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DESCRIPTIONUrinary Incontinence (UI) 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 pharmacological treatment, pelvic muscle exercises (PME), bladder training exercises, electrical stimulation and neuromodulation Biofeedback, in conjunction with pelvic muscle exercises, has been proposed as a treatment modality for stress, urge, mixed and overflow urinary incontinence because it may enhance awareness of body functions and the learning of the pelvic floor exercises. There are several proposed methods of biofeedback which may be employed for the treatment of urinary incontinence including: vaginal cones or weights, perineometers and electromyographic (EMG) systems with vaginal and rectal sensors. 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’s disease, and insomnia. Biofeedback training is done either in individual or group sessions, alone, 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 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 (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.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
SOURCESBlue Cross Blue Shield Association Policy # 2.01.27
CODE REFERENCEThis is not an all-inclusive list of non-covered procedure codes.
All codes billed for this procedure are considered investigational and not eligible for coverage.