NEW DIRECTIONS BEHAVIORAL HEALTH, L.L.C.

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1 NEW DIRECTIONS BEHAVIORAL HEALTH, L.L.C. Medical Policy Repetitive Transcranial Magnetic Stimulation for Treatment of Major Depression Original Effective date: 10/13/2014 Reviewed: 3/2015, 11/2015, 11/2016, 10/2017 Revised: 12/2016, 10/2017 PURPOSE: To provide practice parameters for repetitive Transcranial Magnetic Stimulation (rtms) so that benefits are applied in a consistent and relevant fashion. This document applies to the use of rtms in Treatment Resistant Depression (TRD), which is the only indication for this device in psychiatric disorders. rtms is not a first line treatment of depression, even for those with severe depression. This document addresses only rtms treatment requests for depression. This document is not meant to serve as a standard of care. DEFINITIONS: 1. Repetitive Transcranial Magnetic Stimulation (rtms) was developed in 1985, and was initially a research tool used to non-invasively probe neurologic function in the cortex. The procedure consists of placing an electromagnetic coil on the scalp. A powerful AC current is passed through the coil. This results in a rapidly fluctuating intense magnetic field, which changes ionic flow in neural tissue located below the coil. The frequency of the fluctuation can also be manipulated. Fast rtms is delivered at frequencies of 3 to 20 Hz. By contrast, slow rtms is defined as a frequency of less than 1 Hz. In late 2008, the Food and Drug Administration (FDA) approved the NeoPulse device, now known as NeuroStar rtms, marketed by Neuronetics. The original FDA device approval indication is for treatment of depression in adult patients who have failed one 6-week course of an antidepressant. This approval was done under a 501K submission, demonstrating safety, but not substantial equivalence in efficacy. According to FDA documents, both the Brain Way Deep TMS systems and the NeuroStar TMS Therapy System are currently indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current depressive episode. rtms has been explored in migraine, spinal cord injury, tinnitus, mania, anxiety, movement disorders, pain, OCD and auditory hallucinations in schizophrenia. The side effects of rtms are local discomfort at the site of the magnetic field, muscle twitching and headaches. If the frequency is too great, seizures will develop. In fact, this Repetitive Transcranial Magnetic Stimulation Page 1 of 11

2 has already been tried as an alternative to the electrical induction of seizures in electroconvulsive therapy (ECT). Magnetic Seizure Therapy (MST) is currently in its research infancy. 2. Navigated Transcranial Magnetic Stimulation (ntms) is being studied as a diagnostic tool to stimulate functional cortical areas at precise anatomical locations to induce measurable responses. This technology is being investigated to map functionally essential motor areas for diagnostic purposes and for treatment planning. ntms is considered experimental and investigational. POLICY: A. Requests for rtms 1. Requests for rtms will be completed on the rtms Initial Treatment Request Form and/or the rtms Continuation Request Form. These documents provide pertinent clinical information about the patient s past and current treatment history and response. Timelines for receiving information, making determinations, and peer review if needed will follow standard New Directions timeframes. B. Treatment and Authorization Codes 1. rtms is considered medically necessary when one treatment session per day is given for five days per week for six weeks. Immediately following the six-week treatment period, the treatment frequency is tapered, as follows: a. Week One: 3 treatment sessions b. Week Two: 2 treatment sessions c. Week Three: 1 treatment session 2. These Current Procedural Terminology (CPT) codes will be used in following manner: a : Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; initial, including cortical mapping, motor threshold determination, delivery and management. (Report only once per course of treatment). (Do not report in conjunction with 90868, 90869, , 95928, 95929, 95939) b : Subsequent delivery and management, per session a : Subsequent motor threshold re-determination with delivery and management (Do not report in conjunction with 90867, 90868, , 95928, 95929, 95939) C. Certification Guideline Must meet both 1 and 2: Repetitive Transcranial Magnetic Stimulation Page 2 of 11

3 1. Transcranial magnetic stimulation (including rtms) of the brain administered with an FDA-approved device meets the definition of medical necessity as a treatment of major depressive disorder when ALL of the following criteria (sections a-f) have been met. a. Confirmed diagnosis of severe major depressive disorder (ICD9 codes and 296.2x and 296.3X, WITHOUT psychosis) documented by one clinically accepted depression rating scale from the following list. [One test should be chosen and employed during the entire treatment course.] TABLE 1 Name of test Number of items Minimum score for initial Authorization Beck Depression Inventory 21 >29 (BDI) Inventory of Depressive 30 >36 Symptomatology Clinician-rated (IDS-C) Quick Inventory of Depressive 16 >15 Symptomatology Self-reported (QIDS-SR) Montgomery-Asberg Depression 10 >34 Rating Scale (MADRS) Patient Health Questionnaire (PHQ9) 9 >19 b. The request is for a member between the ages of 18 and 70. c. The member is not actively abusing substances (UDS confirmation may be required). d. The member has any one of the following: i. Failure of four trials of psychopharmacologic agents approved by the FDA for treating Major Depressive Disorder. These must include: 1. A medicine from at least two different antidepressant classes (for example SSRI, SNRI, TCA, MAI-O, etc.) 2. At least two augmentation trials along with the primary antidepressant. The FDA has approved augmentation status for selected second generation antipsychotics, and the clinical literature has established other medications, including but not limited to lithium and thyroid augmentation. Repetitive Transcranial Magnetic Stimulation Page 3 of 11

4 ii. Inability to tolerate a therapeutic dose of medications as evidenced by four trials of psychopharmacologic agents (consistent with d.i.1 and 2 above) with documented distinct intolerable side effects iii. History of response to TMS in a previous depressive episode (at least three months since the prior episode) iv. Is a candidate for electroconvulsive therapy (ECT), and ECT outcome would not be overall superior to TMS (e.g., in cases with psychosis, acute suicidal risk, catatonia, or life-threating dysfunction in basic life needs, rtms should not be utilized) e. Failure of a trial of an evidence-based psychotherapy (e.g., CBT (cognitive behavioral therapy), IPT (interpersonal therapy, etc.) known to be effective in the treatment of major depression (of an adequate frequency and duration), without substantial improvement in depressive symptoms, as documented by a significant difference between pre- and post-treatment scores on *standardized evidence-based depression rating scales that reliably measure depressive symptoms from the following list: Beck Depression Inventory (BDI), Inventory of Depressive Symptomatology Clinician-rated (IDS-C16), Quick Inventory of Depressive Symptomatology Self-reported (QIDS-SR30), Montgomery-Asberg Depression Rating Scale (MADRS), Patient Health Questionnaire9 (PHQ9) f. A 5-day a week treatment course of left dorsolateral prefrontal cortex TMS treatment that lasts for six weeks (total of 30 sessions), followed by a threeweek taper of three TMS treatment sessions in week 1, two TMS treatment sessions the next week, and one TMS treatment session in the third and final week. Treatment frequency of less than five days/week will be reviewed for medical necessity. g. Typical initial authorization will be for one unit of and 19 units of Concurrent authorization will be for 16 units of 90868, and one unit of if requested with necessary medical documentation. 2. Standardized depression rating scales should be performed during TMS treatment to monitor progress at a minimal frequency of an initial pre-treatment test, followed by testing every two weeks and a final test at the last treatment visit. These scores will be required for concurrent authorization. If the rating scales document a lack of meaningful change or worsening of symptom intensity, review by a physician advisor may be indicated. D. Exclusions 1. The member has non-removable metallic objects or implants in his/her head or neck regions. 2. The member has an active neurologic disorder, including but not limited to encephalopathy, dementia from any cause, Parkinson s Disease, post-stroke syndromes, Repetitive Transcranial Magnetic Stimulation Page 4 of 11

5 increased intracranial pressure or bleeding, cerebral aneurysm, A-V malformations, CSF shunts, implants in the CNS or head/neck, etc. 3. There is evidence of active psychotic symptoms. 4. The request is for Maintenance rtms Treatment. A. Training and Requirements 1. The attending physician is a board-certified psychiatrist with training in the use of rtms in Major Depression. 2. The attending physician is required to personally perform codes and Code may be administered by a technician, but this individual is required to have certification in administering rtms. 4. New Directions will register any clinics or practitioners via documentation of certification, prior to allowing use of this benefit. REFERENCES Al-Harbi K.S. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Prefer Adherence 2012; 6: Allan C.L., Herrmann L.L., Ebmeier K.P. Transcranial magnetic stimulation in the management of mood disorders. Neuropsychobiology 2011; 64(3): Avery, D.H., Holtzheimer, P. E., Fawaz, W., Russo, J., Neumaier, J., Dunner, D. L., Haynor, D. R., Claypoole, K. H., Wajdik, C., and Roy-Byrne, P. (2006). A controlled study of repetitive transcranial magnetic stimulation in medication-resistant major depression. Biological Psychiatry, 59 (2), Avery D.H., Isenberg K.E., Sampson S.M., et al. Transcranial magnetic stimulation in the acute treatment of major depressive disorder: clinical response in an open-label extension trial. Journal of Clinical Psychiatry 2008; 69(3): Bauer M., Bschor T., Pfennig A., et al. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Unipolar Depressive Disorders in Primary Care. World Journal of Biological Psychiatry 2007; 8(2): Blue Cross Blue Shield Association Medical Policy Reference Manual Transcranial magnetic stimulation as a treatment of depression ( ), 06/14. Repetitive Transcranial Magnetic Stimulation Page 5 of 11

6 Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Transcranial magnetic stimulation for depression. TEC Assessment 2014; Vol. 28, No. 9. Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Transcranial magnetic stimulation for depression. TEC Assessment 2011; Vol. 26, No. 5. Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Transcranial magnetic stimulation for the treatment of schizophrenia. TEC Assessment 2011; Vol. 26, No. 6. Burt, T., Lisanby, S. H., Sackeim, H.A. (2002). Neuropsychiatric applications of transcranial magnetic stimulation: a meta-analysis. The International Journal of Neuropsychopharmacology, 5 (1), Dowd, S., et. al. (2002). Is repetitive Transcranial Magnetic Stimulation an alternative to ECT for the treatment of Depression? Contemporary Psychiatry, 1, 1-9. ECRI Emerging Technology Evidence Report. Repetitive Transcranial Magnetic Stimulation Using the NeuroStar System for Treating Major Depressive Disorder, April Eranti S., Mogg A., Pluck G., et al. A randomized controlled trial with 6-month follow-up repetitive transcranial magnetic stimulation and electroconvulsive therapy for severe depression. American Journal of Psychiatry 2007; 164(1): First Coast Service Options LCD Transcranial magnetic stimulation for major depressive disorder L33676, 07/07/14. Fitzgerald, P.B., Benitez, J., de Castella, A., Daskalakis, Z. J., Brown, T. L., and Kulkarni, J. (2006). A randomized, controlled trial of sequential bilateral repetitive transcranial magnetic stimulation for treatment-resistant depression. American Journal of Psychiatry, 163 (1), Fitzgerald, P.B., Brown, T. L., Marston, N. A. U., Daskalakis, Z. J., de Castella, A., and Kulkarni, J. (2003). Transcranial magnetic stimulation in the treatment of depression: a double-blind, placebo-controlled trial. Archives of General Psychiatry, 60 (10), Fitzgerald, P.B., Huntsman, S., Gunewardene, R., Kulkarni, J., Daskalakis, Z. J. (2006). A randomized trial of low-frequency right-prefrontal-cortex transcranial magnetic stimulation as augmentation in treatment-resistant major depression. International Journal of Neuropsychopharmacology, 9 (6), Fochtmann L.J. and Gelenberg A.J. Guideline Watch: Practice guideline for the treatment of patients with major depressive disorder, 2nd Edition. FOCUS: The Journal of Lifelong Learning in Psychiatry, Vol. 3, No. 1 Winter 2005: Repetitive Transcranial Magnetic Stimulation Page 6 of 11

7 Gaynes B.N., Lux L., Lloyd S., et al. Nonpharmacologic interventions for treatment-resistant depression in adults. Comparative effectiveness Review No. 33. AHRQ Publication No. 11- EHC056-EF. Rockville, MD: Agency for Healthcare Research and Quality. Sept Gelenburg. A. (2000). Vagal nerve stimulation and repetitive transcranial magnetic stimulation for treatment resistant depression. Biological Therapies in Psychiatry, 23, Gelenberg A.J., freeman M.P., Markowitz J.C., et al. Practice guideline for the treatment of patients with major depressive disorder, third edition, approved May 2010 and published Oct George, M., et. al. (2003). Mechanisms and current state of Transcranial Magnetic Stimulation. CNS Spectrums, 8, George M.S., Lisanby S.H., Avery D., et al. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Archives of General Psychiatry 2010; 67(5): George M.S., Post R.M. Daily left prefrontal repetitive transcranial magnetic stimulation for acute treatment of medication-resistant depression. Treatment in Psychiatry 2011; 168(4): Gershon, A., Pinhas, N., & Gurnhaus, L. (2003). Transcranial Magnetic Stimulation in the treatment of depression. American Journal of Psychiatry, 160 (5), Grunhaus, L., Schreiber, S., Dolberg, O. T., Polak, D., and Dannon, P. N. (2003). A randomized controlled comparison of electroconvulsive therapy and repetitive transcranial magnetic stimulation in severe and resistant nonpsychotic major depression. Biological Psychiatry, 53 (4), Hasey, G. (2001). Transcranial magnetic stimulation in the treatment of mood disorder: a review and comparison with electroconvulsive therapy. Canadian Journal of Psychiatry, 46 (8), Hausmann, A., Kemmler, G., Walpoth, M., Mechtcheriakov, S., Kramer-Reinstadler, K., Lechner, T., Walch, T., Deisenhammer, E. A., Kofler, M., Rupp, C. I., Hinterhuber, H., and Conca, A. (2004). No benefit derived from repetitive transcranial magnetic stimulation in depression: a prospective single centre, randomized, double blind, sham controlled add on trial. Journal of Neurology, Neurosurgery & Psychiatry, 75 (2), Holtzheimer, P. E., Russo, J., and Avery, D.H. (2001). A meta-analysis of repetitive transcranial magnetic stimulation in the treatment of depression. Psychopharmacology Bulletin, 35 (4), Repetitive Transcranial Magnetic Stimulation Page 7 of 11

8 Hoppner, J., Schulz, M., Irmisch, G., Mau, R., Schlafke, D., and Richter, J. (2003). Antidepressant efficacy of two different rtms procedures. High frequency over left versus low frequency over right prefrontal cortex compared with sham stimulation. European Archives of Psychiatry and Clinical Neuroscience, 253 (2), Institute for Clinical Systems Improvement (ICSI). Major depression in adults for mental health care. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2004 May. 52 p. Isenberg, K., Downs, D., Pierce, K., Svarakic, D., Farcia, K., Jarvis, M., North, C., and Kormos, T. C. (2005). Low frequency rtms stimulation of the right frontal cortex is as effective as high frequency rtms stimulation of the left frontal cortex for antidepressant-free, treatmentresistant depressed patients. Annuals of Clinical Psychiatry, 17 (3), Janicak, P.G., Dowd, S. M., Martis, B., Alam, D., Beedle, D., Krasuski, J., Strong, M. J., Sharma, R., Rosen, C., and Viana, M. (2002). Repetitive transcranial magnetic stimulation versus electroconvulsive therapy for major depression: preliminary results of a randomized trial. Biological Psychiatry, 51 (8), Janicak P.G., Nahas Z., Lisanby S.H., et al. Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression: assessment of relapse during a 6-month, multisite, open-label study. Brain Stimulation 2010; 3(4); Janicak P.G., O Reardon J.P., Sampson S.M., et al. Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment. Journal of Clinical Psychiatry 2008; 69(2): Jorge R.E., Moser D.J., Acion L., et al. Treatment of vascular depression using repetitive transcranial magnetic stimulation Archives of General Psychiatry 2008; 65(3): Kennedy S.H., Milev R., Giacobbe P., et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) Clinical guidelines for the management of major depressive disorder in adults. IV. Neurostimulation therapies. Journal of Affective Disorders 2009; 114: S44-S53. Kobayashi M., Pascual-Leone A. Transcranial magnetic stimulation in neurology. Lancet Neurol. 2003; 2(3): Koerselman, F., Laman, D. M., van Duijn, H., van Duijn, M. A. J., and Willems, M. A. M. (2004). A 3-month follow-up, randomized, placebo-controlled study of repetitive transcranial magnetic stimulation in depression. Journal of Clinical Psychiatry, 65 (10), Repetitive Transcranial Magnetic Stimulation Page 8 of 11

9 Lam R.W., Chan P., Wilkins-Ho M., et al. Repetitive transcranial magnetic stimulation for treatment-resistant depression: a systematic review and meta-analysis Canadian Journal of Psychiatry 2008; 53(9): Lisanby, S., et. al. (2003). New developments in ECT and Magnetic Seizure Therapy. CNS Spectrums, 8, Loo, C. K. and Mitchell, P. B. (2005). A review of the efficacy of transcranial magnetic stimulation treatment for depression, and current and future strategies to optimize efficacy. Journal of Affective Disorders, 88 (3), Loo, C. K., Mitchell, P. B., Croker, V. M., Malhi, G. S., Wen, W., Gandevia, S. C., and Sachdev, P. S. (2003). Double-blind controlled investigation of bilateral prefrontal transcranial magnetic stimulation for the treatment of resistant major depression. Psychological Medicine, 33 (1), Martin J.L., Barbanoj M.J., Schlaepfer T.E. et al. Repetitive transcranial magnetic stimulation for the treatment of depression. Systematic review and meta-analysis. British Journal of Psychiatry 2003; 182: Martin J.L.R., Barbanoj M.J., Pérez V., Sacristán M. Transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder. The Cochrane Database of Systematic Reviews 2003, Issue 2. Art. No.: CD DOI: / CD Martin J.L.R., Barbanoj M.J., Schlaepfer T.E., Clos S., Perez V., Kulisevsky J., Gironell, A. Transcranial magnetic stimulation for treating depression. The Cochrane Database of Systematic Reviews 2001, Issue 4. Art. No.: CD DOI: / CD McLoughlin D.M., Mogg A., Eranti S., Pluck G., Purvis R., Edwards D., Landau S., Brown R., Rabe- Heskith S., Howard R., Philpot M., Rothwell J., Romeo R., Knapp M. The clinical effectiveness and cost of repetitive transcranial magnetic stimulation versus electroconvulsive therapy in severe depression: a multicentre pragmatic randomised controlled trial and economic analysis. Health Technol Assess Jul; 11(24): Minichino A., Bersani F.S., Capra E et al. ECT, rtms, and deep TMS in pharmacoresistant drugfree patients with unipolar depression: a comparative review. Neuropsychiatric Disease and Treatment 2012; 8: Miniussi, C., Bonato, C., Bignotti, S., Gazzoli, A., Gennarelli, M., Pasqualetti, P., Tura, G. B., Ventriglia, M., Rossin, and P. M. (2005). Repetitive transcranial magnetic stimulation at high and low frequency: an efficacious therapy for major drug-resistant depression? Clinical Neurophysiology, 116 (5), Repetitive Transcranial Magnetic Stimulation Page 9 of 11

10 Miyasaki J.M., Shannon K., Voon V. et al. Practice parameter: Evaluation and treatment of depression, psychosis and dementia in Parkinson disease (an evidence-based review). American Academy of Neurology 2006; 66 (7): Mohammad, Y. M., Kothari, R., Hughes, G., et al. Transcranial Magnetic Stimulation (TMS) relieves migraine headache. Platform presentation at the American Headache Society annual scientific meeting in Los Angeles, June 23, Mosimann, U. P., Schmitt, W., Greenberg, B. D., Kosel, M., Muri, R. M., Berkhoff, Hess, C. W., Fisch, H. U. and Schlaepfer, T. E. (2004). Repetitive transcranial magnetic stimulation: a putative add-on treatment for major depression in elderly patients. Psychiatry Research, 126 (2), National Institute for Health and Clinical Excellence. Depression in adults: The treatment and management of depression in adults, Oct National Institute for Health and Clinical Excellence. Transcranial magnetic stimulation for severe depression, Nov New England Comparative Effectiveness Public Advisory Council (CEPAC). Coverage Policy Analysis: Repetitive transcranial magnetic stimulation (rtms). Completed by: the Institute for Clinical and Economic Review (ICER), June O'Reardon, J.P., Solvason, H.B., Janicak, P.G., Sampson, S., Isenberg, K. E., Nahas, Z., McDonald, W. M., Avery, D., Fitzgerald, P. B., Loo, C., Demitrack, M. A., George, M. S., and Sackeim, H. A. (2007). Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biological Psychiatry, 62 (11), Rodriguez-Martin, J. L., Barbanoj, M. J., Schlaepfer, T. E., Clos, S. S. C., Perez, V., Kulisevsky, J., and Gironelli, A. (2001, October). Transcranial magnetic stimulation for treating depression. Cochrane Database of Systematic Reviews, 4. Available online at: Last accessed June 8, Rossini, D., Magri, L., Lucca, A., Giordani, S., Smeraldi, E., and Zanardi, R. (2005). Does rtms hasten the response to escitalopram, sertraline, or venlafaxine inpatients with major depressive disorder? A double-blind, randomized, sham-controlled trial. Journal of Clinical Psychiatry, 66 (12), Sachdev P.S., Loo C.K., Mitchell P.B. et al. Repetitive transcranial magnetic stimulation for the treatment of obsessive compulsive disorder: a double-blind controlled investigation Psychological Medicine 2007; 37(11): Repetitive Transcranial Magnetic Stimulation Page 10 of 11

11 Schutter D.J. Antidepressant efficacy of high-frequency transcranial magnetic stimulation over the left dorsolateral prefrontal cortex in double-blind sham-controlled designs: a meta-analysis Psychological Medicine 2009; 39(1): Tranulis C., Sepehry A.A., Galinowski A. et al. Should we treat auditory hallucinations with repetitive transcranial magnetic stimulation? A meta-analysis Canadian Journal of Psychiatry 2008; 53(9): Repetitive Transcranial Magnetic Stimulation Page 11 of 11