FREE ELECTRONIC LIBRARY - Dissertations, online materials

Pages:   || 2 | 3 | 4 | 5 |   ...   | 11 |

«INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna companies. Coverage Policies are intended to ...»

-- [ Page 1 ] --

Cigna Medical Coverage Policy

Effective Date

Next Review Date

Transcranial Magnetic


Coverage Policy Number................. 0383


Table of Contents Related Coverage Resources

Coverage Policy

Assessment and Treatment

General Background

Complementary and Alternative Medicine

Coding/Billing Information

Deep Brain, Motor Cortex and Responsive


Cortical Stimulation Electrical Stimulation Therapy and Devices Vagus Nerve Stimulation (VNS)


The following Coverage Policy applies to health benefit plans administered by Cigna companies. Coverage Policies are intended to provide guidance in interpreting certain standard Cigna benefit plans. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Proprietary information of Cigna. Copyright ©2016 Cigna Coverage Policy Cigna covers an initial regimen of transcranial magnetic stimulation (TMS) using an FDA approved

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).

Pages:   || 2 | 3 | 4 | 5 |   ...   | 11 |

Similar works:

«THE IMPACT OF DIABETIC FOOT ULCER ON HEALTH RELATED QUALITY OF LIFE (HRQL) AND EMPLOYMENT AMONG RURAL DIABETIC POPULATION IN SOUTH KERALA Sithara S Pillai Dissertation submitted in partial fulfillment of the requirement for the award of the degree of Master of Public Health Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology Thiruvananthapuram, Kerala, India October 2012 Acknowledgments I am grateful to God Almighty for giving me...»

«Package leaflet: Information for the patient DUAVIVE 0.45 mg/20 mg modified-release tablets Conjugated oestrogens/bazedoxifene Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.Keep this leaflet. You may need to read it again.If you have any further questions, ask your doctor or pharmacist.This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the...»

«JUSTIN M. KERR jkerr002@umaryland.edu EDUCATION Doctor of Philosophy, Program in Neuroscience. Anticipated January 2012. Program in Neuroscience. University of Maryland, Baltimore. University of Maryland School of Medicine. Mentor: Thomas Blanpied, PhD. Utilized quantitative live-cell imaging and electrophysiology to uncover novel mechanisms determining the positioning of AMPA receptors within single excitatory synapses and resulting regulation of synapse function. Bachelor of Science, Biology....»

«Health in Islam ‫حرص اإلسالم ىلع صحة اإلنسان‬ (English – ‫)اللغة اإلنجليزية‬ Islam Religion Website http://www.islamreligion.com/ ‫موقع دين اإلسالم‬ 1436 – 2015 ‫‪Health in Islam (part 1 of 4): A Holistic Approach‬‬ ‫حرص اإلسالم على صحة اإلنسان‬ ‫الجزء األول: منهج شامل‬ Islam comes from the root word “sa-la-ma”, as do the words Muslim (one who follows the message of...»

«  No. _ IN THE Supreme Court of the United States _ WHOLE WOMAN’S HEALTH; AUSTIN WOMEN’S HEALTH CENTER; KILLEEN WOMEN’S HEALTH CENTER; NOVA HEALTH SYSTEMS D/B/A REPRODUCTIVE SERVICES; SHERWOOD C. LYNN, JR., M.D.; PAMELA J. RICHTER, D.O.; AND LENDOL L. DAVIS, M.D., on behalf of themselves and their patients, Applicants, v. KIRK COLE, M.D., Commissioner of the Texas Department of State Health Services; MARI ROBINSON, Executive Director of the Texas Medical Board, in their official...»

«Thalidomide Pharmion 50mg™ Summary of Product Characteristics UK Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Thalidomide Pharmion 50 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50 mg of thalidomide.Excipient: Each capsule contains 257.2 mg of anhydrous lactose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. White opaque capsules marked “Thalidomide 50 mg Pharmion”. 4. CLINICAL PARTICULARS...»

«Monday morning 1. OBSTETRICAL IMAGING: IMAGINE THE FUTURE 1.1 Quantitative ultrasound in the fetus, Lawrence D. Platt, David Geffen School of Medicine at UCLA, Los Angeles, CA, ldplatt@gmail.com (invited overview). Quantitative ultrasound techniques are currently under development for assessment of the fetal lung and heart. This talk will review those techniques and discuss other fetal organ systems that have potential for quantitative assessment. 1.2 Pitfalls of point-of-care ultrasound in...»

«MALIGNANT LYMPHOMA IN THE DOG AND CAT Douglas H. Thamm, VMD, DACVIM (Oncology) Colorado State University Animal Cancer Center 300 West Drake Road, Fort Collins, CO 80523 USA INTRODUCTION Lymphoma (LSA) is a relatively common disease entity in veterinary medicine. Most small animal practitioners will encounter LSA in their practice, and will be asked to provide information and treatment recommendations for pets with this condition. DIAGNOSIS AND STAGING – DOGS The typical dog with LSA will...»

«STICKLER SYNDROME SUPPORT GROUP (SSSG) Registered Charity: 1060421 STICKLER SYNDROME: A GUIDE TO THE DISORDER FOR MEDICAL AND HEALTHCARE PROFESSIONALS BY WENDY HUGHES INFO 12 11/2006 Text © Wendy Hughes and the Stickler Syndrome Support Group. All rights reserved. No part of this publication may be reproduced or transmitted, in any form or by any means, without permission. This publication was printed thanks to the generosity of the 2005/2006 4th year Fashion Marketing students, School of...»

«Survey Paper July 2015 Volume 2 Issue 11 International Journal of Informative & Futuristic Research ISSN (Online): 2347-1697 Role Of Rotary International Providing Ophthalmic Health Care Facilities In Cuttack City Of Odisha Paper ID IJIFR/ V2/ E11/ 046 Page No. 4235-4242 Subject Area Sociology Key Words Prevalence, Cataract, Glaucoma, Eye Check-Up Camps, Cataract Operation Received On 15-07-2015 Accepted On 26-07-2015 Published On 28-07-2015 Research Scholar, Sameet Sarita Sarangi 1 Department...»

«Journal of Education and Training Studies Vol. 4, No. 3; March 2016 ISSN 2324-805X E-ISSN 2324-8068 Published by Redfame Publishing URL: http://jets.redfame.com A Peer-to-Peer Health Education Program for Vulnerable Children in Uganda Diane S. Falk1, Kristen Pettet2, Charles Mpagi3 1 School of Social and Behavioral Sciences, Stockton University, Galloway, New Jersey, USA 2 Real Partners Uganda, Brigantine, New Jersey, USA 3 Mustard Seed Academy, Lukaya, Uganda Correspondence: Diane S. Falk,...»

«Chapter 2 Psychodynamic Treatment of Panic Disorder Clinical and Research Assessment Frederic N. Busch and Barbara Milrod Introduction Both pharmacological [1–3] and cognitive-behavioral treatments [4–6] of panic disorder have been found to be effective in treatment. Despite this progress, not all patients respond or are able to tolerate these treatments [4–8]. Relapse is frequent if medication is discontinued before a prolonged maintenance phase [9–12]. Questions remain about the...»

<<  HOME   |    CONTACTS
2016 www.dissertation.xlibx.info - Dissertations, online materials

Materials of this site are available for review, all rights belong to their respective owners.
If you do not agree with the fact that your material is placed on this site, please, email us, we will within 1-2 business days delete him.