Commercial

Deep Brain Stimulation (DBS)
11.15.20p

Policy


When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

MEDICALLY NECESSARY

UNILATERAL DEEP BRAIN STIMULATION (DBS) OF THE THALAMUS FOR ESSENTIAL TREMOR (ET) OR PARKINSONIAN TREMOR
Unilateral stimulation of the thalamus using a US Food and Drug Administration (FDA)--approved deep brain stimulator according to the labeled indications for ET or Parkinsonian tremor is considered medically necessary and, therefore, covered when the individual has disabling medically refractive ET or disabling medically refractive tremors associated with Parkinson's disease (PD)*.

*Note: Disabling medically refractive tremors are defined as tremors that cause significant limitation in daily activities and are inadequately controlled with the maximum dosage of medication for at least three months before implant.

BILATERAL DBS OF THE THALAMUS FOR ET OR PARKINSONIAN TREMOR
Bilateral stimulation of the thalamus using an FDA-approved deep brain stimulator according to the labeled indications for ET or Parkinsonian tremor is considered medically necessary and, therefore, covered when the individual has disabling medically refractive tremors in both upper limbs associated with ET or disabling medically refractive tremors in both upper limbs associated with PD.

BILATERAL DBS OF THE GLOBUS PALLIDUS INTERNA (GPi) OR SUBTHALAMIC NUCLEUS FOR PD WITH RECENT ONSET OF MOTOR COMPLICATIONS
Bilateral stimulation of the GPi or subthalamic nucleus using an FDA-approved deep brain stimulator according to the labeled indications is considered medically necessary and, therefore, covered as an adjunct to medical therapy when the individual has an established diagnosis of PD for at least four years duration and all of the following criteria are met:
  • PD responsive to levodopa therapy
  • A neurosurgeon determines that the individual meets a minimal score of six on the Unified Parkinson's Disease Rating Scale (UPDRS) following the discontinuation of medications for approximately 12 hours
  • Recently developed (three years or less) motor complications (e.g., drug-induced dyskinesias, motor fluctuations) not adequately controlled with pharmacologic therapy, that cause significant limitations in daily activities
UNILATERAL OR BILATERAL DBS OF THE GPi OR SUBTHALAMIC NUCLEUS FOR ADVANCED PD
Unilateral or bilateral stimulation of the GPi or subthalamic nucleus using an FDA-approved deep brain stimulator according to the labeled indications is considered medically necessary and, therefore, covered when the individual has an established diagnosis of advanced PD and all of the following criteria are met:
    • PD responsive to levodopa therapy
    • A neurosurgeon determines that the individual meets a minimal score of 30 on the UPDRS following the discontinuation of medications for approximately 12 hours
    • Motor complications (e.g., drug-induced dyskinesias, motor fluctuations) refractory to pharmacologic therapy
HUMANITARIAN DEVICE EXEMPTION (HDE)

UNILATERAL OR BILATERAL DBS OF THE GPi OR SUBTHALAMIC NUCLEUS FOR PRIMARY DYSTONIA
Unilateral or bilateral stimulation of the GPi or subthalamic nucleus for primary dystonia is covered for the following FDA-approved humanitarian device exemption (HDE) indication:
  • Chronic, intractable (refractory to pharmacologic therapy) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in individuals seven years of age or older.
BILATERAL DBS OF THE ANTERIOR LIMB OF THE INTERNAL CAPSULE (AIC) FOR OBSESSIVE COMPULSIVE DISORDER (OCD)
Bilateral DBS of the AIC, as an adjunct to pharmacologic therapy, is covered for the following FDA-approved HDE indication:
  • Severe obsessive compulsive disorder (OCD)
    • Alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant OCD in adults who have failed at least three selective serotonin reuptake inhibitors (SSRIs)
An HDE may only be used in facilities that have an institutional review board (IRB) to oversee the clinical application of such devices. The IRB must approve the application of the device to ensure that it will be used in accordance with the FDA-approved indication(s). In addition, documentation of IRB approval may be requested by the Company to ensure compliance with the HDE indication(s).

NOT MEDICALLY NECESSARY

For individuals who meet the above medically necessary indications for DBS, but due to the presence of any of the following comorbidities, unilateral or bilateral deep brain stimulation is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use:
  • Non-idiopathic Parkinson's disease or "Parkinson's Plus" syndromes
  • Cognitive impairment, dementia, or depression, which would be worsened by or would interfere with the patient's ability to benefit from DBS
  • Current psychosis, alcohol abuse, or other drug abuse
  • Structural lesions such as basal ganglionic stroke, tumor, or vascular malformation as etiology of the movement disorder
  • Previous movement disorder surgery within the affected basal ganglion
  • Significant medical, surgical, neurologic, or orthopedic comorbidities contraindicating surgery or stimulation
  • Botulinum toxin injections within the last six months
EXPERIMENTAL/INVESTIGATIONAL

Deep brain stimulation for all other primary indications, including, but not limited to, the following is considered experimental/investigational and, therefore, not covered because its safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.
  • Alcohol addiction
  • Alzheimer's disease
  • Anorexia nervosa
  • Blepharospasm
  • Cerebral palsy
  • Chronic cluster headache
  • Chronic pain syndrome including complex regional pain syndrome/reflex sympathetic dystrophy
  • Chronic vegetative state
  • Depression
  • Epilepsy
  • Head or voice tremor
  • Huntington's disease
  • Multiple sclerosis tremor
  • Obesity
  • Post-traumatic dyskinesia
  • Tardive dyskinesia
  • Tourette syndrome
REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.


Guidelines


CONTRAINDICATIONS FOR UNILATERAL OR BILATERAL DEEP BRAIN STIMULATION
  • Medical conditions that require exposure to diathermy (deep heat treatment including short-wave diathermy, microwave diathermy, and ultrasound diathermy)
  • Medical conditions that require exposure to magnetic resonance imaging (MRI) using a full body radio-frequency (RF) coil, a receive-only head coil, or a head transmit coil that extends over the chest area
  • Inability to properly operate the stimulator
CAUTIONARY USE OF DEEP BRAIN STIMULATION

Deep brain stimulation (DBS) should be performed with extreme caution in individuals with cardiac pacemakers or other electronically controlled implants, which may adversely affect or be affected by the DBS system.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, DBS is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met. However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

Subject to the terms and conditions of the applicable benefit contract, devices that are used for the FDA-approved humanitarian device exemption (HDE) indications listed in this policy are covered under the medical benefits of the Company's products.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for essential tremor and Parkinson's disease indications. On April 17, 2018, the FDA gave premarket approval for the Medtronic DBS therapy, expanding the approved indications to include refractory epilepsy for individuals 18 years of age or older.

There are numerous devices approved by the FDA under the HDE process for primary dystonia and obsessive compulsive disorder (OCD) indications.


Description


DEEP BRAIN STIMULATION

Deep brain stimulation (DBS) may be used for individuals who become less responsive to medical treatments for essential tremor (ET), tremor associated with Parkinson's disease (PD), primary dystonia, and obsessive compulsive disorder (OCD), or for those who cannot tolerate the side effects from medications that are commonly used to treat these conditions. DBS has several potential advantages over ablative procedures (e.g., pallidotomy) because it is nondestructive and reversible. DBS may also provide better long-term results than can be achieved by a single ablative procedure. PD and ET are progressive diseases, and different neurostimulator parameters may be needed for these conditions over time to achieve optimal symptom control.

DBS is a high-frequency electrical stimulation of targeted nuclei deep within the brain that controls movement and muscle function. DBS is a neurosurgical procedure that involves stereotactic placement of implantable electrodes within targeted nuclei on one (unilateral) or both (bilateral) sides of the brain. There are currently three targeted sites for DBS: the thalamic ventralis intermedius nucleus (VIM), subthalamic nucleus (STN), and globus pallidus interna (GPi). Once effectiveness has been demonstrated by temporary stimulation, the individual returns to surgery, usually within several days, for subcutaneous placement of the pulse generator (neurostimulator) in the chest and subcutaneous placement of the cable that connects the pulse generator to the implanted electrodes. Following implantation, noninvasive programming of the neurostimulator can be adjusted according to the individual's symptoms. The system can also be independently activated by the individual as needed.

ESSENTIAL TREMOR (ET)

ET is a progressive, disabling disorder most often affecting the hands, but it may also affect the head, voice, or legs. The exact etiology of ET is unknown. It may start at any age but peaks within the second and sixth decades of life. Beta-adrenergic blockers and anticonvulsant medications are usually first-line treatments for reducing the severity of tremors. However, many individuals do not adequately respond to or cannot tolerate these medications.

One of the earlier tremor scales developed that is still widely used today is the Fahn–Tolosa–Marin Tremor Rating Scale (TRS). This five-point scale rates tremor severity based on tremor amplitude, from zero (no tremor) to four (severe tremor) in each part of the body, and includes assessments of specific abilities and functional disability.


PARKINSON'S DISEASE (PD)


PD is a chronic and progressive neurodegenerative disease of unknown etiology. The disorder involves the loss of dopaminergic cells in the substantia nigra of the midbrain, which leads to the depletion of dopamine, a neurotransmitter that is essential for the regulation of motor function throughout the body. PD is characterized by tremor, rigidity (a stiffness of the limbs), bradykinesia/akinesia (slowness of motor movements/inability to initiate movement), and progressive postural instability. There are also many non-motor symptoms, including depression, anxiety, apathy, fatigue, and sexual dysfunction. Dopaminergic medication is typically used as a first-line treatment for reducing the primary symptoms of PD. However, after prolonged use, medication can become less effective and can produce significant adverse events such as dyskinesias (abnormality with voluntary muscle movements).

PD staging is accomplished through various rating tools, including the Hoehn and Yahr Staging of Parkinson's Disease, Unified Parkinson's Disease Rating Scale [UPDRS], and the Schwab and England Activities of Daily Living. The UPDRS is a rating tool to follow the longitudinal course of PD. It is made up of three sections: 1) Mentation, Behavior, and Mood; 2) Activities of Daily Living (ADL); and 3) Motor. These sections are evaluated by individual interviews. Some sections require multiple grades assigned to each extremity. A total of 199 points are possible. A score of 199 represents the worst (total) disability, and a score of zero represents no disability.

PRIMARY DYSTONIA

Primary dystonia is a neurological movement disorder of unknown etiology characterized by involuntary muscle contractions that force parts of the body into abnormal, contorted, and painful movements or postures. Primary dystonia is classified as focal (limited to one area [e.g., torticollis]), multifocal (affecting many areas [e.g., eyes, jaw, and tongue]), or generalized (affecting the entire body [e.g., arms, legs, and trunk]). When conservative therapy, such as oral or injectable medications (e.g., benztropine, diazepam, botulinum toxin) has failed, treatment options have included destructive neurosurgical interventions (e.g., thalamotomy, pallidotomy).

The US Food and Drug Administration (FDA) approved the Medtronic Activa® Dystonia Therapy (Medtronic Inc.; Minneapolis, MN) on April 15, 2003, as a Humanitarian Drug Exemption (HDE). It is indicated for the management of long-term primary dystonia in individuals seven years of age and older who are not responsive to drug therapy. The device may improve some symptoms associated with primary dystonia.

OBSESSIVE COMPULSIVE DISORDER (OCD)

OCD is an anxiety disorder and is characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions). Repetitive behaviors such as hand-washing, counting, checking, or cleaning are often performed with the hope of preventing obsessive thoughts or making them go away. Performing these behaviors, however, provides only temporary relief, and not performing them markedly increases anxiety.

The FDA approved the Medtronic Reclaim® DBS Therapy for OCD (Medtronic Inc.; Minneapolis, MN) on February 19, 2009 (as a humanitarian device exemption [HDE]) for the treatment of chronic, severe, treatment-resistant OCD in adult individuals having failed three selective serotonin reuptake inhibitors (SSRIs). This device is indicated for bilateral stimulation of the anterior limb of the internal capsule (AIC), as adjunctive to medications, and as an alternative to anterior capsulotomy for the treatment of OCD. The generic name for the Medtronic Reclaim® is Implantable Multi-Programmable Quadripolar Deep Brain Stimulation System.

HUMANITARIAN DEVICE EXEMPTION (HDE)

In rare instances, certain medical devices intended to be used for humanitarian purposes are evaluated by the FDA through the HDE process. The FDA’s humanitarian use device (HUD) designation permits the use of certain medical devices when there is no comparable device available to treat or diagnose a disease or condition affecting fewer than 4,000 individuals annually. Because clinical investigation demonstrating the efficacy of the device is not feasible (given the low prevalence of the disease in the population), an HDE grants manufacturers an exemption to the usual premarket approval process and allows marketing of the device only for the FDA-labeled HDE indication(s).

Under FDA requirements, an HUD may only be used after institutional review board (IRB) approval has been obtained for the use of the device in accordance with the FDA-labeled indication(s) under the HDE.

OTHER PROPOSED APPLICATIONS FOR DBS

Deep brain stimulation is also being investigated for the treatment of disorders such as treatment resistant depression, chronic cluster headaches, chronic pain syndromes, Tourette syndrome, multiple sclerosis tremor, and refractory epilepsy. Available published peer-reviewed literature demonstrates insufficient evidence upon which to support its effectiveness of these and other proposed indications. Additional controlled studies with larger number of subjects are required to evaluate the role of DBS for these proposed conditions.



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Coding

CPT Procedure Code Number(s)

61850, 61860, 61863, 61864, 61867, 61868, 61880, 61885, 61886, 61888, 95836, 95961, 95962, 95970, 95983, 95984



ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)

F42.2 Mixed obsessional thought and acts
F42.8 Other obsessive-compulsive disorder
F42.9 Obsessive-compulsive disorder, unspecified
G20 Parkinson's disease
G24.1 Genetic torsion dystonia
G24.2 Idiopathic nonfamilial dystonia
G24.3 Spasmodic torticollis
G24.8 Other dystonia
G24.9 Dystonia, unspecified
G25.0 Essential tremor
G25.2 Other specified forms of tremor
M43.6 Torticollis


HCPCS Level II Code Number(s)

C1767 Generator, neurostimulator (implantable), nonrechargeable

C1778 Lead, neurostimulator (implantable)

C1787 Patient programmer, neurostimulator

C1816 Receiver and/or transmitter, neurostimulator (implantable)

C1820 Generator, neurostimulator (implantable), with rechargeable battery and charging system

C1823 Generator, neurostimulator (implantable), non-rechargeable, with transvenous sensing and stimulation leads

C1883 Adaptor/extension, pacing lead or neurostimulator lead (implantable)

C1897 Lead neurostimulator test kit (implantable)​

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

L8689 External recharging system for battery (internal) for use with implantable neurostimulator, replacement only

L8695 External recharging system for battery (external) for use with implantable neurostimulator, replacement only​


Revenue Code Number(s)
N/A



Coding and Billing Requirements


Policy History

1/25/2021
1/25/2021
11.15.20
Medical Policy Bulletin
Commercial
No