Clinical Policy Title: Deep brain stimulation

Transcription

1 Clinical Policy Title: Deep brain stimulation Clinical Policy Number: Effective Date: July 1, 2015 Initial Review Date: February 18, 2015 Most Recent Review Date: March 16, 2016 Next Review Date: March 2017 Related policies: Policy contains: Parkinson s disease. Essential tremor. Obsessive-compulsive disorder. Dystonias and other movement disorders. Tardive dyskinesia or syndrome. None. ABOUT THIS POLICY: AmeriHealth Caritas Iowa has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Iowa s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas Iowa when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas Iowa s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas Iowa s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Iowa will update its clinical policies as necessary. AmeriHealth Caritas Iowa s clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas Iowa considers the use of deep brain stimulation (DBS) at the levels of uni- or bilateral thalamic ventralis intermedius (VIM) and unilateral or bilateral subthalamic nucleus (STN) or globus pallidus interna (GPi) DBS to be clinically proven and, therefore, medically necessary when criteria A, B and C are met: A. Diagnosis: Any one of the following functional impairments is present and is not responsive with standard medical care: Essential tremor (ET). Parkinson s disease (PD). Obsessive-compulsive disorder (OCD) refractory to all non-invasive treatment. B. DBS options for: Stimulation criteria VIM for essential tremor or idiopathic PD eligibility requirements Stimulation criteria Uni- or bilateral STN or GPi PD requirements Bilateral DBS Postural or kinetic tremor of STM or GPi stimulation: OCD refractory to all 1

2 B. DBS options for: Stimulation criteria VIM for essential tremor or idiopathic PD eligibility requirements hand(s) without other neurologic signs. At least two cardinal PD features and tremor-dominant form. Stimulation criteria Uni- or bilateral STN or GPi PD requirements Two cardinal features (tremor, rigidity, bradykinesia). Advanced disease according to Hoen-Yahr scale (see glossary). L-dopa responsive with clearly defined on periods. Persistent disabling symptoms or drug side effects (dyskinesias, motor fluctuations or disabling off periods). Bilateral DBS standard medical and psychotherapies. C. Device criteria: Must be an FDA-approved device. Limitations: Evidence is insufficient for all other conditions such as but not limited to DBS in early PD, epilepsy, treatment-resistant depression, spinal cord injury-associated pain and tic disorders in children. Alternate covered services: Medical management as discussed by diagnosis below. Background DBS is a surgically implanted device applying high-frequency stimulation to a targeted area. The implanted electrode is connected to a computerized pulse generator under the skin, analogous to the arrangement with a cardiac pacemaker. The U.S. Food and Drug Administration (FDA) approved the Activa Tremor Control System (Medtronic, Minneapolis) in 2002, contingent on post-approval studies to assess long-term results. ET (also known as benign tremor, familial tremor or shaky hand syndrome) is a common movement disorder of uncertain cause, typically involving hands, arms or fingers. It is distinct from PD, although it is sometimes misdiagnosed as such and a single individual may (rarely) experience both. In contrast to PD s resting tremor, ET s resting tremor occurs with sustained muscle activity. When symptoms are sufficiently troublesome to warrant treatment, beta-blockers and anti-epileptics may be used. 2

3 OCD is an anxiety disorder characterized by intrusive thoughts that produce uneasiness, apprehension, fear or worry (obsessions); repetitive behaviors aimed at reducing the associated anxiety (compulsions); or a combination of obsessions and compulsions. Symptoms may include excessive washing or cleaning; repeated checking; extreme hoarding; preoccupation with sexual, violent or religious thoughts; relationship-related obsessions; aversion to particular numbers; and rituals such as opening and closing a door a certain number of times before entering or leaving a room. Symptoms are frequently timeconsuming, burdensome to interpersonal relationships and a source of severe emotional and financial distress. This use is not established and remains investigational. PD is a chronic, progressive, neurodegenerative disorder with an estimated prevalence of 31 to 328 per 100,000 people worldwide. It is estimated approximately 1 percent to 2 percent of the population over age 65 have PD; incidence and prevalence increase with age. With the increase in the average age of the population of developed countries, an increase in the prevalence of PD is to be expected. Some studies report PD affects males and females equally, while others report PD is somewhat more prevalent in men. All races and ethnic groups are affected. The mortality for elderly PD patients is two to five times higher than in age-matched controls. PD places a major burden on both individual and societal health care resources, and most cases are classified as idiopathic (of uncertain cause). PD is characterized by resting tremor, rigidity, bradykinesia and postural instability. While treatment with levodopa can usually restore smooth motor function up to five to 10 years after onset, effectiveness gradually diminishes over time. No known treatment halts progression. There is no cure and treatment-resistant symptoms (dementia, dystonia, dysautomonia and motor symptoms affecting speech, swallowing and gait) almost invariably occur. Searches AmeriHealth Caritas Iowa searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on February 12, Search terms were: deep brain stimulation. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. 3

4 Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings CMS covers DBS for PD and ET, although searches for this policy identified only one systematic review (Zesiewicz, 2011), with an insufficient evidence finding for the latter. Use in advanced or late PD is supported by randomized controlled trials (RCTs) and economic analyses (Eggington, 2014; Dams, 2013), although HIQA Ireland (2012) found otherwise in an assessment conducted from the perspective of PD patients who would be treated abroad under Irish funding. Systematic reviews for OCD explicitly applying the Bradford Hill criteria to observational studies classify DBS as compelling or promising. Outstanding research issues include long-term effects, optimal brain sites for application, standardization of outcome measures for PD and battery life/other maintenance issues for DBS. Reviewers found insufficient evidence for DBS in early PD, epilepsy, treatment-resistant depression, tardive syndrome, spinal cord injury-associated pain and tic disorders in children. Policy updates: No change to policy coverage. Updated resources: Three new Local Coverage Determinations (LCDs) on intraoperative neurophysiological testing. One was effective in October 2015 and two were effective in February Summary of clinical evidence: Citation Berlim (2014) Content, Methods, Recommendations Treatment-resistant depression: Prospective studies, Four observational studies (66 subjects). Insufficient evidence. Eggington (2014) Parkinson s disease: cost-effectiveness: DBS and best medical therapy (BMT) versus best medical alone: Markov model: UK payer perspective over five years. Total costs: DBS ( 68,970); BMT( 48,243); quality-adjusted life years (QALYS) 4

5 Citation Hamani (2014) Content, Methods, Recommendations gained, 2.21,1.21 respectively; ICER, DBS is cost-effective for patients who are candidates for surgery. Uncertainty attributable to costs for ongoing medication. OCD: PubMed, articles reviewed, seven with adequate sample size (up to 44 patients in largest series) and follow-up period. Excluded: pre-clinical; reviews; series < six patients; follow-up < six months. Recommendations: RCT support for bilateral STN for medically refractory OCD. Unilateral: insufficient evidence. Kisely (2014) OCD: RCTs, April Five trials (44 subjects). Patients on DBS had significantly lower symptom scores (partial remissions) but also higher rate of adverse effects. Promising but insufficient evidence for other psychiatric conditions. Liu (2014) STN versus GPi stimulation in advanced PD: Comparisons published up to April Six trials (563 patients). Both improve symptoms and function: no therapeutically significant differences. Prestelo-Perez (2014) PD: RCTs, April Six trials (1,184). Moderate effects for motor signs, time in good function and quality of life (QoL). Intense effects for motor signs and improved function in off periods. More research on neuro-cognitive and psychiatric effects needed. Sprengers (Cochrane; 2014) Epilepsy: RCTs without language restriction, August trials (one to three months DBS in various locations versus sham). One trial, anterior thalamic (N 109). Two trials, centro-median thalamic (20 subjects), only one of which reported sufficient information for meta-analysis. 5

6 Citation Bhidayasiri (2013) Content, Methods, Recommendations Only short-term trials available: insufficient evidence. Tardive syndrome: insufficient evidence. Canadian Agency tor Drugs and Technologies in Health (CADTH) (2013) Dams (2013) Battery replacement and maintenance for DBS: only one guideline available (HIQA, 2012). Cost-effectiveness for PD: Markov model using effectiveness data from published studies and costs from German health care system. Lifetime cost-utility per QALY, 6,700. Sensitivity analyses: costs sensitive to values for surgery and battery exchange. DBS is cost-effective: value for money similar to other well-accepted interventions. Health Quality Ontario (2013) Murphy (2013) Treatment-resistant depression (preliminary review): insufficient evidence for full analysis. Tic disorders in children and adolescents: DBS is not recommended. Hayes, Inc. (2012) Treatment-resistant depression: C rating: early positive results from small number of uncontrolled studies and possible conflict of interest for investigators. HIQA (2012) Health Information and Quality Authority-Ireland Albanese (20011) National DBS service in Ireland (for PD and movement disorders) would cost an additional 20,900 per patient over 10 years. Primary dystonias: good option for primary generalized or segmental after botulinum toxin or other medication. Oertel (2011) Management of early uncomplicated PD: DBS is not among interventions considered. 6

7 Citation Zesiewicz (2011) Content, Methods, Recommendations ET: insufficient evidence. APA (2007) American Psychiatric Association Levine (AHRQ; 2003) OCD: potential harms of DBS listed, but otherwise no recommendations for or against. PD: English-language studies, Overall problems with standardized outcomes. DBS (STN and GPi); end-point symptom scores better than baseline, but only former associated with decreased L-dopa doses. Vatz (BCBS TEC; 2002) Advanced PD: Available evidence for bilateral DBS. 14 small trials (186 patients); compares outcomes for STN versus GPi bilateral stimulation; mean FU, months. Evidence judged compelling on grounds of large number of patients (aggregated across descriptive studies); consistency of findings and magnitude of clinical improvements (Bradford-Hill criteria). McMaster Evidence-Based Practice Center(AHRQ; 2002) Chronic neuropathic pain following spinal cord injury: Primary clinical studies, May Low rate of early success and even lower rate long-term, plus important adverse effects. Use is not justified. Glossary Bradford Hill criteria A group of criteria necessary to suggest a causal relationship between intervention and outcome in the absence of RCTs (i.e., based on observational or other uncontrolled studies). The criteria were first defined by, and named for, the English epidemiologist Sir Austin Bradford Hill ( ) in 1965 and consist of the following: Strength The larger the association, the more likely that it is causal. Consistency consistent findings for magnitude and direction of effect observed by different persons in different places and separated in time. 7

8 Specificity very specific population (defined by demographics or disease), a particular place and absence of an alternate explanation. Temporality The effect must occur after the cause (and if there is an expected delay between the cause and expected effect, then the effect must occur after that delay). Dose-response gradient Greater exposure should generally lead to greater magnitude of effect. Plausibility Biologically plausible association, recognizing that definition of pathophysiology is limited by current knowledge. Bradykinesia An impaired ability to adjust body position. Hoen-Yahr scale: for symptom progression in PD Stage Original H-Y scale Modified H-Y Median time to transit (months) 1 Unilateral involvement with minimal Unilateral only -- disability 2 Bilateral or midline without balance Unilateral and axial 20 impairment 3 Bilateral with mild-moderate disability Mild bilateral 25 4 Severely disabling but still able to walk Severe disability but able to 24 or stand unassisted walk or stand 5 Confined to bed or wheelchair Wheelchair or bedridden without assistance 26 Levodopa (or L-dopa) A chemical made and used as part of normal biology in humans, some animals and plants. L-dopa is the precursor to neurotransmitters dopamine, norepinephrine and epinephrine (adrenalin), collectively known as catecholamines. It is used to increase catecholamine concentrations in PD, where effects are characterized by on and off (or wearing off) periods, the former indicating periods of symptom control, the latter, symptom return, which may be predictable or sudden and unexpected. Medically necessary A service or benefit is medically necessary if it is compensable under the Medical Assistance program and if it meets any one of the following standards: The service or benefit will, or is reasonably expected to, prevent the onset of an illness, condition or disability. The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental or developmental effects of an illness, condition, injury or disability. The service or benefit will assist the member to achieve or maintain maximum functional capacity in performing daily activities, taking into account both the functional capacity of the member and those functional capacities that are appropriate for members of the same age. Neuropathic pain Caused by damage or disease within the nervous system. 8

9 Subthalamic nucleus (STN) One of the regions within the brain targeted by DBS for PD. Tic disorders Sudden involuntary and repeated twitches, movements or sounds. Examples include Tourette s syndrome, chronic motor or vocal tic disorder, and provisional tic disorder. References Professional society guidelines/other: American Psychiatric Association (APA). Practice guideline for treatment of patients with obsessivecompulsive disorder. American Psychiatric Association (APA) Canadian Agency for Drugs and Technologies in Health (CADTH). Battery replacement and maintenance of deep brain stimulators: guidelines and recommendations. Rapid response report. August 19, Hayes, Inc. Deep brain stimulation for treatment-resistant depression. Directory pocket summary. November 5, Health Information and Quality Authority (Ireland). Health technology assessment of a national deep brain stimulation service in Ireland. October 11, Health Quality Ontario. Deep brain stimulation for treatment-resistant depression: a preliminary evidence review. [Internet]. Toronto, ON: Health Quality Ontario; July Vatz JB. Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) or the globus Pallidus interna (GPi) for treatment of advanced Parkinson s disease. Technology Evaluation Center. Blue Cross and Blue Shield Association. Chicago Peer-reviewed references: Albanese A, Asmus G, et al. A systematic review on the diagnosis and treatment of primary (idiopathic) dystonias. European Journal of Neurology. 2011;18(1):5 18. Bhidayasiri R, Fahn S, et al. Evidence-based guideline: treatment of tardive syndrome. Neurology. 2013;81(5): Berlim MT, McGerr A, et al. Effectiveness and acceptability of deep brain stimulation (DBS) of the subgenual cingulate cortex for treatment-resistant depression: a systematic review and meta-analysis. Affective Disorders. 2014;159:

10 Eggington S, Valldeoriola F, et al. The cost-effectiveness of deep brain stimulation in combination with best medical therapy, versus best medical therapy alone, in advanced Parkinson s disease. J Neurol. 2014;261: Fasano A, Aquino CC, et al. Axial disability and deep brain stimulation in patients with Parkinson disease. Nature Reviews Neurology Hamani C, Pilitsis J, et al. Deep brain stimulation for obsessive-compulsive disorder: systematic review and evidence-based guideline sponsored by the American Society for Stereotactic and Functional Neurosurgery and the Congress of Neurological Surgeons (CNS) and endorsed by the CNS and American Association of Neurosurgeons. Neurosurgery. 2014;25(4): Kisely S, Hall K, Siskind D, et al. Deep brain stimulation for obsessive-compulsive disorder: a systematic review and meta-analysis. Psychological Medicine.2014;44(16): Levine CB, Fahrbach KR, et al. Diagnosis and management of Parkinson s Disease: a systematic review of the literature. Evidence report/technology assessment no. 57. (Prepared by Meta-Works, Inc. under contract No ) AHRQ publication No. 03-E040. Rockville, MD: Agency for Healthcare Research and Quality. June Liu Y, Li W, et. al. Meta-analysis comparing stimulation sites in advanced Parkinson s disease: a review. J Neurosurg.2014; 121(3): McMaster University Evidence-based Practice Center. Management of chronic central neuropathic pain following traumatic spinal cord injury. Evidence Report/Technology Assessment No. 45. Prepared for the Agency for Healthcare Research and Quality under contract no (archived). Clinical trials: Searched clinicaltrials.gov on February 9, 2015, using terms using deep brain stimulation Open Studies. 315 studies of varying designs and addressing most of the diagnoses covered here. Physicians interested in supporting research participation should consult the website for studies relevant to, and geographically accessible for, individual patients. CMS National Coverage Determinations (NCDs): National Coverage Determination: Deep brain stimulation for essential tremor (ET) and Parkinson s disease (PD). (NCD ). Effective April 1, 2003): Accessed February 15,

11 LCDs: Local Coverage Determination (LCD): Psychological and Neuropsychological Testing (L34646) Effective date 02/01/ Accessed February 15, (LCD): Intraoperative Neurophysiological Testing (L35003). Effective October 1, Accessed February 15, (LCD): Intraoperative Neurophysiological Testing L Effective February 1, Accessed February 15, Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comment 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 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; each additional array (List separately in addition to primary procedure) 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 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) Revision or removal of intracranial neurostimulator electrodes Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to 2 or more electrode arrays 11

12 CPT Code Description Comment Electronic analysis of implanted neurostimulator pulse generator system (eg, 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 (ie, cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex cranial nerve neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, with or without nerve interface testing, first hour Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex cranial nerve neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, each additional 30 minutes after first hour (List separately in addition to code for primary procedure) Electronic analysis of implanted neurostimulator pulse generator system (eg, 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 Electronic analysis of implanted neurostimulator pulse generator system (eg, 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; each additional 30 minutes after first hour (List separately in addition to code for primary procedure) ICD 10 Code Description Comment G20 Parkinson's disease G21.4 Vascular parkinsonism G22.11 Neuroleptic induced parkinsonism G21.19 Other drug induced secondary parkinsonism G21.2 Secondary parkinsonism due to other external agents G21.3 Postencephalitic parkinsonism G21.8 Other secondary parkinsonism G21.9 Secondary parkinsonism, unspecified 12

13 G25.0 Essential tremor G24.1 Genetic torsion dystonia G24.2 Idiopathic nonfamilial dystonia G24.8 Other dystonia G24.01 Drug induced subacute dyskinesia F42 Obsessive-compulsive disorder HCPCS Code Description Comment C1767 C1778 C1816 C1883 C1897 E0745 L8680 L8681 L8682 L8683 L8685 L8686 L8687 L8688 L8689 L8695 Generator, neurostimulator (implantable), nonrechargeable Lead, neurostimulator (implantable) Receiver and/or transmitter, neurostimulator (implantable) Adaptor/ extension, pacing lead or neurostimulator lead (implantable) Lead, neurostimulator test kit (implantable) Neuromuscular stimulator, electronic shock unit Implantable neurostimulator electrode, each Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only Implantable neurostimulator radiofrequency receiver Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver Implantable neurostimulator pulse generator, single array, rechargeable, includes extension Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension External recharging system for battery (internal) for use with implantable neurostimulator, replacement only External recharging system for battery (external) for use with implantable neurostimulator, replacement only 13