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POINT AND CLICK LICENSE FOR USE OF "CURRENT DENTAL TERMINOLOGY", ("CDT")

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July 27, 2016 – Revised 07.15.21 – Reviewed 11.17.21

Solesta™ Treatment for Fecal Incontinence

CGS considers Solesta™ as medically appropriate for the FDA-approved indication of fecal incontinence when all 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)

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).
Submit charges for the sub-mucosal injection with CPT code 46999 (unlisted procedure, anus).

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 must be signed. One or the other must be signed.

References:

Solesta Package Insert
Guidelines regarding signature requirements
- CMS Medicare Program Integrity Manual (Pub. 100-08), chapter 3, section 3.3.2.4
- "Signature Requirements"
- "Signature Requirements for Medical Review Purposes"
  - CMS MLN Matters article MM6698