is diagnosed 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.

Deep brain stimulation 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 severe bilateral 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, such as dysarthria, disequilibrium, or involuntary movements.  At the present time, only one device has been approved by the 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 (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
  • A patient control magnet, which allows the patient to turn the pulse generator on and off, or change between high and low settings.

Rationale:

The policy regarding unilateral deep brain stimulation (DBS) as a treatment for tremor is based on a 1997 Blue Cross Blue Shield Association Technology Evaluation Center Assessment, which concluded that 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 eight years, and the side effects of stimulation were reported as mild and largely reversible.  The TEC Assessment concluded that these results are at least as good as those associated with pallidotomy.  An additional benefit of deep brain stimulation is that recurrence of tremor may be managed by changes in stimulation parameters.

Unilateral DBS of the thalamus has been widely studied as a treatment of tremor. Preliminary studies of unilateral or bilateral DBS of the globus pallidus or subthalamic nucleus appear encouraging. It is hoped that in the future, patients with refractory Parkinson's disease may be able to select from a variety of neuroablative or neurostimulatory procedures tailored to their specific symptoms.  Compared to neuro destructive approaches, advantages of neurostimulation include its reversibility and flexibility in terms of programming.  The drawbacks include the potentially time-consuming requirement of periodic reprogramming of the stimulator to find the optimal parameters, and the complications of an implanted device; i.e., risk of infection, electrode migration, or hardware failure.

Even though long term studies are not complete and preliminary studies for the most part are made up of small numbers of patients, the Parkinson's disease patient with disabling, medically unresponsive tremor has limited treatment options.  Outcomes so far indicate that there is improved quality of life including improvement in Unified Parkinson's Disease Rating Scale (UPDRS) motor scores for some patients having bilateral brain stimulation. When the levodopa dosage was decreased, the result was a decrease in "on" state drug induced dyskinesias (difficulty in performing voluntary movements).

Contract:

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.

Coding:

The coding for deep brain stimulation consists of a series of codes describing the various steps of the procedure;

  • Implantation of the electrodes
  • Implantation of the pulse generator
  • Intraoperative monitoring and programming of the electrodes
  • Postoperative neuroprogramming

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.


Medicare Coverage:

Effective for services furnished on or after April 1, 2003, Medicare will cover unilateral or bilateral thalamic ventralis intermedius nucleus (VIM) DEEP BRAIN STIMULATION (DBS) for the treatment of essential tremor (ET) and/or Parkinsonian tremor and unilateral or bilateral subthalamic nucleus (STN) or globus pallidus interna (GPi) DBS for the treatment of Parkinson's disease (PD) only under the following conditions:

  • Medicare will only consider DBS devices to be reasonable and necessary if they are Food and Drug Administration (FDA) approved devices for DBS or devices used in accordance with FDA approved protocols governing Category B Investigational Device Exemption (IDE) DBS clinical trials.
  • For thalamic VIM DBS to be considered reasonable and necessary, patients must meet all of the following criteria:
    1. Diagnosis of ET based on postural or kinetic tremors of hand(s) without other neurologic signs.
    2. Diagnosis of idiopathic PD (presence of at least 2 cardinal PD features (tremor, rigidity or bradykinesia)) which is of a tremor-dominant form.
    3. Marked disabling tremor of at least level 3 or 4 on the Fahn-Tolosa-Marin Clinical Tremor Rating Scale (or equivalent scale) in the extremity intended for treatment, causing significant limitation in daily activities despite optimal medical therapy.
    4. Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.
  • For subthalamic nucleus or globus pallidus interna DBS to be considered reasonable and necessary, patients must meet all of the following criteria:
    1. Diagnosis of PD based on the presence of at least 2 cardinal PD features (tremor, rigidity or bradykinesia).
    2. Advanced idiopathic PD as determined by the use of Hoehn and Yahr Stage or Unified Parkinson's Disease Rating Scale (UPDRS) part III motor subscale.
    3. L-dopa responsive with clearly defined "on" periods.
    4. Persistent disabling Parkinson's symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
    5. Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.

DBS is not reasonable and necessary and is not covered for ET or PD patients with any of the following:

  • Non-idiopathic Parkinson's disease or "Parkinson's Plus" syndromes.
  • Cognitive impairment, dementia or depression, which would be worsened by or would interfere with the patient's ability to benefit from DBS.
  • Current psychosis, alcohol abuse or other drug abuse.
  • Structural lesions such as basal ganglionic stroke, tumor or vascular malformation as etiology of the movement disorder.
  • Previous movement disorder surgery within the affected basal ganglion.
  • Significant medical, surgical, neurologic or orthopedic co-morbidities contraindicating DBS surgery or stimulation.

Patients who undergo DBS implantation should not be exposed to diathermy (deep heat treatment including shortwave diathermy, microwave diathermy and ultrasound diathermy) or any type of MRI, which may adversely affect the DBS system or adversely affect the brain around the implanted electrodes.

DBS should be performed with extreme caution in patients with cardiac pacemakers or other electronically controlled implants, which may adversely affect or be affected by the DBS system.

While electric nerve stimulation has been employed to control chronic intractable pain for some time, its use in the treatment of motor function disorders, such as multiple sclerosis, is a recent innovation, and the medical effectiveness of such therapy has not been verified by scientifically controlled studies.

Where electric nerve stimulation is employed to treat motor function disorders, no reimbursement may be made for the stimulator or for the services related to its implantation since this treatment cannot be considered reasonable and necessary.

The information contained in this section is for informational purposes only. HCSC makes no representation to its accuracy. This information is not to be used for claims adjudication for HCSC plans.

References:

Benebid, AL, Pollak, P, et. al.  Chronic electrical stimulation of the ventralis intermedius nucleus of the thalamus as a treatment of movement disorders. Journal of Neurosurgery (February 1996)84(2):203-14.

Deep Brain Stimulation of the Thalamus for Tremor.  Chicago, Illinois:  Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program. (1997 Dec) 12(20):1-29.

Gross. C, Rougier, A, et. al.  High-frequency stimulation of the globus pallidus internalis in Parkinson's disease: A study of seven cases.  Journal of Neurosurgery (1997)87:491-98.

Starr. PA. Vitek, JL, et. al. ablative surgery and deep brain stimulation for Parkinson's disease.  Neurosurgery (1998) 43:989-1015.

Tronnier, VM, Fogel, W, et. al.  Pallidal stimulation: An alternative to pallidotomy? Journal of Neurosurgery (1997)87:700-05.

Bejjani, B, Damier, P, et. al.  Pallidal stimulation for Parkinson's disease.  Two targets? Neurology (1997)49:1564-69.

Ghika, J, Villemure, JG, et. al.  Efficiency and safety of bilateral contemporaneous pallidal stimulation in levodopa responsive patients with Parkinson's disease with severe motor fluctuations:  A 2 year follow-up review.    Journal of Neurosurgery (1998) 89:713-18.

Krack, P, Nenazzouz, et. al.  Treatment of tremor in Parkinson's disease by subthalamic nucleus stimulation.    Movement Disorders (1998) 13:907-14.

Kumar, R, Lozano, AM, et. al.  Double-blind evaluation of subthalamic nucleus deep brain stimulation in advanced Parkinson's disease. Neurology (1998)51:850-55.

Limousin, P, Krack, P, et. al.  Electrical Stimulation of the subthalamic nucleus in advanced Parkinson's disease.  New England Journal of Medicine (Oct 1998) 339:1105-1111.

Taha, JM, Janszen, MA, et. al.  Thalamic deep brain stimulation for the treatment of head, voice and bilateral limb tremor.  Journal of Neurosurgery (1999) 91:68-72.

Ardouin, C, Pillon, B, et. al.  Bilateral subthalamic or pallidal stimulation for Parkinson's disease affects neither memory nor executive functions: a consecutive series of 62 patients.  Annals of Neurology (1999)46(2):217-23.

Kumar, R, Lozana, AM, et. al.  Comparative effects of unilateral and bilateral subthalamic nucleus deep brain stimulation.   Neurology (1999)43:561-66.

Moro, E, Scerrati, M, et. al. Chronic subthalamic nucleus stimulation reduces medication requirements in Parkinson's disease. Neurology (1999) 53:85-90.

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 Feb) 16(16): 1-72.

Deep Brain Stimulation.  Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Reference Manual (2003 Feb) Surgery 7.01.63.

FDA – Summary of Safety and Probably Benefit, Medtronic Activa Dystonia Therapy™.  Federal Drug Administration – Center for Devices and Radiologic Health (2003 Apr 15) http://www.fda.gov/cdrh/ode/H020007sum.html

Putzke, J.D., Wharen, Jr., et al.  Thalamic Deep Brain Stimulation for Essential Tremor: Recommendations for Long-Term Outcome Analysis.  The Canadiam Journal of Neurological Sciences (2004) 31: 333-342.

Ushe, M., Mink, J.W., et al.  Effect of stimulation frequency on tremor suppression in essential tremor.  Movement Disorders (2004 Oct) 19(10): 1163-8.

Policy History:

Archived Document(s):

Title:Effective Date:End Date:
Deep Brain Stimulation (DBS)08-15-201706-14-2018
Deep Brain Stimulation (DBS)12-01-201608-14-2017
Deep Brain Stimulation06-01-201511-30-2016
Deep Brain Stimulation for Tremor06-01-201105-31-2015
Deep Brain Stimulation for Tremor08-15-200905-31-2011
Deep Brain Stimulation for Tremor05-01-200808-14-2009
Deep Brain Stimulation for Tremor09-01-200704-30-2008
Deep Brain Stimulation for Tremor05-15-200508-31-2007
Deep Brain Stimulation for Tremor11-01-200005-14-2005
Back to Top