«INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna companies. Coverage Policies are intended to ...»
Cigna Medical Coverage Policy
Next Review Date
Coverage Policy Number................. 0383
Table of Contents Related Coverage Resources
Assessment and Treatment
Complementary and Alternative Medicine
Deep Brain, Motor Cortex and Responsive
Cortical Stimulation Electrical Stimulation Therapy and Devices Vagus Nerve Stimulation (VNS)
INSTRUCTIONS FOR USE
device as medically necessary when an individual meets ALL of the following criteria:
• age 18 years or older
• diagnosis of major depressive disorder (unipolar), moderate-to-severe, single or recurrent episode, without psychosis, as defined by the most recent edition of Diagnostic and Statistical Manual of Mental Disorders
• one of the following criteria:
during the current episode of depression ALL of the following criteria are met:
o at least three trials of antidepressant medications, at adequate therapeutic doses, from at least two different antidepressant agent classes, for at least four weeks o no significant reduction in depressive symptoms following pharmacotherapy as documented by validated depression monitoring scales o had an adequate trial of an evidence-based psychotherapy known to be effective in the treatment of major depressive disorder, without significant improvement in depressive symptoms, as documented by validated depression monitoring scales during the current episode of depression BOTH of the following criteria are met:
intolerance or has a medical contraindication to at least three antidepressant medications, at adequate therapeutic doses, from at least two different antidepressant agent classes, for at least four weeks had an adequate trial of an evidence-based psychotherapy known to be effective in the treatment of major depressive disorder, without significant improvement in depressive symptoms, as documented by validated depression monitoring scales Page 1 of 34 Coverage Policy Number: 0383 has a history of a favorable response to transcranial magnetic stimulation in a previous episode, as evidenced by a greater than 50% improvement in a standard rating scale for depressive Cigna covers repeat transcranial magnetic stimulation (TMS) for an acute relapse of major depressive
disorder as medically necessary when BOTH of the following criteria are met:
• all of the above criteria for initial therapy are met
• had more than a 50% improvement in prior TMS treatments as evidenced by standard rating scale for depressive symptoms Cigna does not cover transcranial magnetic stimulation (TMS) for any other indication or as a maintenance therapy because it is considered experimental, investigational or unproven.
General Background Transcranial Magnetic Stimulation (TMS) for Depression Standard treatments for major depressive disorder (MDD) include psychotherapy, pharmacotherapy, and/or electroconvulsive therapy (ECT). Although the majority of individuals respond to standard treatments for depression, some do not benefit, or cannot tolerate these interventions. Therefore, alternate treatment options are being investigated, including transcranial magnetic stimulation (TMS), vagal nerve stimulation, cranial electrical stimulation and herbal/homeopathic remedies (Miniussi, et al., 2005).
TMS uses brief magnetic field pulses to stimulate nerve cells in the brain. Standard TMS is mostly applied with an electromagnetic coil called a figure-of-eight coil (8-coil). Deep TMS can be applied with different types of coils: the H-coil, the C-core coil and the circular crown coil. The only deep TMS coil whose safety and effectiveness has been tested in clinical trials is the H-coil. During the TMS procedure, clinicians place a large electromagnetic coil on the patient’s scalp near the forehead. The electromagnetic current repeatedly switches on and off for up to 10 times per second to produce the pulses. To determine the therapeutic magnetic strength, the amount of magnetic energy is adjusted until the motor threshold is reached (i.e., the patient’s fingers or hands start to twitch). It has been proposed that the stimulation is intended to alter brain activity in areas responsible for mood. TMS is less invasive than vagal nerve stimulation and is not intended to induce seizures like electroconvulsive therapy (ECT). TMS may cause some short-term side effects such as headache, tingling of facial muscles, scalp discomfort, lightheadedness, or discomfort because of the noise the device makes.
Hearing loss and seizures have been reported as uncommon side effects. Symptom relief may not take place for several weeks (Bersani, et al., 2013).
Although the evidence investigating transcranial magnetic stimulation (TMS) for the treatment of major depressive disorder (MDD) primarily consists of small patient populations and short-term follow-ups, some randomized controlled trials have reported that TMS had better outcomes than sham therapy and in some studies outcomes were reported as good as electroconvulsive therapy (ECT) with fewer side effects. As a result, TMS has become an established treatment option for a carefully selected subset of patients with MDD.
Initial TMS is a treatment option for a patient who is age 18 years or older and has a diagnosis of unipolar, depressive disorder, moderate-to-severe, single or recurrent episode, without psychosis, as defined by the most recent edition of the Diagnostic and Statistical Manual (DSM) of Mental Disorders. Potential TMS candidates are those patients who have failed at least three trials of pharmacotherapy, at adequate therapeutic doses, including at least two different agent classes for a period of at least four weeks. The regimen should have included one or more anti-depressant medication. Antidepressant classes include: selective serotonin reuptake inhibitors (SSRIs; e.g., sertraline, fluoxetine), serotonin-norephinephrin reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine) tricyclic antidepressants, (TCAs; e.g., amitriptyline, nortriptyline, desipramine) and monoamine oxidase inhibitors (MAOIs; e.g., isocarboxazid, phenelzine) and may be given in combination regimens.
Following pharmacotherapy, TMS candidates are those who demonstrate no significant reduction in depressive symptoms which is documented by results of validated depression monitoring scales (e.g., Patient Health Questionnaire [PHQ-9], Beck Depression Inventory [BDI], Hamilton Depression Rating Scale [HAM-D], Montgomery-Asberg Depression Rating Scale [MADRS], Quick Inventory of Depressive Symptomatology SelfPage 2 of 34 Coverage Policy Number: 0383 reported [QIDS], Inventory of Depressive Symptomatology Clinician-rated [IDS-SR score]). Adherence to the medication should be documented or it should be documented if the patient has intolerance to the medication or could not take the agents due to medical contraindications (Lyness, 2015; Trivedi, 2015; FDA, 2014).
A major depressive episode as defined in the DSM-5 implies a prominent and relatively persistent (e.g., nearly every day for at least two weeks) depressed or dysphoric mood that represents a change from previous functioning, and includes at least five of the following nine symptoms, one of which is either of the first two
symptoms (Neuronetics, Inc., 2015):
TMS should also be preceded by evidenced-based psychotherapy (e.g., cognitive behavioral psychotherapy, interpersonal psychotherapy, psychodynamic therapy) known to be effective for the treatment of depression.
TMS candidates are those who do not show significant improvement on depression monitoring scales following psychotherapy. A face-to-face psychiatric evaluation that establishes that the diagnostic criteria are met for major depressive disorder should be performed and documented. An assessment of currently prescribed medications and a medical assessment to evaluate for any medical conditions that might increase the risks associated with TMS and/or the presence of contraindications to TMS are indicated. The patient should be educated regarding potential risks and benefits of the procedure. Because TMS may be associated with an increased risk of a seizure, the benefits of TMS use must be carefully considered against the risk in individuals taking medications which may lower the seizure threshold (Holtzheimer, 2015; Hayes, 2014).
A history of a favorable response to TMS in a previous episode of depression with more than a 50% improvement is predictive of a favorable TMS outcome (Holtzheimer, 2015; Lebow, et al., 2015; Hayes, 2014;
FDA, 2014; O’Reardon, et al., 2007).
The initial course of TMS typically includes up to 30 visits over a 4–6 week period and may be followed by six tapered treatments over a three week period. Treatment will last for 30–60 minutes, and the entire session may take up to two hours. TMS is administered in an outpatient setting by a Board-certified or Board-eligible psychiatrist who has completed specialized training that results in certification for TMS administration. The procedure does not require anesthesia.
Repeat treatments may be appropriate for acute relapse when the patient experienced more than a 50% improvement in the initial TMS regimen as noted by standard rating scales used to measure depressive symptoms (e.g. Patient Health Questionnaire [PHQ-9], Beck Depression Inventory [BDI], Hamilton Depression Rating Scale [HAM-D], Montgomery-Asberg Depression Rating Scale [MADRS], Quick Inventory of Depressive Symptomatology Self-reported [QIDS], Inventory of Depressive Symptomatology Clinician-rated [IDS-SR score]). However, TMS is not indicated for use as maintenance therapy. There is a lack of evidence supporting the long-term, maintenance effects of TMS. Studies are primarily in the form of case series and retrospective reviews with small patient populations (Holtzheimer, 2015; Fitzgerald, et al., 2013; Mantovan, et al., 2012a;
Jacicak, et al., 2010).
Several variations of administering repetitive TMS to patients with major depression have been studied including: accelerated repetitive TMS, high-dose repetitive TMS, theta-burst repetitive TMS, deep-repetitive TMS, and bilateral repetitive TMS (Holtzheimer, 2015). A recent review of the evidence for TMS treatment of depression states that studies are being conducted to test a weak oscillating TMS device that is proposed to not cause seizures and therefore might enable home delivery of TMS for the treatment of schizophrenia and depression (George, et al., 2013). Currently, TMS is not recommended in the home nor are the devices FDA approved for in-home use.
Page 3 of 34 Coverage Policy Number: 0383 While the majority of clinical trials on TMS have evaluated its use in depression, numerous other conditions have also been studied, including, but not limited to: Parkinson’s disease, post-traumatic stress disorder, acute ischemic stroke, obsessive-compulsive disorders, schizophrenia, alcohol dependence, tinnitus, migraines, chronic neuropathic pain, and spinal cord injury. There is insufficient published evidence to support the effectiveness of TMS for these other conditions nor are the devices FDA approved for these indications.
U.S. Food and Drug Administration (FDA) Transcranial Magnetic Stimulation (TMS) systems are FDA 510(k) approved as Class II devices. In July 2011, the FDA issued a Class II TMS guidance detailing special controls that should be combined with general controls to ensure safety and effectiveness of rTMS systems for treatment of patients with MDD.
® The Neurostar TMS Therapy System (Neuronetics, Inc., Malvern, PA) was one of the first systems to be approved by the FDA. The System was originally FDA approved in 2008. Labeling was updated and approved in 2013 to comply with the FDA 2011 TMS guidance. In 2014, based upon the outcomes of a randomized controlled trial (n=197) (George, et al., 2010), a new 510(k) approval was issued to “expand the indicated population in major depression to adult patients who have failed to benefit from one or more prior antidepressant medications in the current episode”. The FDA’s Neurological Devices Panel reviewed Neuronetics’ research comparing the NeuroStar TMS Therapy System device with electroconvulsive therapy (ECT) and concluded that the research did not establish a risk-to-benefit profile that was comparable to the risk to benefit profile of the predicate device, ECT, because effectiveness had not been demonstrated. The Panel agreed that the safety profile of the device was better than of ECT devices, but concluded that additional study was necessary to establish the device’s effectiveness (FDA, 2007).