Deep Brain, Cortical, & Cerebellar Stimulation Policy Number: PG0410 ADVANTAGE | ELITE | HMO Last Review: 09/14/2021

INDIVIDUAL MARKETPLACE | PROMEDICA MEDICARE PLAN | PPO

GUIDELINES  This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder terms, conditions, exclusions and limitations contract. It does not constitute a contract or guarantee regarding coverage or reimbursement/payment. Self-Insured group specific policy will supersede this general policy when group supplementary plan document or individual plan decision directs otherwise.  Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards.  This medical policy is solely for guiding medical necessity and explaining correct procedure reporting used to assist in making coverage decisions and administering benefits.

SCOPE X Professional X Facility

DESCRIPTION Various forms of electrical stimulation have been investigated as an alternative to permanent neuroablative procedures, such as thalamotomy and pallidotomy for neuroelectrical conditions. The technique using deep brain stimulation (DBS) has been most thoroughly investigated as an alternative to thalamotomy for unilateral control of essential tremor, and tremor associated with Parkinson's disease (PD). DBS has also been investigated in individuals with primary dystonia, defined as a neurological movement disorder characterized by involuntary muscle contractions, which force certain parts of the body into abnormal, contorted and painful movements or postures and which is unrelated to any other neurological condition. 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, the central nervous system nucleus (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 individual 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 individuals with bilateral, severe symptoms.

After implantation, noninvasive programming of the neurostimulator can be adjusted to the individual's symptoms. This feature may be important for individuals 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.

Directional deep brain stimulation enables the current to be steered precisely to the targeted structural area purportedly 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 dystonia therapy systems for chronic, intractable primary dystonia including generalized and/or segmental dystonia, hemidystonia and cervical dystonia (torticollis)

PG0410 – 09/14/2021  Activa Parkinson’s and tremor control therapy systems for essential tremor and Parkinson’s disease  Infinity DBS system for directional deep brain stimulation  Reclaim DBS for obsessive compulsive disorder (OCD)  SenSight directional lead system (SenSight lead, Percept PC stimulator) for directional deep brain stimulation  Vercise directional system (Cartesia lead, and DBS, Genus, Gevia or PC stimulators) for directional deep brain stimulation

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 a FDA-approved DBS device for the treatment of drug resistant epilepsy is the Medtronic DBS System for Epilepsy

Cortical stimulation is a newer technology proposed for the treatment of epilepsy. An example of an FDA- approved cortical stimulation system is the Responsive Neurostimulation System (RNS) (NeuroPace, Inc., Mountain View, CA). NeuroPace because it is currently the only responsive neurostimulation (RNS) system commercially available in the United States. The RNS System involves implantation of electrodes onto the surface the brain near areas associated with seizure activity. Those electrodes are then attached to a control/generator unit, which is also implanted in the head. The control unit monitors and records electrical activity of the brain and provides electrical stimulation when needed. Following a trial period, the initial brain activity record is evaluated by a doctor. The record is used to identify the individual's unique pre-seizure electrical brain activity patterns and to set the RNS device to recognize and react to those patterns. Once the recognition parameters are set, the device monitors brain activity for the pre-set patterns of electrical activity. If those patterns are detected the device activates to provide stimulation through the electrodes with the goal of preventing a seizure.

RNS shares some features with DBS, but is differentiated by its use of direct cortical stimulation and by its use in both monitoring and stimulation. The RNS system provides stimulation in response to detection of specific epileptiform patterns, while DBS provides continuous or intermittent stimulation at preprogrammed settings.

Cerebral stimulation or pacing, also referred to as motor cortex stimulation (MCS) or extradural motor cortex stimulation (EMCS), is primarily proposed for relief of refractory neuropathic pain and involves implantation of epidural electrodes in the cerebral cortex. It is a similar technique to DBS, but works in the cerebellar portion of the brain. At this time, there is little information about the use of this technology in humans.

POLICY HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage

Deep brain stimulation does not require prior authorization.

Effective: 11/01/2021 - Cortical stimulation NeuroPace RNS System (NeuroPace Inc.) is not covered.

Cerebellar stimulation is non-covered. The use of cerebellar stimulation/pacing is considered investigational for all indications.

Procedure 0398T is non-covered

COVERAGE CRITERIA HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage DEEP BRAIN STIMULATION  Unilateral or bilateral deep brain stimulators (e.g., stimulation of the ventral intermediate thalamic nucleus, globus pallidus, and subthalamic nucleus) are medically necessary durable medical equipment (DME) for the treatment of intractable tremors as a consequence of Parkinson's disease or essential tremor when ALL of the following criteria are met:

PG0410 – 09/14/2021  Member does not have coagulopathies, dementia, severe depression, previous ablative brain surgery or cerebral atrophy; and  Member is able to properly operate the neurostimulator; and  Member does not have other independent diagnoses that could explain the failure to respond to medical treatment, and  Member suffers from disabling upper extremity essential tremor, which cause significant limitations in daily activities, that is not responding satisfactorily to drug therapy or suffers from a disabling tremor of idiopathic Parkinson's disease that is refractory to pharmacotherapy, and  There is no focal lesion of the basal ganglia (e.g., a space occupying lesion or lacunae) at the target site that would negate the result of thalamic stimulation, and  There is sufficient residual motor function in the upper extremity so that it is reasonable to expect an improvement following the surgery.

 Unilateral or bilateral deep brain stimulators (e.g., stimulation of the globus pallidus and subthalamic nucleus) are medically necessary DME for the treatment of severe, refractory motor complications of Parkinson's disease when ALL of the following criteria are met:  A minimal score of 30 points on the motor portion of the United Parkinson's Disease Rating Scale (UPDRS) when the member has been off medication for about 12 hours (scores on this scale range from 0 to 108; higher values indicate greater severity of symptoms); and  Member does not have dementia, severe depression, or cerebral atrophy; and  Member is levodopa responsive with clearly defined “on” periods; and  Motor complications that cannot be managed with medication; and  Presence of at least two (2) major symptoms of Parkinsonism (e.g., tremor, rigidity, and bradykinesia).

 Unilateral or bilateral deep brain stimulators (e.g., stimulation of the globus pallidus and subthalamic nucleus) are medically necessary DME for the treatment of chronic primary dystonia, including generalized and or segmental dystonia, hemidystonia and cervical dystonia (torticollis) with motor response complications not controlled by pharmacologic therapy or 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 when ALL of the following criteria are met:  Are seven years or older with intractable primary dystonia, including generalized and/or segmental dystonia, hemidystonia and cervical dystonia; and  Member is able to properly operate the neurostimulator; and  No presence of coagulopathies, dementia, moderate to severe depression or previous ablative brain surgery

 Bilateral stimulation of the anterior nucleus of the thalamus (e.g., the Medtronic DBS System for Epilepsy) medically necessary when ALL of the following criteria are met:  Members aged 18 years or older; and  Focal partial onset seizures with or without generalized seizure; and  Members who averaged six (6) or more seizures per month during the previous three (3) months, with no more than 30 days between seizures. It hasn’t been evaluated in persons whose seizures are less frequent; and  Member is able to properly operate the neurostimulator; and  No presence of coagulopathies; and partial onset seizures with or without secondary generalization; and  Seizures refractory to three (3) or more antiepileptic medications.

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 met criteria as medically necessary and is no longer under warranty and cannot be repaired.

DBS for tremors from other causes such as trauma, multiple sclerosis (MS), degenerative disorders, metabolic disorders, infectious diseases, and drug-induced movement disorders are experimental and investigational because DBS has not been shown to be effective for treating tremors due to these other causes.

PG0410 – 09/14/2021

DBS is experimental and investigational for the following indications (not an all-inclusive list), because there is insufficient evidence to support its effectiveness for these indications.  Addiction  Alzheimer's disease  Anorexia nervosa  Autism spectrum disorder  Blepharospasm  Cerebral palsy  Chronic cluster headache  Chronic pain syndrome including complex regional pain syndrome/reflex sympathetic dystrophy  Chronic vegetative state  Cluster headaches  Depression  Epilepsy - except as coverage indicated above  Explosive aggressive behavior  Head or voice tremor  Huntington's disease  Minimally conscious state  Multiple sclerosis tremor  Obesity  Obsessive-compulsive disorder  Orthostatic tremor  Parkinson’s disease-related camptocormia, dysarthria/speech deficits, and gait disorders (e.g., gait instability and freezing of gait)  Post-traumatic tremor  Self-injurious behavior  Substance use disorders  Tourette syndrome  Traumatic brain injury

Members may NOT be eligible under the Plan for directional deep brain stimulation (e.g., Infinity DBS, SenSight and Vercise, directional systems) for any indication. This is considered experimental/investigational, as it is not identified as widely used and generally accepted for the proposed use.

CORTICAL STIMULATION  Cortical stimulation (e.g., NeuroPace RNS) for the Treatment of Drug-Resistant Epilepsy is not covered.

• Evidence from a single randomized controlled trial (RCT) and long-term follow-up of this RCT and other data sources suggest that the RNS System reduces seizure frequency in adults with intractable epilepsy. However, serious adverse events have been reported. • Responsive neurostimulation is considered experimental or investigational for all other indications. The evidence is insufficient to determine the effects of the technology on health outcomes.

A clinical alternative to the NeuroPace RNS System for drug-resistant epilepsy include electrical stimulation of the brain via vagus nerve stimulation (VNS). VNS entails the stimulation of the vagus nerve to prevent seizure. The FDA has approved the implantable VNS Therapy system by LivaNova.

Members may NOT be eligible under the Plan for magnetic resonance image-guided focused ultrasound [MRgFUS, (e.g. ExAblate Neuro)] for any indication. This is considered experimental/investigational, as it is not identified as widely used and generally accepted for the proposed use.

CEREBELLAR STIMULATION The use of cerebellar stimulation/pacing is considered investigational and not medically necessary.

PG0410 – 09/14/2021

CODING/BILLING INFORMATION The inclusion or exclusion of a code in this section does not necessarily indicate coverage. Codes referenced in this clinical policy are for informational purposes only. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered. CPT CODES 61850 Twist drill or burr hole(s) for implantation of neurostimulator electrodes, cortical 61860 Craniectomy or craniotomy for implantation of neurostimulator electrodes, cerebral, 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 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; each additional array (List separately in addition to primary procedure) 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 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; each additional array (List separately in addition to primary procedure) 61880 Revision or removal of intracranial neurostimulator electrodes 61885 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array 61886 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to two or more electrode arrays 61888 Revision or removal of cranial neurostimulator pulse generator or receiver 95961 Functional 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 95962 Functional 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) 95970 Electronic analysis of implanted neurostimulator pulse generator/transmitter (e.g., 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 95971 Electronic analysis of implanted neurostimulator pulse generator/transmitter (e.g., 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 simple spinal cord or peripheral nerve (e.g., sacral nerve) neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional 95983 Electronic analysis of implanted neurostimulator pulse generator/transmitter (e.g., 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;

PG0410 – 09/14/2021 with brain neurostimulator pulse generator/transmitter programming, first 15 minutes face-to-face time with physician or other qualified health care professional 95984 Electronic analysis of implanted neurostimulator pulse generator/transmitter (e.g., 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) 0398T Magnetic resonance image guided high intensity focused ultrasound (MRgFUS), stereotactic ablation lesion, intracranial for movement disorder including stereotactic navigation and frame placement when performed (Not Covered) HCPCS CODES L8679 Implantable neurostimulator, pulse generator, any type L8680 Implantable neurostimulator electrode, each L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only L8682 Implantable neurostimulator radiofrequency receiver L8683 Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes extension L8686 Implantable neurostimulator pulse generator, single array, 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 Paramount reserves the right to review and revise our policies periodically when necessary. When there is an update, we will publish the most current policy to https://www.paramounthealthcare.com/services/providers/medical-policies/ .

REVISION HISTORY EXPLANATION ORIGINAL EFFECTIVE DATE: 09/22/2017 Date Explanation & Changes  Policy created to reflect most current clinical evidence per The Technology Assessment 09/22/17 Working Group (TAWG) 12/28/2020  Medical policy placed on the new Paramount Medical policy format  Added procedures 95961, 95962, 95970, 95971, 95983, 95984, 0398T  Policy updated to reflect most current clinical evidence 09/14/2021  Bilateral stimulation of the anterior nucleus of the thalamus (e.g., the Medtronic DBS System for Epilepsy coverage established  Effective: 11/01/2021 - Cortical stimulation, NeuroPace RNS System (NeuroPace Inc.), is not covered.

REFERENCES/RESOURCES Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services

Ohio Department of Medicaid

American Medical Association, Current Procedural Terminology (CPT®) and associated publications and services

Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS

PG0410 – 09/14/2021 Release and Code Sets

U.S. Preventive Services Task Force, http://www.uspreventiveservicestaskforce.org/ Industry Standard Review

Hayes, Inc.

Industry Standard Review

PG0410 – 09/14/2021