Archived Policies - Surgery


Deep Brain Stimulation for Tremor

Number:SUR712.025

Effective Date:11-01-2000

End Date:05-14-2005

Coverage:

Unilateral or bilateral deep brain stimulation of the thalamus, subthalamic nucleus or globus pallidus may be eligible for coverage in patients with disabling, medically unresponsive tremor due to essential tremor or Parkinson's disease.

Disabling, medically unresponsive tremor is defined by the following:

1.      tremor causes significant limitation in daily activities,

2.      there has been inadequate control by maximal dosage of medication for at least 3 months before implant.

Deep brain stimulation for other movement disorders, including but not limited to multiple sclerosis and posttraumatic dyskinesia, is considered investigational.

Description:

Deep Brain Stimulation involves the stereotactic placement of an electrode(s) into the brain (i.e., thalamus, globus pallidus, or subthalamic nucleus).  The electrode(s) 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.

After implantation, noninvasive programming of the neurostimulator can be adjusted to the patient's symptoms.  This feature may be important for patients with Parkinson's disease (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.

Contraindications to deep brain stimulation include patients who:

1.      are not good surgical risks because of unstable medical problems or because of the presence of a cardiac pacemaker

2.      have a medical condition that requires repeated magnetic resonance imaging (MRI)

3.      have dementia that may interfere with the ability to cooperate

4.      have had botulinum toxin injections within the last 6 months

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.  The System consists of the following components:

1.      the implantable pulse generator

2.      the deep brain stimulator lead

3.      an extension that connects the lead to the power source,

4.      a console programmer

5.      a software cartridge to set electrical parameters for stimulation

6.      a patient control magnet, which allows the patient to turn the pulse generator on and off or change between high and low settings

On March 31, 2000, the Neurological Devices Advisory Panel voted unanimously to recommend that the FDA grant Premarket Approval for the Soletra Model 7426 for patients with advanced Parkinson's disease. This device will be used in conjunction with the existing Medtronic Activa Tremor Control System. Final FDA approval is pending.

Rationale:

The policy regarding unilateral deep brain stimulation (DBS) as a treatment for tremor is based on a 1997 TEC 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 8 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:

Implantation of Electrodes:  CPT code 61868:  If a patient is undergoing a bilateral electrode arrays, this code may be used twice.

Implantation of Pulse Generator:  61885, 61886. 

Electronic Analysis:  Over time, patients may undergo several session of electronic analysis and programming to find the optimal programming parameters.


Medicare Coverage:

None

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.

BCBSA Technology Assessment Program, Deep Brain Stimulation of the Thalamus for Tremor, TEC Assessment (December 1997) 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.

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
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