Humana Deep Brain Stimulation and Cortical Brain Stimulation Form


Effective Date

01/01/2024

Last Reviewed

NA

Original Document

  Reference



Description

Deep brain stimulation (DBS) involves the surgical placement of electrodes, also called leads, in selected areas of the brain to treat neurological disorders. The electrodes are placed using magnetic resonance imaging (MRI) or computed tomography (CT) to guide the neurosurgeon to the site to be stimulated.

Fiducial markers are small titanium screws, which may be placed into the anesthetized scalp prior to DBS, to assist physicians with stereotactic or computerized targeting for the exact DBS lead location during surgery. After placement, a CT scan is performed to verify accuracy. The fiducial markers remain in place until after DBS leads are inserted.

During DBS lead placement, the individual may be asked to move their fingers or toes or answer questions. This stimulation test helps the surgeon confirm accurate placement and effectiveness of the permanent electrodes in the brain.

These are later connected to a neurostimulator (also referred to as a neurotransmitter or pulse generator) that is implanted under the skin, usually near the collarbone. The battery operated neurostimulator sends high frequency electrical signals to the electrodes which inhibit the activity in that region of the brain. The DBS is programmed with the intensity, frequency and duration according to the individual’s symptoms and can be readjusted as symptoms change.

Directional deep brain stimulation enables the current to be steered precisely to the targeted structural area avoiding areas of stimulation that could cause side effects.

Examples of US Food & Drug Administration (FDA) approved DBS devices include, but may not be limited to:

  • Activa RC neurostimulator for essential tremor (ET) and Parkinson’s disease
  • Activa SC neurostimulator for chronic, intractable primary dystonia including generalized and/or segmental dystonia, hemidystonia and cervical dystonia (torticollis)
  • Infinity DBS system for ET and Parkinson’s disease
  • Reclaim DBS for obsessive compulsive disorder (OCD)
  • SenSight directional lead system (SenSight lead, Percept PC stimulator) for dystonia, epilepsy, ET and Parkinson’s disease
  • Vercise directional system (Cartesia lead, and DBS, Genus, Gevia or PC stimulators) for ET and Parkinson’s disease

Stimulation of the anterior nucleus of the thalamus reduces the frequency of seizures in adults with drug resistant or medically refractory epilepsy providing neuromodulation therapy to change how brain cells work by delivering electrical stimulation to the areas involved in seizures. This stimulation is performed bilaterally. An example of an FDA-approved DBS device for the treatment of drug- resistant epilepsy is the Medtronic DBS System for Epilepsy.

Deep Brain Stimulation and Cortical Stimulation

Effective Date: 01/01/2024
Revision Date: 01/01/2024
Review Date: 07/27/2023
Policy Number: HUM-0472-025

Cortical Stimulation

Cortical stimulation is a treatment option for individuals with refractory focal epilepsy and a well delineated seizure focus which may be useful when resective epilepsy surgery is not possible.

Cortical stimulation devices use a closed-loop cortical stimulation unit paired to a seizure detection system. An example of an FDA-approved cortical stimulation system is the NeuroPace RNS System which is used as an adjunct to medication in adults with partial onset seizures from no more than two foci that are refractory to two or more antiepileptic medications. The device is implanted in the skull while the individual is under general anesthesia.

The implantable components include a neurostimulator, a depth lead and a cortical strip lead. The external components include the programmer, a laptop computer with proprietary software that has a wand and telemetry interface enabling communication with an implanted RNS neurostimulator. Physicians use the programmer to noninvasively program the detection and stimulation parameters of an implanted device and are able to view the individual's brain electrical activity in real time as well as upload information that has been stored in the RNS neurostimulator.

The system monitors brain activity to detect seizures as they start and delivers electrical stimulation to the seizure focus to stop seizure activity before it becomes clinically apparent. The typical individual is treated with a cumulative total of 5 minutes of stimulation a day and the treatment is reversible.

Magnetic resonance guided focused ultrasound (MRgFUS, [eg, ExAblate Neuro]), is a treatment option that purportedly treats medication refractory ET or movement disorder and tremor dominant Parkinson’s disease. MRgFUS therapy, also called transcranial MR-guided high-intensity focused ultrasound (MRgHIFU), uses a stereotactic head frame/helmet like device with a cooling cap and an individual ultrasound transducer to thermally ablate the thalamus in the ventral intermediate nucleus creating an intracranial therapeutic lesion. The MR images assist in treatment positioning providing real time feedback. The created lesion disrupts the brain activity thought to be responsible for an ET. This procedure is performed unilaterally and is less invasive than DBS implantation or a traditional thalamotomy that involves drilling or boring a hole into the skull to create a therapeutic lesion.

For information regarding laser interstitial thermal therapy and epilepsy, please refer to Laser Interstitial Thermal Therapy Medical Coverage Policy.

Deep Brain Stimulation and Cortical Stimulation Effective Date: 01/01/2024
Revision Date: 01/01/2024
Review Date: 07/27/2023
Policy Number: HUM-0472-025
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Coverage Determination

Services provided by a psychiatrist, psychologist or other behavioral health professionals are subject to the provisions of the applicable behavioral health benefit.

DBS for Parkinson’s Disease

Humana members may be eligible under the Plan for unilateral or bilateral DBS when ALL of the following criteria are met:

  • Disabling, medically intractable Parkinson’s disease; AND
  • Individual is able to properly operate the neurostimulator; AND
  • Motor response complications not controlled by pharmacologic therapy; AND
  • Symptoms of movement disorder, which cause significant limitations in daily activities; AND
  • The device is FDA approved

Humana members may be eligible under the Plan for bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) when the following criteria are met:

  • Levodopa responsive Parkinson’s disease of at least 4 years duration; AND
  • Motor response complications not controlled by pharmacologic therapy; AND
  • The device is FDA approved

DBS for ET

Humana members may be eligible under the Plan for unilateral or bilateral DBS when ALL of the following criteria are met:

  • Disabling, medically intractable ET; AND
  • Individual is able to properly operate the neurostimulator; AND
  • Individual is not pregnant; AND
  • Motor response complications not controlled by pharmacologic therapy; AND
  • No presence of coagulopathies, dementia, moderate to severe depression or previous ablative brain surgery; AND
  • Symptoms of movement disorder, which cause limitations in daily activities; AND
  • The device is FDA approved

DBS for Dystonia

Humana members may be eligible under the Plan for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) when the following criteria are met:

  • 7 years of age or older; AND
  • Individual is able to properly operate the neurostimulator; AND
  • Individual is not pregnant; AND
  • No presence of coagulopathies, dementia, moderate to severe depression or previous ablative brain surgery; AND
  • The device is FDA approved

AND any of the following:

  • Chronic primary dystonia, including generalized and or segmental dystonia, hemidystonia and cervical dystonia (torticollis) with motor response complications not controlled by pharmacologic therapy; OR
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  • Secondary tardive dyskinesia/dystonia from chronic levodopa treatment for Parkinson’s disease or chronic antidopaminergic treatment for psychiatric disease with motor response complications not controlled by pharmacologic therapy

DBS for Epilepsy

Humana members may be eligible under the Plan for bilateral stimulation of the anterior nucleus of the thalamus (eg, Medtronic DBS system) when the following criteria are met:

  • 18 years of age or older; AND
  • Average of 6 or more seizures per month over the 3 most recent months prior to implant of the DBS system with no more than 30 days between seizures; AND
  • Individual is able to or has the necessary assistance to properly operate the device; AND
  • Individual is not pregnant or nursing; AND
  • No presence of coagulopathies; AND
  • Partial onset seizures with or without secondary generalization; AND
  • Seizures refractory to 3 or more antiepileptic medications; AND
  • The device is FDA approved

Humana members may be eligible under the Plan for the replacement/revision of a DBS generator/battery and/or lead/electrode and/or programmer if the original generator/lead/programmer is no longer under warranty and cannot be repaired.

Note: The criteria for DBS are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Deep Brain Stimulation and Cortical Stimulation Effective Date: 01/01/2024
Revision Date: 01/01/2024
Review Date: 07/27/2023
Policy Number: HUM-0472-025
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Cortical Stimulation

Humana members may be eligible under the Plan for cortical stimulation (eg, NeuroPace RNS) when ALL of the following criteria are met:

  • 18 years of age or older; AND
  • Partial-onset seizures; AND
  • Currently averaging 3 or more disabling seizures (eg, partial motor seizures, complex partial seizures and/or secondarily generalized seizures) a month over the 3 most recent months; AND
  • Individual is able to or has the necessary assistance to properly operate the device or magnet; AND
  • Individual is not pregnant; AND
  • No more than 2 epileptogenic foci localized by diagnostic testing; AND
  • Refractory to 2 or more antiepileptic medications; AND
  • No other implanted medical devices that deliver electrical energy to the brain; AND
  • Not currently a candidate for resective epilepsy surgery; AND
  • Not high risk for surgical complications such as active systemic infection, coagulation disorders (such as the use of antithrombotic therapies) or platelet count below 50,000; AND
  • The device is FDA approved

Humana members may be eligible under the Plan for the replacement/revision of a cortical stimulator/battery and/or leads and/or programmer if the original stimulator/lead/programmer is no longer under warranty and cannot be repaired.

Deep Brain Stimulation and Cortical Stimulation Effective Date: 01/01/2024
Revision Date: 01/01/2024
Review Date: 07/27/2023
Policy Number: HUM-0472-025
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MRgFUS/MRgHIFU for ET

Humana members may be eligible under the Plan for MRgFUS/MRgHIFU (ExAblate Neuro) when ALL of the following criteria are met:

  • Disabling ET; AND
  • Medication refractory ET (defined as refractory to at least 2 trials of medical therapy, including at least 1 first-line agent); AND
  • Moderate to severe postural or intention tremor of the dominant hand; AND
  • Not a surgical candidate for DBS (eg, advanced age, anticoagulant therapy, or surgical comorbidities)

Coverage Limitations

DBS

Humana members may NOT be eligible under the Plan for DBS for any indications other than those listed above including, but not limited to the following:

  • Cerebral palsy; OR
  • Chronic neuropathic pain; OR
  • Cluster headaches; OR
  • Depression; OR
  • Movement disorder caused by multiple sclerosis (MS); OR
  • Obsessive compulsive disorder (OCD); OR
  • Orthostatic tremor; OR
  • Tourette syndrome

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

The placement of fiducial markers is considered integral to the primary procedure and not separately reimbursable.

Deep Brain Stimulation and Cortical Stimulation Effective Date: 01/01/2024
Revision Date: 01/01/2024
Review Date: 07/27/2023
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Cortical Stimulation

Humana members may NOT be eligible under the Plan for cortical stimulation for any indications other than those listed above. This is considered experimental/ investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

MRgFUS/MRgHIFU

Humana members may NOT be eligible under the Plan for magnetic resonance image-guided focused ultrasound or high-intensity focused ultrasound for any indications other than those listed above. This is considered experimental/ investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Background

Additional information about chronic neuropathic pain, cluster headaches, depression, epilepsy, OCD, Parkinson’s disease and Tourette’s syndrome may be found from the following websites:

  • American Academy of Neurology
  • National Institute of Mental Health
  • National Institute of Neurological Disorders and Stroke
  • National Library of Medicine

Alternatives to deep brain or cortical brain stimulation include, but may not be limited to, the following:

Medical Alternatives
  • Prescription drug therapy
  • Surgical treatment

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Deep Brain Stimulation and Cortical Stimulation Effective Date: 01/01/2024
Revision Date: 01/01/2024
Review Date: 07/27/2023
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Humana may offer a disease management program for this condition.

The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

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Revision Date: 01/01/2024
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61868Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (eg, thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), with use of intraoperative microelectrode recording; each additional array (List separately in addition to primary procedure)
61880Revision or removal of intracranial neurostimulator electrodes
61885Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array
61886Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to 2 or more electrode arrays
61888Revision or removal of cranial neurostimulator pulse generator or receiver
61889Insertion of skull-mounted cranial neurostimulator pulse generator or receiver, including craniectomy or craniotomy, when performed, with direct or inductive coupling, with connection to depth and/or cortical strip electrode array/(s)New Code Effective 01/01/2024
61891Revision or replacement of skull-mounted cranial neurostimulator pulse generator or receiver with connection to depth and/or cortical strip electrode array(s)New Code Effective 01/01/2024
61892Removal of skull-mounted cranial neurostimulator pulse generator or receiver with cranioplasty, when performedNew Code Effective 01/01/2024
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Revision Date: 01/01/2024
Review Date: 07/27/2023
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Unlisted procedure, nervous system

Not Covered if used to report any procedure outlined in Coverage Limitations section The placement of fiducial markers is considered integral to the primary procedure and not separately reimbursable.

95961Functional cortical and subcortical mapping by stimulation and/or recording of electrodes on brain surface, or of depth electrodes, to provoke seizures or identify vital brain structures; initial hour of attendance by a physician or other qualified health care professional
95962Functional cortical and subcortical mapping by stimulation and/or recording of electrodes on brain surface, or of depth electrodes, to provoke seizures or identify vital brain structures; each additional hour of attendance by a physician or other qualified health care professional (List separately in addition to code for primary procedure)
95970Electronic 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, cranial nerve, spinal cord, peripheral nerve, or sacral nerve, neurostimulator pulse generator/transmitter, without programming
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95983Electronic 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
95984Electronic 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)
CPT® Category Ill Code(s)DescriptionComments
0398TMagnetic resonance image guided high intensity focused ultrasound (MRgFUS), stereotactic ablation lesion, intracranial for movement disorder including stereotactic navigation and frame placement when performed
HCPCS Code(s)Description PComments
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Revision Date: 01/01/2024
Review Date: 07/27/2023
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C1787Patient programmer, neurostimulator
C1816Receiver and/or transmitter, neurostimulator (implantable)
C1820Generator, neurostimulator (implantable), with rechargeable battery and charging system
C1822Generator, neurostimulator (implantable), high frequency, with rechargeable battery and charging system
C1826Generator, neurostimulator (implantable), includes closed feedback loop leads and all implantable components, with rechargeable battery and charging system
C1827Generator, neurostimulator (implantable), non-rechargeable, with implantable stimulation lead and external paired stimulation controller
C1883Adaptor/extension, pacing lead or neurostimulator lead P (implantable)
C1897Lead, neurostimulator test kit (implantable)
L8679Implantable neurostimulator, pulse generator, any type
L8680Implantable neurostimulator electrode, each
L8681Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only
L8682Implantable neurostimulator radiofrequency receiver
18683Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver
18685Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
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L8686Implantable neurostimulator pulse generator, single array, . P nonrechargeable, includes extension
8687Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
18688Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension
18689External recharging system for battery (internal) for use with implantable neurostimulator, replacement only

References

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Background
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  • American Psychiatric Association (APA). Guideline watch for the practice guideline for the treatment of patients with obsessive-compulsive disorder. https://www.psychiatryonline.org. Published March 2013. Accessed July 14, 2023.
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  • ECRI Institute. Clinical Evidence Assessment. ExAblate Neuro (InSightec, Inc.) for treating essential tremor. https://www.ecri.org. Published July 5, 2017. Updated July 21, 2020. Accessed July 7, 2023.
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  • Hayes, Inc. Health Technology Assessment. Deep brain stimulation for the anterior nucleus of the thalamus for treatment of refractory epilepsy. https://evidence.hayesinc.com. Published November 14, 2019. Updated December 29, 2022. Accessed July 10, 2023.
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  • UpToDate, Inc. Cluster headache: treatment and prognosis.https://www.uptodate.com. Updated June 2023. Accessed July 11, 2023.
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Deep Brain Stimulation and Cortical Stimulation Effective Date: 01/01/2024
Revision Date: 01/01/2024
Review Date: 07/27/2023
Policy Number: HUM-0472-025
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

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Deep Brain Stimulation and Cortical Stimulation Effective Date: 01/01/2024
Revision Date: 01/01/2024
Review Date: 07/27/2023
Policy Number: HUM-0472-025
Page: 21 of 22

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

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Deep Brain Stimulation and Cortical Stimulation Effective Date: 01/01/2024
Revision Date: 01/01/2024
Review Date: 07/27/2023
Policy Number: HUM-0472-025
Page: 22 of 22

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

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