Humana Deep Brain Stimulation and Cortical Stimulation - Medicare Advantage Form

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals. Type Title ID Number Jurisdiction Medicare Administrative Contractors (MACs) Applicable States/Territories Internet Only Manuals NCD NCD NCD Medicare Benefit Policy Manual Chapter 15 – Covered Medical and Other Health Service Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease Electrical Nerve Stimulators Treatment of Motor Function Disorders with Electric Nerve Stimulation Category III Codes Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Tremor Magnetic Resonance Guided Focused Ultrasound Surgery System (MRgFUS) for the treatment of neurologic conditions Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease Deep Brain Stimulation and Cortical Stimulation Page: 2 of 15 §120 - Prosthetic Devices 160.24 160.7 160.2 L35490 A56902 L37421 A57435 L37790 A58323 J5 – J8 - Wisconsin Physicians Service Insurance Corporation J6 – JK - National Government Services, Inc. (Part A/B MAC) IA, KS, MO, NE IN, MI IL, MN, WI CT, NY, ME, MA, NH, RI, VT J15 - CGS Administrators, LLC (Part A/B MAC) KY, OH L37729 A57512 JE - Noridian Healthcare Solutions, LLC CA, HI, NV, American Samoa, Guam, Northern Mariana Islands L37738 A57513 JF - Noridian Healthcare Solutions, LLC AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor L38495 A57839 JH – JL Novitas Solutions, Inc. (Part A/B MAC) AR, CO, NM, OK, TX, LA, MS DE, D.C., MD, NJ, PA Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor L37761 A56690 JJ – JM - Palmetto GBA (Part A/B MAC) AL, GA, TN NC, SC, VA, WV Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor L38506 A57884 JN - First Coast Service Options, Inc. (Part A/B MAC) FL, PR, U.S. VI LCD LCA LCD LCA LCD LCA LCD LCA LCD LCA LCD LCA LCD LCA LCD LCA Deep Brain Stimulation and Cortical Stimulation Page: 3 of 15 Description Deep brain stimulation (DBS) involves the surgical placement of electrodes, also called leads, in selected areas of the brain to treat neurological disorders. The electrodes are placed using magnetic resonance imaging (MRI) or computed tomography (CT) to guide the neurosurgeon to the site to be stimulated. Fiducial markers are small titanium screws, which may be placed into the anesthetized scalp prior to DBS, to assist physicians with stereotactic or computerized targeting for the exact DBS lead location during surgery. After placement, a CT scan is performed to verify accuracy. The fiducial markers remain in place until after DBS leads are inserted. During DBS lead placement, the individual may be asked to move their fingers or toes or answer questions. This stimulation test helps the surgeon confirm accurate placement and effectiveness of the permanent electrodes in the brain. These are later connected to a neurostimulator (also referred to as a neurotransmitter or pulse generator) that is implanted under the skin, usually near the collarbone. The battery operated neurostimulator sends high frequency electrical signals to the electrodes which inhibit the activity in that region of the brain. The DBS is programmed with the intensity, frequency and duration according to the individual’s symptoms and can be readjusted as symptoms change. Directional deep brain stimulation enables the current to be steered precisely to the targeted structural area 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 RC neurostimulator for essential tremor (ET) and Parkinson’s disease 59 • Activa SC neurostimulator for chronic, intractable primary dystonia including generalized and/or segmental dystonia, hemidystonia and cervical dystonia (torticollis)65 • Infinity DBS system for ET and Parkinson’s disease27 • Reclaim DBS for obsessive compulsive disorder (OCD)66 • SenSight directional lead system (SenSight lead, Percept PC stimulator) for dystonia, epilepsy, ET and Parkinson’s disease • Vercise directional system (Cartesia lead, and DBS, Genus, Gevia or PC stimulators) for ET and Parkinson’s disease64 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 Deep Brain Stimulation and Cortical Stimulation Page: 4 of 15 bilaterally. An example of an FDA-approved DBS device for the treatment of drug-resistant epilepsy is the Medtronic DBS System for Epilepsy.34,62 Cortical stimulation is a treatment option for individuals with refractory focal epilepsy and a well delineated seizure focus which may be useful when resective epilepsy surgery is not possible. Cortical stimulation devices use a closed-loop cortical stimulation unit paired to a seizure detection system.24,34,48 An example of an FDA-approved cortical stimulation system is the NeuroPace RNS System which is used as an adjunct to medication in adults with partial onset seizures from no more than two foci that are refractory to two or more antiepileptic medications. The device is implanted in the skull while the individual is under general anesthesia. 28,33,63 The implantable components include a neurostimulator, a depth lead and a cortical strip lead. The external components include the programmer, a laptop computer with proprietary software that has a wand and telemetry interface enabling communication with an implanted RNS neurostimulator. Physicians use the programmer to noninvasively program the detection and stimulation parameters of an implanted device and are able to view the individual's brain electrical activity in real time as well as upload information that has been stored in the RNS neurostimulator. The system monitors brain activity to detect seizures as they start and delivers electrical stimulation to the seizure focus to stop seizure activity before it becomes clinically apparent. The typical individual is treated with a cumulative total of 5 minutes of stimulation a day and the treatment is reversible. Magnetic resonance guided focused ultrasound (MRgFUS, [eg, ExAblate Neuro]), is a treatment option that purportedly treats medication refractory ET or movement disorder and tremor dominant Parkinson’s disease. MRgFUS therapy, also called transcranial MR-guided high-intensity focused ultrasound (MRgHIFU), uses a stereotactic head frame/helmet like device with a cooling cap and an individual ultrasound transducer to thermally ablate the thalamus in the ventral intermediate nucleus creating an intracranial therapeutic lesion. The MR images assist in treatment positioning providing real time feedback. The created lesion disrupts the brain activity thought to be responsible for an ET. This procedure is performed unilaterally and is less invasive than DBS implantation or a traditional thalamotomy that involves drilling or boring a hole into the skull to create a therapeutic lesion. Coverage Determination Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. Please refer to the above CMS guidance for Deep brain stimulation. Please refer to the above CMS guidance for MRgFUS/MRgHIFU. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following: Deep Brain Stimulation and Cortical Stimulation Page: 5 of 15 Cortical Stimulation Cortical stimulation (eg, NeuroPace RNS) will be considered medically reasonable and necessary ALL of the following criteria are met28,33,63: • Partial-onset seizures; AND • Currently averaging 3 or more disabling seizures (eg, partial motor seizures, complex partial seizures and/or secondarily generalized seizures) a month over the 3 most recent months; AND • Individual is able to or has the necessary assistance to properly operate the device or magnet; AND • Individual is not pregnant; AND • No more than 2 epileptogenic foci localized by diagnostic testing; AND • Refractory to 2 or more antiepileptic medications; AND • No other implanted medical devices that deliver electrical energy to the brain; AND • Not currently a candidate for resective epilepsy surgery; AND • Not high risk for surgical complications such as active systemic infection, coagulation disorders (such as the use of antithrombotic therapies) or platelet count below 50,000; AND • The device is FDA approved Replacement/revision of a stimulator/generator/battery and/or lead/electrode and/or programmer is considered medically necessary if the original generator/lead/programmer is no longer under warranty and cannot be repaired.10 The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage DBS will not be considered medically reasonable and necessary for any indications other than those listed above including, but not limited to the following11,22,30,37: • Alzheimer’s Disease21 • Cerebral palsy43 Deep Brain Stimulation and Cortical Stimulation Page: 6 of 15 • Chronic neuropathic pain42 • Cluster headaches45 • Depression8, 27, 57, 58 • Movement disorder caused by multiple sclerosis (MS)52 • Obsessive compulsive disorder (OCD)7,9,23,35,46 • Orthostatic tremor • Tourette syndrome4,54 A review of the current medical literature shows that the evidence is insufficient to determine that this service is standard medical treatment for these indications. There remains an absence of randomized blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management for these indications. The placement of fiducial markers is considered integral to the primary procedure and not separately reimbursable.