Corporate

October 4, 2013 - Revised: 02.09.15

Solesta™ Treatment for Fecal Incontinence

CGS considers Solesta™ as medically appropriate for the FDA-approved indication of fecal incontinence when all of the following criteria are met:

  • Patient is 18 years or older;
  • Has a documented history of fecal incontinence for at least 12 months;
  • Documentation supports the patient has tried and failed conservative therapy (e.g., diet, fiber, anti-motility medications);
  • Documentation supports ≥ 4 fecal incontinence episodes over a 14-day period; and 
  • The beneficiary does NOT have any of the following conditions:
    • Active inflammatory bowel disease;
    • Immunodeficiency disorders or ongoing immunosuppressive therapy;
    • Previous radiation treatment to the pelvic area;
    • Significant mucosal or full thickness rectal prolapse;
    • Active anorectal conditions including: abscess, fissures, sepsis, bleeding, proctitis, or other infections;
    • Anorectal atresia, tumors, stenosis or malformation;
    • Rectocele;
    • Rectal varices;
    • Presence of existing implant (other than Solesta) in anorectal region;
    • Allergy to hyaluronic acid based products (e.g., Synvisc, Synvisc-One, Hyalgan, Supartz, Euflexxa, Orthovisc);
    • Grade IV hemorrhoids; and
    • History of anorectal surgery within the previous 12 months.

Other uses of Solesta™ will be considered investigational and will be denied accordingly.

Frequency

If coverage criteria are met, CGS will allow the services based on the FDA-recommended dose of 4 sub-mucosal injections for an initial treatment and 4 sub mucosal injections  for repeat therapy no less than 4 weeks after the initial treatment. Treatment exceeding the FDA recommendations will be denied.

Claim Submission

  • Submit charges for the drug Solesta™ (dextromer/hyaluronic acid copolymer implant) with HCPCS code L8605 (Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml, includes shipping and necessary supplied).
  • For dates of service prior to 1/1/2015, submit charges for the sub-mucosal injection using CPT code 46999 (unlisted procedure, anus).  For dates of service on or after 1/1/2015, submit CPT code 0377T (Anoscopy with directed submucosal injection of bulking agent for fecal incontinence, using products such as NASHA/Dx (Solesta®)).  As with all other anoscopy services, this code is reported only once per session.

Orders and Signatures

Please note that all services ordered or rendered to Medicare beneficiaries must be signed. While orders for diagnostic tests do not have to be signed, either the order must have a signature or the intent to order the specific test must be clearly documented in the medical record, and that must be signed. One or the other must be signed.

Guidelines regarding signature requirements are located in the CMS Medicare Program Integrity Manual (Pub. 100-08), chapter 3, section 3.3.2.4External PDF, “Signature RequirementsExternal PDF.”  Information is also available in CMS MLN Matters article MM6698External PDF, “Signature Requirements for Medical Review Purposes.”


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