Experimental/Ininvestigational — Denial Risk

Contact dissolution (direct solvent dissolution/litholysis) for gallstones is considered experimental and investigational by Aetna; claims for this therapy are at high risk of denial.

• Agents: ethyl propionate, isopropyl acetate, methyl tertiary butyl ether
• Reason: No FDA-approved agent for this indication; safety and effectiveness not established

Prior Authorization and Documentation

Prior authorization is required when requesting contact dissolution therapies. Provide complete clinical justification and documentation to support medical necessity; absence of adequate documentation may lead to denial.

• Include proposed agent, route of administration, and planned monitoring
• Document high surgical risk or contraindication to standard surgical treatment if applicable

Therapy Alternatives / Step Therapy Context

Conservative and established alternatives must be considered and documented before pursuing contact dissolution. Actigall (ursodiol) therapy and standard surgical approaches (laparoscopic or open cholecystectomy) are the accepted treatments for symptomatic gallstones.

• Document trials of or contraindications to: Ursodiol (oral bile acid therapy)
• Document why laparoscopic or open cholecystectomy are not appropriate (e.g., prohibitive operative risk, patient refusal, comorbidities)

Preferred Documentation Elements

When reporting attempts at alternative therapies or prior treatments, include method, agent, duration, response, and any complications to support the request for nonstandard therapy.

• Preferred documentation elements: method (e.g., percutaneous catheter instillation), agent used, duration of therapy, clinical response, and any complications (e.g., duodenitis, hemolytic anemia, aspiration)
• Imaging and procedure reports (fluoroscopic/ultrasonographic guidance) and notes on attempts at drainage or stone clearance should be included