Bowel Management Devices

Number: 0522

Policy

Aetna considers manual pump enema systems (e.g., Peristeen Anal Irrigation System, Coloplast, Minneapolis, MN) medically necessary for the management of chronic neurogenic bowel when initial management involving diet, bowel habit, laxatives or constipating mediations has failed. Aetna considers manual pump enema systems experimental and investigational for the treatment of idiopathic constipation and treatment of fecal incontinence, because their effectiveness for these indications has not been established.

Aetna considers pulsed irrigation and evacuation systems (e.g., Pulsed Irrigation Evacuation (PIE), P.I.E. Medical Inc., Buford, GA) experimental and investigational because its clinical value for persons with chronic constipation has not been established. Note: Consistent with Medicare policy, pulsed irrigation evacuation systems are not covered because they are considered institutional equipment.

Aetna considers gravity-administered enema systems medically necessary for the treatment of constipation, fecal incontinence, and bowel management protocols.

Aetna considers rectal inserts and related accessories experimental and investigational because of inadequate evidence of their effectiveness.

For incontinence garments (e.g., briefs, diapers) and disposable underpads, see CPB 0533 - Urologic Supplies.

For toilet seats, raised toilet seats, toilet seat lift mechanisms, bidets and bidet toilets, see CPB 0429 - Bathroom and Toilet Equipment and Supplies.

Background

Generally accepted standard treatments for chronic constipation include: minimization of use of any medications known to cause constipation; correction of metabolic abnormalities (e.g., hypothyroidism) that may contribute to constipation; exercise; increased fluid intake; increase dietary fiber; and bulk (fiber) forming laxatives.  In addition, hyper-osmotic laxatives (e.g., lactulose, magnesium hydroxide, and sorbitol), enemas, and emollient laxatives (docusate sodium) are used in selected cases.

Pulsed Irrigation Evacuation (PIE)

A pulsed irrigation evacuation system is a colorectal irrigation system that consists of an irrigation fluid holding chamber, a rectal catheter with an inflatable balloon and an electric pump. Irrigation fluid is administered in a pulsatile manner to hydrate stool to a semi-liquid form and allow the liquefied stool to evacuate. 

Pulsed irrigation evacuation (PIE) (P.I.E. Medical Inc., Oakwood, GA) has been used for bowel management of chronic constipation patients without voluntary bowel control (e.g., paraplegics, quadriplegics, and spina bifida, etc.).  Pulsed irrigation evacuation has been described as an automated enema in which small pulses of warm tap water are delivered into the rectum, serving to rehydrate feces and promote peristalsis.  The system consists of a speculum, tubing, a disposable collection container, and an electrical unit that delivers positive and negative air pressure through the tubing.  The device was cleared by the Food and Drug Administration (FDA) based on a 510(k) application due to its substantial equivalence to pre-amendment devices.   Hence, the manufacturer was not required to present clinical efficacy data to the FDA.

The published evidence of efficacy of PIE in patients with conditions predisposing them to chronic constipation is limited to several uncontrolled case series.  Most of the published studies are from the experience of a single investigator.

However, the only comparative study of PIE compared the device to a standard per-oral colonic lavage in patients undergoing colonoscopy preparation.  The study found PIE equivalent to, but not superior to, standard per-oral lavage.

There are no comparative studies of PIE in patients with conditions predisposing them to fecal impaction.  Hence, the value of PIE in place of or in addition to a standard bowel regimen in these patients has not been demonstrated.  Reviews on chronic constipation by Lembo and Camilleri (2003) as well as by Talley (2004) did not include PIE as a tool for managing patients with this condition.

Guidelines from the Paralyzed Veterans of America (1998) concluded that "the research is insufficient to support recommendations" for PIE.  "Randomized controlled trials involving people with varying levels of SCI [spinal cord injury] should be conducted to determine the efficacy and safety of this treatment.  Such studies will provide data on risk of autonomic dysreflexia and indications of when and when not to use this technique".

Lyons et al (2015) determined the most effective preparation for elective colonoscopy applying a novel and traditional approach to bowel cleansing. A total of 24 subjects with SCI were consented and scheduled to receive
  1. pulsed irrigation enhanced evacuation (PIEE) or
  2. polyethylene glycol-electrolyte lavage solution (PEG; CoLyte).  
The quality of the preparation was scored during the colonoscopy by applying the Ottawa scoring system.  Patients with SCI who received PIEE tended to have lower Ottawa scores and a higher percentage of acceptable preparations than did those who received PEG; however, the results were not statistically different.  The authors concluded that in this preliminary study in subjects with SCI, neither PIEE nor PEG produced acceptable bowel preparation for elective colonoscopy.  They stated that future studies should confirm these findings and consider studying alternative, more effective approaches to bowel cleansing prior to colonoscopic procedures in patients with SCI, which should provide better outcomes.

The Peristeen Anal Irrigation System

A manual pump enema system describes a device used to empty the lower bowel and to prevent chronic constipation and fecal incontinence or simply as a method of bowel management. An enema system consists of an irrigation fluid holding chamber and a rectal catheter (with or without an inflatable balloon). Fluid is instilled either via a manual pump.

The Peristeen Anal irrigation (PAI; also known as rectal irrigation and trans-anal irrigation) is a method for bowel management; it is used to prevent chronic constipation and fecal incontinence. The PAI can be administered either on one’s own or with assistance. The PAI consists of a control unit with a pump, a water bag and a rectal catheter. The water bag is designed to stand on the floor and can easily be moved around. The rectal catheter is small, smooth, and discreet that facilitates easy insertion into the rectum. The soft balloon ensures that the rectal catheter is fixed inside the bowel so both hands are free during the irrigation.

In a multi-center study, Del Popolo et al (2008) evaluated the effects of the PAI on neurogenic bowel dysfunctions (NBD) and patient quality of life (QoL). A total of 36 patients with unsatisfactory treatment of NBD were enrolled from Spinal Units and Rehabilitation Centers in Italy. Treatment was for 3 weeks using a newly developed integrated system with an enema continence catheter for trans-anal irrigation (Peristeen, Coloplast A/S Kokkedal Denmark). Lesion level, ambulatory status and hand functionality were determined in all patients. Symptoms of NBD and QoL were evaluated before and after treatment, using a specific questionnaire. Statistical analysis was performed using McNemar Test and Sign Test. Of the 36 enrolled patients, 32 patients completed the study. At the end of the treatment, 28.6 % of patients reduced or eliminated their use of pharmaceuticals; 24 (75 %) patients became less dependent on their caregiver. There was a significant increase in patients' opinion of their intestinal functionality (p = 0.001), QoL score (p = 0.001) and their answers regarding their degree of satisfaction (p = 0.001). A successful outcome was recorded for 68 % of patients with fecal incontinence, and for 63 % of patients with constipation. The authors concluded that the PAI is a simple therapeutic method for managing NBD and improving QoL. It should be considered as the treatment of choice for NBD, playing a role in the neurogenic bowel analogous to that of intermittent clean catheterization in bladder treatment.

Christensen et al (2009) estimated the cost-effectiveness of trans-anal irrigation using a self-administered irrigation system when compared with conservative bowel management.  A randomized clinical trial was conducted at 5 spinal centers situated in Denmark, Germany, Italy, United Kingdom and Sweden.  Estimates of resources and unit costs were made for the German health care system.  Efficacy outcomes were drawn from a randomized controlled trial (RCT) conducted in 2003 to 2005.  Adult SCI patients with NBD were randomized to 10 weeks with either PAI or to conservative bowel management.  Costs were calculated based on results from the clinical trial and on 24 interviews conducted in Germany.  Unit costs were obtained from the Federal Statistical Office Germany and product list prices.  When comparing outcome measures at termination, trans-anal irrigation significantly reduced symptoms of NBD.  Product-related costs were higher for PAI; however, costs for a care-giver to help with bowel management and changes/washing due to leakage were lower.  For PAI, costs associated with urinary tract infections and patient time spent were reduced.  Thus, the total cost to society is lower when patients use PAI.  The results were shown to be robust in the sensitivity analysis.  The authors concluded that trans-anal irrigation using a self-administered system reduced symptoms of NBD and resulted in a lower total cost to society than conservative bowel management.

Neel (2010) prospectively evaluated the effectiveness and durability of combined intra-detrusor botulinum-A toxin and endoscopic treatment for vesicoureteral reflux with anal irrigation as a total endoscopic and anal irrigation management approach.  This minimally invasive protocol is used to manage myelomeningocele and non-compliant bladder in children who do not respond to standard conservative therapy and have urine and stool incontinence.  A total of 13 patients (10 females and 3 males with a mean +/- SD age of 5.3 +/- 2.5 years) with myelomeningocele and vesico-ureteral reflux (VUR) who did not respond to standard conservative treatment were prospectively included in this study.  All had at least 1 year of follow-up.  All patients received a cystoscopic intra-detrusor injection of 12 U/kg (maximum 300 U) botulinum-A toxin into an infection-free bladder.  Vesico-ureteral reflux in a total of 20 refluxing ureters, including bilateral VUR in 7 patients, showed no resolution on pre-treatment voiding cystourethrogram.  Thus, these investigators administered a submucosal Deflux injection.  Since most patients were still diaper-dependent due to stool incontinence, these researchers extended management to include complete bowel rehabilitation with the PAI to manage stool incontinence.  Mean maximum bladder capacity increased significantly from 75 +/- 35 to 150 +/- 45 ml after 1 month (p < 0.02), to 151 +/- 48 after 6 months (p < 0.002) and to 136 +/- 32 after 1 year (p < 000).  Maximum detrusor pressure decreased significantly from 58 +/- 14 to 36 +/- 9 cm H(2)O after 1 month (p < 0.001), to 39 +/- 9 after 6 months (p < 0.001) and to 38 +/- 6 after 1 year (p = 000).  Of 20 refluxing ureters, 95 % completely resolved, including 1 after the 2nd attempt; and 1 with grade-V VUR remained unchanged despite 2 attempts. Seven of 8 urinary incontinent patients (87.5 %) attained complete dryness between catheterizations and 1 partially improved. Ten of 13 patients achieved stool dryness with the PAI 1 to 2 times weekly; 3 patients who were stool continent on standard enemas did not require this irrigation system.  The authors concluded that this new total endoscopic and anal irrigation management approach is a comprehensive, minimally invasive, safe, simple, effective way to achieve most goals when treating these patients by protecting the upper tract, maintaining the bladder at safe pressure and providing a satisfactory social life with satisfactory urine and stool continence.

Rosen et al (2011) stated that trans-anal irrigation has been reported to be a cheap and effective treatment for the “anterior resection syndrome (ARS)”.  In a prospective study, these researchers evaluated the effect of trans-anal irrigation on the QoL of patients suffering from ARS.  A total of 14 patients (11 males; median age of 68 (45 to 80) years) were included in the study.  The median duration of ARS was 19 (9 to 48) months.  The median number of defecations was 8 (4 to 12)/day and 3 (2 to 5)/night.  All patients were trained to perform trans-anal irrigation using the PAI under the guidance of a stoma nurse.  Anal physiology was performed; QoL was estimated by the SF-36 and Rockwood (ASCRS) questionnaires and continence by the Cleveland Incontinence Score.  At the last follow-up, the median time of using trans-anal irrigation was 29 (15 to 46) months.  The median volume of water used for the irrigation was 900 (500 to 1,500) ml.  There was a significant decrease in the number of defecations during the day (baseline, 8 [4 to 12]; last follow-up, 1 [1 to 2]) and at night (baseline, 3 [2 to 5]; last follow-up, 0 [0 to 0]).  The Cleveland Incontinence Score fell from 17 [15 to 20] (baseline) to 5 [4 to 9] (last follow-up) and the mental component of the SF-36 and all domains of the Rockwood QOL instrument improved.  The authors concluded that trans-anal irrigation was an effective treatment of anterior resection syndrome and resulted in a marked improvement of the continence score and QoL.

Corbett et al (2014) reported their 5-year experience with the PAI to manage children with fecal incontinence secondary to myelomeningocele, Hirschsprung disease, and anorectal anomalies.  This study was a combination of a retrospective case note review and assessment using a validated QoL questionnaire to determine pre- and post-PAI bowel function and continence.  Functional outcomes and QoL scores before and during PAI use were compared using Wilcoxon matched pairs test (p < 0.05 significant).  A total of 24 children (median age of 6 years) were managed with the PAI to treat fecal incontinence; 3 did not tolerate the system.  Median QoL scores in 20 out of 21 patients using the PAI demonstrated significant improvement in bowel management and continence; 2 discontinued use due to failure to improve continence; 1 underwent the Malone antegrade continence enema (MACE) procedure and 1 returned to oral/rectal medications; 19 of 24 patients (79 %) continued using the PAI.  The authors concluded that the PAI is a safe, effective, non-operative alternative to MACE in children with fecal incontinence, if initial compliance can be achieved.

Alenezi et al (2014) evaluated the effectiveness of the PAI, as a stool cleansing mechanism, to gain stool continence in children who need reconstructive bladder surgery and have fecal incontinence.  These investigators prospectively evaluated children with neuropathic bladder and bowel dysfunction who were intended for reconstructive bladder surgery and the MACE procedure.  All patients were started on the PAI at least 3 months before surgery to assess their response.  Each patient's bowel function, frequency of using the system, satisfaction (and that of their parents) and diaper independency were evaluated before and after reconstructive surgery.  These investigators included 18 patients (11 females, 7 males) who were evaluated from April 2006 to the present.  The mean age of the group was 7.6 years (range of 4 to 15); 15 patients (83.3 %) showed complete dryness from stools.  Of the 15 patients, 8 (53.3 %) were able to be diaper-free, while 6 continued wearing diapers due to fear of soiling and 1 due to urinary incontinence.  Patients underwent reconstructive bladder surgery and continued to use the PAI with the same results post-operatively.  The authors concluded that these initial results suggested that the PAI is a successful conservative substitute for the MACE procedure in children who require reconstructive bladder surgery.

Pacilli et al (2014) examined the effectiveness of the PAI in a series of children with incontinence or constipation and overflow soiling.  Irrigations were performed with a volume of 10 to 20 ml/kg of water with schedules depending on patient response.  Data were reported as median (range).  A total of 23 patients were reviewed.  Median age at commencement of irrigations was 7 (2 to 15) years.  Median follow-up was 2 (0.7 to 3.4) years.  Diagnoses include the following: spina bifida (n = 11), anorectal anomaly (n = 6), Hirschsprung's (n = 1), and other complex anomalies (n = 5).  Sixteen (70 %) patients had associated anomalies; 12 (52 %) had constipation and overflow soiling, and 11 (48 %) had fecal incontinence; 20 (87 %) had associated urinary wetting.  Sixteen (70 %) children used alternate-day irrigations, 4 (17 %) used daily irrigations, and 3 (13 %) used every 3rd-day irrigations; 9 (39 %) patients were taking oral laxatives.  Sixteen (70 %) reported to be clean and 3 (13 %) reported a significant improvement with occasional soiling; 4 patients (17 %) did not tolerate the irrigations and underwent subsequent colostomy formation for intractable soiling.  The authors concluded that in their experience, the PAI is an effective method of managing patients with focal soiling in childhood.  The majority (83 %) of children achieved social fecal continence or a significant improvement with occasional soiling.  This was accompanied by high parental satisfaction.  They stated that the PAI is a valid alternative to invasive surgical procedures and should be considered the first-line of treatment for bowel management in children with soiling where simple pharmacological maneuvers failed to be effective.

Midrio et al (2016) presented the results of a multi-center study using the PAI in a group of pediatric patients with ano-rectal malformations (ARM) and congenital or acquired spinal cord lesions (SCL).  A total of 8 Italian pediatric surgery and spina bifida centers participated in the study.  The inclusion criteria were age between 6 to 17 years, weight above 20 kg, and unsatisfactory bowel management.  Patients with chronic inflammatory bowel disease, mental disability and surgery within the previous 3 months were excluded.  At the beginning of treatment (T0) and after 3 months (T1), the Bristol scale, a questionnaire assessing bowel function and 2 questionnaires on QoL for patients aged 6 to 11 years (CHQ pf50) and 12 to 17 years (SF36) were administered.  A total of 83 patients were enrolled, and 78 completed the study (41 ARM, 37 SCL).  At T1, constipation was reduced in ARM from 69 % to 25.6 % and in SCL from 92.7 % to 41.5 %, fecal incontinence in ARM from 50 % to 18.6 %, and in SCL from 39 % to 9.8 % and flatus incontinence in ARM from 20.9 % to 9.8 %, and in SCL from 31.7 % to 10 %. At T0, the Bristol Stool Scale types were 1 to 2 in 45 % of ARM and 77.5 % of SCL patients, whereas at T1 types 1 to 2 were recorded in only 2.5 % of SCL patients; QoL improved in both groups.  In the younger group, a significant improvement in QoL was recorded in ARM patients for 8 of 9 variables and in SCL patients for 7 of 9 variables.  The authors concluded that the findings of this study showed that the PAI resulted in a significant time reduction in colonic cleansing, increased independence from the care-giver, and improved QoL in pediatric patients with ARM and SCL.

The United Kingdom’s NHS assessment on “Transanal Irrigation/Rectal Irrigation Systems” (2015) states that “For fecal incontinence in adults, the NICE CG49 recommends rectal irrigation as one of a number of options following failure of initial management involving diet, bowel habit, toilet access, medication and coping strategies.  The NICE CG99 does not recommend transanal irrigation as an option for the management of idiopathic constipation in children, due to a lack of robust evidence for this indication”.

Other Bowel Management Devices

Rectal inserts are prosthetic devices constructed of rubber, latex, silicone or other similar material and act as a barrier to the passage of fecal matter through the rectum.

A gravity administered enema system is a reusable enema bag with tubing used to empty the lower bowel and to prevent chronic constipation and fecal incontinence or simply as a method of bowel management.  An enema system consists of an irrigation fluid holding chamber and a rectal catheter (with or without an inflatable balloon). Fluid is instilled via gravity. 

A bed pan is a shallow vessel placed under a bedridden patient to collect feces and urine.

Table: CPT Codes / HCPCS Codes / ICD-10 Codes
Code Code Description

Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":

Other CPT codes related to the CPB:
99511 Home visit for fecal impaction management and enema administration

Gravity-administered enema systems:

HCPCS codes covered if selection criteria is met:
A4458 Enema bag with tubing, reusable

ICD-10 codes covered if selection criteria is met:
K59.00 - K59.09 Constipation
R15.0 - R15.9 Fecal incontinence

Manual pump enema system:

HCPCS codes covered if selection criteria is met:
A4459 Manual pump-operating enema system, including balloon, catheter and all accessories, reusable, any type [covered for chronic neurogenic bowel when initial management involving diet, bowel habit, laxatives or constipating medications have failed] [not covered for idiopathic constipation and treatment of fecal incontinence]

HCPCS codes not covered for indications listed in the CPB:
E0350 Control unit for electronic bowel irrigation/evacuation system
E0352 Disposable pack (water reservoir bag, speculum, valving mechanism and collection bag/box) for use with the electronic bowel irrigation/evacuation system

ICD-10 codes covered if selection criteria is met:
K59.2 Neurogenic bowel [chronic]

ICD-10 codes not covered for indications listed in the CPB (not all inclusive):
K59.00 - K59.09 Constipation
R15.0 - R15.9 Fecal incontinence

The above policy is based on the following references:

General References

  1. NHIC, Corp. Proposed/Draft Local Coverage Determination (LCD): Bowel Management Devices (DL36267). DME MAC Jurisdiction A. Hingham, MA: NHIC; July 16, 2015.
  2. NHIC, Corp. Local Coverage Article: Draft Bowel Management Devices - Policy Article (A54516). DME MAC Jurisdiction A. Hingham, MA: NHIC; October 1, 2015.

Pulsed Irrigation Evacuation

  1. Puet TA, Jackson H, Amy S. Use of pulsed irrigation evacuation in the management of the neuropathic bowel. Spinal Cord. 1997;35:694-699.
  2. Gilger MA, Wagner ML, Barrish JO, et al. New treatment for rectal impaction in children: An efficacy, comfort, and safety trial of pulsed-irrigation enhanced-evacuation procedure. J Ped Gastroenterol Nutr. 1994;18:92-95.
  3. Chang KJ, Erickson RA, Schandler S, et al. Per-rectal pulsed irrigation versus per-oral colonic lavage for colonoscopy preparation: A randomized, controlled trial. Gastrointest Endosc. 1991;37:444-448.
  4. Puet TA, Phen L, Hurst DL. Pulsed irrigation enhanced evacuation: A new method for treating fecal impaction.  Arch Phys Med Rehabil. 1991;71:935-936.
  5. Kokoszka J, Nelson R, Falconio M, et al. Treatment of fecal impaction with pulsed irrigation enhanced evacuation. Dis Colon Rectum. 1994;37:161-164.
  6. Gramlich T, Puet T. Long-term safety of pulsed irrigation evacuation (PIE) use with chronic bowel conditions. Dig Dis Sci. 1998;43:1831-1834.
  7. Innovatec Medical Corporation. Pulsing water therapy. Pulsed Irrigation Evacuation (PIE). Oakwood, GA: Innovatec; 2000. Available at: http://www.piemed.com/page2.htm. Accessed July 28, 2000.
  8. Kearney DJ, McQuaid KR. Approach to the patient with gastrointestinal disorders. In: Current Diagnosis & Treatment in Gastroenterology. 1st ed. JH Grendell, KR McQuaid, SL Friedman, eds. Stamford, CT: Appleton & Lange; 1996.
  9. Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003;349(14):1360-1368.
  10. Talley NJ. Management of chronic constipation. Rev Gastroenterol Disord. 2004;4(1):18-24.
  11. Bosshard W, Dreher R, Schnegg JF, Bula CJ. The treatment of chronic constipation in elderly people: An update. Drugs Aging. 2004;21(14):911-930.
  12. Paralyzed Veterans of America, Consortium for Spinal Cord Medicine. Neurogenic bowel management in adults with spinal cord injury. Clinical Practice Guidelines. Washington, DC: Paralyzed Veterans of America; 1998.
  13. Coggrave M, Wiesel PH, Norton C. Management of faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev. 2006;(2):CD002115.
  14. Tod AM, Stringer E, Levery C, et al. Rectal irrigation in the management of functional bowel disorders: A review. Br J Nursing. 2007;16(14):858-864.
  15. Lyons BL, Korsten MA, Spungen AM, et al. Comparison between pulsed irrigation enhanced evacuation and polyethylene glycol-electrolyte lavage solution for bowel preparation prior to elective colonoscopy in veterans with spinal cord injury. J Spinal Cord Med. 2015;38(6):805-811.

The Peristeen Anal Irrigation System

  1. Del Popolo G, Mosiello G, Pilati C, et al. Treatment of neurogenic bowel dysfunction using transanal irrigation: A multicenter Italian study. Spinal Cord. 2008;46(7):517-522.
  2. Christensen P, Andreasen J, Ehlers L. Cost-effectiveness of transanal irrigation versus conservative bowel management for spinal cord injury patients. Spinal Cord. 2009;47(2):138-143.
  3. Neel KF. Total endoscopic and anal irrigation management approach to noncompliant neuropathic bladder in children: A good alternative. J Urol. 2010;184(1):315-318.
  4. Rosen H, Robert-Yap J, Tentschert G, et al. Transanal irrigation improves quality of life in patients with low anterior resection syndrome. Colorectal Dis. 2011;13(10):e335-e338.
  5. Corbett P, Denny A, Dick K, et al. Peristeen integrated transanal irrigation system successfully treats faecal incontinence in children. J Pediatr Urol. 2014;10(2):219-222.
  6. Alenezi H, Alhazmi H, Trbay M, et al. Peristeen anal irrigation as a substitute for the MACE procedure in children who are in need of reconstructive bladder surgery. Can Urol Assoc J. 2014;8(1-2):E12-E15.
  7. Pacilli M, Pallot D, Andrews A, et al. Use of Peristeen® transanal colonic irrigation for bowel management in children: A single-center experience. J Pediatr Surg. 2014;49(2):269-272; discussion 272.
  8. Midrio P, Mosiello G, Ausili E, et al. Peristeen® transanal irrigation in paediatric patients with anorectal malformations and spinal cord lesions: aAmulticentre Italian study. Colorectal Dis. 2016;18(1):86-93.