Aetna considers pulsed irrigation evacuation (PIE), a device used for bowel management, experimental and investigational because its clinical value for persons with chronic constipation has not been established.
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) (Innovatec Medical Corporation, 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 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."
CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
99511
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-9 codes not covered for indications listed in the CPB:
564.00 - 564.09
Constipation
The above policy is based on the following references:
Puet TA, Jackson H, Amy S. Use of pulsed irrigation evacuation in the management of the neuropathic bowel. Spinal Cord. 1997;35:694-699.
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.
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.
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.
Kokoszka J, Nelson R, Falconio M, et al. Treatment of fecal impaction with pulsed irrigation enhanced evacuation. Dis Colon Rectum. 1994;37:161-164.
Gramlich T, Puet T. Long-term safety of pulsed irrigation evacuation (PIE) use with chronic bowel conditions. Dig Dis Sci. 1998;43:1831-1834.
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.
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.
Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003;349(14):1360-1368.
Talley NJ. Management of chronic constipation. Rev Gastroenterol Disord. 2004;4(1):18-24.
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.
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.
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.
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.
Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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