Proposed LCD - Transcranial Magnetic Stimulation (TMS) (DL37088)

CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA) 1862(a)(1)(A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary.Social Security Act:1862 (a) (1)(A) Medically Reasonable & Necessary1862 (a) (1)(D) & (E) Investigational or ExperimentalCoverage Indications, Limitations, and/or Medical NecessityTranscranial Magnetic Stimulation (TMS) is a non-invasive method of brain stimulation. The technique involves placement of a small electromagnetic coil over the scalp and applying a rapidly alternating current through the coil wire which produces a magnetic field that passes unimpeded through the brain. Depending on stimulation parameters (frequency, intensity, pulse duration, stimulation site), repetitive TMS (rTMS) to specific cortical regions can either increase or decrease the excitability of the affected brain structures. The procedure is usually carried out in an outpatient setting and does not require anesthesia or analgesia.When used as an antidepressant therapy, TMS produces a clinical benefit without the systemic side effects attendant with standard oral medications. TMS does not have adverse effects on cognition. Unlike electroconvulsive therapy (ECT), rTMS does not induce amnesia or seizures.Indications for CoverageTMS may be covered if prescribed and administered by a licensed physician under direct supervision who is trained and experienced in the use of repetitive transcranial magnetic stimulation. Outpatient rTMS may be indicated for patients with DSM-IV defined Major Depressive Disorder who have failed to benefit from initial treatment of their depression.Initial TreatmentLeft Prefrontal rTMS of the brain is considered medically necessary for use in an adult who has a confirmed diagnosis of severe Major Depressive Disorder (MDD) single or recurrent episode; andOne or more of the following:Resistance to treatment with psychopharmacologic agents as evidenced by a lack of a clinically significant response to one trial of psychopharmacologic agents in the current depressive episode from at least two different agent classes. Each agent in the treatment trial must have been administered at an adequate course of mono- or poly- drug therapy; orInability to tolerate psychopharmacologic agents as evidenced by two trials of psychopharmacologic agents from at least two different agent classes, with distinct side effects; orHistory of response to rTMS in a previous depressive episode; orIf patient is currently receiving electro-convulsive therapy, rTMS may be considered reasonable and necessary as a less invasive treatment option.ANDA trial of an evidence-based psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration without significant improvement in depressive symptoms as documented by standardized rating scales that reliably measure depressive symptoms.ANDThe order for treatment (or retreatment) is written by a psychiatrist (MD or DO) who has examined the patient and reviewed the record. The physician will have experience in administering TMS therapy. The treatment shall be given under direct supervision of this physician (physician present in the area but does not necessarily personally provide the treatment).Coverage LimitationsThe benefits of TMS use must be carefully considered against the risk of potential side effects in patients with any of the following:Seizure disorder or any history of seizures (except those induced by ECT or isolated febrile seizures in infancy without subsequent treatment or recurrence); orPresence of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode; orNeurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, history of repetitive or severe head trauma, or primary or secondary tumors in the central nervous system, orPresence of an implanted magnetic-sensitive medical device located less than or equal to 30 cm from the TMS magnetic coil or other implanted metal items including, but not limited to a cochlear implant, implanted cardiac defibrillator (ICD), pacemaker, Vagus nerve stimulator (VNS), or metal aneurysm clips or coils, staples or stents. (Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with TMS).All other uses of Transcranial Magnetic Stimulation are considered experimental or investigational and are not allowed reimbursement per Statute XVIII, 1862 (a) (1)(D) & (E).RetreatmentRetreatment may be considered for patients who met the guidelines for initial treatment and subsequently developed relapse of depressive symptoms if the patient responded to prior treatments as evidenced by a greater than 50% improvement in standard rating scale measurements for depressive symptoms.All other uses of TMS therapy are considered investigational or experimental and remain non-covered services.General InformationAssociated InformationN/ASources of InformationOther Contractors LCDsBibliographyClinical TMS Society: Coverage Guidance for TMS for OCD. 2021; https://www.clinicaltmssociety.org/news/2021-02/ctmss-recommended-ocd-policy. Accessed Nov. 11, 2021.Perera MPN, Mallawaarachchi S, Miljevic A, Bailey NW, Herring SE, Fitzgerald PB. Repetitive Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Meta-analysis of Randomized, Sham-Controlled Trials. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021;6(10):947-960.Liang K, Li H, Bu X, et al. Efficacy and tolerability of repetitive transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder in adults: a systematic review and network meta-analysis. Transl Psychiatry. 2021;11(1):332.Homan S, Muscat W, Joanlanne A, et al. Treatment effect variability in brain stimulation across psychiatric disorders: A meta-analysis of variance. Neuroscience and biobehavioral reviews. 2021;124:54-62.Acevedo N, Bosanac P, Pikoos T, Rossell S, Castle D. Therapeutic Neurostimulation in Obsessive-Compulsive and Related Disorders: A Systematic Review. Brain sciences. 2021;11(7).Bijanki KR, Pathak YJ, Najera RA, et al. Defining functional brain networks underlying obsessive-compulsive disorder (OCD) using treatment-induced neuroimaging changes: a systematic review of the literature. Journal of neurology, neurosurgery, and psychiatry. 2021;92(7):776-786.Rapinesi C, Kotzalidis GD, Ferracuti S, Sani G, Girardi P, Del Casale A. Brain Stimulation in Obsessive-Compulsive Disorder (OCD): A Systematic Review. Curr Neuropharmacol. 2019;17(8):787-807.Marques RC, Vieira L, Marques D, Cantilino A. Transcranial magnetic stimulation of the medial prefrontal cortex for psychiatric disorders: a systematic review. Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999). 2019;41(5):447-457.Zhou DD, Wang W, Wang GM, Li DQ, Kuang L. An updated meta-analysis: Short-term therapeutic effects of repeated transcranial magnetic stimulation in treating obsessive-compulsive disorder. J Affect Disord. 2017;215:187-196.Euser AM, Stapert AF, Oosterhoff M, van Balkom IDC, Figee M. [Transcranial magnetic stimulation in obsessive compulsive disorder: a systematic review]. Tijdschr Psychiatr. 2017;59(10):617-625.Trevizol AP, Shiozawa P, Cook IA, et al. Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: An Updated Systematic Review and Meta-analysis. The journal of ECT. 2016;32(4):262-266.Ma ZR, Shi LJ. Repetitive transcranial magnetic stimulation (rTMS) augmentation of selective serotonin reuptake inhibitors (SSRIs) for SSRI-resistant obsessive-compulsive disorder (OCD): a meta-analysis of randomized controlled trials. Int J Clin Exp Med. 2014;7(12):4897-4905.Rehn S, Eslick GD, Brakoulias V. A Meta-Analysis of the Effectiveness of Different Cortical Targets Used in Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Obsessive-Compulsive Disorder (OCD). Psychiatr Q. 2018;89(3):645-665.Berlim MT, Neufeld NH, Van den Eynde F. Repetitive transcranial magnetic stimulation (rTMS) for obsessive-compulsive disorder (OCD): an exploratory meta-analysis of randomized and sham-controlled trials. J Psychiatr Res. 2013;47(8):999-1006.Martin JL, Barbanoj MJ, Perez V, Sacristan M. Transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder. Cochrane Database Syst Rev. 2003(3):CD003387.Fontenelle LF, Coutinho ES, Lins-Martins NM, Fitzgerald PB, Fujiwara H, Yucel M. Electroconvulsive therapy for obsessive-compulsive disorder: a systematic review. J Clin Psychiatry. 2015;76(7):949-957.Lusicic A, Schruers KR, Pallanti S, Castle DJ. Transcranial magnetic stimulation in the treatment of obsessive-compulsive disorder: current perspectives. Neuropsychiatr Dis Treat. 2018;14:1721-1736.Carmi L, Alyagon U, Barnea-Ygael N, Zohar J, Dar R, Zangen A. Clinical and electrophysiological outcomes of deep TMS over the medial prefrontal and anterior cingulate cortices in OCD patients. Brain Stimul. 2018;11(1):158-165.Carmi L, Tendler A, Bystritsky A, et al. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019;176(11):931-938.Elbeh KAM, Elserogy YMB, Khalifa HE, Ahmed MA, Hafez MH, Khedr EM. Repetitive transcranial magnetic stimulation in the treatment of obsessive-compulsive disorders: Double blind randomized clinical trial. Psychiatry Res. 2016;238:264-269.Dutta P, Dhyani M, Garg S, et al. Efficacy of intensive orbitofrontal continuous Theta Burst Stimulation (iOFcTBS) in Obsessive Compulsive Disorder: A Randomized Placebo Controlled Study. Psychiatry Res. 2021;298:113784.Badawy AA, El Sawy H. Efficacy of repetitive transcranial magnetic stimulation in the management of obsessive compulsive disorder.NICE: Transcranial magnetic stimulation for obsessive-compulsive disorder | Interventional Procedures Guidance. 2020; https://www.nice.org.uk/guidance/ipg676/resources/transcranial-magnetic-stimulation-for-obsessivecompulsive-disorder-pdf-1899874288332997. Accessed Nov. 10, 2021.UpToDate: Technique for performing transcranial magnetic stimulation (TMS). https://www.uptodate.com/contents/technique-for-performing-transcranial-magnetic-stimulation-tms/print?search=Transcranial%20Magnetic%20Stimulation%20&source=search_result&selectedTitle=2~71&usage_type=default&display_rank=2. Accessed Nov. 10, 2021.ECRI Clinical Evidence Assessment: Transcranial Magnetic Stimulation for Treating Adults with Obsessive-compulsive Disorder. 2021; https://www.ecri.org/components/Hotline/Pages/210287.aspx. Accessed Nov. 11, 2021.Social Security Administration. Social Security Act 1862. Exclusions From Coverage and Medicare as Secondary Payer. Compilation Of The Social Security Laws 2021; Accessed 3/11/22.