BlueCross BlueShield of Tennessee Medical Policy Manual

Complementary and Alternative Medicine

DESCRIPTION

Complementary and alternative medicine (CAM), as defined by the National Center for Complementary and Integrative Health (NCCIH), is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. Therapies and diagnostics are termed “complementary” when used in addition to conventional medicine while therapies and diagnostics used in place of conventional medicine are considered “alternative”. Complementary health approaches typically include natural products, mind and body practices, and the practices of traditional healers (e.g., Chinese medicine, homeopathy and naturopathy).

POLICY

• Complementary and alternative medicine including, but not limited to, the modalities listed below for the diagnosis, prevention, and/or treatment of diseases and health related symptoms or conditions are considered investigational: (*See Additional Information below for definition/description.)

• • Antigen Leukocyte Cellular Antibody Test (ALCAT)*

  • Aromatherapy

  • Ayurveda*

  • Balneotherapy*

  • Carbogen inhalation (also known as Meduna’s Mixture)*

  • Chinese herbal medicines (e.g., Dang Shen, Fang Feng, Tian Xian, Yin Chen, Pao Jiang)

  • Colon therapy (i.e., colonic hydrotherapy, high colonic, detoxification therapy, coffee enemas)

  • Di Bella Cancer Therapy*

  • Food Intolerance Testing, specifically IgG and IgG4* (i.e., Complement Antigen Testing)

  • Gerson Therapy*

  • GI Effects Comprehensive Stool Profile*

  • Greek Cancer Cure*

  • Heart Rate Variability Test* (e.g. Nerve Express, Heart Rhythm Scanner PE, Intelwave, PD2i®)

  • Herbs (e.g., Black cohosh, Chaparral, Echinacea, FeverFew, Ginkgo biloba, Goldenseal, Green tea, St. John's Wort, Valerian)

  • Homeopathy*

  • Intravenous nutrient therapy (e.g., Myers’ Cocktail) for non-mineral/vitamin deficiency diagnoses (e.g., chronic pain, fatigue, fibromyalgia, migraine)

  • Kelly's Nutritional-Metabolic Therapy*

  • Livingston-Wheeler Therapy*

  • Magnet therapy

  • Moxibustion*

  • MTHFR Testing for Homocystinuria, Cardiovascular disease, Cerebrovascular disease, Hypertension, Inherited thrombophilia, Psychiatric disease, Metabolic disease, or Cancer*

  • Neural Therapy*

  • Neurotransmitter Profile (Urinary)*

  • Nutrient/Nutritional Panel Testing*

  • O-Shot*

  • Oxidative and Cellular Stress Testing*

  • Qi Gong*

  • Reiki*

  • Revici Cancer Therapy*

  • Therapeutic Touch

  • Vampire Facelift*

  • Zonulin intestinal permeability testing*

IMPORTANT REMINDERS

• Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.

• BCBST may consider other products not listed within this medical policy investigational if they are not determined to be conventional medicine.

• We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

ADDITIONAL INFORMATION

• General definitions/descriptions of terms:

• • Antigen Leukocyte Cellular Antibody Test (ALCAT) - An in vitro test intended for the purpose of diagnosing intolerance to foods and other environmental agents. It is a blood test that assesses the response of leukocytes and platelets to a panel of foods and/or other environmental agents, by measuring the change in size and number of cells following exposure to a specific agent. 

  • Ayurveda -traces its roots to the Vedic period in ancient India. The Ayurvedic medicine program utilizes foods, spices, herbal medicines, colors, metals, gems and sound to allegedly overcome illness and strengthen an individual.

  • Balneotherapy - This therapy utilizes natural elements, such as hot springs, climatic factors, chronobiological and circadian rhythmic phases and peat substances. The term balneology refers to the study of the art and science of bathing. Balneotherapy is the use of balneology in the treatment of disease.

  • Carbogen Inhalation - Carbogen is also known as Meduna's Mixture after its inventor Ladislas Meduna. Carbogen is a mixture of 95% oxygen and 5% carbon dioxide and is inhaled as an adjunct to treatment for various oncologic applications. Tumors are generally hypoxic in nature and researchers theorize that increasing the tumor oxygenation during administration of chemotherapy or radiation treatments make the tumor more susceptible to the therapy being administered.

  • Di Bella Cancer Therapy - Di Bella therapy consist of a mixture of the drugs somatostatin, bromocriptine, as well as vitamins, melatonin, and sometimes other substances combined in varying amounts depending on the individual under treatment. Proponents claim the drug mixture stimulates the body's self-healing properties and can shrink tumors and even cure cancer.

  • Food Intolerance Testing, specifically IgG and IgG4  - This is an invalidated form of testing for food sensitivity, food intolerance or food allergy offered by alternative health providers, as well as distributed through direct-to-consumer marketing by nationwide chains of pharmacies and laboratories. The use of IgG testing for food intolerance has been widely discredited as reliable information, as the likelihood that circulating levels of IgG occur in most in people in health and in disease. Additionally, claims are widely circulated that this lab test is a tool that helps treat conditions such as Multiple Sclerosis, Autism, ADHD, obesity, thyroid disorders, acne, IBS, and arthritis, among others.

  • Gerson Therapy - The practitioners of Gerson therapy allege that the treatment is effective for a wide variety of ailments because it restores the body's ability to heal itself. Practitioners do not claim that this therapy will cure everything or everyone. A number of components are considered important to this therapy. These components include: juicing (as many as 13 glasses of fresh, organic vegetable/fruit juice are recommended per day), diet (three full vegetarian meals from organic sources), detoxification of tissues and blood (accomplished foremost via coffee enemas), and medications (e.g., Lugol's solution, vitamin B-12, injectable crude liver extract, pancreatic enzymes, enemas of coffee and/or chamomile). Certain complementary therapies may also be recommended, such as: polarizing treatment (GKI), ozone therapy by rectal insufflation, hydrotherapy, and acupuncture.   

  • GI Effects Composite Stool Profile - This multianalyte assay is alleged to link autoimmune disorders, diabetes, cardiovascular disease and/or other conditions to imbalanced bacteria in the intestinal tract, to differentiate IBS from IBD, and to optimize gut health management. This type of test quantifies approximately 26 gut microbiotas (more or less), and may utilize standard biochemical and culture methods to test levels of other stool components such as lipids and occult blood, and possible pathogens such as ova and parasites, yeast, and opportunistic bacteria.

  • Greek Cancer Cure - This treatment consists of a blood test reportedly used to diagnose cancer, and a secret intravenous therapy believed to consist of, among other things, brown sugar, niacin, vitamin C, and alanine (an amino acid). The blood test is alleged to determine the nature, location and seriousness of an individual’s cancer.  

  • Heart Rate Variability - This automated, diagnostic tool is a non-invasive electrophysiologic test to assess the cardiac autonomic nervous system (ANS) and the effect of stress on the heart. Heart rate variations are recorded and are categorized as representing a response of the sympathetic or parasympathetic nervous system. The test is used to assess for cardiac risk, the role of ANS in arrhythmias, heart failure, vertigo, and obesity, to monitor therapeutic effects of manipulation, massage, and dietary supplements, and to enhance athletic training and performance.

  • Homeopathy -  As reported by MayoClinic.com, homeopathy utilizes highly diluted preparations of natural substances, typically plants and minerals to treat symptoms of illness. Homeopathic medicine is based on two beliefs: 1) the law of similars - Sometimes called "like cures like". When given to a healthy person in large quantities, some plant, animal and mineral substances produce symptoms of disease. But when given to a sick person, much smaller doses of the same substances can (theoretically) relieve the same symptoms. 2) The law of infinitesimals - Literally, infinitesimal means too small to be measured. According to this belief, substances treat disease most effectively when they are highly diluted, often in distilled water or alcohol.

  • Kelly's Nutritional-Metabolic Therapy - William D. Kelley, a dentist, developed this therapy. Dr. Kelley held that the root cause of cancer is an individual's inability to properly metabolize protein. He linked this faulty metabolism to a deficiency of pancreatic enzymes. The three primary elements of Kelly's Nutritional-Metabolic Therapy program are nutrition, detoxification (utilizing coffee enemas) and supplements of pancreatic enzymes.    

  • Livingston-Wheeler Therapy - This therapy includes vaccines, antibiotics, vitamin and mineral supplements, digestive enzymes, cleansing enemas, and a vegetarian diet. Livingston-Wheeler therapy is promoted primarily for use in the treatment of cancer but it is also used to treat lupus, arthritis, and other chronic conditions.

  • Moxibustion - Reportedly treats and prevents disease by applying heat to points or certain locations on the human body. The material/instrument used to apply the heat is primarily moxa-wool in the shape of a cone or stick. Some proponents suggest that when a disease fails to respond to medication and/or acupuncture, moxibustion should be applied.

  • MTHFR (methylenetetrahydrofolate reductase) Testing - This testing for the following conditions: Homocystinuria, Cardiovascular disease, Cerebrovascular disease, Hypertension, Inherited thrombophilia, Psychiatric disease, Metabolic disease, or Cancer is not supported by evidence-based studies.

  • Neural Therapy - Neural therapy is a method of diagnosing and treating illness and pain caused by electrical disturbances called "interference fields". These disturbances are believed to be manifestations of cell membrane instability and typically trigger abnormal autonomic nervous system responses. If an interference field is found, it is claimed to be easily treated by injecting it with a local anesthetic.

  • Neurotransmitter Profile (Urinary) - Urinary neurotransmitter testing is proposed as a method to assess and manage neurotransmitter levels that affect mood, hormones, sleep, and cognitive function. It is proposed that administration of amino acids directly impacts urinary neurotransmitter levels. A baseline test in the absence of supplemental amino acids is proposed to diagnose and define the neurotransmitter imbalance and serve as a reference point to gauge treatment effectiveness after the initiation of the recommended nutritional supplements.  The validity of the urinary neurotransmitter testing model has not been clinically proven.

  • Nutrient/Nutritional Panel Testing - Nutrient/nutritional panel testing is proposed for individuals with certain chronic conditions (e.g., mood disorders, pain, fatigue, digestive complaints) to identify nutritional deficiencies that may be a causative factor. Genova Diagnostics offers NutrEval, which involves analysis of urine and/or blood samples to assess nutrients including antioxidants, minerals and essential fatty acids. Other nutrient/nutritional tests marketed by Genova include ONE, Metabolic Analysis Profile, Amino Acid Analysis, and Essential and Metabolic Fatty Acids.

  • O-Shot - An injection of the individual’s own plasma into the anterior portion of the vagina and clitoris for improving sexual function and bladder leakage.

  • Oxidative and cellular stress testing - Oxidative and cellular stress is proposed to be a contributing factor in various conditions and diseases. Oxidative stress occurs after a build-up of free radical molecules allegedly causes damage to DNA, RNA, and proteins. Measurement of oxidative and cellular stress markers is under investigation for clinical use; however, their significance has yet to be determined. Literature is heterogeneous and there is no standardization of testing.  

  • Qi Gong - The Qi Gong Association of America defines Qi Gong as the skill of attracting vital energy. Qi Gong is alleged to be a self-healing art that combines movement, meditation and visualizations to enhance the mind/body connection and assist healing. The association claims that the regular practice of Qi gong can prevent and treat illness.

  • Reiki - According to the International Center for Reiki Training, Reiki is defined as spiritually guided life force energy. Reiki is allegedly a technique for stress reduction and relaxation that allows an individual to tap into an unlimited supply of life force energy for the purpose of improving health and enhancing the quality of life.  

  • Revici Cancer Therapy - The Revici Life Science Center was established by Emanuel Revici, M.D. The Revici Guided Chemotherapy varies for each individual but can include a chemical formulation consisting of lipid alcohols, caffeine, zinc, and iron, or a formulation consisting of fatty acids, selenium, magnesium and sulfur. Proponents claim they can treat late stage cancers, especially brain, lung, pancreatic, and metastasized breast carcinomas, and also AIDS.  

  • Vampire Facelift - A procedure performed by a provider by injecting an individual’s own plasma into his or her wrinkles, under the premise those growth factors in the plasma will gradually stimulate collagen production.

  • Zonulin intestinal permeability testing - Zonulin is a protein that is synthesized in intestinal and liver cells, and is being investigated as a biomarker for intestinal permeability. Increased permeability, or leaky gut syndrome, is defined as a reduced barrier to the passage of molecules from the intestine into the wall of the intestine and from there, possibly into the bloodstream resulting in an immune response. The standard test for measuring increased gut permeability is the lactulose-mannitol urine test. Testing of the zonulin protein is being marketed as an alternative to standard testing.

While scientific evidence exists for some CAM therapies and diagnostics, for most there are key questions that are yet to be answered through well-designed scientific studies. Systematic reviews of traditional Chinese medicine were inconclusive due specifically to poor methodology and heterogeneity of the studies.

Complementary and alternative medicine including, but not limited to, those listed above, do not meet the following Technology Evaluation Center (TEC) criteria:

• The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
• The technology must improve the net health outcome.
• The technology must be as beneficial as any established alternatives.
• The improvement must be attainable outside of the investigational settings.

SOURCES

Ali, A., Njike, V., Northrup, V., Sabina, A., Williams, A., Liberti, L., Perlman, A., et al. (2009). Intravenous micronutrient therapy (Myers’ cocktail) for fibromyalgia: a placebo-controlled pilot study. Journal of Alternative and Complementary Medicine, 15 (3), 247-257. (Level 2 evidence)

Altınbilek, T., Terzi, R., Başaran, A., Tolu, S., & Küçüksaraç, S. (2019). Evaluation of the effects of neural therapy in patients diagnosed with fibromyalgia. Turkish Journal of Physical Medicine and Rehabilitation, 65 (1), 1–8. (Level 2 evidence)

American Academy of Allergy, Asthma & Immunology. (2021). The myth of IgG food panel testing. Retrieved November 2, 2021 from https://www.aaaai.org/tools-for-the-public/conditions-library/allergies/igg-food-test.

American Cancer Society. (2021). Complementary and Integrative methods. Retrieved December 15, 2022 from https://www.cancer.org/.

American College of Medical Genetics and Genomics (ACMG). (2013, February). ACMG practice guideline: lack of evidence for MTHR polymorphism testing. Retrieved November 9, 2017 from http://www.acmg.net/docs/MTHFR_gim2012165a_Feb2013.pdf.

American Society of Plastic Surgeons. (2012). The vampire facelift: not really a face lift and no vampires involved. Retrieved November 6, 2017 from https://www.plasticsurgery.org/news/blog/the-vampire-facelift-not-really-a-facelift-and-no-vampires-involved.

BlueCross BlueShield Association. Evidence Positioning System. (1:2023). Nutrient/Nutritional Panel Testing (2.04.136). Retrieved December 5, 2023 from https://www.bcbsaoca.com/eps/. (15 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Evidence Positioning System. (11:2023). Antigen leukocyte antibody test (2.01.93). Retrieved December 5, 2023 from https://www.bcbsaoca.com/eps/. (7 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Evidence Positioning System. (12:2023) Biofeedback for miscellaneous indications. Retrieved December 5, 2023 from https://www.bcbsaoca.com/eps/. (46 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Evidence Positioning System. (12:2023). Neural therapy (2.01.85). Retrieved December 5, 2023 from https://www.bcbsaoca.com/eps/. (13 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Evidence Positioning System. (3:2024). Biomarker Testing in Risk Assessment and Management of Cardiovascular Disease (2.04.65). Retrieved March 21, 2024 from https://www.bcbsaoca.com/eps/. (164 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Evidence Positioning System. (6:2023). Genetic testing for inherited thrombophilia (2.04.82). Retrieved December 5, 2023 from https://www.bcbsaoca.com/eps/. (44 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Evidence Positioning System. (8:2023). Genetic testing for diagnosis and management of mental health conditions (2.04.110). Retrieved December 5, 2023 from https://www.bcbsaoca.com/eps/. (42 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Evidence Positioning System. (9:2023). Miscellaneous genetic and molecular diagnostic tests (2.04.121). Retrieved December 5, 2023 from https://www.bcbsaoca.com/eps/. (41 articles and/or guidelines reviewed)

Demir, E., Ozkan, H., Seckin, K.D., Sahtiyanci, B., Demir, B., Tabak, O., et al. (2019). Plasma zonulin levels as a non-invasive biomarker of intestinal permeability in women with gestational diabetes mellitus. Biomolecules, 9 (24), 1-8. (Level 4 evidence)

Goessl, V. C., Curtiss, J. E., & Hofmann, S. G. (2017). The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis. Psychological Medicine, 47 (15), 2578–2586. Retrieved December 15, 2022 from PubMed database.

Hinz, M., Stein, A., & Uncini, T. (2011). Validity of urinary monamine assay sales under the “spot baseline urinary neurotransmitter testing marketing model”. International Journal of Nephrology and Renovascular Disease, 4, 101-113. (Level 2 evidence)

Hinz, M., Stein, A., Trachte, G., & Uncini, T. (2010). Neurotransmitter testing of the urine: a comprehensive analysis. Open Access Journal of Urology, 2, 177-183. (Level 2 evidence)

Jiménez, M., & Molina Mora, J. (2017). Effect of heart rate variability biofeedback on sport performance, a systematic review. Applied Psychophysiology and Biofeedback, 42 (3), 235-245. Abstract retrieved February 4, 2020 from PubMed database.

Khan, Z. & Ali, S.A. (2018). Oxidative stress-related biomarkers in Parkinson’s disease: a systematic review and meta-analysis. Iranian Journal of Neurology, 17 (3), 137-144. (Level 1 evidence)

Nair, N. & Gongora, E. (2017). Oxidative stress and cardiovascular aging: interaction between NRF-2 and ADMA. Current Cardiology Reviews, 13, 183-188. (Level 2 evidence)

National Institute of Allergy and Infectious Diseases. (2010) Guidelines for the diagnosis and management of food allergy in the United States. Retrieved July 16, 2012 from https://www.nih.gov/.

National Institutes of Health. National Center for Complementary and Integrative Health. (2023). Health topics A – Z. Retrieved December 6, 2023 from https://nccih.nih.gov.

Seely, D., Szczurko, O., Cooley, K., Fritz, H., Aberdour, S., Herrington, C., Herman, P., et al. (2013). Naturopathic medicine for the prevention of cardiovascular disease: a randomized clinical trial. Canadian Medical Association Journal, 185 (9), E409-E416. (Level 2 evidence)

Tennessee Code: Title 63 Professions of the Healing Arts: Chapter 6 Medicine and Surgery: Part 2 General Provisions: 63-6-205. Practice of naturopathy. Retrieved December 6, 2023 from http://www.lexisnexis.com/hottopics/tncode/.

U. S. Food and Drug Administration. (2011, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K101867. Retrieved July 3, 2012 from http://www.accessdata.fda.gov/cdrh_docs/pdf10/K101867.pdf.

Wegh, C.A.M., de Roos, N.M., Hovenier, R., Meijerink, J., Besseling-van der Vaart, I., van Hemert, S., & Witteman, B.J.M. (2019). Intestinal permeability measured by urinary sucrose excretion correlates with serum zonulin and faecal calprotectin concentrations in UC patients in remission. Journal of Nutrition and Metabolism, volume 2019, article ID 2472754. (Level 2 evidence)

Yip, K., & Alonzi, R. (2013). Carbogen gas and radiotherapy outcomes in prostate cancer. Therapeutic Advances in Urology, 5 (1), 25-34. (Level 4 evidence)

ORIGINAL EFFECTIVE DATE:  2/1/2003

MOST RECENT REVIEW DATE:  4/11/2024

ID_BT

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