Description

Transcranial magnetic stimulation (TMS) uses an alternating current passed through a metal coil placed against the scalp near the forehead, to generate rapidly pulsing magnetic fields, which pass through the skull. This produces electric currents that are thought to stimulate certain areas of the brain involved in mood control and depression. Treatment for depression involves delivering repeated magnetic pulses, and is referred to as repetitive TMS or rTMS. The relative intensity or strength of stimulation required for treatment is referred to as a percentage of motor threshold and is regarded as an indicator of the ability to respond to TMS.

Transcranial Magnetic Stimulation and Cranial Electrical Stimulation

Effective Date: 04/27/2023

Revision Date: 04/27/2023

Review Date: 03/23/2023

Policy Number: HUM-0457-022

Page: 2 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Determining the motor threshold takes place prior to beginning therapy and is specific to the individual to be treated.

The standard form of rTMS stimulates the brain’s cortex and is called surface cortical TMS or superficial TMS. It is the most extensively studied form of TMS as well as the most commonly available in clinical practice. It is generally performed in an outpatient setting with a treatment regimen of five days per week for four to six weeks. In addition to its use in treating depression, rTMS is being explored for other conditions.

Deep TMS (dTMS) uses a coil design that induces a magnetic field with a wider and deeper distribution than the standard coil used for surface cortical rTMS.

Other proposed forms of TMS include:

• Accelerated proposes a faster treatment schedule, using multiple sessions per day for fewer weeks duration.
• Bilateral combines high frequency stimulation of the left dorsolateral prefrontal cortex with low frequency stimulation of the right dorsolateral prefrontal cortex (either simultaneously or sequentially) during each session.
• High dose delivers more pulses than usual over the same treatment period (eg, 6000 pulses per session instead of 3000).
• Theta burst, also called intermittent theta-burst stimulation (iTBS) or express TMS, delivers magnetic pulses that are administered at such a rapid speed of delivery that the session may be completed in only six minutes rather than 30 to 40 minutes.

Examples of US Food & Drug Administration (FDA)-approved TMS systems for treating major depressive disorder include, but may not be limited to, Apollo, Brainsway Deep, Horizon, MagVenture and NeuroStar. The Brainsway Deep, Horizon 3.0 and MagVenture TMS systems are also FDA-approved for use as an adjunct treatment of adults with obsessive-compulsive disorder (OCD). NeuroStar has additional clearance for treating major depressive disorder with comorbid anxiety symptoms and has been designated by the FDA as a breakthrough device for treating bipolar depression.

Transcranial Magnetic Stimulation and Cranial Electrical Stimulation

Effective Date: 04/27/2023

Revision Date: 04/27/2023

Review Date: 03/23/2023

Policy Number: HUM-0457-022

Page: 3 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

(Refer to Coverage Limitations section)The SAVI Dual central neuromodulation therapy for the treatment and prevention of migraine headaches in individuals 12 years of age and older. It is proposed that the delivery of single low frequency electromagnetic pulses, also referred to as single pulse TMS (STMS), targets and signals the brain to quiet the hyperactive nerves thought to be the source of the migraine. The SAVI Dual was preceded by Cerena TMS, Spring TMS and sTMS Mini which are no longer marketed. (Refer to Coverage Limitations section)

Navigated transcranial magnetic stimulation (nTMS), also referred to as navigated brain stimulation, is being studied as a way to enhance rTMS therapy and as a noninvasive diagnostic tool for preoperative treatment planning for individuals with brain lesions. nTMS stimulates functional cortical areas at precise anatomical locations to induce a measurable response, which is theorized to locate the target area for depression therapy or to guide surgical resection with fewer neurological deficits.

Examples of nTMS systems include, but may not be limited to:

• Nexstim Navigated Brain Therapy (NBT) System 2: FDA-approved for treating depression and theorized to enhance rTMS
• TMS-Cobot TS MV: FDA-approved robotic aid for use with the MagVenture TMS Therapy System that provides continuous head motion tracking which purportedly improves coil to head position and contact
• Magnus neuromodulation system with SAINT technology: FDA-approved for use with structural and functional magnetic resonance imaging (MRI) and a proprietary algorithm that purportedly identifies the optimal anatomic target allowing TMS to be delivered on an accelerated timeline
• StimGuide+: Software that uses stereotactic three-dimensional (3D) navigation to determine treatment location prior to use with the Horizon 3.0 TMS therapy system

Transcranial Magnetic Stimulation and Cranial Electrical Stimulation

Effective Date: 04/27/2023

Revision Date: 04/27/2023

Review Date: 03/23/2023

Policy Number: HUM-0457-022

Page: 4 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Cranial electrostimulation (CES) (cranial electrotherapy stimulation, transcranial electrotherapy) applies a low energy pulsed alternating current to stimulate cranial nerves in the forehead. The treatment usually lasts for 20 minutes per session and occurs either daily or every other day. CES is marketed for anxiety, depression and insomnia and is being studied for other uses, such as addiction and improving mental focus. Examples of CES devices include, but may not be limited to, Alpha- Stim AID, Cervella, CES Ultra and the Fisher Wallace stimulator. (Refer to Coverage Limitations section)

For information regarding the proposed use of the Alpha-Stim for the treatment of pain, please refer to Electrical Stimulators for Pain and Nausea/Vomiting Medical Coverage Policy.

Transcranial direct current stimulation (tDCS) applies a low energy constant direct current to a targeted region of the brain via electrodes. Studies are underway to assess the effects of tDCS depending on electrode placement, for conditions such as addiction, attention deficit/hyperactivity disorder, chronic pain, depression and insomnia. Currently no devices have been granted FDA approval.

(Refer to Coverage Limitations section)Coverage DeterminationCommercial Plan members: requests for repeat TMS treatment require review by a medical director.Please refer to the member’s applicable pharmacy benefit to determine benefit availability and the terms and conditions of coverage for medication for the treatment of depression or psychiatric disorders.Services provided by a psychiatrist, psychologist or other behavioral health professionals are subject to the provisions of the applicable behavioral health benefit.

Initial Treatment

Humana members may be eligible under the Plan for TMS in a healthcare provider’s office, hospital or outpatient/ambulatory care center when the following criteria are met:

Transcranial Magnetic Stimulation and Cranial Electrical Stimulation

Effective Date: 04/27/2023

Revision Date: 04/27/2023

Review Date: 03/23/2023

Policy Number: HUM-0457-022

Page: 5 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• 18 years of age or older; AND
• Absence of absolute or relative contraindications; AND
• Confirmed diagnosis of severe major depressive disorder (single or recurrent episode), documented by standardized rating scales*; AND
• Documentation of failure of a trial of a psychotherapy known to be effective in the treatment of major depressive disorder, of an adequate frequency and duration, without significant improvement in depressive symptoms, as documented by standardized rating scales*; AND
• Prescribing/requesting provider is a psychiatrist (MD or DO), experienced in TMS therapy, who has examined the patient, reviewed the clinical records, supervises treatment and is available at the treatment location; AND
• Prior to initiating treatment, the individual’s motor threshold is determined to establish coil location and magnetic field intensity (may occur the same day that TMS treatment begins); AND
• Treatment consists of up to 30 sessions (5 days a week for 6 weeks) followed by 6 tapering sessions over 3 weeks (3 treatments in first week, 2 treatments the next week, and 1 treatment the final week) for a maximum total of 36 sessions allowed; AND
• One of the following:
  • Documentation of failure of four trials of psychopharmacologic agents, including two different agent classes, during the current depressive episode, at or above the minimum effective dose and duration**, without significant improvement in depressive symptoms, as documented by standardized rating scales*; OR
  • Inability to tolerate a therapeutic dose of medications as evidenced by documentation of four trials of psychopharmacologic agents with distinct side effects

Transcranial Magnetic Stimulation and Cranial Electrical Stimulation

Effective Date: 04/27/2023

Revision Date: 04/27/2023

Review Date: 03/23/2023

Policy Number: HUM-0457-022

Page: 6 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.*A standardized rating scale is a recognized instrument that reliably measures depressive symptoms (eg, Beck Depression Inventory [BDI], Hamilton Depression Rating Scale [HDRS, HAM-D], Montgomery-Asberg Depression Rating Scale [MADRS], Patient Health Questionnaire-9 [PHQ-9]). **Duration is considered a minimum of six weeks after efficacious dose is reached. The prescriber must define the medication, dose, and reason for failure (side effects, no efficacy, etc.)

Repeat Treatment

Commercial Plan members: requests for repeat TMS treatment require review by a medical director.

Humana members may be eligible under the Plan for repeat TMS in a healthcare provider’s office, hospital or outpatient/ambulatory care center when the following criteria are met:

• Relapse of severe major depressive disorder; AND
• Response to previous TMS treatment as evidenced by a 50% or greater improvement in standardized rating scales*; AND
• Prescribing/requesting provider is a psychiatrist (MD or DO), experienced in TMS therapy, who has examined the patient, reviewed the clinical records, supervises treatment and is available at the treatment location; AND
• Prior to initiating repeat treatment, the individual’s motor threshold is determined to establish coil location and magnetic field intensity (may occur the same day that TMS treatment begins); AND
• Treatment consists of up to 30 sessions (5 days a week for 6 weeks) followed by 6 tapering sessions over 3 weeks (3 treatments in first week, 2 treatments the next week, and 1 treatment the final week) for a maximum total of 36 sessions allowed

Transcranial Magnetic Stimulation and Cranial Electrical Stimulation

Effective Date: 04/27/2023

Revision Date: 04/27/2023

Review Date: 03/23/2023

Policy Number: HUM-0457-022

Page: 7 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Limitations

Transcranial Magnetic Stimulation

Humana members may NOT be eligible under the Plan for TMS in ANY setting (eg, ambulatory care center, healthcare provider office, home, hospital, outpatient facility) for any indications other than those listed above including, but may not be limited to:

• Alzheimer disease; OR
• Anxiety; OR
• Attention deficit hyperactivity disorder (ADHD); OR
• Bipolar disorder; OR
• Chronic pain (including fibromyalgia); OR
• Headache (including migraine with aura); OR
• Insomnia; OR
• Other neuropsychiatric disorders (eg, obsessive-compulsive disorder [OCD], schizophrenia); OR
• Tinnitus

This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Absolute Contraindications

Humana members may NOT be eligible under the Plan for TMS in the presence of any of the following absolute contraindications64:

• Individual is experiencing a psychiatric emergency such that outpatient treatment is unsafe (psychosis, acute suicidal risk, catatonia or life-threatening inanition [nonfunctional due to lack of nourishment]); OR

Transcranial Magnetic Stimulation and Cranial Electrical Stimulation

Effective Date: 04/27/2023

Revision Date: 04/27/2023

Review Date: 03/23/2023

Policy Number: HUM-0457-022

Page: 8 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

• Metal implant in or around the head (eg, aneurysm coil or clip, metal plate, ocular implant, stent); OR
• Presence of implanted devices or metallic objects in or near the head or within 30 cm of treatment coil (eg, bullet fragments, cochlear implant, electrodes, deep brain stimulator, vagus nerve stimulator)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Relative Contraindications

Humana members may NOT be eligible under the Plan for TMS in the presence of any of the following relative contraindications64:

• Active substance use disorder (daily to near daily use of alcohol and/or drugs which causes clinically significant impairment, including health problems, disability, and failure to meet major responsibilities at work, school, or home); OR
• Implanted devices not located in or near the head (eg, cardiac pacemaker or defibrillator, infusion/medication pumps, spinal cord stimulators)
• Neurological conditions (eg, cerebrovascular disease, dementia, history of repetitive or severe head trauma, increased intracranial pressure or primary or secondary tumors in the central nervous system); OR
• Pregnant or nursing; OR
• Seizure risk due to any of the following:
  • Personal history of epilepsy or seizure disorder; OR
  • Lowered seizure threshold due to active substance withdrawal; OR
  • Lowered seizure threshold due to medications (eg, neuroleptics, stimulants, tricyclic antidepressants, etc. )

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Transcranial Magnetic Stimulation and Cranial Electrical Stimulation

Effective Date: 04/27/2023

Revision Date: 04/27/2023

Review Date: 03/23/2023

Policy Number: HUM-0457-022

Page: 9 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

1. Changing TMS brand or device type during the initial treatment or repeat treatment periods; OR
2. Greater than 36 TMS sessions during either the initial treatment or repeat treatment periods; OR
3. Maintenance TMS; OR
4. TMS administered in any setting other than a hospital, provider office or outpatient/ambulatory care center; OR
5. TMS using nonstandard variations or research protocols (eg, accelerated, bilateral, high dose, theta burst)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Cranial Electrostimulation/Transcranial Direct Current Stimulation

Humana members may NOT be eligible under the Plan for cranial electrostimulation (CES) or transcranial direct current stimulation (tDCS) in ANY setting (eg, ambulatory care center, healthcare provider office, home, hospital, outpatient facility) for ANY indication including, but may not be limited to:

• Anxiety; OR

Transcranial Magnetic Stimulation and Cranial Electrical Stimulation

Effective Date: 04/27/2023

Revision Date: 04/27/2023

Review Date: 03/23/2023

Policy Number: HUM-0457-022

Page: 10 of 20

Humana's documents are updated regularly online.

When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Chronic pain (including fibromyalgia); OR
• Depression; OR
• Headache (including migraine with aura); OR
• Insomnia; OR
• Other neuropsychiatric disorders (eg, obsessive-compulsive disorder [OCD], schizophrenia); OR
• Tinnitus

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Navigated Transcranial Magnetic Stimulation

Humana members may NOT be eligible under the Plan for navigated transcranial magnetic stimulation (nTMS) for any indication including, but may not be limited to:

• Enhanced rTMS therapy; OR
• Preoperative planning for brain surgery

This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Background

Additional information about anxiety, depression, obsessive-compulsive disorder and other mental health conditions may be found from the following websites:

• American College of Physicians
• National Institute of Mental Health
• National Library of Medicine

Transcranial Magnetic Stimulation and Cranial Electrical Stimulation

Effective Date: 04/27/2023

Revision Date: 04/27/2023

Review Date: 03/23/2023

Policy Number: HUM-0457-022

Page: 11 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Additional information about headaches may be found from the following websites:

• American College of Physicians
• National Headache Foundation
• National Library of Medicine

Additional information about insomnia may be found from the following websites:

• National Library of Medicine
• National Sleep Foundation

Medical Alternatives

Alternatives to TMS include, but may not be limited to, the following:

• ECT

Alternatives to navigated transcranial magnetic stimulation (nTMS) includes, but may not be limited to:

• Imaging (eg, magnetic resonance imaging [MRI], positron emission tomography [PET])

Alternatives to cranial electrostimulation (CES) and transcranial direct current stimulation (tDCS) include, but may not be limited to:

• Prescription drug therapy

Physician consultation is advised to make an informed decision based on an individual’s health needs.