Friday, December 14, 2018

CPT 61850, 61860, 61863, 61864, 61867, 61868 - Deep brain stimulation






Coding Code Description CPT

61850 Twist drill or burr hole(s) for implantation of neurostimulator or 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 (eg, 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 (eg, thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), without use of


61867 Twist 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; first array

61868 Twist 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)

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 2 or more electrode arrays

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



Introduction

Deep brain stimulation (DBS) can be used to treat essential tremor, Parkinson disease, and a movement disorder called dystonia. Deep brain stimulation is used when drugs aren’t able to control symptoms. It works by blocking electrical signals in specific areas of the brain that control movement. Surgery is needed to place a thin metal rod, called an electrode, in the brain.(When severe movement affects both sides of the body, an electrode may be implanted on each side of the brain.) The electrode is attached to a small device called a neurostimulator, which is placed under the skin below the collar bone. Batteries power the neurostimulator to send electrical signals to the electrode. This policy describes when deep brain stimulation may be considered medicall necessary.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Policy Coverage Criteria Application Medical Necessity DBS of the thalamus Deep brain stimulation of the thalamus may be considered medically necessary for:
* Unilateral treatment of disabling, medically unresponsive tremor* due to:
o Parkinson’s disease OR
o Essential Tremor
* Bilateral treatment of disabling, medically unresponsive tremor* in both upper limbs due to:
o Parkinson’s disease OR
o Essential tremor
*See Definition of Terms DBS of the globus pallidus or subthalamic nucleus (unilateral or bilateral) Deep brain stimulation of the globus pallidus or subthalamic nucleus may be considered medically necessary for:
* Parkinson’s disease with ALL of the following:
o A good response to levodopa
o Motor complications not controlled by drug treatment AND
o One of the following:
* A minimum score of 30 points on the motor portion of the Unified Parkinson Disease Rating Scale (UPDRS) when the patient has been without medication for approximately 12 hours OR
* Parkinson’s disease for at least 4 years
* Primary dystonia** with ALL of the following:
o Patients older than 7 years of age AND
o Chronic, intractable (drug refractory)
**Note: may include generalized and/or segmental dystonia, hemidystonia, and


Application Medical Necessity cervical dystonia (torticollis) Application Investigational

DBS for other disorders Deep brain stimulation is considered investigational for:
* Other disorders, including but not limited to:
o Multiple sclerosis
o Post-traumatic dyskinesia
o Tardive dyskinesia
o Chronic cluster headaches
* Other psychiatric or neurologic diagnoses, including but not limited to:
o Alcohol addiction
o Alzheimer disease
o Anorexia nervosa
o Chronic pain
o Depression
o Epilepsy
o Obsessive-compulsive disorder
o Tourette syndrome

Definition of Terms

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
* Patients who have dementia that may interfere with the ability to cooperate
* Patients who have had botulinum toxin injections within the last 6 months

Evidence Review Background

Deep brain stimulation (DBS) is used as an alternative to permanent neuroablative proceduresfor control of essential tremor and Parkinson disease. DBS is also being evaluated for the treatment of a variety of other neurologic and psychiatric disorders.

Deep Brain Stimulation

Deep brain stimulation involves the stereotactic placement of an electrode into the brain (ie, 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 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, use of bilateral stimulation using 2 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 Parkinson disease (PD), whose disease may progress over time, requiring different neurostimulation parameters. Setting the optimal neurostimulation parameters may involve the balance between optimal symptom control and appearance of adverse effects of neurostimulation such as dysarthria, disequilibrium, or involuntary movements.

Essential Tremor and PD

DBS has been investigated as an alternative to permanent neuroablative procedures, such as thalamotomy and pallidotomy. DBS has been most thoroughly investigated as an alternative to thalamotomy for unilateral control of essential tremor (ET) and tremor associated with Parkinson’s disease (PD). More recently, there has been research interest in the use of DBS of the globus pallidus or subthalamic nucleus as a treatment of other parkinsonian symptoms, such as rigidity, bradykinesia, or akinesia. Another common morbidity associated with PD is the occurrence of motor fluctuations, referred to as an "on and off" phenomena, related to the maximum effectiveness of drugs (ie, “on” state) and the nadir response during drug troughs (ie, “off” state). In addition, levodopa, the most commonly used anti-Parkinson drug, may be associated with disabling drug-induced dyskinesias. Therefore, the optimal pharmacologic treatment of PD may involve a balance between optimal effects on PD symptoms versus the appearance of drug-induced dyskinesias. The effect of DBS on both PD symptoms and druginduced dyskinesias has also been studied.

Primary and Secondary Dystonia

DBS has also been investigated in patients with primary and secondary dystonia, defined as a neurologic movement disorder characterized by involuntary muscle contractions, which force certain parts of the body into abnormal, contorted, and painful movements or postures. Dystonia can be classified according to age of onset, bodily distribution of symptoms, and cause. Age of onset can occur during childhood or during adulthood. Dystonia can affect certain portions of the body (focal dystonia and multifocal dystonia) or the entire body (generalized dystonia). Torticollis is an example of a focal dystonia. Primary dystonia is defined when dystonia is the only symptom unassociated with other pathology. Treatment options for dystonia include oral or injectable medications (ie, botulinum toxin) and destructive surgical or neurosurgical interventions (ie, thalamotomies or pallidotomies) when conservative therapies fail. Secondary dystonia is a dystonia brought on by an inciting event, such as a stroke, trauma, or drugs.

Tardive dystonia is a form of drug-induced secondary dystonia.

Cluster Headaches

DBS has been investigated in patients with chronic cluster headaches. Cluster headaches occur as episodic attacks of severe pain lasting from 30 minutes to several hours. The pain is usually unilateral and localized to the eye, temple, forehead, and side of the face. Autonomic symptoms that occur with cluster headaches include ipsilateral facial sweating, flushing, tearing, and rhinorrhea. Cluster headaches occur primarily in men and have been classified as vascular headaches that have been associated with high blood pressure, smoking, and alcohol use. However, the exact pathogenesis of cluster headaches is uncertain. Positron emission tomography (PET) scanning and magnetic resonance imaging(MRI) have shown the hypothalamic region may be important in the pathogenesis of cluster headaches. Alterations in hormonal or serotonergic function may also play a role. Treatment of cluster headaches includes pharmacologic interventions for acute episodes and prophylaxis, sphenopalatine ganglion(SPG) blockade, and surgical procedures such as percutaneous sphenopalatine ganglion radiofrequency rhizotomy, and gamma knife radiosurgery of the trigeminal nerve.

Neurologic and Psychiatric Disorders

The role of DBS in treatment of other treatment-resistant neurologic and psychiatric disorders, particularly Tourette syndrome, epilepsy, major depressive disorders, and obsessive-compulsive disorder (OCD), is also being investigated. Ablative procedures are irreversible and, though they have been refined, remain controversial treatments for intractable illness. Interest has shifted to neuromodulation through DBS of nodes or targets within neural circuits involved in these disorders. Currently, a variety of target areas are being studied.

Summary of Evidence

For individuals who have essential tremor or tremor in PD who receive DBS 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 DBS of the thalamus results in clinically significant tremor suppression and that outcomes after DBS 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 DBS. The evidence is sufficient to determine thatthe technology results in a meaningful improvement in the net health outcome.


For individuals who have symptoms (eg, speech, motor fluctuations) associated with PD (advanced or >4 years in duration with early motor symptoms) who receive DBS of the globus pallidus interna (GPi) or subthalamic nucleus (STN), the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatmentrelated morbidity. One of the systematic reviews (a TEC Assessment) concluded that studies on DBS of the GPi or STN have consistently demonstrated clinically significant improvements in outcomes (eg, neurologic function). Other systematic reviews also found significantly better outcomes after DBS than after a control intervention. An RCT in patients with levodoparesponsive PD of at least 4 years in duration and uncontrolled motor symptoms found that quality of life at 2 years was significantly higher when DBS was provided in addition to medical therapy. Meta-analyses of RCTs comparing DBS of the GPi and STN have reported mixed findings and have not shown that 1 type of stimulation is clearly superior to the other. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have primary dystonia who receive DBS of the GPi or STN, the evidence includes systematic reviews, an RCT, 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 the last follow-up (mean, 32 months). A double-blind RCT found that severity scores improved more after active than after sham stimulation. The evidence is sufficient todetermine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have tardive dyskinesia or tardive dystonia who receive DBS, the evidence includes case series, one of which included a double-blind comparison of outcomes when the DBS device was turned on versus off. 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). Additional studies, especially RCTs or other controlled studies, are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have epilepsy who receive DBS, the evidence includes 2 systematic reviews of RCTs and many observational studies. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Two RCTs were identified. The larger reported that DBS had a positive impact during some parts of the blinded trial phase but not others, and a substantial number of adverse events (in >30% of patients). The smaller RCT (N=16) showed a benefit with DBS. 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 DBS on patient outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have multiple sclerosis (MS) who receive DBS, 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 impact of DBS in this population. Additional trials are required. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have Tourette syndrome who receive DBS, the evidence includes crossover RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Several small (=15 patients) crossover studies and a 2015 meta-analysis have suggested that DBS may improve outcomes in patients with Tourette syndrome. However, the optimal target of the brain for DBS is unknown, so additional controlled studies in larger numbers of patients are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have cluster headaches or facial pain who receive DBS, 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 randomized study, 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 the effects of the technology on health outcomes.

For individuals who have treatment-resistant depression who receive DBS, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The only double-blind, parallel-group RCT in patients with depression did not find that DBS significantly increased the response rate compared with sham; 2 other RCTs were stopped due to futility. A crossover controlled trial randomized patients to active or to sham stimulation 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; these findings may not be generalizable. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have obsessive-compulsive disorder who receive DBS, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Among the RCTs on DBS for obsessive-compulsive disorder, only 1 has reported the outcome of greatest clinical interest (therapeutic response rate), and that trial did not find a statistically significant benefit for DBS compared to sham treatment. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have anorexia nervosa, alcohol addiction, Alzheimer disease, Huntington disease, or chronic pain who receive DBS, 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 DBS for these conditions. The evidence is insufficient to determine the effects of the technology on health outcomes.

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