Medical Policy: 02.01.05
Original Effective Date: October 2002
Reviewed: July 2020
Revised: July 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Biofeedback is a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. It is frequently used in conjunction with other therapies (i.e., relaxation, behavioral management, medication) to reduce the severity and/or frequency of headaches and as a treatment for a variety of diseases and disorders including anxiety, hypertension, movement disorders, incontinence, pain, and asthma. Professionals who use this technique assume that patients who achieve greater biofeedback control over the relevant physiological functions will be more successful in reducing their symptoms.
Biofeedback involves the feedback of a variety of types of information not normally available to the patient, followed by a concerted effort on the part of the patient to use this feedback to help alter the physiological process in some specific way. Biofeedback training is done either in individual or group sessions, alone or in combination with other behavioral therapies designed to teach relaxation. A typical course of treatment consists of 10 to 20 training sessions of 30 to 60 minutes each. Training sessions are conducted in a quiet, non-rousing environment. Subjects are instructed to use mental techniques to affect the physiologic variable monitored, and feedback is provided for successful alteration of the physiologic parameter. This feedback may be signals such as lights or tone, verbal praise, or other auditory or visual stimuli.
The various forms of biofeedback differ mainly in the nature of the disease or disorder under treatment, the biologic variable that the individual attempts to control, and the information that is fed back to the individual. Biofeedback techniques include peripheral skin temperature feedback, blood-volume-pulse feedback (vasoconstriction and dilation), vasoconstriction training (temporalis artery), and electromyographic (EMG) biofeedback; these may be used alone or in conjunction with other therapies. Generally, EMG biofeedback is used to treat tension headaches, and thermal biofeedback is used to treat migraine headaches. In EMG biofeedback, electrodes are attached to the temporal muscles. The degree of muscle tension is fed back to the individual being treated and the subject is asked to reduce muscle tension. For thermal biofeedback, a temperature sensor is placed on the finger, and the subject is taught to increase the temperature, an effect that is mediated through peripheral vasodilation. According to the National Center for Complementary and Alternative Medicine (NCCAM), biofeedback is considered an alternative medicine technique.
Another form of biofeedback is electroencephalogram (EEG) biofeedback, also called neurofeedback, brainwave biofeedback or neurotherapy, which measures alpha (associated with relaxation and meditation) and theta (associated with focused attention) brainwave activity. It is proposed to counterbalance genetic and environmental tendencies by learning to alter brain wave patterns. Neurofeedback describes techniques of providing feedback about neuronal activity, as measured by electroencephalogram (EEG) biofeedback or functional magnetic resonance imaging (fMRI), in order to teach patients to self-regulate brain activity. Neurofeedback may utilize several techniques in an attempt to normalize unusual patterns of brain function in patients with central nervous system (CNS) disorders, such as attention deficit/hyperactivity disorder (ADHD), autism spectrum disorder, substance abuse, epilepsy, and insomnia.
Yet another form of biofeedback is Heart Rate Variability (HRV) biofeedback. It is a relatively new technique for training people to change the variability and dominant rhythms of their heart activity. Research is ongoing applying HRV biofeedback techniques to a variety of medical and psychiatric conditions, including: anger, anxiety disorders, asthma, cardiovascular conditions including heart failure, chronic obstructive pulmonary disorder (COPD), depression, irritable bowel syndrome (IBS), chronic fatigue, and chronic pain.
The American Academy of Neurology’s recommendations for the evaluation and treatment of migraine headaches states that behavioral and physical interventions are used for preventing migraine episodes rather than for alleviating symptoms once an attack has begun. Although these modalities may be effective as monotherapy, they are more commonly used in conjunction with pharmacologic management. Relaxation training, thermal biofeedback combined with relaxation training, electromyographic biofeedback, and cognitive-behavioral therapy may be considered treatment options for prevention of migraine. Specific recommendations regarding which of these to use for specific patients cannot be made.
In 2010, the European Federation of Neurological Societies gave an A-level recommendation for use of EMG biofeedback for the treatment of tension-type headache, based on the meta-analysis by Nestoriuc et al. The guidelines state that the aim of EMG biofeedback is to help the patient to recognize and control muscle tension by providing continuous feedback about muscle activity. Sessions typically include an adaptation phase, baseline phase, training phase, during which feedback is provided, and a self-control phase, during which the patient practices controlling muscle tension without the aid of feedback.
A report from The AAN and the ACNS on the assessment of digital EEG, quantitative EEG, and EEG brain mapping was reaffirmed in 2013. The report states that: :On the basis of current clinical literature, opinions of most experts, and proposed rationales for their use, QEEG remains investigational for clinical use in post concussion syndrome, mild or moderate head injury, learning disability, attention disorders, schizophrenia, depression, alcoholism, and drug abuse."
In reference to the management of cancer pain, the National Cancer Institute (NCI) (2014) states that alternative therapies (e.g., biofeedback) may be used in conjunction with pain medication in an effort to control pain. NCI stated that even though non-medical therapies have not been tested in cancer pain studies, they may help to relieve pain, stress and anxiety therefore, improving the patient’s quality of life.
The clinical guideline on the management of irritable bowel syndrome (IBS) published by NICE (2008; updated 2017) stated that reviews of biofeedback suggested a positive effect on the control of IBS symptoms, but evidence was limited and not sufficient to make recommendations. A systematic review of the literature identified four randomized controlled trials that met inclusion criteria. One study compared biofeedback to counseling and three studies evaluated multi-component therapy (a combination of educational information, progressive relaxation therapy, thermal biofeedback treatment and training in stress coping strategies) compared to symptom monitoring or attention placebo controls. There was limited, weak evidence to show a statistically significant improvement in global symptoms for biofeedback and reduction in diarrhea compared to symptom monitoring. No significant differences between biofeedback and attention placebo or between symptom monitoring and attention placebo were reported, but there was much uncertainty due to wide confidence intervals. There was insufficient evidence to determine the effects of biofeedback on pain, bloating and constipation.
The 2010 guideline (updated 2017) on the management of constipation in children and young adults stated that biofeedback should not be used for ongoing treatment in children and young people with idiopathic constipation. Meta-analysis showed no improvement in outcomes when conventional treatment (e.g., use of laxatives, advice on a high-fiber diet, attempting defecation after meals) was compared to conventional treatment plus biofeedback.
The National Institute of Neurologic Disorders and Stroke (2018) indicated that when headaches occur 3 or more times a month, preventive treatment is usually recommended:
"Drug therapy, biofeedback training, stress reduction, and elimination of certain foods from the diet are the most common methods of preventing and controlling migraine and other vascular headaches. Drug therapy for migraines is often combined with biofeedback and relaxation training."
In the guidelines on adult cancer pain (V.1.2019), the National Comprehensive Cancer Network (NCCN) recommends biofeedback as an evidence-based treatment modality (2A recommendation).
Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. 2019. This guideline states: “Some nonmedication treatments for ADHD-related problems have either too little evidence to recommend them or have been found to have little or no benefit. These include mindfulness, cognitive training, diet modification, EEG biofeedback, and supportive counseling."
Canadian ADHD Practice Guidelines. 2020. This guideline states: "Further research of NF should be conducted with more rigorous research designs and include more subjects. In light of the data available at this stage, we conclude there is insufficient data to recommend NF as a standard treatment for ADHD."
A variety of biofeedback devices are cleared for marketing through the U.S. Food and Drug Administration (FDA) 510(k) process. These devices are designated by the FDA as class II with special controls and are exempt from the premarket notification requirements. The FDA defines a biofeedback device as "an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient’s physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters."
Neurofeedback (NF) is an interactive technology that uses electroencephalographs (EEGs) to monitor real-time brain activity and help patients control their mental state based on operant-conditioning principles. Feedback consists of auditory or visual cues, such as video games. The report focuses on how well NF works compared with pharmacologic and nonpharmacologic treatments for improving attention and behavioral control in children and adolescents with attention deficit hyperactivity disorder (ADHD).
Evidence from 3 meta-analyses of low-quality studies and 3 additional randomized controlled trials (RCTs) shows that NF is less effective than pharmacotherapy and behavioral therapy for managing ADHD symptoms. Whether NF is more effective than inactive interventions (sham NF, waiting list, attention training, physical exercise) or placebo is unclear because studies reported mixed findings. Studies used different NF protocols, outcome assessment methods, and patient groups. Larger RCTs using standardized methods for NF are needed to assess comparative safety and effectiveness. Clinical guidelines state that evidence is insufficient to recommend NF for ADHD management.
See the related policy: Anorectal Biofeedback 02.01.04
Biofeedback may be considered medically necessary as part of the overall treatment plans for
Home use of biofeedback equipment is not medically necessary.
Devices used in biofeedback therapy (eg, electromyography [EMG], biofeedback device) are not eligible for separate reimbursement because they are inherent to the biofeedback service.
The use of biofeedback technology to help children and teenagers enhance their performance in school (i.e. Neurocore) is considered investigational.
Heart rate variability (HRV)/ Heart Rate Variability Training (HRVT) type biofeedback is considered investigational for all indications. There is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this therapy as well as any longevity of benefits with this therapy.
Neurofeedback is considered investigational. Neurofeedback and EMG controlled neuromuscular electrical stimulation (e.g., the Care EMG), is considered investigational, as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure.
Biofeedback/Neurofeedback is considered investigational for all indications not listed above including, but not limited to:
There continues to be insufficient evidence to demonstrate the effectiveness of biofeedback for the miscellaneous conditions listed above. Studies either fail to demonstrate any beneficial impact of biofeedback or have design flaws that leave the durability of effects in question or create uncertainty about the contribution of nonspecific factors such as attention or placebo effects. There is insufficient evidence from high-quality controlled studies that biofeedback improves outcomes in patients with depression.
For neurofeedback the evidence is poor in showing effect on health outcomes and a number of questions regarding clinical efficacy remain to be answered.
Most of the published randomized controlled trials (RCTs) on biofeedback from chronic pain have not found a significantly greater benefit when biofeedback is offered instead of or in addition to other conservative interventions.
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