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Deep Brain and Motor Cortex Stimulation

Policy Number: MP-347

Latest Review Date: May 2022

Category:  Surgery                                                               

POLICY:

Effective for dates of service on or after October 8, 2019:

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.

Disabling, medically unresponsive tremor is defined as all of the following:

  • Tremor causing significant limitation in daily activities
  • Inadequate control by maximal dosage of medication for at least three months before implant

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:

  • Those with Parkinson’s disease with ALL of the following:
    • A good response to levodopa;

AND

  • A minimal 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 greater than seven (7) years with chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis).

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

Motor Cortex Stimulation

Motor cortex stimulation for any indication is considered investigational.

POLICY GUIDELINES:

Disabling, medically unresponsive tremor is defined as all of the following: tremor causing significant limitation in daily activities inadequate control by maximal dosage of medication for at least 3 months before implant.

Contraindications to deep brain stimulation include:

  • Patients who are not good surgical risks because of unstable medical problems or because of the presence of a cardiac pacemaker
  • Patients who have medical conditions that require repeated magnetic resonance imaging (MRI)
  • Patients who have dementia that may interfere with the ability to cooperate
  • Patients who have had botulinum toxin injections within the last 6 months

Effective for dates of service on or after November 13, 2014 and prior to October 8, 2019:

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.

Disabling, medically unresponsive tremor is defined as all of the following:

  • Tremor causing significant limitation in daily activities
  • Inadequate control by maximal dosage of medication for at least three months before implant

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:

  • Those with Parkinson’s disease with ALL of the following:
    • A good response to levodopa;

AND

  • A minimal 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 greater than seven (7) years with chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis).

Contraindications to deep brain stimulation include:

  • Patients who are not good surgical risks because of unstable medical problems or because of the presence of a cardiac pacemaker
  • Patients who have medical conditions that require repeated magnetic resonance imaging (MRI)
  • Patients who have dementia that may interfere with the ability to cooperate
  • Patients who have had botulinum toxin injections within the last 6 months

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

Deep brain stimulation for the treatment of chronic cluster headaches is considered not medically necessary and 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 not medically necessary and investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Deep brain stimulation (DBS) involves the stereotactic placement of an electrode into the brain (i.e., hypothalamus, thalamus, globus pallidus, or subthalamic nucleus). DBS is used as an alternative to permanent neuroablative procedures for control of essential tremor (ET) and Parkinson's disease (PD). DBS is also being evaluated for the treatment of a variety of other neurologic and psychiatric disorders.

Deep Brain Stimulation

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 two 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.

Motor Cortex Stimulation

Motor cortex stimulation (MCS), also referred to as cerebral cortex stimulation or extradural motor cortex stimulation (EMCS), is primarily utilized for the treatment of refractory neuropathic pain and involves implantation of epidural electrodes into the cerebral cortex.

A temporary placement of a MCS device is completed to determine if the device will relieve pain consistently over the course of 3–14 days and produce a reduction in pain by at least 50%. If the patient reports such relief, a permanent placement occurs connecting the electrodes and implanting the programmable device just underneath the skin proximate to the collarbone.

KEY POINTS:

This policy was updated with a literature review of the PubMed database through March 3, 2022.

Summary of Evidence

For individuals who have essential tremor or tremor in Parkinson disease who receive deep brain stimulation of the thalamus, the evidence includes a systematic review and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The systematic review (a TEC Assessment) concluded that there was sufficient evidence that deep brain stimulation of the thalamus results in clinically significant tremor suppression and that outcomes after deep brain stimulation were at least as good as thalamotomy. Subsequent studies reporting long-term follow-up have supported the conclusions of the TEC Assessment and found that tremors were effectively controlled 5 to 6 years after deep brain stimulation. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have symptoms (eg, speech, motor fluctuations) associated with Parkinson disease (advanced or >4 years in duration with early motor symptoms) who receive deep brain stimulation of the globus pallidus interna or subthalamic nucleus, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. One of the systematic reviews (a TEC Assessment) concluded that studies evaluating deep brain stimulation of the globus pallidus interna or subthalamic nucleus have consistently demonstrated clinically significant improvements in outcomes (eg, neurologic function). Other systematic reviews have also found significantly better outcomes after deep brain stimulation than after a control intervention. An RCT in patients with levodopa-responsive Parkinson disease of at least 4 years in duration and uncontrolled motor symptoms found that quality of life at 2 years was significantly higher when deep brain stimulation was provided in addition to medical therapy. Meta-analyses of RCTs comparing deep brain stimulation of the globus pallidus interna with deep brain stimulation of the subthalamic nucleus have reported mixed findings and have not shown that one type of stimulation is superior to the other. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have primary dystonia who receive deep brain stimulation of the globus pallidus interna or subthalamic nucleus, the evidence includes systematic reviews, RCTs, and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. A pooled analysis of 24 studies, mainly uncontrolled, found improvements in motor scores and disability scores after 6 months and at last follow-up (mean, 32 months). Both double-blind RCTs found that severity scores improved more after active than after sham stimulation. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have tardive dyskinesia or tardive dystonia who receive deep brain stimulation, the evidence includes an RCT and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Few studies were identified and they had small sample sizes (range, 9-19 patients). The RCT did not report statistically significant improvement in the dystonia severity outcomes or the secondary outcomes related to disability and quality of life, but these may have been underpowered. Additional studies, especially RCTs or other controlled studies, are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have epilepsy who receive deep brain stimulation, the evidence includes systematic reviews, RCTs and many observational studies. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Two RCTs with more than 15 patients were identified. The larger RCT evaluated anterior thalamic nucleus deep brain stimulation and reported that deep brain stimulation had a positive impact on seizure frequency during some parts of the blinded trial phase, but not others, and a substantial number of adverse events (in >30% of patients). There were no differences between groups in 50% responder rates, Liverpool Seizure Severity Scale, or Quality of Life in Epilepsy scores. A 7-year open-label follow-up of the RCT included 66% of implanted patients; reasons for missing data were primarily related to adverse events or dissatisfaction with the device. Reduction in seizure frequency continued to improve during follow-up among the patients who continued follow-up. The smaller RCT (n=16) showed a benefit with deep brain stimulation. Many small observational studies reported fewer seizures compared with baseline, however, without control groups, interpretation of these results is limited. Additional trials are required to determine the impact of deep brain stimulation on patient outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have Tourette syndrome who receive deep brain stimulation, the evidence includes observational studies, RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Two RCTs with 15 or more patients have been reported. One RCT found differences in severity of Tourette syndrome for active versus sham at 3 months while the other RCT did not. Neither study demonstrated improvements in comorbid symptoms of obsessive-compulsive disorder or depression. Both studies reported high rates of serious adverse events. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have cluster headaches or facial pain who receive deep brain stimulation, the evidence includes a randomized crossover study and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. In the RCT, the between-group difference in response rates did not differ significantly between active and sham stimulation phases. Additional RCTs or controlled studies are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have treatment resistant depression who receive deep brain stimulation, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. A number of case series and several prospective controlled trials evaluating deep brain stimulation have been published. Two RCTs of deep brain stimulation in the subgenual cingulate cortex and ventral striatum/ventral capsule were terminated for futility. Another RCT of stimulation of the same brain area (ventral striatum/ventral capsule) did not find a statistically significant difference between groups in the primary outcome (clinical response), and adverse psychiatric events occurred more frequently in the treatment group than in the control group. More recently, a controlled crossover trial randomized patients to sham or active stimulation of the anterior limb of the internal capsule after a year of open-label stimulation. There was a greater reduction in symptom scores after active stimulation, but only in patients who were responders in the open-label phase. Stimulation of the subcallosal (subgenual) cingulate was evaluated in a 2019 sham-controlled within-subject study that found prolonged response in 50% of patients and remission in 30% of patients with treatment resistant depression. Deep brain stimulation for patients with major depressive disorder who have failed all other treatment options is an active area of research, but the brain regions that might prove to be effective for treatment resistant depression have yet to be established. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have obsessive-compulsive disorder who receive deep brain stimulation, the evidence includes RCTs and meta-analyses. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Among the RCTs on deep brain stimulation for obsessive-compulsive disorder, only one has reported an outcome of clinical interest (therapeutic response rate), and that trial did not find a statistically significant benefit for deep brain stimulation compared with sham treatment. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have multiple sclerosis who receive deep brain stimulation, the evidence includes an RCT. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. One RCT with 10 multiple sclerosis patients is insufficient evidence on which to draw conclusions about the efficacy of deep brain stimulation in this population. Additional trials are required. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have anorexia nervosa, alcohol addiction, Alzheimer disease, Huntington disease, or chronic pain who receive deep brain stimulation, the evidence includes case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. RCTs are needed to evaluate the efficacy of deep brain stimulation for these conditions. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

European Academy of Neurology

The European Academy of Neurology (2016) published guidelines on neuromodulation in management of chronic pain. Due to “very low” quality of evidence, the Academy could not recommend deep brain stimulation (DBS) for treatment of neuropathic pain.

American Academy of Neurology

Essential Tremor

In 2011, the American Academy of Neurology (AAN) updated its guidelines on the treatment of essential tremor, which were reaffirmed in 2017. This update did not change the conclusions and recommendations of the AAN (2005) practice parameters on deep brain stimulation for essential tumor. The guidelines stated that bilateral deep brain stimulation of the thalamic nucleus might be used to treat medically refractory limb tremor in both upper limbs (level C, possibly effective) but that there were insufficient data on the risk/benefit ratio of bilateral versus unilateral deep brain stimulation in the treatment of limb tremor. There was insufficient evidence to make recommendations on the use of thalamic deep brain stimulation for head or voice tremor (level U, treatment is unproven). This guideline is being updated.

Parkinson Disease

In 2018, the AAN affirmed the guideline developed by the Congress of Neurological Surgeons (see Table 1).

Tardive Syndromes

Guidelines from AAN on the treatment of tardive syndromes were reaffirmed in 2019. The latest guidelines state, “Pallidal deep brain stimulation possibly improves tardive dyskinesia and might be considered as a treatment for intractable tardive dyskinesia (Level C, which indicates that the treatment is possibly effective, based on ≥1 class II study and consistent with ≥2 class III studies).

Tourette Syndrome

Guidelines from AAN (2019) provide recommendations on the assessment for and use of deep brain stimulation in adults with severe, treatment-refractory tics. The AAN notes that patients with severe Tourette syndrome resistant to medical and behavioral therapy may benefit from deep brain stimulation, but there is no consensus on the optimal brain target. Brain regions that have been stimulated in patients with Tourette syndrome include the centromedian thalamus, the globus pallidus internus (ventral and dorsal), the globus pallidus externus, the subthalamic nucleus, and the ventral striatum/ventral capsular nucleus accumbens region. The AAN concludes that deep brain stimulation of the anteromedial globus pallidus is possibly more likely than sham stimulation to reduce tic severity.

American Society for Stereotactic and Functional Neurosurgery et al

In 2021, the American Society for Stereotactic and Functional Neurosurgery and the Congress of Neurological Surgeons) updated their 2014 guidelines on deep brain stimulation for obsessive-compulsive disorder. The document concluded that there was a single level I study supporting the use of bilateral subthalamic nucleus deep brain stimulation for medically refractory obsessive-compulsive disorder and a single level II study supporting bilateral nucleus accumbens or bed nucleus of stria terminalis deep brain stimulation for medically refractory obsessive-compulsive disorder. It also concluded that the evidence on unilateral deep brain stimulation was insufficient.

Congress of Neurologic Surgeons

In 2018, evidence-based guidelines from the Congress of Neurologic Surgeons, affirmed by the AAN, compared the efficacy of bi-lateral deep brain stimulation of the subthalamic nucleus and globus pallidus internus for the treatment of patients with Parkinson disease.

Table 1. Recommendations of the Congress of Neurologic Surgeons for DBS for Parkinson Disease

Goal

Most Effective Area of Stimulation (subthalamic nucleus or globus pallidus internus)

Level of Evidence

Improving motor symptoms

subthalamic nucleus or globus pallidus internus are similarly effective

I

Reduction of dopaminergic medication

subthalamic nucleus

I

Treatment of "on" medication dyskinesias

globus pallidus internus if reduction of medication is not anticipated

I

Quality of life

no evidence to recommend one over the other

I

Lessen impact of DBS on cognitive decline

globus pallidus internus

I

Reduce risk of depression

globus pallidus internus

I

Reduce adverse effects

insufficient evidence to recommend one over the other

Insufficient

DBS: Deep brain stimulation

National Institute for Clinical Excellence

The U.K.’s National Institute for Health and Care Excellence (NICE; previously the National Institute for Clinical Excellence) has published Interventional Procedure Guidance documents on DBS.

Tremor and Dystonia

In 2006, NICE made the same statement for use of DBS for treatment of tremor and dystonia. Unilateral and bilateral stimulation of structures responsible for modifying movements, such as the thalamus, the globus pallidus and the subthalamic nucleus, which interact functionally with the substantia Negra, are included in both guidance statements. The guidance stated: “Current evidence on the safety and efficacy of deep brain stimulation for tremor and dystonia (excluding Parkinson's disease) appears adequate to support the use of this procedure.”

Refractory Chronic Pain Syndromes (excluding headache)

The 2011 guidance states that there is evidence that DBS is efficacious in some patients who are refractory to other forms of pain control and that this procedure may be used provided that normal arrangements are in place for clinical governance, consent, and audit. Patients should be informed that DBS may not control their chronic pain symptoms and that possible risks associated with this procedure include the small risk of death.

Intractable Trigeminal Autonomic Cephalgias

The 2011 guidance states that current evidence on the efficacy of DBS for intractable trigeminal autonomic cephalalgias (e.g., cluster headaches) is limited and inconsistent, and the evidence on safety shows that there are serious but well-known side effects.

Refractory Epilepsy

In 2020, guidance from NICE indicated that the evidence on the efficacy and safety of deep brain stimulation for refractory epilepsy (for anterior thalamic targets) was limited in both quantity and quality, and "this procedure should only be used with special arrangements for clinical governance, consent, and audit or research". For targets other than the anterior thalamus, NICE recommends, "this procedure should only be used in the context of research".

Parkinson Disease

In 2003, NICE stated that current evidence on the safety and efficacy of DBS for treatment of PD appears adequate to support the use of the procedure. The guidance noted that DBS should only be offered when Parkinson disease is refractory to best medical treatment.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Activa Tremor Control System, deep brain stimulation, dystonia, essential tremor, Parkinson’s disease, Reclaim™ DBS therapy, obsessive compulsive disorder (OCD), Vercise ™, chronic cluster headaches, Brio Neurostimulation System, Infinity DBS device, epilepsy, Motor Cortex Stimulation, MCS, cerebral cortex stimulation, CCS, extradural motor cortex stimulation (EMCS), Percept PC DBS System, Vercise Genus DBS System, Medtronic DBS System

APPROVED BY GOVERNING BODIES:

In 1997, the U.S. Food and Drug Administration (FDA) cleared the Activa® Tremor Control System (Medtronic) for marketing for deep brain stimulation. The Activa® Tremor Control System consists of an implantable neurostimulator, a 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 stimulation, and a patient control magnet, which allows the patient to turn the neurostimulator on and off, or change between high and low settings.

The original FDA-labeled indications for Activa® were limited to unilateral implantation of the device for the treatment of tremor, but, in 2002, FDA-labeled indications were expanded to include bilateral implantation as a treatment to decrease the symptoms of advanced Parkinson disease not controlled by medication. In 2003, the labeled indications were further 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 was cleared for marketing by FDA through the humanitarian device exemption (HDE) process. In 2017, the indications for Parkinson disease were modified to include “adjunctive therapy in reducing some of the symptoms in individuals with levodopa-responsive Parkinson’s Disease of at least 4 years’ duration that are not adequately controlled with medication.”

In 2009, the Reclaim® device (Medtronic), a deep brain stimulator, was cleared for marketing by the FDA through the HDE process for the treatment of severe obsessive-compulsive disorder.

In 2014, the FDA for the treatment of Parkinsonian tremor cleared the Brio Neurostimulation System (now called Infinity; St. Jude Medical Neuromodulation) for marketing.

In 2016, the FDA approved the St. Jude Medical’s Infinity DBS device with directional leads. The directional leads enable the clinician to “steer” current to different parts of the brain. This tailored treatment reduces side effects. The Infinity system can be linked to Apple’s iPod Touch and iPad Mini.

In 2017, the FDA approved a second system with directional leads, the Vercise Deep Brain Stimulation System (Boston Scientific). This system is to be used as an adjunctive therapy from reducing motor symptoms of moderate-to-advanced levodopa-responsive PD inadequately controlled with medication alone.

In 2018, the FDA approved the Medtronic DBS System for Epilepsy (Medtronic, Inc) through the Premarket Approval process. The pivotal study was the SANTÉ (Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy) study. The intended use is bilateral stimulation of the anterior nucleus of the thalamus as an adjunctive therapy for reducing the frequency of seizures in individuals 18 years of age or older diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to three or more antiepileptic medications.

The Percept™ PC neurostimulator is the next generation of the Activa PC. The Percept PC features BrainSense™ technology to record brain signals using the implanted DBS lead. The signals can be recorded while it delivers therapeutic stimulation. The information recorded is used to guide treatment. The Percept PC is full body 3T and 1.5T MRI eligible. Battery life is >5 years (Medtronic, 2020).

In 2021, The Vercise Genus DBS System was approved for conditional use in a magnetic resonance imaging (MRI) environment. It features Bluetooth-enabled, rechargeable and non-rechargeable implantable pulse generators with the capacity of powering Cartesia directional leads to offer symptom relief for those diagnosed with Parkinson’s disease. Vercise Genus is indicated for use in the bilateral stimulation of the subthalamic nucleus as an adjunctive therapy for reducing symptoms of moderate-to-advanced levodopa-responsive Parkinson’s. In addition, the system has indications for use in the bilateral stimulation of the internal globus pallidus.

There are currently no devices approved by the FDA for motor cortex stimulation.

Table 2. Deep Brain Stimulation Systems

System

Manufacturer

Features

PMA or HDE

Approval Date

Indications

Activa® Deep Brain

Stimulation Therapy System

Medtronic

 

P96009

1997

Unilateral or bilateral stimulation of the internal globus

Reclaim® DBS Therapy for Obsessive Compulsive Disorder

Medtronic

Approved for OCD

H050003

2009

Bilateral stimulation of the anterior limb of the internal capsule for severe obsessive-compulsive disorder

Brio Neurostimulation System

St. Jude Medical

 

P140009

2015

Parkinsonian tremor (subthalamic nucleus) and essential tremor (thalamus)

Infinity DBS

St. Jude Medical

Directional leads that "steer" current, reducing side effects.

P140009

2016

Parkinsonian tremor

Vercise DBS System

Boston Scientific

Directional leads

P150031

2017

Moderate-to-advanced levodopa-responsive PD inadequately controlled with medication alone

Medtronic DBS System for Epilepsy

 

Medtronic

 

MBX

 

P960009-S219

 

2018

 

Expanded indication for epilepsy with bilateral stimulation of the anterior nucleus of the thalamus

 

Percept PC Deep Brain Stimulation

 

Medtronic

 

MHY

 

P960009-S

 

2020

Records brain signals while delivering therapy for PD or primary dystonia

 

Vercise Genus DBS System

 

Boston Scientific

 

NHL

 

P150031-S034

 

2021

Stimulation of the subthalamic nucleus and globus pallidus for PD

 

Sen Sight Directional Lead System

 

Medtronic

 

MHY

 

P960009

 

2021

 

Unilateral or bilateral stimulation for PD, tremor, dystonia, and epilepsy

 

DBS: deep brain stimulation; HDE: humanitarian device exemption; OCD: obsessive-compulsive disorder; PD: Parkinson disease; PMA: premarket approval

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

CPT Codes:

Implantation of Electrodes:

61850

Twist drill or burr hole for implantation of neurostimulator electrodes, cortical

*61863

Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (e.g., thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), without use of intraoperative microelectrode recording; first array

*61864

; as above, but with each additional array

*61867

Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (e.g., thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), with use of intraoperative microelectrode recording; first array

*61868

; as above, but with each additional array.

*The above four codes recognize the option of the implantation of electrodes using microelectrode recording or not.  In addition, if the patient is undergoing bilateral implantation of electrodes, one of the “each additional array” codes may be used. In some instances, patients undergo bilateral implantation in a staged procedure.

Implantation of Pulse Generator:

61885

Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array; OR

 

61886

; as above, but with connection to two or more electrode arrays

 

Electronic Analysis:

95970

Electronic analysis of implanted neurostimulator pulse generator system (e.g. rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, 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 programming

 

 

95983

Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain neurostimulator pulse generator/transmitter programming, first 15 minutes face-to-face time with physician or other qualified health care professional (Effective 01/01/2019)

95984

Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain neurostimulator pulse generator/transmitter programming, each additional 15 minutes face-to-face time with physician or other qualified health care professional (List separately in addition to code for primary procedure) (Effective 01/01/2019)

Neurostimulator analysis and programming is classified as either simple (95970) or complex (95983-84).  CPT codes 95983 and 95984 are time based. Simple neurostimulators are defined as those affecting three or fewer neurostimulatory parameters (e.g., pulse amplitude, duration, and frequency, number of electrode contacts) while a complex device affects more than three parameters.  In the setting of deep brain stimulation for tremor control, it is anticipated that the neuro-programming and analysis would be classified as simple.  However, deep brain stimulation of the globus pallidus and subthalamic nucleus stimulation requires intraoperative monitoring of more than one clinical feature, (i.e., rigidity, dyskinesia, and tremor) and the neuro-programming would probably be classified as complex.

Over time, patients may undergo several sessions of electronic analysis and programming to find the optimal programming parameters. CPT codes 95970, 95983, and 95984, described here, may be used.

HCPCS:             

L8680

Implantable neurostimulator electrode, each

L8685

Implantable neurostimulator pulse generator, single array, rechargeable, includes extension

L8686

Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension

L8687

Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension

L8688

Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension

                      

PREVIOUS CODING:   

95978

Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude and duration, battery status, electrode selectability and polarity, impedance, and patient compliance measurements), complex deep brain neurostimulator pulse generator/transmitter, with initial or subsequent programming; first hour (Deleted 12/31/18)

95979

; each additional 30 minutes after first hour (Deleted 12/31/18)

REFERENCES:

  1. Ackermans L, Duits A, van der Linden C et al. Double-blind clinical trial of thalamic stimulation in patients with Tourette syndrome. Brain 2011; 134(Pt 3):832-44.
  2. Alonso P, Cuadras D, Gabriels L, et al. Deep Brain Stimulation for Obsessive-Compulsive Disorder: A Meta-Analysis of Treatment Outcome and Predictors of Response. PLoS One. 2015; 10(7):e0133591.
  3. American Psychiatric Association. 2007 guideline on Treatment of Patients with Obsessive-Compulsive Disorder. 2007; www.psychiatryonline.com/pracGuide/pracGuideTopic_10.aspx.
  4. Appleby BS, Duggan PS, Regenberg A et al. Psychiatric and neuropsychiatric adverse events associated with deep brain stimulation: A meta-analysis of ten years' experience. Mov Disord 2007; 22(12):1722-1728.
  5. Baldermann JC, Schuller T, Huys D, et al. Deep brain stimulation for Tourette-syndrome: a systematic review and meta-analysis. Brain Stimul. Mar-Apr 2016; 9(2):296-304.
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POLICY HISTORY:

Medical Policy Group, January 2009 (3)

Medical Policy Administration Committee, February 2009

Available for comment February 6-March 23, 2009

Medical Policy Group, June 2011; Updated Description, Key Points, and References

Medical Policy Group, December 2011: 2012 Code Updates – verbiage update to 95970

Medical Policy Group, June 2012 (3): 2012 Updates – Key Points & References

Medical Policy Panel, June 2013

Medical Policy Group, June 2013 (3): 2013 Updates to Policy statement – anorexia nervosa, alcohol addiction, and chronic pain added to list of disorders (not an all-inclusive list) considered not to meet criteria for coverage), Key Points & References

Medical Policy Group, October 2013 (3): Removed ICD-9 Procedure codes; no change in policy statement.

Medical Policy Group, May 2014 (5): 2014 Coding Update:  Deleted code L8680 effective July 1, 2014.

Medical Policy Group, June 2014 (5): Quarterly 2014 Coding Update:  Code L8680 did not delete added back to policy under current codes.

Medical Policy Panel, November 2014

Medical Policy Group, November 2014 (3): Updates to Key Points, Key Words and References. Policy statement updated to include bilateral deep brain stimulation of thalamus as meeting criteria for disabling, medically unresponsive tremor in both limbs due to essential tremor or Parkinson disease.

Medical Policy Administration Committee, December 2014

Available for comment December 16 through January 29, 2015\

Medical Policy Panel, April 2016

Medical Policy Group, April 2016 (6): Updates to Key Points and References; clarification made to Policy statement – no change in policy intent.

Medical Policy Panel, April 2017

Medical Policy Group, May 2017 (6): Updates to Key Points, Governing Bodies and References.

Medical Policy Panel, April 2018

Medical Policy Group, May 2018 (6): Updates to Key Points, Governing Bodies and References.

Medical Policy Group, June 2018:  Removed effective for dates of service prior to November 13, 2014 policy statements from policy section.

Medical Policy Group, December 2018:  2019 Annual Coding Update.  Added CPT codes 95983 and 95984 to the Current coding section. Moved CPT codes from Current coding section to previous coding. Created previous coding section to include codes 95978 and 95979.

Medical Policy Panel, April 2019

Medical Policy Group, June 2019 (3): 2019 Updates to Description, Key Points, Practice Guidelines and Position Statements, References, and Key Words: added: Brio Neurostimulation System, Infinity DBS device, and epilepsy. No changes to policy statement or intent.

Medical policy Group, October 2019 (3): 2019 Updates to Description, Key Points, Approved by Governing Bodies, References, and Key Words: added: Motor Cortex Stimulation, MCS, Cerebral Cortex Stimulation, CCS, Extradural Motor Cortex Stimulation (EMCS).

Policy statement added: Motor Cortex Stimulation is considered not medically necessary and investigational. No other changes to medical policy statement or intent. Title changed to Deep Brain and Motor Cortex Stimulation.

Medical Policy Panel, April 2020

Medical Policy Group, May 2020 (3): 2020 Updates to Key Points, Practice Guidelines and Position Statements, and References. Added Policy Guidelines Section. No changes to policy statements or intent.

Medical Policy Panel, April 2021

Medical Policy Group, May 2021 (3): 2021 Updates to Key Points, Practice Guidelines and Position Statements, Approved By Governing Bodies, References and Key Words: added: Percept PC DBS System, Vercise Genus DBS System, and Medtronic DBS System. Moved the diagnosis of multiple sclerosis from movement disorders in policy statement to neurological disorders. This did not change the investigational stance for the use of deep brain stimulation for the diagnosis of multiple sclerosis. Policy statement updated to remove “not medically necessary,” no other changes to policy statement or intent.

Medical Policy Panel, April 2022

Medical Policy group, May 2022 (3): 2022 Updates to Key Points, Practice Guidelines and Position Statements, Approved By Governing Bodies, and References. No changes to policy statement or intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.