BlueCross and BlueShield of Montana Medical Policy/Codes
Biofeedback as a Treatment of Fecal Incontinence
Chapter: Medicine: Treatments
Current Effective Date: July 18, 2013
Original Effective Date: October 01, 1990
Publish Date: July 18, 2013
Revised Dates: January 26, 2012; April 26, 2013
Description

Biofeedback, a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control, is used to treat a variety of conditions and is proposed as a treatment of fecal incontinence and constipation.

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 affects quality of life through restricting work, recreation, and activities related to “getting out of the house,” impaired social role function, diminished sexual activity, and increase in social isolation due to embarrassment. Fecal incontinence brings about 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 (e.g., fiber), bowel and toilet scheduling, and medications (e.g., bulking or antidiarrheal agents).

Constipation refers to infrequent bowel movements and difficulty during defecation. Primary constipation is generally categorized into three 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, 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 recommendations (i.e., adequate fiber and fluid intake), use of supplemental bulking substances, exercises, and medications.

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 (i.e., 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 recommendations, bowel and toilet scheduling, softening agents, and education. Behavioral interventions aim at restoring 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.

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 and to decrease delay in response to a sensation of distension. For constipation, the aim of biofeedback is to teach patients how to tighten and relax their external anal sphincter in order to pass bowel movements.

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, and the balloon is filled with air to produce a sensation of rectal filling. Strength training uses either anal canal pressure (manometric) or intra-anal electromyography (EMG) feedback of pelvic floor muscles (PFM). The purpose is to strengthen the force of the PFM contraction without including rectal distention. Some training increases endurance (duration of external anal sphincter contraction), as well as peak strength. Coordination training uses pressure feedback of intra-rectal balloon distention using a water-perfused catheter or Schuster-type balloon probe and PFM contractions in a simultaneous feedback display. The purpose of coordination training is to synchronize the contraction of the external anal sphincter with relaxation of the internal anal sphincter.

Biofeedback techniques convert the physiologic measures from an intra-anal EMG sensor, anal manometric probe (measuring intra-anal pressure), or perianal surface EMG electrodes to either visual or audio display for feedback. Ultrasound has also been used to show patients’ contraction of the anal sphincter on a screen. Biofeedback training is done alone, or in combination with other behavioral therapies designed to teach relaxation. Training sessions are performed in a quiet, non-arousing environment

Regulatory Status

A variety of biofeedback devices are cleared for marketing though the U.S. Food and Drug Administration’s (FDA) 510(k) marketing clearance process. These devices are designated by the FDA as class II with special controls and are exempt from the premarket notification requirements. 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.”

Policy

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.

Investigational

Blue Cross and Blue Shield of Montana (BCBSMT) considers biofeedback experimental, investigational and unproven as a treatment of fecal incontinence or constipation.

Rationale

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. Moreover, it is important that studies demonstrate that biofeedback improves disease-related health outcomes, as opposed to potentially affecting only physiologic, intermediate outcomes, and that they address the durability of effects beyond the initial, short-term biofeedback training period.

The relevant clinical outcome for biofeedback as a treatment in incontinence should be an overall change in the patient’s symptoms. Reduction in episodes of fecal incontinence and increase in voluntary bowel movements are the primary clinical outcomes, and these are typically reported as the percentage of individuals cured or improved. Achieving normal defecation dynamics (e.g., anal pressure, squeeze pressure, sensory threshold, rectal inhibitory reflex, or defecation dynamics) does not correspond with symptom relief (i.e., clinical outcomes). Anorectal physiology measurements are a poor proxy for changes in clinical symptoms. Patient symptoms are usually assessed through diary, questionnaire, or interview (completed by the patient and, in the case of children, parents).

Fecal incontinence

Adults

Several systematic reviews of biofeedback treatment for fecal incontinence in adults have been published; the most recent were a meta-analysis by Enck and colleagues published in 2009 and a Cochrane Review published in 2006. (1,2)

The Enck review searched the literature through 2008 and identified eleven randomized controlled trials (RCTs) with adult populations. (1) Two were excluded, one because of the small sample size, and the other because it did not include an appropriate control group. The remaining nine studies consisted of five comparisons of different modalities of biofeedback and six comparisons of electromyographic (EMG) biofeedback versus other types of therapy, mainly pelvic floor exercises (two studies had multiple treatment groups and were included in both categories). The total number of patients included in the nine studies was 540; sample sizes of individual studies ranged from 18 to 171. A meta-analysis of five studies did not find a significant difference in the efficacy of different types of biofeedback (pooled odds ratio [OR]: 1.23, 95% confidence interval [CI]: 0.74-2.20, p=0.38). Similarly, a meta-analysis of studies comparing biofeedback to other therapies did not find a significant difference in efficacy (pooled OR: 1.19, 95% CI: 0.69-2.05). The outcome measure used in the analysis was not specified and appears to vary from study to study.

The Cochrane review of randomized or quasi-randomized controlled trials did not find evidence that biofeedback enhanced the outcome of treatment compared to other conservative management methods. (2) The authors noted a suggestion that some particular elements of biofeedback and sphincter exercises may have a therapeutic effect but that larger well-designed trials are needed to enable safe conclusions.

Representative RCTs are described below:

Norton and colleagues reported on the results of a trial that randomly assigned 171 patients with fecal incontinence to 1 of 4 groups: standard care (advice), advice plus instruction on sphincter exercises, hospital-based computer-assisted sphincter pressure biofeedback, and hospital biofeedback plus the use of a home EMG biofeedback device. (3) Outcomes included diary reports of incontinence, quality of life, and anal manometry measurements. The authors reported that biofeedback yielded no greater benefit than standard care.

Solomon and colleagues reported on the results of a trial that randomly assigned 120 patients with mild to moderate fecal incontinence to 1 of 3 groups: biofeedback with anal manometry, biofeedback with transanal ultrasound, or pelvic floor exercises with feedback from digital examination alone. (4) There were no significant differences in outcomes among the treatment groups; all reported modest improvements.

The Miner et al. (5) study randomly assigned thirteen patients to three 20-minute sessions of sensory biofeedback and twelve patients to a sham procedure of no feedback. The no-feedback control group showed an improvement rate of 42% and cure rate of 0%. The sensory biofeedback group obtained an 85% improvement rate and 31% cure rate. There was no correlation between improvement in incontinence and training in sphincter function. The diminishing returns following Phase one and small sample size prevented any further meaningful statistical analysis for the crossover conditions.

In an RCT of 23 female patients, Ilnyckyj and colleagues found no evidence biofeedback with education improved fecal continence over pelvic exercises with education. (6)

Several studies were published after the systematic review literature search date. In 2009, Heymen and colleagues randomly assigned 168 individuals with fecal incontinence to three months of biweekly pelvic floor exercise training alone (n=85) or exercise training with manometric biofeedback (n=83). (7) Twenty-two patients in the exercise-only group and 38 in the biofeedback group improved during a 4-week run-in period and did not participate further, leaving 63 in the exercise group and 45 in the biofeedback group. The primary efficacy outcome was decrease in scores on the Fecal Incontinence Severity Instrument (FISI), a validated 4-item scale, from the end of the run-in to 3 months. The analysis included all patients who completed at least one treatment (a total of 15 patients dropped out). The authors reported that there was a greater reduction in FISI scores in the biofeedback group compared to the exercise-only group (p=0.01, exact scores were not reported). Complete continence (no staining) was reported by 13 of 63 (21%) in the exercise-only group and 20 of 45 (44%) in the biofeedback group; this difference was statistically significant (p=0.008). A study limitation was that only 108 of 168 randomized patients (64%) received the intervention, and therefore there may have been baseline differences in the treated groups that affected study outcomes. A stronger design is to randomize patients after, not before, a run-in period.

In 2011, Bartlett and colleagues in Australia published an RCT with 72 participants comparing two exercise regimens used with biofeedback for fecal incontinence. (8) The study did not find significant differences in outcomes with the two types of exercises. It is not possible to make conclusions about the efficacy of biofeedback from this study’s findings, since all participants received biofeedback.

Children

A Cochrane review on behavioral and cognitive interventions for children with fecal incontinence was published in 2006. (9) Of the eighteen studies, nine compared conventional treatment alone (i.e., laxatives, toilet training, dietary advice) to conventional treatment plus biofeedback. Eight trials included children with functional fecal incontinence, and the ninth included children with fecal incontinence due to myelomeningocele (n=12). In four trials, children were included who had fecal incontinence due to constipation, and in three other trials, children had fecal incontinence due to constipation and pelvic floor dyssynergia. When data from the nine studies were combined, 133 of 260 (50.4%) in the conventional treatment plus biofeedback group were not cured or improved at follow-up compared to 121 of 250 (48.4%) patients in the conventional only group. In a meta-analysis (random effects), this difference was not statistically significant (pooled OR: 1.08, 95% CI: 0.63 to 1.84). The analysis combined 6- and 12-month follow-up data; 12-month data were used when available. The authors concluded that findings from RCTs do not support the claim that biofeedback training provides additional benefit to conventional treatment in the management of fecal incontinence associated with constipation. They also stated that they were unable to evaluate the effects of biofeedback in children with organic fecal incontinence due to a lack of sufficient trials.

Constipation

Adults

The Enck et al. systematic review, described above in the section on fecal incontinence, also reviewed the literature on biofeedback for constipation. (1) Eight RCTs conducted in adults were identified. Four of these compared two types of biofeedback; a meta-analysis of these four studies did not find a significant benefit of one technique over another (pooled OR: 1.44, 95% CI: 0.69-3.09, p=0.32). The other four studies compared biofeedback to another treatment. Comparison treatments (one study each) were botulinum toxin, laxatives, diazepam, and best supportive care (diet, exercise, and laxatives). Two studies also included a third arm, in which treatment was a sham or placebo intervention. Three of the four studies included patients with dyssynergia-type constipation and the fourth included patients with anismus. A meta-analysis of the four studies comparing one treatment to another (using the active intervention arm as the comparison in the 3-arm trials) found a significantly greater benefit of biofeedback in improving constipation symptoms (pooled OR: 3.23, 95% CI: 1.88-5.58, p<0.001). The results of this systematic review are limited by the heterogeneity in patient populations, comparison treatments, and outcome measures, creating difficulties in forming conclusions for specific treatments in specific populations. The two 3-arm studies, as well as a publication with long-term follow-up of patients in one of the studies, are described in more detail below:

Heyman and colleagues included adults who met Rome II diagnostic criteria for pelvic floor dyssynergia, had two or more symptoms of functional constipation for at least 12 weeks in the past year, and had manometry or electromyography findings consistent with chronic constipation (e.g., evidence of inadequate propulsive forces and incomplete evacuation). (10) Patients participated in a 4-week run-in period consisting of education on diet and exercise and provision of fiber and stool softeners. Those who still met eligibility criteria at the end of the run-in period (84 of 117, 72%) were randomly assigned to EMG biofeedback (n=30), diazepam 5 mg (n=30), or placebo medication (n=24). All participants were trained to perform pelvic floor exercises, and all received 6 biweekly visits over 3 months, each lasting approximately 50 minutes. Patients and investigators were blinded to which patients received active versus placebo medication but not to whether or not they received biofeedback. In an intention-to-treat (ITT) analysis after the 3-month intervention, the proportion of patients reporting adequate relief of constipation symptoms was 70% in the biofeedback group, 23% in the diazepam group, and 38% in the placebo group; biofeedback had a significantly greater benefit when compared either to diazepam (p<0.001) or placebo (p<0.017). A strength of this study was that it attempted to control for nonspecific effects of biofeedback e.g., increased contact with a healthcare provider and lifestyle modification advice, by including a run-in period and similar follow-up visits for all groups. Moreover, randomization did not occur until after the run-in period, so treatment groups were more likely to be similar at the start of the treatment phase.

Rao and colleagues included patients who met Rome II diagnostic criteria for functional constipation, had dyssynergia-type constipation and, when expelling a simulated stool, had either prolonged difficulty (at least 1 minute) or prolonged delay (at least 20% marker retention in colonic transfer). (11) All participants had failed routine management of constipation. A total of 77 patients were randomly assigned to receive 3 months of standard therapy i.e., education, dietary advice (n=24), standard therapy and biofeedback therapy (n=28), or standard therapy and sham feedback (n=24). In the sham treatment group, patients used a rectal manometry probe but did not receive visual and verbal feedback. Patients were not blinded to treatment group, but the manometry reader was unaware of treatment assignment. In an ITT analysis, after the 3-month intervention, patients in the biofeedback group reported a significantly greater increase in complete spontaneous bowel movements than the sham feedback group (p<0.05) and the standard treatment group (p<0.062). In addition, a greater proportion of the patients in the biofeedback group reported improved global bowel satisfaction compared to the sham feedback group (p=0.04), but the comparison with the standard treatment group was not significantly different. (The authors did not report exact numbers for either of these preceding primary analyses). Of the primary physiologic parameters, the ITT analysis found that the dyssynergia pattern was corrected in 79% of those in the biofeedback group, 4% in the sham group, and 8% in the standard treatment group. This difference was statistically significant in favor of the biofeedback group compared to each of the other groups (p<0.001 for both analyses). Moreover, the balloon expulsion time during simulated defecation decreased significantly more in the biofeedback group compared to sham (p=0.003) or standard treatment (p=0.03) (exact times not reported for the ITT analysis).

A 2010 publication reported on 1-year findings of the Rao study in 13 of 21 (62%) patients in the biofeedback group and 13 of 23 (57%) in the standard treatment group. (12) Patients in the sham group were not included in this follow-up study. The extension study included visits at 3-month intervals, with additional advice provided as needed. Seven of the 13 (54%) biofeedback patients and all thirteen patients in the standard treatment group completed the 1-year follow-up. Mean change in complete spontaneous bowel movements (the primary outcome) favored the biofeedback group (increase of 2.9) compared to the standard treatment group (decrease of 0.2). However, the small numbers of patients in this follow-up study, along with the drop-out rate in the biofeedback group limit the conclusions that can be reached.

An additional trial, conducted in Iran, was published in 2011. (13) The trial was non-blinded and pseudo-randomized (patients were allocated to treatment group by alternative assignment rather than by random assignment). The study included individuals who met Rome III criteria for dyssynergic defecation and did not respond to conservative therapy. They were assigned to receive EMG biofeedback (n=34) or balloon-assisted training (n=31). The latter intervention consisted of inserting a balloon into the rectum and inflating it by water injection, so the patient experienced the sensation of a full rectum. The individual was then asked to expel the balloon. In the biofeedback group, a pen electrode was inserted into the rectum, and the patient was asked to relax the rectal muscles. Follow-up evaluation took place one week after the single-session intervention. Improvement in incomplete evacuation and need for manual maneuvers were significantly better in the biofeedback group (p<0.05). There was not a significant difference in the proportion of patients that reported complete or partial satisfaction one week after the intervention (77% in the balloon-assisted training group and 64% in the biofeedback group, p>0.05). Limitations of the study included that it did not use true randomization techniques, was not blinded, and did not evaluate the incremental effect of biofeedback compared to standard treatment.

Children

No systematic reviews or meta-analyses on biofeedback for constipation in children, not associated with fecal incontinence, were identified. The literature search did identify the one RCT published since 2000. Van Ginkel and colleagues in the Netherlands included 212 children at least 5 years-old with constipation who met at least two of the following four criteria: 1) stool frequency fewer than 3 times per week; 2) two or more soiling and/or encopresis episodes per week; 3) periodic passage of very large amounts of stool every 7 to 30 days; or 4) a palpable abdominal or rectal fecal mass. (14) Participants were randomly assigned to 6 weeks of standard treatment i.e., education, laxatives (n=111) or standard treatment plus two sessions of anorectal manometry (n=91). During the manometry sessions, the child was asked to squeeze the sphincter as tight as possible five times. Squeeze pressure data were converted to digital values and transmitted to a computer; the data could be viewed by the child and parent. The data were discussed after the sessions, and instructions were given on how to perform defection exercises at home. Ten of 212 (5%) randomly assigned patients did not receive treatment, and the remainder completed the intervention. Treatment success was defined as achievement of three or more bowel movements per week and fewer than one soiling and/or encopresis episodes per 2 weeks while not receiving laxatives. At 6 weeks, 4 of 111 (4%) in the standard treatment group and 6 of 91 (7%) in the biofeedback group were considered to have successful treatment; this difference was not significantly different. There was also no statistically significant difference between groups at any other follow-up point. At the final 104-week follow-up, 36 of 83 (43%) patients in the standard treatment group and 23 of 65 (35%) in the biofeedback group were considered treatment successes. Data on 30% of the randomized patients were missing at the final follow-up. This intervention did not control for the non-specific effects of biofeedback.

Summary

There is a relatively large body of literature evaluating the efficacy of biofeedback for treating fecal incontinence and constipation. Most of the clinical trials are small, and there is a large degree of heterogeneity in study design. Heterogeneity includes differences in patient populations, treatment protocols, comparison treatments, and outcome measures. As a result, it is difficult to synthesize this literature and to form conclusions on the efficacy of specific treatment protocols for specific populations.

For the treatment of fecal incontinence, systematic reviews have not found that biofeedback provides additional benefit when offered in conjunction with conventional therapy, compared to conventional therapy alone. While one recent RCT found that there was a significantly greater decrease in fecal incontinence symptoms with biofeedback plus exercise training than with exercise training alone, the majority of trials do not show a significant benefit. Overall, the evidence is insufficient to conclude that biofeedback improves the net health outcome for adults and children with fecal incontinence; therefore, this treatment is considered experimental, investigational and unproven.

For the treatment of constipation, a systematic review of RCTs found a benefit of biofeedback as a treatment of constipation in adults; most of the studies included individuals with dyssynergia-type constipation, and participants had failed conservative treatment. However, the conclusions of this systematic review were limited by small sample sizes and by variability in patient populations, comparison groups, and outcome measures. Data on additional patients are required before concluding whether biofeedback has an incremental impact on the net health outcome for adults with constipation beyond that of standard therapy. A 2011 trial did not fill this gap because it was non-blinded, was not truly randomized and did not include a placebo or sham group. There is a lack of evidence from controlled studies that biofeedback is an effective treatment for constipation in children. Thus, biofeedback is considered experimental, investigational and unproven for treating constipation in adults and children.

Practice Guidelines and Position Statements

In May 2010, the National Institute for Clinical Excellence (NICE) issued a guideline on constipation in children and young people which states that biofeedback should not be used for ongoing treatment. (15) In June 2007, they issued a guideline on fecal incontinence in adults which states the following regarding biofeedback: “The evidence we found did not show biofeedback to be more effective than standard care, exercises alone, or other conservative therapies. The limited number of studies and the small number of participants in each group of the studies make it difficult to come to any definitive conclusion about its effectiveness.” (16)

In 2008, the National Institutes of Health issued a state-of-the science statement on fecal and urinary incontinence based on a consensus conference held in December 2007. (17) Included in the conclusions was the following statement, “pelvic floor muscle training and biofeedback are effective in preventing and reversing fecal and urinary incontinence in women for the first year after giving birth…”

In December 2007, an Evidence Report/Technology Assessment, Prevention of Urinary and Fecal Incontinence in Adults, (18) based on research conducted by the Minnesota Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ), was issued. One of the research objectives was to review the effectiveness of clinical interventions to reduce the risk of incontinence. The authors identified one RCT that found twice the rate of control of fecal incontinence in women who had obstetric and sphincter trauma after biofeedback training with pelvic floor muscle (PFM) training compared to muscle training alone. The review concluded that limited evidence supports a reduction in fecal incontinence after complex behavioral interventions, which include exercises augmented with biofeedback.

In October 2007, the American Society of Colon and Rectal Surgeons released Practice Parameters for the Treatment of Fecal Incontinence. (19) The report stated that biofeedback can be considered as a treatment option for patients who have not responded to dietary modification or medication (Level of Evidence: III; Grade of Recommendation: B). It also states that biofeedback may be considered in the early post-partum period for women with symptomatic sphincter weakness. Also, in 2007, they published Practice Parameters for the Evaluation and Management of Constipation. (20) They recommend biofeedback therapy for patients with symptomatic pelvic floor dyssynergia (Level of Evidence: Class II; Grade of Recommendation: B).

In 2004, the American College of Gastroenterology published a practice guideline on the diagnosis and treatment of fecal incontinence. (21) They recommend offering biofeedback, which they call a safe treatment that is relatively inexpensive and easy to administer, to all patients with fecal incontinence who have failed supportive measures. They especially recommend biofeedback for older patients and those with comorbid illness or pudendal neuropathy and patients before reconstructive surgery. The guideline acknowledges limitations of the evidence on biofeedback: “The technique of biofeedback therapy has not been standardized and the optimal method of defining clinical improvement is also unclear. This limits our ability to perform a meta-analysis. Similarly, it is unclear which component of biofeedback therapy is most effective and which patients are suitable for this therapy. Furthermore, the use of this treatment is largely restricted to specialized center…”

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes
93.08, 94.39.  Experimental, investigational and unproven for all diagnoses.
ICD-10 Codes

GZC9ZZZ.  Experimental, investigational and unproven for all diagnoses.

Procedural Codes: 90875 , 90876, 90901, 90911, E0746
References
  1. Enck P, Van der Voort IR, Klosterhalfen S. Biofeedback therapy in fecal incontinence and constipation. Neurogastroenterol Motil 2009; 21(11):1133-41.
  2. Norton C, Cody JD, Hosker G. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database Syst Rev 2006; (3):CD002111.
  3. Norton C, Chelvanayagam S, Wilson-Barnett J et al. Randomized controlled trial of biofeedback for fecal incontinence. Gastroenterology 2003; 125:1320-09.
  4. Solomon MJ, Pager CK, Rex J et al. Randomized controlled trial of biofeedback with anal manometry, transanal ultrasound, or pelvic floor retraining with digital guidance alone in the treatment of mild to moderate fecal incontinence. Dis Colon Rectum 2003; 46:703-10.
  5. Miner PB, Donnelly TC, Read NW. Investigation of mode of action of biofeedback in treatment of fecal incontinence. Dig Dis Sci 1990; 35(10):1291-8.
  6. Ilnyckyj A, Fachnie E, Tougas G. A randomized-controlled trial comparing an educational intervention alone vs education and biofeedback in the management of faecal incontinence in women. Neurogastroenterol Motil 2005; 17(1):58-63.
  7. Heymen S, Scarlett Y, Jones K et al. Randomized controlled trial shows biofeedback to be superior to pelvic floor exercises for fecal incontinence. Dis Colon Rectum 2009; 52(10):1730-7.
  8. Bartlett L, Sloots K, Nowak M et al. Biofeedback for fecal incontinence: a randomized study comparing exercise regimens. Dis Colon Rectum 2011; 54(7):846-56.
  9. Brazzelli M, Griffiths P. Behavioural and cognitive interventions with or without other treatments for the management of faecal incontinence in children. Cochrane Database Syst Rev 2006; (2):CD002240.
  10. Heymen S, Scarlett Y, Jones K et al. Randomized, controlled trial shows biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia-type constipation. Dis Colon Rectum 2007; 50(4):428-11.
  11. Rao SS, Seaton K, Miller M et al. Randomized controlled trial of biofeedback, sham feedback and standard therapy for dyssynergic defecation. Clin Gastroenterol Hepatol 2007; 5(3):331-8.
  12. Rao SS, Valestin J, Brown CK et al. Long-term efficacy of biofeedback therapy for dyssynergic defection: randomized controlled trial. Am J Gastroenterol 2010; 105(4):890-6.
  13. Pourmomeny A, Emami MH, Amooshahi M et al. Comparing the efficacy of biofeedback and balloon-assisted training in the treatment of dyssynergic defecation. Can J Gastroenterol 2011; 25(2):89-92.
  14. van Ginkel R, Buller HA, Boeckxstaens GE et al. The effect of anorectal manometry on the outcome of treatment in severe childhood constipation: a randomized controlled trial. Pediatrics 2001; 108(1): E9.
  15. National Institute for Health and Clinical Excellence (NICE). Guideline 99: Constipation in children and young people, May 2010. Available online at: http://www.nice.org.uk . Last accessed June 2012.
  16. National Institute for Health and Clinical Excellence (NICE). Guideline 49: Faecal incontinence: the management of faecal incontinence in adults, June 2007. Available online at: http://www.nice.org.uk . Last accessed June 2012.
  17. Landefeld CS, Bowers BJ, Feld AD et al. National Institutes of Health State-of-the-Science Conference Statement: Prevention of fecal and urinary incontinence in adults. Ann Intern Med 2008; 148(6):449-58.
  18. Shamliyan T, Wyman J, Bliss DZ et al. Prevention of urinary and fecal incontinence in adults. Evid Rep Technol Assess (Full Rep) 2007; (161):1-379. AHRQ Publication No. 08-E003. Available online at: http://www.ahrq.gov . Last accessed June 2012.
  19. Tjandra JJ, Dykes SL, Kumar RR et al.; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the treatment of fecal incontinence. Dis Colon Rectum 2007; 50(10):1497-507.
  20. Ternent CA, Bastawrous AL, Morin NA et al. Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the evaluation and management of constipation. Dis Colon Rectum 2007; 50(12):2013-22.
  21. Rao SS. American College of Gastroenterology Practice Parameters Committee. Diagnosis and management of fecal incontinence. Am J Gastroenterol 2004; 99(8):1585-604.
  22. Biofeedback as a Treatment of Fecal Incontinence or Constipation. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (October 2011) Medicine 2.01.64.
History
January 2012 Policy updated with literature search through July 2011; no change to policy statements; References 8 and 13 added; other references renumbered
April 2013 Policy formatting and language revised.  Policy statement unchanged.  Title changed from "Biofeedback as a Treatment of Fecal Incontinence" to "Biofeedback as a Treatment of Fecal Incontinence or Constipation".
BCBSMT Home
®Registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. ®LIVE SMART. LIVE HEALTHY. is a registered mark of BCBSMT, an independent licensee of the Blue Cross and Blue Shield Association, serving the residents and businesses of Montana.
CPT codes, descriptions and material only are copyrighted by the American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS Restrictions Apply to Government Use. CPT only © American Medical Association.
Biofeedback as a Treatment of Fecal Incontinence