Archived Policies - Mental Health
Biofeedback and Neurofeedback
FOR TEXAS (when not used to treat aquired brain injury), ILLINOIS AND NEW MEXICO:
Biofeedback and Neurofeedback therapy is considered experimental, investigational and unproven for all conditions.
Biofeedback and/or neurofeedback are frequently used to treat the following conditions.
Biofeedback is a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. The technique 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 has been proposed as a treatment for a variety of diseases and disorders including but not limited to anxiety, headaches, hypertension, movement disorders, incontinence, pain, asthma, Raynaud’s disease, insomnia, fibromyalgia, rheumatoid arthritis and recurrent abdominal pain in children.
The type of feedback used in an intervention depends on the nature of the disease or disorder under treatment. For hypertension, blood pressure is monitored, and the data are reported back to the patients. For tension headaches, electromyographic (EMG) measurement of muscular contraction is used. For migraine headaches, EMG measuring contraction of the frontalis muscle and skin temperature feedback data are used. EMG data is also used for fecal and urinary incontinence.
Treatment of chronic pain is often multimodal, and typically includes a component of behavioral therapy. Behavior techniques vary, but are geared toward reducing muscle tension to break the pain cycle. EMG biofeedback has been used as part of a behavioral treatment program, with the assumption that the ability to reduce muscle tension will be improved through feedback of data regarding degree of muscle tension to the subject. Other behavioral therapies include a variety of relaxation techniques, such as meditation, mental imagery, and cognitive therapy, which teaches subjects the ability to cope with stressful stimuli by attempting to alter negative thought and dysfunctional attitudes. Relaxation exercises may be part of the coping skills taught with cognitive-behavior therapy.
The application of biofeedback to the treatment of urinary and rectal incontinence differs somewhat from the different tenets of biofeedback in that the biofeedback is used to help the patient learn to control and coordinate the contraction of sphincter muscles i.e. skeletal, muscles, which are under voluntary control. In particular, biofeedback as a treatment for urinary or fecal incontinence is often used to enhance training in pelvic floor muscle exercises (PME).
Biofeedback training for fecal incontinence focuses on improving the ability to voluntarily contract the external anal sphincter and puborectalis muscles in response to rectal filling. Specifically, biofeedback attempts to improve rectal sensory perception, strength, coordination, or some combination of these three components. Sensory training involves inducing intrarectal pressure using a balloon feedback device. A manometric balloon probe is inserted into the rectum. The balloon is filled with air to produce a sensation of rectal filling. The patient is trained to perceive the stimulation of rectal distention and to respond without delay with an immediate and forceful external anal sphincter contraction to counteract reflex inhibition (relaxation) of the internal anal sphincter. The purpose of sensory training is to increase an awareness of the presence of fecal material in the rectum and to decrease delay in response to sensation of distention. By retraining the sensory threshold, the patient becomes able to discriminate and respond to smaller rectal volumes, thus lowering the threshold for sensing rectal distention.
Biofeedback as a form of behavioral treatment for migraine and tension headaches can be done either in individual or group sessions, alone or in combination with other behavioral therapies designed to teach relaxation. A typical program consists of ten to twenty training sessions of 30 minutes each. Training sessions are performed in a quiet, non-arousing environment. Subjects are instructed to use mental techniques to affect the physiologic variable monitored. Typically, some type of reward system is incorporated for successful alteration of the feedback parameter. This reward may be in the form of sensory signals such as lights or tone, verbal praise, or other pleasant stimuli.
The various forms of biofeedback differ mainly in the physiologic information that is fed back to the individual. 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 attempts to reduce muscle tension. Thermal biofeedback is commonly used for migraine headaches. In this technique, 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.
Neurofeedback training is a term used to describe the feedback of neural information to patients with certain central nervous system (CNS) disorders in an attempt to teach these patients to modify their brain function. Neurofeedback may be conceptualized as a type of biofeedback that uses the electroencephalogram (EEG) as a source of feedback data. It is hypothesized that using the EEG as a measure of CNS functioning can help train patients to modify or control their brain function in the treatment of a variety of disorders including attention deficit/hyperactivity disorder, learning disabilities, seizure disorders, substance abuse-related disorders, menopausal hot flashes, panic and anxiety disorders, substance abuse, depression, stress management, or sleep disorders.
Although related in concept to biofeedback, neurofeedback differs in that the information fed back to the patient, i.e., EEG tracings, is not physiologic in nature.
Several methodologic difficulties exist in assessing biofeedback. For example, most interventions that include biofeedback are multimodal and include relaxation and behavioral instruction, which may have effects separate from those that may occur due to biofeedback. While studies may report a beneficial effect of multimodality treatment, without appropriate control conditions, it is impossible to isolate the specific contribution of biofeedback to the overall treatment effect. For example, relaxation, attention, or suggestion may account for the successful results that have been attributed to biofeedback. These are nonspecific therapeutic factors, some of which can be considered placebo effects.
A 1995 Blue Cross Blue Shield Association BCBSA) Technology Evaluation Center (TEC) Assessment evaluated the use of biofeedback in the treatment of nine different conditions:
The TEC Assessment concluded that while a substantial number of studies reported improvement in the biofeedback group relative to the no-treatment group, there were generally no differences when the isolated effect of biofeedback was compared with relaxation or behavioral therapy alone. The TEC Assessment also concluded that while there was evidence that feedback on physiological processes provides patients with an enhanced ability to control these processes, there was, nevertheless, no consistent evidence of any relationship between a patient’s ability to exert control over the targeted physiological process and any health benefits of the intervention. These findings underscore the importance of seeking controlled studies showing whether use of biofeedback improves disease-related health outcomes, as opposed to physiological, intermediate outcomes. Studies also failed to consistently address the durability of effects beyond the initial, short-term biofeedback training period. The findings that were reviewed suggested that the outcomes of biofeedback relative to no treatment are due to the other components of therapy or to the nonspecific effects of the therapeutic setting and are not a result of the biofeedback training.
For conditions other than incontinence, a literature search covering 1996 – 2005 was performed to identify any subsequent controlled studies. No controlled trials meeting the 1995 TEC Assessment study selection criteria have appeared between 1996 and 2005 for anxiety disorders, insomnia, and asthma.
Two studies used the same sample of patients with mild, unmedicated essential hypertension. Investigators randomized patients to either active or true biofeedback or feedback in which systematic changes in blood pressure were particularly disguised. The earlier study used a shorter overall training period and failed to show differences between groups. In contrast, the later study period and failed to show differences between groups. In contrast, the later study performed laboratory training plus four weeks of home training; the active group lowered blood pressure to a greater extent than placebo group patients at the end of training. While the results of the second study suggest nonspecific effects for biofeedback, it is unclear whether the partial disguising of treatments achieved effective double blinding. It is also unclear whether blood pressure reductions are maintained over the long term.
In a meta-analysis on biofeedback in hypertension, Nakao, et al., found that biofeedback was effective in lowering systolic and diastolic blood pressure but only when the biofeedback was combined with relaxation techniques. The authors noted that further study is needed to determine if biofeedback has any blood pressure lowering effect without relaxation techniques.
Current approaches to treatment of chronic pain are multidisciplinary. Behavioral and psychological interventions are now a standard component of therapy in the majority of centers treating chronic pain in the
Behavioral treatments involve both nonspecific and specific therapeutic effects. Nonspecific effects, sometimes called placebo effects, occur as a result of therapist contact, positive expectancies on the part of the subject and the therapist, and other beneficial effects that occur as a result of being a patient in a therapeutic environment. Specific effects are those that occur only because of the active treatment, above any nonspecific effects that may be present. Because an ideal placebo control is problematic with behavioral treatments, and because treatment of chronic pain is typically multimodal, isolating the specific contribution of biofeedback is difficult.
The National Institutes of Health (NIH) convened a technology assessment panel in 1996, entitled “Integration of Behavior and Relaxation Approaches into the Treatment of Chronic Pain and Insomnia.” The panel reviewed a variety of behavioral interventions in addition to biofeedback, including relaxation, hypnosis, and cognitive-behavioral therapy. For biofeedback, the panel concluded that the evidence is moderate for the effectiveness of biofeedback in treating a variety of types of pain. The statement did not discuss in depth the independent contribution of the feedback component beyond that of relaxation alone. In their summary conclusion on treating chronic pain, the assessment stated that “Although relatively good evidence exists for the efficacy of several behavioral and relaxation interventions in the treatment of chronic pain, the data are insufficient to conclude that one technique is usually more effective than another for a given condition.”
Based on the 1996 BCBSA TEC Assessment on biofeedback, which concluded that evidence was insufficient to demonstrate the effectiveness of biofeedback for treatment of chronic pain. The available evidence did not clearly show whether biofeedback’s effects exceeded nonspecific placebo effects. It was also unclear whether biofeedback added to the effectiveness of relaxation training alone. An update of the literature appearing between 1996 and 2002 finds that the previous concerns with the evidence remain unresolved and the conclusions of the 1996 TEC Assessment and the policy update are unchanged.
A variety of randomized, controlled clinical trials have been published that have attempted to isolate the contribution of biofeedback in the treatment of chronic pain. The largest study of biofeedback in the treatment of lower back pain was published by Bush and colleagues who randomized 62 patients to receive either EMG biofeedback, sham biofeedback, or a no-treatment control. At the conclusion of the trial, all three groups showed significant improvement in multiple measures of pain. There were no significant effects found for treatment type, leading the authors to conclude that biofeedback is not superior to placebo in controlling chronic pain. Two smaller controlled trials (24 patients in each trial) of biofeedback for low back pain reported conflicting results.
A study by Buckelew et al., addressed fibromyalgia. A total of 119 patients were randomly assigned to one of four treatment groups:
While the combination treatment group had better tender point index scores than other treatment groups, this study does not address placebo effects or the impact of adding biofeedback to relaxation therapy.
Dursun, et al., randomized 60 patients with knee pain to EMG biofeedback plus conventional exercise or conventional exercise alone. There were no differences between groups on pain or function.
Humphreys and Gevirtz randomly assigned 64 patients to groups treated with increased dietary fiber; fiber and biofeedback; fiber, biofeedback, and cognitive-behavioral therapy; and fiber, biofeedback, cognitive-behavioral therapy, and parental support. The three multi-component treatment groups were similar and had better pain reduction than the fiber-only group. This study does not address placebo effects.
A randomized study by Bergeron of 78 patients with vulvar vestibulitis compared biofeedback, surgery, and cognitive-behavioral therapy. Surgery patients had significantly better pain scores than patients who received biofeedback or cognitive-behavioral therapy. No placebo treatment was used.
In a randomized clinical trial, 143 females with fibromyalgia, biofeedback and fitness training were compared to usual care by van Santen and colleagues. The primary outcome evaluated was pain using a visual analogue scale. The authors reported there were no clear improvements in objective or subjective patient outcomes with biofeedback (or fitness training) over usual care.
In a meta-analysis of psychological interventions for rheumatoid arthritis including relaxation, biofeedback, and cognitive-behavioral therapy, Astin et al., found psychological interventions may be important adjunctive therapies in rheumatoid arthritis treatment. In the 25 studies analyzed, significant pooled effect sizes were found for pain after an intervention. However, the same effect was not seen long term, and the meta-analysis did not isolate biofeedback from other psychological interventions. Therefore, the specific effects of biofeedback cannot be isolated. Finally, in a systematic review of recurrent abdominal pain therapies in children, Weydert and colleagues concluded that behavioral interventions (cognitive-behavioral therapy and biofeedback) have a general positive effect on nonspecific recurrent abdominal pain and are safe. Like the Astin meta-analysis, the specific effects of biofeedback were not isolated in this systematic review and cannot be assessed.
Based on a 1997 BCBSA TEC Assessment on neurofeedback, which noted that there were inadequate data to permit conclusions regarding the health outcome effects of neurofeedback for any indication. Among the available studies reviewed in the 1997 BCBSA TEC Assessment, few were randomized controlled trials and those that were did not support the efficacy of neurofeedback in improving health outcomes. In addition, even among the randomized clinical trials, only two studies used appropriate control conditions.
2002-2005 Update (Biofeedback)
A literature search focusing on articles published between 1998 and 2005 identified no clinical trials that would alter the above conclusions. It is noted that there are indications other than those listed here for which biofeedback and neurofeedback are being evaluated, including hand hemiplegia, facial palsy, low vision, cardiovascular disorders, chronic obstructive pulmonary disease and epilepsy. However, there are no clinical trial publications sufficient to demonstrate the effectiveness of biofeedback in these other indications.
2002-2005 Update (Neurofeedback)
A literature search of peer reviewed literature published between 1998 and 2005 did not identify any articles that would change the conclusions of the 1997 BCBSA TEC assessment. There was inadequate data available to permit conclusions regarding the health outcome effects of neurofeedback for any indication. Among the available studies reviewed in the 1997 BCBSA TEC Assessment, few were randomized controlled trials and those that were did not support the efficacy of neurofeedback in improving health outcomes. Of the few randomized clinical trials reported, only two studies used appropriate control conditions.
Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.
When benefits are paid for biofeedback or neurofeedback services for the diagnosis of an acquired brain injury, they should be paid as a medical service, not as a psychiatric service.
Biofeedback therapy is covered under Medicare only when it is reasonable and necessary for the individual patient for muscle re-education of specific muscle groups or for treating pathological muscle abnormalities of spasticity, incapacitating muscle spasm, or weakness, and more conventional treatments (heat, cold, massage, exercise, and support) have not been successful. This therapy is not covered for treatment of ordinary muscle tension states or for psychosomatic conditions. (See the Medicare Benefit Policy Manual, Chapter 15, for general coverage requirements about physical therapy requirements).
Biofeedback is covered for the treatment of stress and/or urge incontinence in cognitively intact patients who have failed a documented trial of pelvic muscle exercise (PME) training. Biofeedback is not a treatment, per se, but a tool to help patients learn how to perform PME. Biofeedback-assisted PME incorporates the use of an electronic or mechanical device to relay visual and/or auditory evidence of pelvic floor muscle tone, in order to improve awareness of pelvic floor musculature and to assist patients in the performance of PME.
A failed trial of PME training is defined as no clinically significant improvement in urinary incontinence after completing 4 weeks of an ordered plan of pelvic muscle exercises to increase periurethral muscle strength.
The use of biofeedback therapy conducted in the home is not eligible for coverage.
Medicare does not have a national position on Neurofeedback. It is subject to local carrier discretion. Please refer to the local carrier for more information.
The information contained in this section is for informational purposes only. HCSC makes no representation to its accuracy. This information is not to be used for claims adjudication for HCSC plans.
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|Biofeedback for Miscellaneous Indications||07-15-2017||06-30-2018|
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