Clinical Policy Bulletin: Complementary and Alternative Medicine
Number: 0388
Policy
Aetna considers alternative medicine interventions medically necessary if they are supported by adequate evidence of safety and effectiveness in the peer-reviewed published medical literature. The following are some of the alternative medicine interventions that Aetna considers medically necessary for properly selected members, subject to applicable benefit plan limitations and exclusions.
Airrosti (Applied Integration for the Rapid Recovery of Soft Tissue Injuries) is proven nonpreferentially for physical therapy, as there is a lack of reliable published evidence that Airrosti is superior to other physical therapy providers.
Aetna considers the following alternative medicine interventions experimental and investigational, because there is inadequate evidence in the peer-reviewed published medical literature of their effectiveness:
Active release technique Acupressure Alexander technique AMMA therapy Antineoplastons - see CPB 0240 - Antineoplaston Therapy and Sodium Phenylbutyrate Anti-oxidant function testing (e.g., Spectrox™) Actra-Rx Apitherapy Applied kinesiology Aromatherapy Art therapy Aura healing Autogenous lymphocytic factor Auto urine therapy Bioenergetic therapy Biofield Cancell (Entelev) cancer therapy Bioidentical hormones Biomagnetic therapy Bovine cartilage products Brain integration therapy Carbon dioxide therapy Cellular therapy Chakra healing Chelation therapy for Atherosclerosis - see CPB 0234 - Chelation Therapy Chung Moo Doe therapy Coley's toxin Colonic irrigation Color therapy Conceptual mind-body techniques Craniosacral therapy Crystal healing Cupping Dance/Movement therapy Digital myography Ear Candling Egoscue method Electrodermal stress analysis Electrodiagnosis according to Voll (EAV) Equestrian therapy -- see CPB 0151 - Hippotherapy Essential Metabolics Analysis (EMA) Essiac Feldenkrais method of exercise therapy (also known as awareness through movement) Flower essence Fresh cell therapy Functional intracellular analysis* Gemstone therapy Gerson therapy Glyconutrients Graston technique Greek cancer cure Guided imagery Hair analysis - see CPB 0300 - Hair Analysis Hako-Med machine (electromedical horizontal therapy) Hellerwork Hivamat therapy (deep oscillation therapy) Hoxsey method Human placental tissue hydrolysate injections Humor therapy
* Functional intracellular analysis is also known as essential metabolic analysis, intracellular micronutrient analysis, leukocyte nutrient analysis, as well as micronutrient testing.
Aetna considers Airrosti (Applied Integration for the Rapid Recovery of Soft Tissue Injuries) as proven nonpreferentially for physical therapy, as there is a lack of reliable published evidence that Airrosti is superior to other physical therapy providers.
Background
"Alternative medicine" is a term used for a broad range of treatments and practices that have not gained wide acceptance in the traditional medical community and so are not considered standard medical treatment. Other terms used to describe such procedures include "holistic", "unconventional", and "complementary".
Alternative therapies are based on no common or consistent ideology, therapy of illness, or treatment. They derive from a variety of sources: ethnic and folk traditions, mainstream medical practices, established religions or semi-religious cults, philosophies or metaphysical movements, and health-and-wellness groups. The National Institutes of Health's Office of Alternative Medicine classified alternative therapies into the following 7 categories:
Alternative systems of medical practice -- use of medicine from another culture (e.g., Ayurvedia, Chinese medicine)
Bioelectromagnetic therapies -- use of electrical currents or magnetic fields to promote healing (e.g., bone repair, electroacupuncture)
Diet and nutrition -- use of specific foods, vitamins, and minerals to prevent illness and to treat disease
Herbal medicine -- use of plants as medicine
Manual healing methods -- use of the hands to promote healing (e.g., massage, chiropractic)
Mind-body interventions - use of the mind to enhance health (e.g., hypnosis, meditation, yoga)
Pharmacologic and biologic treatments -- use of various substances (e.g., drugs, serums) to treat specific medical problems.
The efficacy of various alternative medicine regimens is generally unproven, and some alternative therapies have been shown to be ineffective or even harmful.
Active release technique (ART) is a patented soft tissue system that treats problems with muscles, tendons, ligaments, fascia and nerves (e.g., headaches, back pain, carpal tunnel syndrome, shin splints, shoulder pain, sciatica, plantar fasciitis, knee problems, and tennis elbow). These conditions have one important commonality -- they often result from injury to over-used muscles. Each ART session is a combination of examination and treatment. The ART provider uses his/her hands to evaluate the texture, tightness and movement of muscles, fascia, tendons, ligaments and nerves. Abnormal tissues are treated by combining precisely directed tension with very specific patient movements. These treatment protocols -- over 500 specific moves -- are unique to ART. They supposedly allow providers to identify and correct the specific problems that are affecting each individual patient. Active release technique is similar to some massage techniques, albeit more aggressive.
While ART may be utilized by some chiropractors, it is different from conventional chiropractic manipulation. Furthermore, Drover et al (2004) reported that ART protocols did not reduce inhibition or increase strength in the quadriceps muscles of athletes with anterior knee pain. Further study is required.
Airrosti (applied integration for the rapid recovery of soft tissue injuries) centers are primarily concentrated in Texas, and focus on management of soft tissue injuries and chronic pain. Airrosti uses standard physical therapy modalities. There is a lack of published scientific evidence that Airrosti is superior to other physical therapy providers.
Bioidentical hormones (e.g., estrogen, testosterone, dehydroepiandrosterone [DHEA], etc.) are manufactured to have the same molecular structure as the hormones made by one's own body, and have been used in conjunction with laboratory tests of salivary hormone levels. These preparations can be custom-made for patients according to a physician's specifications. Based on test results, providers prescribe dosages of bioidentical hormones that are compounded at a pharmacy. Proponents of bioidentical hormones state that they are better than synthetic hormones in that they are "natural" and that they are more easily metabolized by the body, minimizing side effects. They state that synthetic hormones are stronger than bioidentical hormones and often produce intolerable side effects.
According to a committee opinion by the American College of Obstetricians and Gynecologists (ACOG, 2005), there is no scientific evidence to support claims of increased safety or effectiveness for individualized estrogen or progesterone regimens prepared by compounding pharmacies. Furthermore, hormone therapy does not belong to a class of drugs with an indication for individualized dosing. The opinion by ACOG also pointed out that salivary hormone level testing used by proponents to 'tailor' this therapy isn't meaningful because salivary hormone levels vary within each woman depending on her diet, the time of day, the specific hormone being tested, and other variables.
According to ACOG, most compounded products, including bioidentical hormones, have not undergone rigorous clinical testing for either safety or efficacy. Also, there are concerns regarding the purity, potency, and quality of compounded products. In 2001, the United States Food and Drug Administration (FDA) analyzed a variety of 29 product samples from 12 compounding pharmacies and found that 34 % of them failed one or more standard quality tests. Additionally, 9 of the 10 failing products failed assay or potency tests, with all containing less of the active ingredient than expected. In contrast, the testing failure rate for FDA-approved drug therapies is less than 2 %. The FDA requires manufacturers of FDA-approved products that contain estrogen and progestogen to include a black box warning that reflects the findings of the Women's Health Initiative. However, compounded products, including bioidentical hormones, are not approved by the FDA and therefore, compounding pharmacies are exempt from including warnings and contraindications required by the FDA in class labeling for hormone therapy.
Given the lack of well-designed and well-conducted clinical trials of these compounded hormones, ACOG recommended that all of them should be considered to have the same safety issues as those hormone products that are approved by the FDA and may also have additional risks unique to the compounding process.
In a position statement, the Endocrine Society (2006) stated that it is concerned that patients are receiving potentially misleading or false information about the benefits and risks of bioidentical hormones. It stated that the efficacy of bioidentical hormone therapy is unproven.
There are few, if any, carefully designed studies on the use of hypnotherapy in the treatment of mental health problems (Kirsch et al, 1995; Mamtani and Cimino, 2002; Fromm and Shor, 2006). Based on the current research literature, there is insufficient evidence to support the use of hypnosis in the treatment of psychiatric and psychological disorders, such as depression and anxiety. Furthermore, there also has been no experimental validation of the effectiveness of hypnosis in controlling the symptoms of attention deficit disorder (Baumgartel, 1999).
Proponents of neural therapy believe that (i) the nervous system influences all bodily functions, (ii) energy flows freely through the body of a healthy person, and (iii) illness and chronic pain disrupt this flow of energy. It involves the injection of anesthetics into various places of the body to eliminate pain and cure illness. This method is not to be confused with nerve blocks and local anesthesia used in conventional medicine. In neural therapy, anesthetics such as lidocaine and procaine, are injected into areas of the body that may be located far from the pain source. These injections are meant to eliminate "interference fields" and restore the body's natural energy flow. The injections may be given into nerves, acupuncture points, glands, scars, and trigger points. A course of treatment may involve 1 or more injections spread over several weeks. A few practitioners use electrical current and lasers instead of injected drugs. Research into neural therapy has been done mainly in Germany where it is widely used; however, there is insufficient evidence on the effectiveness of neural therapy for pain management or for any other health problems (American Cancer Society, 2007).
Griffiths et al (1998) examined the the role of the T-lymphocytic cell cycle as well as an autogenous lymphocytic factor (ALF) in the diagnosis and regulation of immunological incompetence. A total of 315 individuals (chemically sensitive immunocompromised patients, n = 290; controls, n = 25) were investigated. Each patient had been on a standard therapy of avoidance of pollutants, nutritional supplementation, and injections of antigens for foods, and biological inhalants, but did not achieve immunological competence. Peripheral lymphocytes were collected and DNA histograms were constructed. The flow cytometer was used to evaluate the cell cycle, hematological, and other immunological profiles. From the other portion of the blood specimen, lymphocytes were propagated in-vitro, harvested, and a lysate, termed ALF, was prepared. When treated with ALF, 88 % of these individuals showed a significant (p < 0.001) clinical improvement that correlated with laboratory findings, involving regulation of abnormal cell cycles, increase in total lymphocytes and subsets T4, T8, (p < 0.05) and cell-mediated immunity (CMI) response (p < 0.001). The authors stated that ALF presumably acts as a biological response modifier. More research is needed to determine the role of ALF in clinical medicine.
The Juvent 1000 Dynamic Motion Therapy (DMT) Platform is advocated as a non-drug, non-invasive treatment for osteoporosis. It provides very small vertical movements of about 50 micrometers that repeat at a rate of approximately 34 times/second. This repetition rate is automatically varied to correspond to an individual's body mass. Consequently, the vertical motion transmitted to the musculoskeletal system by the Juvent Platform is barely noticeable. The user supposedly can obtain the full benefits of the Juvent therapy by standing on the Juvent 1000 Platform for 20 minutes each day. However, there is a lack of evidence regarding the effectiveness of this device.
MEDEK, a form of physiotherapy, refers to Metodo Dinamico de Estimulacion Kinesica or Dynamic Method for Kinetic Stimulation. It was developed by a Chilean physical therapist in the 1970s. MEDEK is used for developing gross motor skills in children with physical disabilities and movement disorders (e.g., cerebral palsy, Down syndrome, hypotonia, muscular dystrophy, and developmental motor delay). It does not focus on modifying muscle tone, primitive reflexes or abnormal patterns of movement. It focuses on training movements leading to sitting, standing, and walking. Muscles are trained in postural and functional tasks rather than in isolation. Tight muscles are stretched in dynamic situations. The motor developmental sequence is not used. MeDEK assumes that different skills require different movement strategies. Unlike other interventions, tasks are performed without the child’s attention, conscious thought or co-operation. It is assumed that motivation will increase temporary performance only but will not create a permanent change. The therapist’s task is to provoke automatic postural reactions that contribute to the postural control needed for functional tasks. Well-designed clinical studies are needed to ascertaine the effectiveness of MEDEK.
In a review on autism, Levy and colleagues (2009) stated that popular biologically based treatments include anti-infectives, chelation medications, gastrointestinal medications, hyperbaric oxygen therapy, and intravenous immunoglobulins. Non-biologically based treatments include auditoru integration therapy, chiropractic therapy, cranio-sacral manipulation, facilitated communication, interactive metronome, and transcranial stimulation. However, few studies have addressed the safety and effectiveness of most of these treatments.
According the American Cancer Society, there is no scientific evidence that hydrogen peroxide is a safe, effective or useful cancer treatment. Current mainstream medical applications of hydrogen peroxide are limited to 1.5 % to 3 % solutions used as surface disinfectants and wound cleansers.
Traumeel injection solution is an anti-inflammatory, anti-edematous, anti-exudative combination formulation of 12 botanical substances and 1 mineral substance. It is classified as a homeopathic combination remedy.
Ina Cochrane review, Kassab and colleagues (2009) evaluated safety and effectiveness of homeopathic medicines used to prevent or treat adverse effects of cancer treatments. Randomized controlled trials (RCTs) of homeopathic medicines in participants with a clinical or histological diagnosis of cancer where the intervention was aimed at preventing or treating symptoms associated with cancer treatments were included in this review. All age groups, and all stages of disease were included. Two review authors independently assessed studies for inclusion and 2 review authors extracted data. Three review authors independently assessed trial quality using the Delphi List and the Cochrane Collaboration's tool for assessing risk of bias. Disagreements were resolved by consensus. Where available, data were extracted for analysis. A total of 8 controlled trials (7 placebo controlled and 1 trial against an active treatment) with a total of 664 participants met the inclusion criteria. Three studied adverse effects of radiotherapy, 3 studied adverse effects of chemotherapy and 2 studied menopausal symptoms associated with breast cancer treatment. Two studies with low-risk of bias demonstrated benefit: one study with 254 subjects demonstrated superiority of topical calendula over trolamine (a topical agent not containing corticosteroids) for prevention of radiotherapy-induced dermatitis, and another study with 32 subjects demonstrated superiority of Traumeel S (a proprietary complex homeopathic medicine) over placebo as a mouthwash for chemotherapy-induced stomatitis. Two other studies reported positive results, although the risk of bias was unclear, and 4 further studies reported negative results. No serious adverse effects or interactions were reported attributable to the homeopathic medicines used. The authors concluded that this review found preliminary data in support of the efficacy of topical calendula for prophylaxis of acute dermatitis during radiotherapy and Traumeel S mouthwash in the treatment of chemotherapy-induced stomatitis. Moreover, they stated that these trials need replicating. There is no convincing evidence for the efficacy of homeopathic medicines for other adverse effects of cancer treatments. Further research is required.
In a randomized controlled trial, Singer et al (2010) evaluated the effectiveness of the homeopathic preparation Traumeel S in minimizing post-operative pain and analgesic consumption following surgical correction of hallux valgus. A total of 80 consecutive patients were randomized to receive either Traumeel tablets or an indistinguishable placebo, and took primary and rescue oral analgesics as needed. Maximum numerical pain scores at rest and consumption of oral analgesics were recorded on day of surgery and for 13 days following surgery. Traumeel was not found superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial, however a transient reduction in the daily maximum post-operative pain score favoring the Traumeel arm was observed on the day of surgery, a finding supported by a treatment-time interaction test (p = 0.04). The authors concluded that Traumeel was not superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial. A transient reduction in the daily maximum post-operative pain score on the day of surgery is of questionable clinical importance.
Biomagnetic therapy is an approach to pain-relief that employs the use of magnets to generate an electro-magnetic field (EMF) to areas of musculo-skeletal discomfort or injuries. This approach can reportedly reduce the discomfort arising from various degenerative diseases (e.g., osteoarthritis) and help in the recovery of joint or tendon injury. However, the exact mechanism(s) of these recuperative effects remain elusive. Further ambiguity also stems from the fact that the reported effectiveness of this intervention is based largely on subjective experiences of participants in clinical trials that display a significant investigators' bias as well as placebo-effect. Thus, the effectiveness of biomagnetic therapy for pain-relief has yet to be established.
Lorentzen et al (2012) stated that neural tension technique (NTT) is a therapy believed to reduce spasticity and to increase range of motion (ROM). These investigatiors compared the ability of NTT and random passive movements (RPMs) to reduce spasticity in the knee flexors in 10 spastic patients with brain injury. An RCT study with cross-over design evaluated muscle tone measured by: (i) hand-held dynamometer; (ii) Modified Ashworth Scale (MAS); and ROM by angles of resistance onset "catch" (R1) compensatory movement (R2) and "subjectively perceived reduction in muscle tone". Outcome measures were recorded by 3 raters before and after a single treatment session. Objective stiffness measured with the hand-held device showed no significant changes for the NTT or RPM (p ≥ 0.09 to 0.79). The subjective measures showed significant changes after the NTT for the non-blinded rater (MAS: p < 0.05: R1: p < 0.05; R2: p < 0.05), but for the blinded rater a significant reduction was found only for R1 (p < 0.05) and R2 (p < 0.05). For the non-blinded rater, intervention effects were found for R1 (p < 0.01), R2 (p < 0.01) and subjectively perceived tone reduction (p < 0.01). For the blinded rater, no intervention effect was found. The authors concluded that an objective evaluation of NTT demonstrated that it does not reduce spasticity. However, it does increase ROM with the same effect as RPM.
Hivamat therapy (deep oscillation therapy) utilizes an intermittent electrostatic field via a Hivamat machine. It supposedly penetrates deeper into the body tissue than manual methods, allowing previously “untreatable” injuries to be manipulated with a minimum of physical pressure. Electrostatic waves create a kneading effect deep within the damaged tissues, restoring flexibility and blood supply to the affected area.
Aliyev (2009) noted that in Germany approximately 2 million sports injuries occur per year. Most common are distortions and ligamentous injury going along with post-traumatic lymphedema. Deep oscillation therapy provided very good results in lymph drainage and in other indications. In an experimental study, these researchers evalauted the effects of deep oscillation therapy in immediate therapy and after-care of different sports injuries in addition to usual care (complex physical and medical therapy). Two soccer teams were supported by a sports medicine section of a rehabilitation hospital. In 14 people (mean age of 23.9 years), 49 sports injuries of different kind were treated. Subjective rating of the symptoms by VAS improved significant (p = 0.001) from 8.7 (baseline) to 2.1 points (post-treatment). Objective rating by the attending physician according to different clinically relevant parameters lead to "very good" or "good" results in 90 % of the patients. The authors concluded that deep oscillation therapy is an easy to use and comparably cost-effective adjuvant therapy option. These investigators already had good experience with it in other indications concerning re-absorption of edema, reducing pain, anti-inflammatory effect, promotion of motoricity, promotion of wound healing, anti-fibrotic effect and improvement in trophicity and quality of the tissue. All these mentioned effects can be confirmed in the treatment of patients with acute sports injury and trauma. The soft mode of action is the reason that in contrast to other electric and mechanical therapies it is no contraindication in immediate therapy. In general, the authors noted no side effects; patients were highly compliant and rated this therapy as very good. Limitations of this small study (n = 14) were its retrospective and uncontrolled nature; findings were also confounded by the concomitant use of usual care.
CPT codes not covered for indications listed in the CPB:
86353
90880
Other CPT codes related to the CPB:
20974
20975
64550
82136
82180
82306
82310
82379
82495
82525
82607
82652
82725
82746
82978
83735
83785
84207
84252
84255
84425
84446
84590
84591
84597
84630
90875
90876
90901
90911
96902
97014
97032
97039
97110
97124
97139
97140
97150
97530
97799
97810
+ 97811
97813
+ 97814
98940
98941
98942
98943
HCPCS codes not covered for indications listed in the CPB:
G0176
Activity therapy, such as music, dance, art or play therapies not for recreation, related to the care and treatment of patient's disabling mental health problems per session (45 minutes or more)
G0455
Physician documentation of face-to-face visit for durable medical equipment determination performed by nurse practitioner, physician assistant or clinical nurse specialist
J3570
Laetrile, amygdalin, vitamin B-17
M0075
Cellular therapy
M0300
IV chelation therapy (chemical endarterectomy)
P2031
Hair analysis (excluding arsenic)
S8940
Equestrian/hippotherapy, per session
Other HCPCS codes related to the CPB:
A4595
Electrical stimulator supplies, 2 lead, per month (e.g., TENS, NMES)
E0720
Transcutaneous electrical nerve stimulation (TENS) device, two leads, localized stimulation
E0730
Transcutaneous electrical nerve stimulation (TENS) device, four or more leads, for multiple nerve stimulation
E0731
Form-fitting conductive garment for delivery of TENS or NMES (with conductive fibers separated from the patient's skin by layers of fabric)
E0746
Electromyography (EMG), biofeedback device
G0281
Electrical stimulation, (unattended), to one or more areas, for chronic stage III and stage IV pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcers not demonstrating measurable signs of healing after 30 days of conventional care, as part of a therapy plan of care
G0282
Electrical stimulation, (unattended), to one or more areas, for wound care other than described in G0281
G0283
Electrical stimulation (unattended), to one or more areas for indication(s) other than wound care, as part of a therapy plan of care
J1815, J1817, S5550 - S5571
Insulin
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