Medical Policy: 02.01.04
Original Effective Date: July 2001
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.
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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.
Anorectal biofeedback is a treatment program that utilizes neuromuscular conditioning techniques to treat patients with fecal incontinence or chronic constipation that is associated with dyssynergic constipation. Dyssynergic constipation, also known as anismus or pelvic floor dyssynergia, is characterized by failure of the abdominal, rectal, pelvic floor and anal sphincter muscles to coordinate and complete the act of defecation. It is characterized by impaired propulsion of stool from the rectum, paradoxical anal contraction, or inadequate anal relaxation, or a combination of these mechanisms.
Biofeedback is not a treatment, per se, but a tool to help patients learn how to perform muscle exercise training. Appropriate candidates for receiving biofeedback therapy (neuromuscular training) are:
In dyssynergic-type constipation there is a loss of the ability to coordinate contractions of the pelvic floor muscles and to relax the anal sphincter during defecation. Rome IV diagnostic criteria explain dyssynergic defecation as the inappropriate contraction of the pelvic floor with adequate propulsive forces during attempted defecation as measured with anal surface EMG or manometry.
Rome IV criteria for dyssynergic defecation consists of:
Anorectal biofeedback is an instrument-based learning technique wherein an instrument such as a manometry probe is placed inside the body to provide visual or auditory information to the patient regarding their anorectal muscle function. When mechanical, anatomic, and disease- and diet-related causes of constipation have been ruled out, clinical suspicion should be raised to the possibility that PFD (pelvic floor dysfunction) or dyssynergia is causing or contributing to constipation. Based on the principle of operant conditioning, biofeedback helps patients modify bowel habits by restoring defecation, which normally entails propulsive forces coordinated with relaxation.
Biofeedback therapy is a process based on operant conditioning techniques and the governing principle is that any behavior - whether complex or simple - is reinforced. It can be performed either by placing a manometry probe with multiple micro-transducers and a balloon or a water perfused probe with multiple side holes into the rectum. This in turn provides either visual or auditory display of muscle activity. The patient and the therapist use this information to learn how to control and improve anorectal function. In addition to office biofeedback training, portable units are also available to facilitate home training.
The treatment consists of advice and instruction during an initial visit regarding bowel habits, exercise, laxatives, dietary fiber and fluid intake and timed toilet training. In addition to receiving the instruction, subjects have an initial training session by a specialist generally followed by biweekly, 1-hour biofeedback sessions, up to a maximum of 6 therapy sessions during a period of 3 months during the active phase. A follow up phase typically consists of reinforcement at 6 weeks and 3, 6, and 12 months.
Currently the study of biofeedback use in children with dyssynergic type constipation is lacking. There is a lack of clinical trials or randomized studies involving biofeedback in the use of children.
Biofeedback is not indicated in patients with the following:
In 2013, the American Gastroenterological Association updated their position statement on constipation. The following statement on biofeedback was included: "Pelvic floor retraining by biofeedback therapy rather than laxatives is recommended for defecatory disorders (Strong Recommendation, High-Quality Evidence)."
On treating incontinence after prostate treatment states that the randomized controlled trials that were assessed differed on the regimen of pelvic floor muscle training, with some studies including biofeedback or electrical stimulation. Guideline Statement 16 recommends pelvic floor muscle exercises or pelvic floor muscle training but biofeedback is not mentioned as part of the treatment.
In 2014, the American College of Gastroenterology published guidelines on the management of fecal incontinence. The guidelines indicated that pelvic floor rehabilitation techniques (eg, biofeedback, therapeutic exercises) are effective in patients with fecal incontinence who do not respond to conservative measures (strong recommendation, moderate quality of evidence).
In 2015, the American Society of Colon and Rectal Surgeons (ASCRS) updated its guidelines on treatment of fecal incontinence. The guidelines recommended that biofeedback be considered as an initial treatment for patients with fecal incontinence who have some preserved voluntary sphincter contraction ability.
In 2016, ASCRS published guidelines on the evaluation and management of constipation. The guidelines state that biofeedback therapy is a first-line treatment for symptomatic pelvic floor dyssynergia (strong recommendation, moderate quality of evidence).
In 2015, the American Neurogastroenterology and Motility Society and the European Society of Neurogastroenterology and Mobility jointly published consensus guidelines on biofeedback therapy for anorectal disorders. The guideline included the following recommendations:
In practice guidelines on the management of constipation, the American Society of Colon and Rectal Surgeons (ASCRS) (2016) states that in general, biofeedback should be used to treat slow-transit constipation and pelvic floor dyssynergia before subtotal colectomy. ASCRS recommended biofeedback as a first-line treatment option for patients with constipation due to symptomatic pelvic floor dyssynergia.
Why biofeedback would help this problem: The muscles of the pelvic floor (including those controlling the anus and urinary sphincters) can become weakened due to overall loss of conditioning with age, stretching during delivery, etc. These muscles may be in fine shape but they may have to resist more pressure than they can handle during a cough or jump. Many people do not have a good sense of when the actually have to urinate or defecate and are either fooled by sensations which are just warnings or miss the warnings entirely. Most people tense the wrong muscles when they are trying to avoid leaking. Biofeedback sensors inserted into the vaginal canal or anus or taped to the pelvic floor can easily pick-up these signals so people can learn to recognize them by watching the biofeedback display and relating the changes in the display to sensations in their bodies. Pressure sensors (which look like tiny balloons) can both pick up the signals and simulate them so the signals can be produced on demand. Muscle tension biofeedback used in combination with Kegal exercises and other forms of home practice help the person strengthen the muscles and contract only the correct muscles when they should be contracted. This same methodology can be used to help patients recognize when they need to have a bowel movement and to relax the appropriate muscles in the appropriate sequence when ready.
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.
For additional information regarding biofeedback see policy Biofeedback as a Treatment of Headache and Other Disorders 02.01.05
Anorectal biofeedback may be considered medically necessary for documented dyssynergic defecation/constipation in adults.
Anorectal biofeedback is considered not medically necessary for all other indications.
Anorectal biofeedback is considered investigational in children.
Anorectal biofeedback is considered investigational in the home setting.
Electroencephalography (EEG) biofeedback/neurofeedback are unproven and considered investigational.
Anorectal biofeedback is considered investigational for fecal incontinence when the cause is not dyssynergic defication/constipation.
For the treatment of fecal incontinence, systematic reviews have not found that biofeedback provides additional benefit when offered in conjunction with conventional therapy, compared with conventional therapy alone.
Anorectal biofeedback is considered investigational for any condition not listed above including but not limited to:
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 quality of life. 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, comparator groups, and outcome measures, and biofeedback was not clearly beneficial for any other type of constipation. For urinary incontinence since there is lack of evidence that biofeedback is more effecitve than pelvic muscle exercises alone. The evidence is insufficient to determine the effects of the technology on health outcomes.
Defining Dyssynergic Defecation/Constipation - The diagnosis of dyssynergic type of defecation/constipation is based on clinical signs and symptoms, as well as test results.
Rome IV criteria for dyssynergic defecation consists of:
To report provider services, use appropriate CPT* codes, Modifiers Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
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