Medical Policy: 02.01.04
Original Effective Date: July 2001
Reviewed: July 2017
Revised: July 2017
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
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 defecation. Dyssynergic defecation, 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:
- Patients who have a diagnosis of dyssynergic defecation.
- Patients who have tried standard approaches for treatment of constipation including OTC laxatives, dietary changes, and exercises and failed these approaches for at least three months.
- They must fulfill the symptomatic criteria for dyssynergic defecation.
- They must fulfill the objective physiologic criteria for dyssynergic defecation described.
Diagnostic criteria for dyssynergic defecation: Patients must fulfill both criteria A and criteria B as defined below.
- Patients must fulfill the symptomatic criteria for functional constipation as defined by ROME III criteria, which states that patients must report two or more of the following symptoms for at least 3 months with a symptom onset of at least 6 months duration.
- Straining during at least 25% defecations.
- Lumpy or hard stools with at least 25% defecations.
- Sensation of incomplete evacuation following at least 25% decations.
- Sensation of anorectal obstruction or blockage during at least 25% defecations.
- Manual maneuvers to facilitate bowel movements with at least 25% defecations (digital evacuation, etc.)
- Fewer than three bowel movements per week.
- Constipated patients must fulfill two or more of the following objective physiological criteria during repeated attempts to defecate.
- Dyssnergic pattern of defecation that comprises of either inappropriate contraction of the pelvic floor muscles (anal sphincter of puborectalis) or less than 20% relaxation of basal resting sphincter pressure.
- Inadequate propulsive forces as assessed by manometry or imaging or EMG.
- Inability to expel a 50 ml water-filled balloon or a stool-like device such as fecom within 1 minute.
- A prolonged colonic transit time (more than 6 markers on a plain abdominal radiograph taken 120 hours after ingestion of one Stizmarks® capsule containing 24 radio opaque markers or using other technology such as nuclear scintigraphy or SmartPill® colonic transit study.)
- Inability to expel barium paste or greater than 50% retention of barium paste during defecography.
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 defecation is lacking. There is a lack of clinical trials or randomized studies involving biofeedback in the use of children.
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).”
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:
- “Biofeedback is recommended for the short-term and long-term treatment of constipation with dyssynergic defecation.”
- “Biofeedback therapy is recommended for the short-term and long-term treatment of fecal incontinence.”
- “Biofeedback therapy is not recommended for the routine treatment of children with functional constipation, with or without overflow fecal incontinence."
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.
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.
Anorectal biofeedback may be considered medically necessary for documented dyssynergic defecation in adults:
- Per the Rome III criteria as documented above
- After 3 months of conservative treatment, including possible laxatives, documented dietary changes, and exercises
The recommended treatment course for those with dyssynergic defecation is biofeedback sessions over 3 months. There should be objective improvement after four treatments in the documentation. There should not be a necessity for treatments after three months of continuous treatment. This is consistent with the protocol used in randomized trials showing benefit of biofeedback.
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 defecation.
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:
- urinary incontinence
- fecal incontinence
- irritable bowel syndrome
- anorectal pain syndrome
- neurogenic bladder
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. The evidence is insufficient to determine the effects of the technology on health outcomes.
See related medical policy number 02.01.05 Biofeedback/Neurofeedback as a Treatment of Headache and other Disorders.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 90911 Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG or manometry
- 90875 Individual psychophysiological therapy incorporating biofeedback training by any modality (face-to-face with the patient), with psychotherapy (eg, insight oriented, behavior modifying or supportive psychotherapy); 30 minutes
- 90876 Individual psychophysiological therapy incorporating biofeedback training by any modality (face-to-face with the patient), with psychotherapy (eg, insight oriented, behavior modifying or supportive psychotherapy); 45 minutes
- E0746 Electromyography (EMG), biofeedback device
- Ko, C.Y., Tong, J., Lehman, R.E., Selton, A.A., Schrock, T.R., Welton, M.L. Biofeedback is effective therapy for fecal incontinence and constipation. Archives of Surgery 1997; 132: 829-834.
- Chiotakakou-Faliakou, E., Kamm, M.A., Roy, A.J., Storrie, J.B., Turner, I.C. Biofeedback provides long term benefit for patients with intractable, slow and normal transit constipation. Gut 1998; 42: 517-521.
- McKee, R.F., McEnroe, L., Anderson, J.H., Finlay, I.G. Identification of patients likely to benefit from biofeedback for outlet obstruction constipation. British Journal of Surgery 1999; 86: 355-359.
- Gilliland, R., Hyemen, S., Altomare, D.F., Park, U.C., Vickers, D., Wexner, S.D. Outcome and predictors of success of biofeedback for constipation. British Journal of Surgery 1997; 84: 1123-1126.
- Rao, S.S.C. The technical aspects of biofeedback therapy for defecation disorder. The Gastroenterologist 1998; 6:96-103.
- ECRI. Biofeedback for the Treatment of Constipation in Children. Plymouth Meeting (PA): ECRI Health Technology Assessment Information Service 1998 October 19 p. (Windows on medical technology; Issue No. 10).
- ECRI. Biofeedback for the Treatment of Fecal Incontinence. Plymouth Meeting (PA): ECRI Health Technology Assessment Information Service 1998 October 18 p. (Windows on medical technology; Issue No. 11).
- Dailianas, A., Skandlis, N., Rimikis, M.N., Koutsomanis, D., Kardasi, M., Archimandritis, A. Pelvic floor study in patients with obstructive defecation. Journal of Clinical Gastroenterology 2000; 30(2):176-180.
- McKee, R.F., McEnroe, L., Anderson, J.H., Finlay, I.G. Identification of patients likely to benefit from biofeedback for outlet obstruction constipation. British Journal of Surgery 1999;86:355-359.
- AHRQ 01-E030. Mind-Body Interventions, Gastrointestinal Conditions. Evidence Report/ Technology Assessment No. 40. Evidence Report. July 2001.
- Solomon MJ, Pager CK, Rex J, Roberts R, Manning J. 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 Jun;46(6):703-10.
- Norton C, Chelvanayagam S, Wilson-Barnett J, Redfern S, Kamm MA Randomized controlled trial of biofeedback for fecal incontinence. Gastroenterology. 2003 Nov;125(5):1320-9.
- 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 Feb;17(1):58-63.
- 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 19; (2):CD002240. Abstract viewed on-line.
- Rao SS, Seaton K, et al. Randomized controlled trial of biofeedback, sham feedback, and standard therapy for dyssynergic defecation. Clin Gastroenterol Hepatol. 2007 Mar;5(3):331-8.
- Rao SS Dyssynergic Defecation. Gastroenterology Clinics of North America. 2001 Mar;30(1): 97-114.
- Rao SS. Biofeedback therapy for constipation in adults. Best Pract Res Clin Gastroenterol. 2011 Feb; 25(1):159-66.
- Schey R, Cromwell J, Rao SS. Medical and surgical management of pelvic floor disorders affecting defecation. Am J Gastroenterol. 2012 Nov;107(11):1624-33.
- Brazzelli M, Griffiths PV, Cody JD, Tappin D. Behavioural and cognitive interventions with or without other treatments for the management of faecal incontinence in children. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD002240.
- Hart SL, Lee JW, Berian J, et al. A randomized controlled trial of anorectal biofeedback for constipation. Int J Colorectal Dis. 2012 Apr;27(4):459-66.
- American Gastroenterological Association. American Gastroenterological Association medical position statement on constipation. Available online at: National Guideline Clearinghouse
- National Institute for Health and Clinical Excellence (NICE). Guideline 99: Constipation in children and young people 2010.
- National Institute for Health and Clinical Excellence (NICE). Guideline 49: Faecal incontinence: the management of faecal incontinence in adults. 2007.
- EEG Education and Research Inc. Neurofeedback. 2014. Accessed Sept 5, 2014. Therapeutic Uses
- National Coverage Determination (NCD) for Biofeedback Therapy (30.1)
- American Society of Colon and Rectal Surgeons. Clinical practice guideline for the treatment of fecal incontinence. 2015. Available at URL address: Clinical Practice Guidelines
- Paquette IM, Varma MG, Kaiser AM, et al. The American Society of Colon and Rectal Surgeons' clinical practice guideline for the treatment of fecal incontinence. Dis Colon Rectum. Jul 2015;58(7):623-636. PMID 26200676
- Rao SS, Benninga MA, Bharucha AE, et al. ANMS-ESNM position paper and consensus guidelines on biofeedback therapy for anorectal disorders. Neurogastroenterol Motil. May 2015;27(5):594-609. PMID 25828100
- Qaseem A, Dallas P, Forciea MA, et al. Nonsurgical management of urinary incontinence in women: a clinical practice guideline from the American College of Physicians. Ann Intern Med. Sep 16 2014;161(6):429-440. PMID 25222388
- Anderson CA, Omar MI, Campbell SE, et al. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev. 2015;1:CD001843. PMID 25602133
- Moroni R., Magnani P., Haddad J., et. al. Conservative treatment of stress urinary incontinence: a systematic review with meta-analysis of randomized controlled trials. 2016; 38(02): 097-111 DOI: 10.1055/s-0035-1571252.
- Centers for Medicare and Medicaid Services. National coverage decision for biofeedback therapy for the treatment of urinary incontinence (Publication No. 100-3, Section 30.1.1).
- Paquette IM, Varma M, Ternent C, et al. The American Society of Colon and Rectal Surgeons' Clinical Practice Guideline for the Evaluation and Management of Constipation. Dis Colon Rectum. Jun 2016;59(6):479-492. PMID 27145304
- Wald A, Bharucha AE, Cosman BC, et al. ACG clinical guideline: management of benign anorectal disorders. Am J Gastroenterol. Aug 2014;109(8):1141-1157; (Quiz) 1058. PMID 25022811
- July 2017 - Annual Review, Policy Revised
- July 2016 - Annual Review, Policy Revised
- August 2015 - Annual Review, Policy Revised
- September 2014 - Annual Review, Policy Revised
- April 2014 - Interim Review, Policy Revised
- October 2013 - Annual Review, Policy Revised
- December 2012 - Annual Review, Policy Renewed
- December 2011 - Annual Review, Policy Renewed
- December 2010 - Annual Review, Policy Renewed
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