Print

Date Printed: June 23, 2017: 11:45 AM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-A9000-03

Original Effective Date: 02/15/12

Reviewed: 01/22/15

Revised: 11/01/15

Subject: Injectable Bulking Agents for the Treatment of Fecal Incontinence (e.g., hyaluronic acid and dextranomer)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement

Billing/Coding

Reimbursement

Program Exceptions

Definitions

Related Guidelines

Other

References

Updates

   

Previous Version

DESCRIPTION:

Various injectable bulking agents have been used for the treatment of fecal incontinence. Solesta is one biocompatible tissue bulking agent, developed as an injectable treatment for fecal incontinence. It consists of a viscous combination of stabilized hyaluronic acid (hyaluronan) and dextranomer-linked beads. It is an injectable gel that can be administered in an outpatient setting under local anesthesia. Solesta is injected into the submucosal layer (submucosa) of the anal canal. The exact mechanism of action has not been identified, however it is believed that the Solesta injections may narrow the anal canal, allowing for better sphincter control.

POSITION STATEMENT:

The injection of biocompatible tissue bulking agents (e.g., Solesta) for the treatment of fecal incontinence is considered experimental or investigational. There is insufficient clinical evidence to support the safety and efficacy of these treatments. The available peer-reviewed clinical literature does not support long term effects of this therapy on health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

0377T

Anoscopy with directed submucosal injection of bulking agent for fecal incontinence (investigational)

HCPCS Coding:

L8605

Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml, includes shipping and necessary supplies (investigational)

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

All diagnoses for the injection of biocompatible tissue bulking agents (e.g., Solesta) for the treatment of fecal incontinence are considered experimental or investigational.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Hyaluronan: hyaluronic acid, or hyaluronate, a naturally occurring macromolecule that is a major component of synovial fluid, thought to contribute to its elastoviscosity.

Submucosa: a layer of tissue beneath a mucous membrane; the layer of connective tissue.

RELATED GUIDELINES:

None applicable.

OTHER:

Other terms for injectable bulking agents:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of
one product over another, and is not intended to represent a complete listing of all products available.

Coaptite

Contigen

Dextranomer hyaluronic acid

Durasphere

NASHA Dx

Solesta

REFERENCES:

  1. American College of Gastroenterology. Diagnosis and Management of Fecal Incontinence (Am J Gastroenterol 1999;99:1585-1604. Received February 27, 2004; accepted March 5, 2004.) Accessed 11/05/14.
  2. American Society of Colon and Rectal Surgeons. Practice Parameters for the Treatment of Fecal Incontinence (Dis Colon Rectum 2007; 50: 1497–1507). Accessed 11/05/14.
  3. ClinicalTrials.gov:

a. NCT01110681- Study to Evaluate Solesta for Treatment of Fecal Incontinence Condition: Fecal Incontinence.

b. NCT00971269 - Pilot Study of NASHA/Dx Gel for Fecal Incontinence Condition: Fecal Incontinence.

c. NCT00303030 - A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence Condition: Fecal Incontinence.

d. NCT01380132 - Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence Condition: Fecal Incontinence.

e. NCT00605826 - ClinicalTrials.gov – A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence. Accessed 12/31/12.

f. NCT01647906 - Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI) Accessed 12/10/13.

  1. ECRI Product Brief. Solesta Injectable Gel (Salix Pharmaceuticals, Inc.) for Treating Fecal Incontinence (12/2012).
  2. Giuseppe Dodi, Johannes Jongen, Fernando de la Portilla, Manoj Raval, Donato F. Altomare, and Paul-Antoine Lehur. An Open-Label, Noncomparative, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx Gel as a Bulking Agent for the Treatment of Fecal Incontinence. Gastroenterology Research and Practice; Volume 2010, Article ID 467136.
  3. Graf W, Mellgren A, Matzel KE, et al; NASHA Dx Study Group. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: A randomised, sham-controlled trial. Lancet. 2011;377(9770):997-1003.
  4. Mayo Clinical Health Information - Fecal incontinence treatments (website). Accessed 11/06/12.National Association for Continence. Fecal Incontinence. Charleston, SC: NAFC (website); March 7, 2012. Accessed 11/09/12.
  5. Mellgren, J. Pollack, K. Matzel, T. Hull, M. Bernstein, W. Graf. Long-term Efficacy of NASHA/DX Injection Therapy (Solesta) for Treatment of Fecal Incontinence. Diseases of the Colon & Rectum Volume 55: 5 (2012).
  6. National Guideline Clearinghouse. Practice parameters for the treatment of fecal incontinence (10/2007).
  7. National Institute for Health and Clinical Excellence (NICE). Injectable bulking agents for faecal incontinence. Interventional Procedure Guidance 210. London, UK: NICE; 2007.
  8. Norton C. Treating faecal incontinence with bulking-agent injections. Lancet. 2011;377(9770):971-972.
  9. Rao SC. Practice Guidelines; Diagnosis and Management of Fecal Incontinence. American Journal of Gastroenterology 2004.
  10. Ratto C, Parello A, Donisi L, Litta F, De Simone V, Spazzafumo L, Giordano P. Novel bulking agent for faecal incontinence. Br J Surg. 2011 Nov;98(11):1644-52.
  11. Solesta prescribing information (package insert).
  12. Tjandra JJ, Dykes SL, Kumar RR, Ellis CN, Gregorcyk SG, Hyman NH, Buie WD, Standards Practice Task Force of The American Society of Colon and Rectal Surgeons. Practice parameters for the treatment of fecal incontinence. Dis Colon Rectum 2007 Oct; 50(10):1497-507.
  13. U.S. Food and Drug Administration premarket approval for Solesta (P100014) 05/27/11.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 01/22/15.

GUIDELINE UPDATE INFORMATION:

02/15/12

New Medical Coverage Guideline.

01/01/13

Annual HCPCS coding update: added L8605.

02/15/13

Scheduled review; position statement unchanged, references updated.

02/15/14

Annual review; position statement unchanged; Program Exceptions section updated; references updated.

01/01/15

Annual coding update; added 0377T.

02/15/15

Annual review; position statement unchanged, references updated.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: June 23, 2017: 11:45 AM