Medical policy: Biofeedback as a Treatment of Fecal Incontinence or Constipation

Número de política: MP 2.398

Fecha de entrada en vigor: 9/1/2026

Política

Biofeedback for constipation in adults may be considered medically necessary for individuals with dyssynergia-type constipation as demonstrated by meeting all 3 of the following criteria:

• Symptoms of functional constipation that meet Rome IV criteria (see Policy Guidelines section).
• Objective physiologic evidence of pelvic floor dyssynergia (see Policy Guidelines section) demonstrated by inappropriate contraction of the pelvic floor muscles or less than 20% relaxation of basal resting sphincter pressure by manometry, imaging, or electromyography.
• Failed a 3-month trial of standard treatments for constipation including laxatives, dietary changes, and exercises (as many of the previous as are tolerated).

Biofeedback is considered investigational as a treatment of constipation in adults and children in all other situations. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure for the above indications.

Biofeedback is considered investigational as a treatment of fecal incontinence in adults and children. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure for the above indications.

Directrices de la política

Rome IV diagnostic criteria for functional constipation^a is as follows:

1. Must include 2 or more of the following^b:
   1. Straining during more than one-fourth (25%) of defecations
   2. Lumpy or hard stools (Bristol Stool Form Scale¹ to 2) for more than one-fourth (25%) of defecations
   3. Sensation of incomplete evacuation for more than one-fourth (25%) of defecations
   4. Sensation of anorectal obstruction/blockage for more than one-fourth (25%) of defecations
   5. Manual maneuvers to facilitate more than one-fourth (25%) of defecations (eg, digital evacuation, support of the pelvic floor)
   6. Fewer than 3 spontaneous bowel movements per week
2. Loose stools are rarely present without the use of laxatives
3. Insufficient criteria for irritable bowel syndrome

Rome IV diagnostic criterion for dyssynergic defecation is "inappropriate contraction of the pelvic floor as measured with anal surface EMG [electromyography] or manometry with adequate propulsive forces during attempted defecation."^c

^a Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.

^b For research studies, patients meeting criteria for opioid-induced constipation should not be given a diagnosis of functional constipation because it is difficult to distinguish between opioid side effects and other causes of constipation. However, clinicians recognize that these 2 conditions might overlap.

^c These criteria are defined by age- and sex-appropriate normal values for the technique.

Guidance on biofeedback protocol:

The recommended treatment course for patients with constipation who meet criteria is up to 6 biofeedback sessions over 3 months. This is consistent with the protocol used in key randomized trials showing benefit of biofeedback for selected patients.

Cross-reference:

• MP 1.033 Sacral Nerve Neuromodulation-Stimulation
• MP 2.029 Neurofeedback
• MP 2.062 Temporomandibular Disorder
• MP 2.064 Biofeedback as a Treatment of Chronic Pain
• MP 2.096 Electromyography (EMG) (Needle and Non-Needle) of the Anal or Urethral Sphincter
• MP 2.304 Medical Treatments of Autism Spectrum Disorders
• MP 2.399 Biofeedback as a Treatment of Urinary Incontinence in Adults
• MP 2.400 Biofeedback as a Treatment of Headache
• MP 2.401 Biofeedback for Miscellaneous Indications
• MP 4.012 Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence
• MP 6.020 Transcutaneous Electrical Nerve Stimulation and Transcutaneous Afferent Patterned Stimulation

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Refer to FEP medical policy manual. The FEP medical policy manual can be found at: FEP medical policy manual.

Descripción/Antecedentes

Biofeedback is intended to teach individuals self-regulation of certain physiologic processes not normally considered to be under voluntary control. The various forms of biofeedback mainly differ in the nature of the disease or disorder under treatment, the biologic variable that the subject attempts to control, and the information that is fed back to the subject.

Biofeedback techniques include peripheral skin temperature feedback, blood-volume-pulse feedback (vasoconstriction and dilation), vasoconstriction training (temporalis artery), and electromyographic biofeedback; they may be used alone or in conjunction with other therapies (eg, relaxation, behavioral management, medication). Biofeedback training is done either in individual or group sessions. A typical program consists of 10 to 20 training sessions of 30 minutes each.

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.

Fecal Incontinence and Constipation

Adultos

Fecal incontinence in adults is the recurrent uncontrolled passage of fecal material. Pathophysiology of the disorder ranges from abnormalities in intestinal motility (diarrhea or constipation) to poor rectal compliance, impaired rectal sensation, or weak or damaged pelvic floor muscles. There is no increase in mortality attributable to fecal incontinence. Morbidity includes skin breakdown and urinary tract infections. Fecal incontinence may affect the quality of life by restricting work, recreation, and activities related to "getting out of the house," impaired social role function, diminished sexual activity, and increase of social isolation due to embarrassment. Fecal incontinence can bring about the loss of independence and mobility. It is the second most common reason for elderly institutionalization. The most common causes of fecal incontinence in adults are obstetric trauma coupled with age-related degeneration, previous anorectal surgery, rectal prolapse, and perineal trauma. In many individuals, the condition is multifactorial, involving a combination of structural, physiological, and psychosocial factors. Conventional interventions to treat fecal incontinence include dietary recommendations (eg, fiber), bowel and toilet schedules, and medications (eg, bulking or antidiarrheal agents).

Constipation refers to infrequent bowel movements and difficulty expelling stool during defecation. Primary constipation is categorized into 3 groups. The most common type is normal-transit constipation in which there is a normal rate of stool movement, but patients feel constipated and may complain of abdominal pain and/or bloating. In the second type, slow-transit constipation, the stool moves more slowly through the colon and individuals often experience a limited urge to defecate. The third type, dyssynergic defecation, refers to a loss of ability to coordinate contractions of the pelvic floor muscles and to relax the anal sphincter during defecation. Patients often report an inability to defecate despite the urge to do so. There are also secondary causes of constipation such as the use of certain medications, including opioids and psychoactive drugs; neurologic, endocrine, or metabolic disorders; structural abnormalities; and lifestyle factors. Conventional treatment includes dietary changes (ie, adequate fiber and fluid intake), use of supplemental bulking substances, exercise, and medications.

Niños

In children, most cases of fecal incontinence and constipation are functional, in which structural, endocrine, or metabolic diseases have been ruled out. Factors contributing to functional incontinence and constipation are fear and/or pain associated with large, hard stools. This leads to retentive posturing in approximately half the children with chronic constipation (ie, the avoidance of defecation by purposefully contracting the external anal sphincter, also termed anismus or paradoxical sphincter contraction). Customary or conventional medical intervention includes dietary changes, bowel and toilet scheduling, softening agents, and education. Behavioral interventions aim to restore normal bowel habits through toilet training, reward and incentive contingency management programs, desensitization of phobia and fear, or skill-building and goal-setting techniques with home practice. Counseling and psychotherapy provide support to the child and address social and psychological problems.

Situación reglamentaria

A variety of biofeedback devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. These devices are designated by the FDA as class II with special controls and are exempt from premarket notification requirements. The FDA defines a biofeedback device as "an instrument that provides a visual or auditory signal corresponding to the status of 1 or more of a patient's physiological parameters (eg, brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters."

Evidence pertaining to the use of biofeedback for urinary incontinence is addressed in evidence review in MP 2.399.

Evidence pertaining to the use of biofeedback for headaches is addressed in evidence review MP 2.400.

Evidence pertaining to the use of biofeedback for chronic pain is addressed in evidence review MP 2.064.

Evidence pertaining to the use of biofeedback for miscellaneous indications (treatment of hypertension, anxiety, asthma, movement disorders [eg, motor function after stroke, injury, or lower-limb surgery], and other applications) is addressed in evidence review MP 2.401.

Fundamento

For individuals who have fecal incontinence who receive biofeedback, the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, functional outcomes, and quality of life (QOL). One RCT reported a significantly greater decrease in fecal incontinence symptoms with biofeedback plus exercise training compared with exercise training alone; however, most trials have not shown a significant benefit. Systematic reviews have not found that biofeedback plus conventional therapy provides an additional benefit compared with conventional therapy alone. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

For individuals who have constipation other than dyssynergia-type constipation who receive biofeedback, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, and QOL. A systematic review of RCTs found a benefit of biofeedback as a treatment for constipation in adults. Conclusions of the systematic review were limited by variability in patient populations (which combined both dyssynergia-type and non-dyssynergia-type), comparator groups, and outcome measures, and biofeedback was not clearly beneficial for non-dyssynergia types of constipation. Two systematic reviews conducted in children also found no clear benefit of biofeedback when added to medical management, and a third systematic review could not make a strong conclusion about the efficacy of biofeedback due to a low quality of evidence. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

For individuals who have dyssynergia-type constipation who receive biofeedback, the evidence includes RCTs and 2 systematic reviews. Relevant outcomes are symptoms, functional outcomes, and QOL. Several well-conducted RCTs focusing on patients with dyssynergia-type constipation have reported benefits in a subgroup of patients meeting well-defined criteria. Las pruebas son suficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Definiciones

Electromyogram (EMG): is the graphic record of resting and voluntary muscle activities as a result of electrical stimulation.

Physiologic: pertains to normal functions of the human body as opposed to pathological.

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen un consejo médico y están sujetas a cambios según lo permita la ley o la evidencia clínica aplicable de las pautas de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios de los miembros, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Nota: esta lista de códigos puede no ser exhaustiva y los códigos están sujetos a cambios en cualquier momento. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Cubierto cuando sea médicamente necesario:

* when BOTH psychotherapy & biofeedback are provided

Referencias

1. Food and Drug Administration. Biofeedback device. 21 CFR - 882.5050 (1998). Último acceso el 22 de septiembre de 2025.
2. Vonthien R, Heimerl T, Schwandner T, et al. Electrical stimulation and biofeedback for the treatment of fecal incontinence: a systematic review. Int J Colorectal Dis. Nov 2013; 28(11): 1567-77. PMID 23900652
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