National Medical Policy Subject: Transcendental Meditation Policy Number: NMP72 Effective Date*: October 2003 Updated: June 2016 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State's Medicaid manual(s), publication(s), citations(s) and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use X Source National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* Other None Reference/Website Link Transcendental Meditation: http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under “Reference/Website” and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) Transcendental Meditation Jun 16 1 If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net, Inc. considers transcendental meditation investigational. Although there continues to be ongoing studies, there remains a lack of large-scale clinical studies with long-term follow-up, in the peer-reviewed literature validating its effectiveness. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 N/A ICD-10 N/A CPT Codes 90875 Individual psychophysiological therapy incorporating biofeedback training by any modality (face-to-face with the patient), with psychotherapy (eg, insight oriented, behavior modifying or supportive psychotherapy); approximately 20-30 minutes 90876 approximately 45-50 minutes 90899 Unlisted psychiatric service or procedure HCPCS Codes N/A Scientific Rationale – Update June 2016 Victorson et al (2016) examined the feasibility and preliminary efficacy of an 8-week, mindfulness training program (Mindfulness Based Stress Reduction) in a sample of men on active surveillance on important psychological outcomes including prostate cancer anxiety, uncertainty intolerance and posttraumatic growth in a pilot randomized controlled trial. Men were randomized to either mindfulness (n=24) or an attention control arm (n=19) and completed self-reported measures of prostate cancer anxiety, uncertainty intolerance, global quality of life, mindfulness and posttraumatic growth at baseline, 8 weeks, 6 months and 12 months. Participants in the mindfulness arm demonstrated significant decreases in prostate cancer anxiety and uncertainty intolerance, and significant increases in mindfulness, global mental health and posttraumatic growth. Participants in the control condition also Transcendental Meditation Jun 16 2 demonstrated significant increases in mindfulness over time. Longitudinal increases in posttraumatic growth were significantly larger in the mindfulness arm than they were in the control arm. The authors concluded while mindfulness training was found to be generally feasible and acceptable among participants who enrolled in the 8-week intervention as determined by completion rates and open-ended survey responses, the response rate between initial enrollment and the total number of men approached was lower than desired (47%). While larger sample sizes are necessary to examine the efficacy of mindfulness training on important psychological outcomes, in this pilot study posttraumatic growth was shown to significantly increase over time for men in the treatment group. Mindfulness training has the potential to help men cope more effectively with some of the stressors and uncertainties associated with active surveillance. Innes et al (2016) reported older adults with subjective cognitive decline (SCD) are at increased risk not only for Alzheimer's disease, but for poor mental health, impaired sleep, and diminished quality of life (QOL), which in turn, contribute to further cognitive decline, highlighting the need for early intervention. The authors assessed the effects of two 12-week relaxation programs, Kirtan Kriya Meditation (KK) and music listening (ML), on perceived stress, sleep, mood, and health-related QOL in older adults with SCD in a randomized controlled trial. Sixty communitydwelling older adults with SCD were randomized to a KK or ML program and asked to practice 12 minutes daily for 12 weeks, then at their discretion for the following 3 months. At baseline, 12 weeks, and 26 weeks, perceived stress, mood, psychological well-being, sleep quality, and health-related QOL were measured using wellvalidated instruments. Fifty-three participants (88%) completed the 6-month study. Participants in both groups showed significant improvement at 12 weeks in psychological well-being and in multiple domains of mood and sleep quality (p's≤0.05). Relative to ML, those assigned to KK showed greater gains in perceived stress, mood, psychological well-being, and QOL-Mental Health (p's≤0.09). Observed gains were sustained or improved at 6 months, with both groups showing marked and significant improvement in all outcomes. Changes were unrelated to treatment expectancies. The authors concluded findings suggest that practice of a simple meditation or ML program may improve stress, mood, well-being, sleep, and QOL in adults with SCD, with benefits sustained at 6 months and gains that were particularly pronounced in the KK group. Keller et al (2016) investigated the characteristics of cortical activity and stress coping in migraine patients, meditation experienced subjects, and healthy controls in a exploratory cross-sectional study. 45 meditation experienced subjects, 46 migraine patients, and 46 healthy controls took part in the study. Cortical activity was measured with the contingent negative variation (CNV), a slow cortical event-related potential. Stress coping was examined with the standardized Stress Coping Questionnaire SVF-78. A one-way analysis of variance was used to investigate possible differences between the groups. CNV-amplitude was significantly higher in migraineurs than in controls. The meditators showed significantly lowest amplitudes. Migraine patients used negative stress-coping strategies significantly more often than meditators and healthy controls. Especially the application of the strategy "rumination" was most frequent in migraine patients and least frequent in meditators. Moreover, frequent rumination was significantly correlated with high CNV-amplitudes. Cortical and stress processing in people with meditation experience was improved compared to migraine patients and healthy controls. Transcendental Meditation Jun 16 3 Zgierska et al (2016) assessed the benefits of mindfulness meditation and cognitive behavioral therapy (CBT)-based intervention for opioid-treated chronic low back pain (CLBP) in a 26-week parallel-arm pilot randomized controlled trial (Intervention and Usual Care versus Usual Care alone). Adults with CLBP, prescribed ≥30mg/day of morphine-equivalent dose (MED) for at least 3 months. The intervention comprised eight weekly group sessions (meditation and CLBP-specific CBT components) and 30 minutes/day, 6 days/week of at-home practice. Outcome measures were collected at baseline, 8, and 26 weeks: primary-pain severity (Brief Pain Inventory) and function/disability (Oswestry Disability Index); secondary-pain acceptance, opioid dose, pain sensitivity to thermal stimuli, and serum pain-sensitive biomarkers (Interferon-γ; Tumor Necrosis Factor-α; Interleukins 1ß and 6; C-reactive Protein). Thirty-five (21 experimental, 14 control) participants were enrolled and completed the study. They were 51.8 ± 9.7 years old, 80% female, with severe CLBP-related disability (66.7 ± 11.4), moderate pain severity (5.8 ± 1.4), and taking 148.3 ± 129.2mg/day of MED. Results of the intention-to-treat analysis showed that, compared with controls, the meditation-CBT group reduced pain severity ratings during the study (P = 0.045), with between-group difference in score change reaching 1 point at 26 weeks (95% Confidence Interval: 0.2,1.9; Cohen's d=0.86), and decreased pain sensitivity to thermal stimuli (P < 0.05), without adverse events. Exploratory analyses suggested a relationship between the extent of meditation practice and the magnitude of intervention benefits. The authors concluded meditation-CBT intervention reduced pain severity and sensitivity to experimental thermal pain stimuli in patients with opioid-treated CLBP. Scientific Rationale – June 2015 Leach et al (2015) reported that the burden on those caring for people with dementia is substantial, with widespread implications for the caregiver, the care recipient and the community. Relaxation techniques, such as Transcendental Meditation (TM), have been shown to reduce stress and anxiety in healthy workers; similar benefits are anticipated in dementia caregivers. The objective of this study was to ascertain whether TM can improve psychological stress, quality of life, affect and cognitive performance in dementia caregivers. The study was conducted as a pilot prospective, multi-centre, community-based, randomised wait-list controlled trial. Community-dwelling caregivers of persons with diagnosed dementia were randomly assigned to a 12-week (14-hour) TM training program or wait-list control. Participants were assessed for quality of life, stress, affect, cognitive performance and adverse effects. The feasibility of the study was also evaluated. Seventeen caregivers were recruited and randomized. Improvements in WebNeuro response speed scores over time were significantly (p=0.03) greater in the TM group relative to control. Changes between groups over time in all other primary and secondary outcome measures did not reach statistical significance. However, there was a trend toward greater improvement in WebNeuro stress, depression and negativity bias scores in the TM group. Adverse events were reported amongst 63 % of TM-treated subjects; however, events were generally transient, of mild-moderate intensity and only 'possibly' related to TM. The authors concluded dementia caregivers exposed to TM demonstrated varying degrees of improvement in several measures of cognitive function, mood, quality of life and stress following exposure to TM. However, as the pilot study was underpowered, no firm conclusions can be made about the effectiveness of TM in this caregiver population. Findings from full-scale trials are now warranted. Scientific Rationale – Update June 2014 Transcendental Meditation Jun 16 4 Keyworth et al (2014) tested a six-week meditation and mindfulness intervention in people (n = 40) with diabetes mellitus and coronary heart disease. They used a sequential mixed-methods approach that measured change in worry and thought suppression and qualitatively explored acceptability, feasibility, and user experience with a focus group (n = 11) and in-depth interviews (n = 16). The intervention was highly acceptable, with 90% completing ≥5 sessions. Meditation and mindfulness skills led to improved sleep, greater relaxation, and more-accepting approaches to illness and illness experience. At the end of the six-week meditation course, worry, and thought suppression were significantly reduced. Positive impacts of mindfulnessbased interventions on psychological health may relate to acquisition and development of meta-cognitive skills but this needs experimental confirmation Treat et al (2014) compared use of CAM among children aged 3 to 17 years with and without common neurological conditions (headaches, migraines, seizures) where CAM might plausibly play a role in their self-management using the 2007 National Health Interview Survey (NHIS) data. Children with common neurological conditions reported significantly more CAM use compared to the children without these conditions (24.0% vs 12.6%, P<.0001). Compared to other pediatric CAM users, children with neurological conditions report similarly high use of biological therapies and significantly higher use of mind-body techniques (38.6% vs 20.5%, P<.007). Of the mind-body techniques, deep breathing (32.5%), meditation (15.1%), and progressive relaxation (10.1%) were used most frequently. The authors concluded about one in four children with common neurological conditions use CAM. The nature of CAM use in this population, as well as its risks and benefits in neurological disease, deserve further investigation. Tonelli and Wachholtz (2014) evaluated the effectiveness of meditation as an immediate intervention for reducing migraine pain as well as alleviating emotional tension, examined herein as a negative affect hypothesized to be correlated with pain. Twenty-seven migrainers, with two to ten migraines per month, reported migraine-related pain and emotional tension ratings on a Likert scale (ranging from 0 to 10) before and after exposure to a brief meditation-based treatment. All participants were meditation- naïve, and attended one 20-minute guided meditation session based on the Buddhist "loving kindness" approach. After the session, participants reported a 33% decrease in pain and a 43% decrease in emotional tension. The data suggest that a single exposure to a brief meditative technique can significantly reduce pain and tension, as well as offer several clinical implications. It can be concluded that single exposure to a meditative technique can significantly reduce pain and tension. The effectiveness and immediacy of this intervention offers several implications for nurses. Scientific Rationale - Update November 2011 Rosenthal et al. (2011) conducted an uncontrolled pilot study to determine whether transcendental meditation (TM) might be helpful in treating veterans from Operation Enduring Freedom or Operation Iraqi Freedom with combat-related posttraumatic stress disorder (PTSD). Five veterans were trained in the technique and followed for 12 weeks. All subjects improved on the primary outcome measure, the Clinician Administered PTSD Scale (mean change score, 31.4; p = 0.02; df = 4). Significant improvements were also observed for 3 secondary outcome measures: Clinician's Global Inventory-Severity (mean change score, 1.60; p < 0.04; df = 4), Quality of Life Enjoyment and Satisfaction Questionnaire (mean change score, -13.00; p < 0.01; df = 4), and the PTSD Checklist-Military Version (mean change score, 24.00; p < 0.02; df = 4). TM may have helped to alleviate symptoms of PTSD and improve Transcendental Meditation Jun 16 5 quality of life in this small group of veterans. Larger, placebo-controlled studies should be undertaken to further determine the efficacy of TM in this population. Haaga et al. (2011) A randomized wait-list controlled trial (N = 295 university students) of the effects of the Transcendental Meditation program was conducted in an urban setting. Substance use was assessed by self-report at baseline and 3 months later. For smoking and illicit drug use, there were no significant differences between conditions. For alcohol use, sex X intervention condition interactions were significant; TM instruction lowered drinking rates among male but not female students. TM instruction could play a valuable role in reducing alcohol use among male university students. Limitations are noted, along with suggestions for further research. Bay et al. (2011) The main aim of this research was to evaluate the effect of combined therapy using acupressure therapy, hypnotherapy, and transcendental meditation (TM) on the blood sugar (BS) level in comparison with placebo in type 2 diabetic patients. We used "convenience sampling" for selection of patients with type 2 diabetes; 20 patients were recruited. For collection of data, we used an identical quasi-experimental design called "nonequivalent control group." Therapy sessions each lasting 60-90min were carried out on 10 successive days. We prescribed 2 capsules (containing 3g of wheat flour each) for each member of the placebo group (one for evening and one for morning). Pre-tests, post-tests, and follow-up tests were conducted in a medical laboratory recognized by the Ministry of Health and Medical Education of Iran. Mean BS level in the post-tests and follow-up tests for the experimental group was reduced significantly in comparison with the pre-tests whereas in the placebo group no changes were observed. Combined therapy including acupressure therapy, hypnotherapy, and TM reduced BS of type 2 diabetic patients and was more effective than placebo therapy on this parameter. Scientific Rationale Initial Transcendental meditation is a technique to produce a state of rest and relaxation. Objective evidence for effectiveness of the treatment of medical conditions is lacking and a professional skill level is not required to train another individual to use this technique Review History October 2003 April 2006 March 2007 March 2011 November 2011 November 2012 November 2013 June 2014 June 2015 June 2016 Medical Advisory Council Update – no revisions Coding Update – no revisions Update – no revisions Update. Added revised Medicare Table with link to NCD. No revisions. Update – no revisions Update - no revisions Update – no revisions Update – no revisions Update – no revisions References – Update June 2016 1. 2. Chan RR, Lehto RH. The Experience of Learning Meditation and Mind/Body Practices in the COPD Population. Explore (NY). 2016 May-Jun;12(3):171-9. Innes KE, Selfe TK, Khalsa DS, Kandati S. Effects of Meditation versus Music Transcendental Meditation Jun 16 6 3. 4. 5. 6. 7. 8. Listening on Perceived Stress, Mood, Sleep, and Quality of Life in Adults with Early Memory Loss: A Pilot Randomized Controlled Trial. J Alzheimers Dis. 2016 Apr 8. Kanter G, Komesu YM, Qaedan F, et al. Mindfulness-based stress reduction as a novel treatment for interstitial cystitis/bladder pain syndrome: a randomized controlled trial. Int Urogynecol J. 2016 Apr 26. Keller A, Meyer B, Wöhlbier HG, et al. Migraine and Meditation: Characteristics of Cortical Activity and Stress Coping in Migraine Patients, Meditators and Healthy Controls-An Exploratory Cross-Sectional Study. Appl Psychophysiol Biofeedback. 2016 Mar 16. Lee J, Song Y, Lindquist R, et al. Nontraditional Cardiac Rehabilitation in Korean Patients with Coronary Artery Disease. Rehabil Nurs. 2016 Apr 14. Victorson D, Hankin V, Burns J, et al. Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial. Psychooncology. 2016 May 3 Salhofer I, Will A, Monsef I, Skoetz N. Meditation for adults with hematological malignancies. Cochrane Database Syst Rev. 2016 Feb 3;2:CD011157. Zgierska AE, Burzinski CA, Cox J, et al. Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in OpioidTreated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial. Pain Med. 2016 Mar 10. References – Update June 2015 1. 2. 3. Amtul Z, Arena A, Hirjee H, et al. A randomized controlled longitudinal naturalistic trial testing the effects of automatic self transcending meditation on heart rate variability in late life depression: study protocol. BMC Complement Altern Med. 2014 Aug 19;14:307 Leach MJ, Francis A, Ziaian T. Transcendental Meditation for the improvement of health and wellbeing in community-dwelling dementia caregivers [TRANSCENDENT]: a randomised wait-list controlled trial. BMC Complement Altern Med. 2015 May 8;15(1):145. Leung NT, Lo MM, Lee TM. Potential therapeutic effects of meditation for treating affective dysregulation. Evid Based Complement Alternat Med. 2014;2014:402718 References – Update June 2014 1. 2. 3. 4. 5. Innes KE, Selfe TK. Meditation as a Therapeutic Intervention for Adults at Risk for Alzheimer's Disease - Potential Benefits and Underlying Mechanisms. Front Psychiatry. 2014 Apr 23;5:40. eCollection 2014. Keyworth C, Knopp J, Roughley K, et al. A mixed-methods pilot study of the acceptability and effectiveness of a brief meditation and mindfulness intervention for people with diabetes and coronary heart disease. Behav Med. 2014;40(2):53-64. Manchanda SC, Madan K. Yoga and meditation in cardiovascular disease. Clin Res Cardiol. 2014 Jan 25. Tonelli ME, Wachholtz AB. Meditation-based treatment yielding immediate relief for meditation-naïve migraineurs. Pain Manag Nurs. 2014 Mar;15(1):36-40. Treat L, Liesinger J, Ziegenfuss JY, et al. Patterns of complementary and alternative medicine use in children with common neurological conditions. Glob Adv Health Med. 2014 Jan;3(1):18-24. References – Update November 2012 Transcendental Meditation Jun 16 7 1. 2. Fox KC, Zakarauskas P, Dixon M, et al. Meditation Experience Predicts Introspective Accuracy. PLoS One. 2012;7(9):e45370. Epub 2012 Sep 25. Guglietti CL, Daskalakis ZJ, Radhu N, et al. Meditation-related increases in GABA(B) modulated cortical inhibition. Brain Stimul. 2012 Sep 7. References – Update November 2011 1. 2. 3. 4. Bay R, Bay F. Combined Therapy Using Acupressure Therapy, Hypnotherapy, and Transcendental Meditation versus Placebo in Type 2 Diabetes. J Acupunct Meridian Stud. 2011 Sep;4(3):183-6. Haaga DA, Grosswald S, Gaylord-King C, et al. Effects of the Transcendental Meditation Program on Substance Use among University Students. Cardiol Res Pract. 2011 Mar 21;2011:537101. Rosenthal JZ, Grosswald S, Ross R, et al. Effects of transcendental meditation in veterans of Operation Enduring Freedom and Operation Iraqi Freedom with posttraumatic stress disorder: a pilot study. Mil Med. 2011 Jun;176(6):626-30. Travis F. Comparison of coherence, amplitude, and eLORETA patterns during Transcendental Meditation and TM-Sidhi practice. References – Update March 2011 1. 2. 3. 4. 5. 6. Chiesa A, Serretti A. Mindfulness based cognitive therapy for psychiatric disorders: A systematic review and meta-analysis. Psychiatry Res. 2010 Sep 14 Erwin Wells R, Phillips RS, McCarthy EP. Patterns of mind-body therapies in adults with common neurological conditions. Neuroepidemiology. 2011;36(1):46-5 Gross CR, Kreitzer MJ, Thomas W, et al. Mindfulness-based stress reduction for solid organ transplant recipients: a randomized controlled trial. Altern Ther Health Med. 2010 Sep-Oct; 16(5):30-8. Krisanaprakornkit T, Ngamjarus C, Witoonchart C, Piyavhatkul. Meditation therapies for attention-deficit/hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2010 Jun 16;(6):CD0065 Saquib J, Madlensky L, Kealey S, et al. Classification of CAM Use and Its Correlates in Patients With Early-Stage Breast Cancer. Integr Cancer Ther. 2011 Mar 7. Zeidan F, Johnson SK, Gordon NS, Goolkasian P. Effects of brief and sham mindfulness meditation on mood and cardiovascular variables. J Altern Complement Med. 2010 Aug; 16(8):867-73. References – Update March 2007 Lamanque P, Daneault S. Does meditation improve the quality of life for patients living with cancer? Can Fam Physician. 2006 Apr; 52:474-5. 2. Jayadevappa R, Johnson JC, Bloom BS, et al. Effectiveness of transcendental meditation on functional capacity and quality of life of African Americans with congestive heart failure: a randomized control study. Ethn Dis. 2007 Winter; 17(1):72-7. 3. Arias AJ, Steinberg K, Banga A, Trestman RL. Systematic review of the efficacy of meditation techniques as treatments for medical illness. J Altern Complement Med. 2006 Oct; 12(8):817-32. 1. References - Initial 1. Tacon AM. Meditation as a complementary therapy in cancer. Fam Community Health. 2003 Jan-Mar;26(1):64-73 Transcendental Meditation Jun 16 8 2. Tacon AM, McComb J, Caldera Y, Randolph P. Mindfulness meditation, anxiety reduction, and heart disease: a pilot study. Fam Community Health. 2003 JanMar; 26(1):25-33. 3. Vyas R, Dikshit N. Effect of meditation on respiratory system, cardiovascular system and lipid profile. Indian J Physiol Pharmacol. 2002 Oct; 46(4):487-91. Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. 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If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code 1367.63 requires health care service plans to cover reconstructive surgery. “Reconstructive surgery” means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean “cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code 1367.6 requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. 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