BlueCross BlueShield of Tennessee Medical Policy Manual

Radiofrequency Energy Transanal Treatment of Fecal Incontinence

DESCRIPTION

Fecal incontinence is the involuntary leakage of stool from the rectum and anal canal. It is estimated that the disorder affects some 8% of the adult population. Medical management includes dietary measures, such as the addition of bulk producing agents to the diet and elimination of foods associated with diarrhea. Antidiarrheal drugs can be used for mild degrees of incontinence. Bowel management programs, commonly used in individuals with spinal cord injuries, may be effective in treating fecal incontinence.

Radiofrequency energy is being investigated as a treatment of fecal incontinence. This outpatient procedure utilizes conscious sedation and a local anesthetic. Radiofrequency energy is delivered to the sphincteric complex by an anoscopic device. The device (e.g., the Secca® System) has multiple needle electrodes that create thermal lesions deep into the mucosa of the anal canal. Over several months these lesions heal and the tissue contracts which is proposed to improve continence. Clinical trials to date have shown only a moderate effect that declines over time.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION  

Published data is inadequate to permit conclusions regarding the utilization of radiofrequency energy transanal treatment of fecal incontinence.  Therefore this technology remains investigational.

SOURCES 

Abbas, M. A., Tam, M. S., & Chun, L. J. (2012). Radiofrequency treatment for fecal incontinence: Is it effective long-term? Diseases of the Colon and Rectum, 55 (5), 605-610. (Level 4 evidence)

American Society of Colon and Rectal Surgeons. (ASCRS) (2015). Practice parameters for the treatment of fecal incontinence. Retrieved June 7, 2016 from http://www.fascrs.org.

BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2016). Transanal radiofrequency treatment of fecal incontinence (2.01.58). Retrieved March 24, 2017 from BlueWeb. (15 articles and/or guidelines reviewed)

Center for Medicare and Medicaid Services. CMS.gov. LCD fornoncovered services (L33777).  Retrieved March 24, 2017 from https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33777.

Felt-Bersma, R. (2014, February) Temperature-controlled radiofrequency energy in patients with anal incontinence: an interim analysis of worldwide data. Gastroenterology Report 2 (2014) 121-125. (Level 5 evidence - Independent review)

National Institute for Health and Clinical Excellence. (2011). Endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence. Retrieved July 30, 2013 from http://www.nice.org.uk.

Rosenblatt, P. (2015). New developments in therapies for fecal incontinence. Current Opinion in Obstetrics and Gynecology, 27 (5), 3453-358. Abstract retrieved March 24, 2017 from PubMed database.

U. S. Food and Drug Administration. (2002, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K014216. Retrieved July 30, 2013 from http://www.accessdata.fda.gov.

ORIGINAL EFFECTIVE DATE:  1/1/2005

MOST RECENT REVIEW DATE:  5/11/2017

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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