Effective Date: 1/1/2019 Section: SUR Policy No: 395 1/1/19 Medical Policy Committee Approved Date: 8/17; 2/18; 12/18 Medical Officer Date APPLIES TO: Medicare Only See Policy CPT/HCPCS CODE section below for any prior authorization requirements BENEFIT APPLICATION CRITERIA This policy is based on the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) for for Essential Tremor and Parkinson s Disease (160.24), National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7), and National Coverage Determination (NCD) for Treatment of Motor Function Disorders with Electric Nerve Stimulation (160.2). 1-3 NCD for for Essential Tremor and Parkinson s Disease (160.24) I. Effective for services furnished on or after April 1, 2003, Medicare will cover unilateral or bilateral thalamic ventralis intermedius nucleus (VIM) deep brain stimulation (DBS) for the treatment of essential tremor (ET) and/or Parkinsonian tremor and unilateral or bilateral subthalamic nucleus (STN) or globus pallidus interna (GPi) DBS for the treatment of Parkinson's disease (PD) only under the following (A.-C.) conditions: A. Medicare will only consider DBS devices to be reasonable and necessary if they are Food and Drug Administration (FDA) approved devices for DBS or devices used in accordance with FDA approved protocols governing Category B Investigational Device Exemption (IDE) DBS clinical trials. B. For thalamic VIM DBS to be considered reasonable and necessary, patients must meet all of the following criteria: 1. Diagnosis of ET based on postural or kinetic tremors of hand(s) without other neurologic signs, or diagnosis of idiopathic PD (presence of at least 2 cardinal PD features (tremor, rigidity or bradykinesia)) which is of a tremor-dominant form. 2. Marked disabling tremor of at least level 3 or 4 on the Fahn-Tolosa-Marin Clinical Tremor Rating Scale (or equivalent scale) in the extremity intended for treatment, causing significant limitation in daily activities despite optimal medical therapy. Page 1 of 7
3. Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings. C. For STN or GPi DBS to be considered reasonable and necessary, patients must meet all of the following criteria: 1. Diagnosis of PD based on the presence of at least 2 cardinal PD features (tremor, rigidity or bradykinesia). 2. Advanced idiopathic PD as determined by the use of Hoehn and Yahr stage or Unified Parkinson's Disease Rating Scale (UPDRS) part III motor subscale. 3. L-dopa responsive with clearly defined "on" periods. 4. Persistent disabling Parkinson's symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy. 5. Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings. II. The DBS is not reasonable and necessary and is not covered for ET or PD patients with any of the following (A.-H.): A. Non-idiopathic Parkinson's disease or "Parkinson's Plus" syndromes. B. Cognitive impairment, dementia or depression, which would be worsened by or would interfere with the patient's ability to benefit from DBS. C. Current psychosis, alcohol abuse or other drug abuse. D. Structural lesions such as basal ganglionic stroke, tumor or vascular malformation as etiology of the movement disorder. E. Previous movement disorder surgery within the affected basal ganglion. F. Significant medical, surgical, neurologic or orthopedic co-morbidities contraindicating DBS surgery or stimulation. G. Patients who undergo DBS implantation should not be exposed to diathermy (deep heat treatment including shortwave diathermy, microwave diathermy and ultrasound diathermy) or any type of MRI, which may adversely affect the DBS system or adversely affect the brain around the implanted electrodes. H. The DBS should be performed with extreme caution in patients with cardiac pacemakers or other electronically controlled implants, which may adversely affect or be affected by the DBS system. III. For DBS lead implantation to be considered reasonable and necessary, providers and facilities must meet all of the following (A.-D.) criteria: A. Neurosurgeons must: 1. Be properly trained in the procedure; 2. Have experience with the surgical management of movement disorders, including DBS therapy; and 3. Have experience performing stereotactic neurosurgical procedures. B. Operative teams must have training and experience with DBS systems, including knowledge of anatomical and neurophysiological characteristics for localizing the targeted nucleus, surgical and/or implantation techniques for the DBS system, and operational and functional Page 2 of 7
characteristics of the device. C. Physicians specializing in movement disorders must be involved in both patient selection and post-procedure care. D. Hospital medical centers must have: 1. Brain imaging equipment (MRI and/or CT) for pre-operative stereotactic localization and targeting of the surgical site(s); 2. Operating rooms with all necessary equipment for stereotactic surgery; and 3. Support services necessary for care of patients undergoing this procedure and any potential complications arising intraoperatively or postoperatively. NCD for Electrical Nerve Stimulators (160.7) IV. The implantation of central nervous system stimulators may be covered as therapies for the relief of chronic intractable pain, subject to the following (A.-B.) conditions: A. There are two types of implantations covered by this instruction: 1. Dorsal Column (Spinal Cord) Neurostimulation - The surgical implantation of neurostimulator electrodes within the dura mater (endodural) or the percutaneous insertion of electrodes in the epidural space is covered. 2. Depth Brain Neurostimulation - The stereotactic implantation of electrodes in the deep brain (e.g., thalamus and periaqueductal gray matter) is covered. B. No payment may be made for the implantation of dorsal column or depth brain stimulators or services and supplies related to such implantation, unless all of the conditions listed below have been met: 1. The implantation of the stimulator is used only as a late resort (if not a last resort) for patients with chronic intractable pain; 2. With respect to item a, other treatment modalities (pharmacological, surgical, physical, or psychological therapies) have been tried and did not prove satisfactory, or are judged to be unsuitable or contraindicated for the given patient; 3. Patients have undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to implantation. (Such screening must include psychological, as well as physical evaluation); 4. All the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment training, and follow up of the patient (including that required to satisfy item c) must be available; and 5. Demonstration of pain relief with a temporarily implanted electrode precedes permanent implantation. NCD for Treatment of Motor Function Disorders with Electric Nerve Stimulation (160.2) V. While electric nerve stimulation has been employed to control chronic intractable pain for some time, its use in the treatment of motor function disorders, such as multiple sclerosis, is a recent innovation, and the medical effectiveness of such therapy has not been verified by scientifically controlled studies. VI. Where electric nerve stimulation is employed to treat motor function disorders, no reimbursement Page 3 of 7
may be made for the stimulator or for the services related to its implantation since this treatment cannot be considered reasonable and necessary. CPT/HCPCS CODES Medicare Only Prior Authorization Required 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 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 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 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 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 2 or more electrode arrays 61888 Revision or removal of cranial neurostimulator pulse generator or receiver 95836 Electrocorticogram from an implanted brain neurostimulator pulse generator/transmitter, including recording, with interpretation and written report, up to 30 days 95976 Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact Page 4 of 7
other qualified health care professional; with simple cranial nerve neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional 95977 Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact other qualified health care professional; with complex cranial nerve neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional 95978 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 95979 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) 95983 Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact 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 95984 Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact 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) C1767 Generator, neurostimulator (implantable), non-rechargeable C1778 Lead, neurostimulator (implantable) 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 Adapter/, pacing lead or neurostimulator lead (implantable) C1897 Lead, neurostimulator test kit (implantable) L8679 Implantable neurostimulator, pulse generator, any type L8680 Implantable neurostimulator electrode, each Page 5 of 7
L8681 L8682 L8683 L8685 L8686 L8687 L8688 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 Implantable neurostimulator pulse generator, single array, non-rechargeable, includes Implantable neurostimulator pulse generator, dual array, rechargeable, includes Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes No Prior Authorization Required 95970 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 L8689 External recharging system for battery (internal) for use with implantable neurostimulator, replacement only Unlisted Codes All unlisted codes will be reviewed for medical necessity, correct coding, and pricing at the claim level. If an unlisted code is billed related to services addressed in this policy then priorauthorization is required. 64999 Unlisted procedure, nervous system INSTRUCTIONS FOR USE Providence Health Assurance (PHA) Medical Policies serve as guidance for the administration of plan benefits. Medical policies do not constitute medical advice nor a guarantee of coverage. PHA Medical Policies are reviewed annually and are based upon Centers for Medicare & Medicaid (CMS) coverage guidance available as of the last policy update. PHA reserves the right to determine the application of Medical Policies and make revisions to its Medical Policies at any time. Providers will be given at least 60-days notice of policy changes that are restrictive in nature. The scope and availability of all plan benefits are determined in accordance with the applicable coverage agreement. Any conflict or variance between the terms of the coverage agreement and PHA Medical Policy will be resolved in favor of the coverage agreement. Page 6 of 7
REGULATORY STATUS Mental Health Parity Statement Coverage decisions are made on the basis of individualized determinations of medical necessity and the experimental or investigational character of the treatment in the individual case. REFERENCES 1. Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) for for Essential Tremor and Parkinson s Disease (160.24). 2003; https://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=279&ncdver=1&searchtype=advanced&coverageselection=both&ncselect ion=nca%7ccal%7cncd%7cmedcac%7cta%7cmcd&articletype=sad%7ced&policytype=bot h&s=44&keyword=deep+brain+stimulation&keywordlookup=doc&keywordsearchtype=exact &kq=true&bc=iaaaacaaaaaaaa%3d%3d&. Accessed 7/6/2017. 2. Centers for Medicare & Medicaid Services National Coverage Determination: Electrical Nerve Stimulators (160.7). 1995; https://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=240&ncdver=1&docid=160.7&bc=gaaaaagaaaaaaa%3d%3d&. Accessed 7/6/2017. 3. Centers for Medicare & Medicaid Services National Coverage Determination (NCD): Treatment of Motor Function Disorders with Electric Nerve Stimulation (160.2). 2003; https://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=22&ncdver=2&docid=160.2&bc=gaaaaagaaaaaaa%3d%3d&. Accessed 7/6/2017. Page 7 of 7