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Biofeedback is a technique to teach patients self-regulation of physiologic processes not generally considered to be under voluntary control; a variety of approaches and devices are available. Biofeedback, in conjunction with pelvic floor muscle training (PFMT), is proposed as a treatment of urinary incontinence.
Urinary Incontinence is a common condition defined as an involuntary leakage of urine. Women are twice as likely to be affected as men, and prevalence increases with age. The severity of incontinence affects quality of life and treatment decisions. The types of urinary incontinence include stress, urge, overflow, functional, and post-prostatectomy incontinence. Nonsurgical treatment options may include pharmacologic treatment, pelvic muscle exercises, bladder training exercises, electrical stimulation, and neuromodulation.
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 commonly 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 anxiety, headaches, hypertension, movement disorders, incontinence, pain, asthma, Raynaud disease, and insomnia. Biofeedback training is done either in individual or group sessions and as a single therapy, or in combination with other therapies designed to teach relaxation. A typical program consists of 10 to 20 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, and feedback is provided for successful alteration of the physiologic parameter. This feedback may be in the form of signals, such as lights or tone, verbal praise, or other auditory or visual stimuli.
Biofeedback, in conjunction with pelvic floor muscle training, is a possible treatment modality for stress, urge, mixed, and overflow urinary incontinence because it may enhance awareness of body functions and the learning of exercises to train pelvic muscles. Several proposed methods of biofeedback that may be employed to treat urinary incontinence, including vaginal cones or weights, perineometers, and electromyographic (EMG) systems with vaginal and rectal sensors.
The various forms of biofeedback mainly differ 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 (e.g., relaxation, behavioral management, medication).
A variety of biofeedback devices are cleared for marketing though the Food and Drug Administration’s (FDA) 510(k) process. 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”.
Other indications for Biofeedback are addressed in a separate policy.
POLICYBiofeedback is considered investigational as a treatment of urinary incontinence in adults.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY9/24/2009: Policy added to address biofeedback specifically for urinary incontinence.
07/15/2010: Policy description and statement unchanged. FEP verbiage added to the Policy Exceptions section.
09/25/2012: Policy reviewed; no changes.
10/23/2013: Policy description re-arranged for clarity purposes. No changes to policy statement.
09/10/2014: Policy reviewed; no changes.
08/25/2015: Code Reference section updated for ICD-10. Removed ICD-9 procedure codes 89.21, 89.23, and 93.08.
01/05/2016: Policy description updated. Policy statement unchanged. Investigative definition updated in policy guidelines section.
06/01/2016: Policy number A.2.01.27 added.
01/26/2017: Policy reviewed; no changes.
SOURCESBlue Cross Blue Shield Association Policy # 2.01.27
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
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