Bowel Management Devices - CAM 252

Description
Manual Pump Enema Systems
Manual pump enema systems (e.g., Peristeen Anal Irrigation System; PAI), also known as rectal irrigation or transanal irrigation (TAI), is used in patients with a history of extensive bowel management programs, neurogenic bowel dysfunction (NBD), fecal incontinence, and chronic constipation. TAI removes stool by introducing water directly into the bowel by using a secured, inflatable rectal balloon. The water stimulates muscles in the bowel and flushes out the stool, emptying the lower portion of the colon. The PAI device should only be prescribed by a licensed physician and consists of a control unit with a manual pump, a water bag and a single-use rectal catheter. (1)

Pulsed Irrigation and Evacuation Systems
Pulsed Irrigation Evacuation (PIE) is a colorectal irrigation system used to treat chronic constipation and fecal impaction in patients with neurological conditions that alter bowel function (e.g. quadriplegia, paraplegia, spinal cord injury, spinal bifida) and as a bowel preparation prior to colonoscopy. PIE involves insertion of a speculum into the rectum and then a cuff is inflated. Small amounts of warm water are pulsed into the colon followed by a drainage cycle, which is repeated until the expelled rectal fluid is clear. The goal of PIE is to rehydrate the stool and cleanse the colon. PIE is a closed system and consists of an electric control unit to control inflow and outflow time and disposable supplies including a water reservoir bag, a cuffed speculum, and an outflow bag. (2)

Regulatory Status
In 2012, the PAI System (Coloplast Corp, Minneapolis, MN.) was U.S. Food and Drug Administration (FDA) approved as a Class II device for use in individuals 2 years of age or older with NBD who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures. Product code KNT. (1)

In September 1986, PIE (P.I.E. Medical Inc., Oakwood, GA) was U.S. FDA approved as a class II device thru the 510(k)-process based on a substantial equivalence to pre-amended devices. Hence, the manufacturer was not required to present clinical efficacy data to the FDA. (2) Refer to <https://www.accessdata.fda.gov> for a complete list of U.S. FDA approved bowel management devices. (2)

Policy
*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Manual pump enema systems (e.g. Peristeen™ Anal Irrigation System) is considered MEDICALLY NECESSARY for patients diagnosed with neurogenic bowel dysfunction (NBD) when ALL the following criteria are met: 

  • The member is age 2 years of age or older; AND
  • The member suffers from fecal incontinence, chronic constipation and/or time-consuming bowel management procedures; AND
  • Initial management involving diet, bowel habits, laxatives and constipating medications has failed.

Manual pump enema systems (e.g. Peristeen™ Anal Irrigation System) is Investigational/unproven therefore considered NOT MEDICALLY NECESSARY when the above criteria are not met. 

Pulsed irrigation evacuation systems (PIE) is investigational/unproven, and therefore considered NOT MEDICALLY NECESSARY for all indications.

Rationale 
Manual Pump Enema Systems
In 2008, Del Popolo et al. (3) sought to evaluate the effects of Peristeen anal irrigation (PAI) on patients with neurogenic bowel dysfunction (NBD). Thirty-six patients with unsatisfactory treatment of NBD were enrolled from Spinal Units/Rehabilitation Centers in Italy. Patients were treated with the PAI for 3 weeks. NBD symptoms and quality of life (QoL) were evaluated pre- and post-treatment, using a specific questionnaire. Statistical analysis was performed using the McNemar and Sign Test. Out of 36 enrolled patients, 32 completed the program. Twenty eight percent of patients reported a reduction/elimination of pharmaceutical use and 24 patients demonstrated increased independence. A successful outcome was present in 68% of patients with fecal incontinence, and for 63% of patients with constipation. The authors concluded that PAI is a simple therapeutic treatment which improves overall QoL therefore, it should be considered as the treatment of choice for neurogenic bowel dysfunctions (NTB).

Christensen and colleagues (2009) examined the cost-effectiveness of transanal irrigation (TAI) using a self-administered irrigation system compared to conservative bowel management. (4) This randomized clinical trial (RCT) of 80 adult patients was conducted at 5 spinal centers located in Denmark, Germany, Italy, United Kingdom and Sweden. Adult spinal cord injury (SCI) patients with NBD were randomized to 10 weeks with either PAI or conservative bowel management. Costs were analyzed based on results from the clinical trial and on 24 interviews conducted in Germany. Unit costs were obtained from the Federal Statistical Office in Germany. When comparing outcome measures at termination, TAI significantly reduced symptoms of NBD. Product related costs were higher for PAI; however, costs for a caregiver to assist with bowel management programs and patient hygiene (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 TAI using a self-administered system reduced symptoms of NBD and resulted in a lower total cost than conservative bowel management. Overall, this study only offered a short perspective (10 weeks) in terms of outcome measurements.

Neel (2010) prospectively evaluated the effectiveness and durability of combined intra-detrusor botulinum-A toxin and endoscopic treatment for vesicoureteral reflux (VUR) with anal irrigation as a total endoscopic and anal irrigation management approach. (5) 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/3 males with a mean +/- SD age of 5.3 +/- 2.5 years) with myelomeningocele and VUR who did not respond to standard conservative management were prospectively included in this study. All participants had a minimum of 1-year 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. VUR in a total of 20 refluxing ureters, including bilateral VUR in 7 patients, showed no resolution on pretreatment voiding cystourethrogram. Therefore, the patients were administered a submucosal Deflux injection. Since most patients were still diaper dependent due to stool incontinence, management was extended to include complete bowel rehabilitation with the PAI system 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 H2O at 1 month (p <0.001), to 39 +/- 9 at 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 when used 1 to 2 times a week; 3 patients who were stool continent on standard enemas did not require this irrigation system. The author concluded that the total endoscopic and anal irrigation management approach is a comprehensive, minimally invasive, safe, simple, effective way to achieve most goals when treating patients by protecting the upper tract, maintaining the bladder at a safe pressure and providing a satisfactory social life and stool continence.

Rosen et al. (2011) performed a small prospective study which evaluated the effect of TAI on the QoL of patients suffering from anterior resection syndrome (ARS) at 2 colorectal centers. (6) A total of 14 patients (11 males; median age of 68 [45 to 80] years) with a median number of defecations was 8 (4 to 12)/day and 3 (2 to 5)/night were included in the study. All patients were trained to perform TAI using the PAI system under the guidance of a stoma nurse. Anal physiology was performed; QoL was estimated by the SF-36 and Rockwood questionnaires and continence by the Cleveland Incontinence Score. At the last follow-up, the median time of using TAI was 29 (15 to 46) months. The median volume of water used for the irrigation was 900 (500 to 1,500) ml. The authors noted that 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 decreased 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 TAI is an effective treatment of ARS evidenced by a marked improvement of the continence score and QoL.

Corbett et al. (2014) reported on a 5-year experience utilizing the PAI system to manage children with fecal incontinence secondary to myelomeningocele, Hirschsprung disease, and anorectal anomalies. (7) 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 the use of PAI were compared using the Wilcoxon matched pairs test (p < 0.05 significant). From 2006-2011, a total of 24 children (median age of 6 years) were managed with PAI for the treatment of fecal incontinence; 3 did not tolerate the system. Median QoL scores in 20 out of 21 patients using the TAI 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. Nineteen of 24 patients (79 %) continued using PAI. The authors conclude that PAI is a safe, effective, non-operative alternative to the MACE procedure in children with fecal incontinence, if initial compliance is attained.

Alenezi et al. (2014) prospectively evaluated children with neuropathic bladder and bowel dysfunction who were intended for reconstructive bladder surgery and the MACE procedure. (8) The goal was to assess the efficacy of PAI as a stool cleansing mechanism, to gain stool continence in children who need reconstructive bladder surgery and have fecal incontinence. All patients received PAI at least 3 months prior to surgery to assess their response. Individual bowel function, frequency of use of the PAI system, patient satisfaction (and that of their parents) and diaper independency were evaluated pre- and post-reconstructive surgery. This study included 18 patients (11 females, 7 males) who were evaluated from April 2006 to 2014. The mean age was 7.6 years (range of 4 to 15). Fifteen patients (83.3 %) demonstrated 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 continued to use the PAI with the same results post reconstructive bladder surgery. The authors concluded that these initial results suggest that PAI is a successful conservative substitute for the MACE procedure.

Pacilli et al. (2014) analyzed the effectiveness of the PAI in a series of children with incontinence or constipation and overflow soiling in a retrospective study. (9) Irrigations were performed with a volume of 10 to 20 milliliter/kilogram (ml/kg) of water with schedules contingent on patient response. A total of 23 patients were reviewed with a median age at commencement of irrigations was 7 (2 to 15) years. Median follow-up was 2 (0.7 to 3.4) years. Diagnoses included 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 incontinence. 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 although they were having occasional soiling. Four patients (17 %) did not tolerate the irrigations and underwent subsequent colostomy formation for intractable soiling. The authors concluded that PAI is an effective method of managing patients with fecal soiling in childhood. The majority (83 %) of children achieved social fecal continence or a significant improvement with occasional soiling which was accompanied by high parental satisfaction. The authors concluded that PAI is a valid alternative to invasive surgical procedures and should be considered as first-line treatment for bowel management in children with soiling where simple pharmacological maneuvers fail to be effective. Although this study is limited by a small subset of patients from a single center.

Midrio et al. (2016) reported the results of a multicenter pilot study using the PAI in a group of pediatric patients with anorectal malformations (ARM) and congenital or acquired spinal cord lesions (SCL). (10) A total of 8 Italian pediatric surgery and spina bifida centers participated in the study. Patients between the age of 6 to 17 years of age with a weight above 20 kg and unsatisfactory bowel management were included. Patients with chronic inflammatory bowel disease, mental disability and surgery within the previous 3 months were excluded. At the initiation 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 performed. 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 SCLs 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 demonstrate that PAI resulted in significant time reduction in colonic cleansing, increased independence from the caregiver, and improved QoL in pediatric patients with ARM and SCL.

Professional Guidelines and Position Statements
National Institute for Health and Care Excellence (NICE)
The NICE CG99 (2010) does list TAI as a recommended treatment modality for the management of idiopathic constipation in children. (11)

In 2017 (reaffirmed 2018), the NICE published an assessment on TAI/rectal irrigation for adults with fecal incontinence (CG49) which includes rectal irrigation as one of several options following failure of initial management involving diet, bowel habit, toilet access, medication and coping strategies. (12)

In 2018, the NICE published guidance specific to the PAI (13) which states, “The case for adopting Peristeen for transanal irrigation in people with bowel dysfunction is supported by the evidence” and “if bowel continence cannot be achieved by medication, changes to diet and physiotherapy and long-term management strategies such as transanal irrigation should be considered”. This guidance includes a single RCT published in 2006 (Christensen et al.) which demonstrates significant improvement in bowel-related patient reported outcomes for Peristeen compared to standard bowel care over 10 weeks. NICE considered this study to be the best quality evidence to support the use of this device. NICE states despite uncertainties, the evidence demonstrates that adults who choose Peristeen demonstrate improved clinical outcomes.

American Society of Colon and Rectal Surgeons (ASCRS)
In 2015, the ASCRS (14) published guidance on the treatment of fecal incontinence that includes the following recommendations:  

  • Dietary or medical management is recommended as first line therapy for patients with fecal incontinence-strong recommendation based on low or very low-quality evidence.
  • If bowel continence cannot be achieved by medication, changes to diet and physiotherapy then long-term management strategies such as TAI should be examined. There are several TAI systems available, including Peristeen. Patients may try several TAI devices prior to opting on a specific system. Some patients may need and/or prefer surgery.

Additional Guidance
In 2012, a multidisciplinary association of spinal cord professionals published guidance on the management of patients with NBD which states (15):

TAI has been found to reduce fecal incontinence, constipation and time spent on bowel management and improves the patients’ symptoms and QOL. The guidance states TAI is a safe and effective intervention and long-term use is not thought to impact colonic function.

Summary of Evidence: Manual Pump Enema Systems
The majority of the published literature is specific to patients with neurogenic bowel dysfunction (NBD). Two randomized controlled trials (RCTs), multiple observational studies, prospective studies, retrospective reviews, systematic reviews and review articles were identified that utilize manual pump enema systems (e.g. Peristeen) in patients with spinal cord injuries/NBD. Some studies are limited by the small subset of enrolled participants with short-term outcomes, but the overall results demonstrate a reduction of incontinence, increased independence and improved quality of life in patients with NBD. In addition, the Peristeen System serves as a non-surgical option in patients with NBD when other conservative measures have failed.

Pulsed Irrigation and Evacuation Systems
To date, published evidence for the safety and efficacy of pulsed irrigation and evacuation systems in patients with diseases which predispose them to chronic constipation is limited to a single randomized trial and several uncontrolled case series.

Gilger et al. (1994) wanted to determine the efficacy, comfort, and safety of the pulsed irrigation enhanced evacuation (PIEE) procedure when used in the pediatric population. (16) The authors evaluated 27 procedures performed on 24 consecutive children, 16 boys and 8 girls, 4-15 years old (mean, 8.7), with chronic constipation, encopresis, and rectal impaction. Children with known heart, lung, and/or neurologic diseases were excluded. Temperature, pulse, respiratory rate, and blood pressure were obtained prior to, during, and post-procedure. Abdominal radiographs were obtained pre- and post-procedure, and the degree of dis-impaction was estimated by a single radiologist. Patients graded the discomfort at the time of speculum insertion and every 15 min from 1 to 5: 1, painless; 2, mild discomfort; 3, moderate discomfort; 4, severe discomfort; 5, extremely painful. Serum sodium, potassium, chloride, and bicarbonate values were obtained before, immediately after, and 90 min post-procedure. A digital rectal examination confirmed rectal impaction prior to insertion of the speculum. One course of PIE was performed, lasting 25-30 min. No significant changes in vital signs were noted during or following the procedure. In 18 of 23 (78%) procedures, there was at least a 50% emptying of feces from the colon immediately post procedure. Patients continued to empty their colon up to 12 hours later; thus, the procedure effectively disimpacted all patients. In terms of comfort, patients graded the PIEE procedure a 2.6 × 0.75 (range, 1–5). Speculum insertion was the most uncomfortable factor and received a 2.7. No child demonstrated any sign(s) of water intoxication. Serum sodium levels (mean×SD) before the procedure were 139.4 × 1.95 mm. Immediate post-procedure levels fell to 136.8 × 2.21 mm, p < 0.05; 90 min later, and returned to 137.9 × 2.67 mm, p < 0.05. The largest change in serum sodium pre- and post-procedure was 7 mm (from 139 to 132), noted in 2 patients. No other electrolyte changes were noted. The PIEE procedure successfully disimpacted all patients, either immediately or within hours of completion. Patients accepted the procedure well, and no clinically significant electrolyte changes were noted. The authors stated that the PIEE procedure appears to be safe, effective, and acceptable to perform in children although this study is limited to small sample size. Additional larger RCTs are warranted.

Poor preparation for elective colonoscopy is common in persons with spinal cord injury (SCI). In 2015, Lyons et al. (17) sought to determine the most effective preparation for elective colonoscopy. A total of 24 subjects with SCI were scheduled to receive PIE or 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 patients who received PEG; however, the results were not statistically different. The authors concluded in this preliminary study that neither PIEE nor PEG is an acceptable bowel preparation for elective colonoscopy in patients with SCI. Future studies are needed to confirm these findings.

In 2017, Ayub et al. (18) strived to compare pulsed irrigation evacuation (PIE), polyethylene glycol (PEG) and sodium phosphate colon preparations at a single center. Altogether, 391 patients participated in the study (129 in the PEG group, 127 in the sodium phosphate and 135 in the PIE group), with a mean age of 62 years, of whom 75% were men. Colon cleansing was assessed blindly using a five-point scale: 0 (very poor) to 4 (excellent). PIE and sodium phosphate were superior to PEG: median cleansing scored 4 (excellent) versus 3 with PEG (P < 0.01). Inadequate preparations were more common with PEG than PIE (18% vs 5%) (P < 0.01). Side effects included vomiting: 37% in the sodium phosphate group versus 5% in the PEG and 2% in the PIE groups (P < 0.01). Three preparations were judged intolerable in ≤ 5%. This study concludes that PIE and sodium phosphate are superior to PEG for colon preparations. PIE is the preferred preparation for those at high-risk of unsatisfactory preparations or with unsatisfactory traditional preparations.

Professional Guidelines and Position Statements
Paralyzed Veterans of America
The Paralyzed Veterans of America (19) issued guidance in 1998 that concluded "research is insufficient to support recommendations" for PIEE. "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". Large-scale clinical trials are needed to test the long-term safety and efficacy of PIEE.

American Society of Colon and Rectal Surgeons (ASCRS) and the NIH 2015 Consensus Statement
The 2015 ASCRS (14) does not mention PIEE procedures as a treatment modality.

Summary of Evidence: Pulsed Irrigation and Evacuation Systems
Published evidence for the safety and efficacy of pulsed irrigation enhanced evacuation (PIEE) procedures is limited to 1 RCT and several small, uncontrolled case series (n=4 to n=37). Available studies are limited by the lack of enrolled participants. Additional long-term studies with larger cohorts are needed to demonstrate the long-term safety and efficacy of this treatment.

Ongoing and Unpublished Clinical Trials
There are no ongoing and unpublished trials that might influence this policy.

References 

  1. FDA – Peristeen Anal Irrigation System. 510(k) Premarket Notification (k112860). Food and Drug Administration – Center for Devices and Radiologic Health (2012). Available at <http://www.accessdata.fda.gov> (accessed May 2, 2019).
  2. FDA – Code of Federal Regulations (April 1, 2018); Title 21, Volume 8. Title 21. Section 876.5220 Colonic irrigation system. Available at <http://www.accessdata.fda.gov> (accessed July 28, 2021).
  3. 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. PMID 18317488.
  4. 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. PMID 18679401
  5. 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. PMID 20488484
  6. 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. PMID 21689359
  7. 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. PMID 24439630
  8. 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. PMID 24454594
  9. 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. PMID 24528964
  10. Midrio P, Mosiello G, Ausili E, et al. Peristeen® transanal irrigation in paediatric patients with anorectal malformations and spinal cord lesions: Amulticentre Italian study. Colorectal Dis. 2016; 18(1):86-93. PMID 26304756
  11. National Institute for Health and Care Excellence. Constipation in children and young people: Diagnosis and management. CG99 (2010). Available at <https://www.nice.org.uk> (accessed July 29, 2021).
  12. National Institute for Health and Care Excellence. Faecal incontinence in adults: Management. CG49 (2007, reaffirmed 2018). Available at <https://www.nice.org.uk> (accessed July 29, 2021).
  13. National Institute for Health and Care Excellence. Peristeen transanal irrigation system for managing bowel dysfunction. MTG 36 (2018). Available at <https://www.nice.org.uk> (accessed July 29, 2021).
  14. Paquette I, Varma M, Kaiser A, et al. American Society of Colon and Rectal Surgeons. Clinical practice guideline for the treatment of fecal incontinence. No. 210 (2015). Available at <https://journals.Iww.com> (accessed July 29, 2021).
  15. Multidisciplinary Association of Spinal Cord Injured Professionals. Guidelines for Management of Neurogenic Bowel Dysfunction in Individuals with Central Neurological Conditions. (2012). Available at <https://www.rnoh.nhs.uk> (accessed July 29, 2021).
  16. 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. PMID 8126626
  17. 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. PMID 25096918
  18. Ayub K, Ketwaroo G, Abudayyeh S, et al. Mechanical colon cleansing for screening colonoscopy: A randomized controlled trial. J Dig Dis. 2017 Dec; 18(12):691-697. PMID 29160622
  19. Paralyzed Veterans of America. Consortium for Spinal Cord Medicine. Neurogenic bowel management in adults with spinal cord injury clinical practice guidelines. (1998). Available at <https://pva.org> (accessed July 29, 2021).

Contract:

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. 

Coding:

Code Number Description
CPT 45399 Transabdominal colonoscopy via colotomy
HCPCS A4458 Enema bag with tubing, reusable 
  A4459 Manual pump-operated enema system, includes balloon, catheter and all accessories, reusable, any type 
  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 Diagnosis    
ICD-10 Pocedure Code    

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. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association.  All Rights Reserved" 

History From 2020 Forward     

12/13/2021 

Annual review, no change to policy intent. Updating rationale and references. 

12/08/2020

New Policy

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