Contact Dissolution for Gallstones
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Defines Aetna's coverage stance on percutaneous contact dissolution (direct solvent dissolution) of gallstones and describes the rationale and background; applies to providers treating members with cholelithiasis.
No material clinical or coverage changes in this revision.
Coverage Determination
Not covered — investigational
Aetna coverage stance
Agents cited: ethyl propionate (EP), isopropyl acetate (IA), methyl tert-butyl ether (MTBE); none approved by FDA for this indication; safety and effectiveness have not been established.
Aetna does not cover contact dissolution (also called direct solvent dissolution or litholysis) for treatment of gallstones. This procedure is classified as experimental, investigational, or unproven because the agents used—ethyl propionate (EP), isopropyl acetate (IA), and methyl tertiary butyl ether (MTBE) are not approved by the U.S. Food and Drug Administration for this indication and the safety and effectiveness have not been established.
The rationale for noncoverage is that safety and effectiveness have not been established for contact dissolution of gallstones and none of the solvents cited for this use (EP, IA, MTBE) is FDA‑approved for gallstone dissolution. Published commentary and reviews describe limited acceptance of this approach and note substantial risks and insufficient evidence to support routine use.
Coding
| K80.00 - K80.81 | Cholelithiasis |
Provider Actions and Expectations
Coding and prior authorization note — no specific CPT/HCPCS codes; ICD-10 for cholelithiasis listed
There are no specific CPT or HCPCS procedure codes assigned for contact dissolution (direct solvent dissolution/litholysis) of gallstones. The policy lists ICD-10 diagnosis codes for cholelithiasis (K80.00 - K80.81) but inclusion of those ICD-10 codes does not indicate coverage for the procedure.
- No specific CPT/HCPCS codes for contact dissolution are defined in the policy.
- ICD-10 codes listed: K80.00 - K80.81 (Cholelithiasis).
Established alternatives — ursodiol and standard surgical management
Use established, covered alternatives when appropriate: noninvasive oral bile acid dissolution with ursodiol (Actigall) for selected patients and standard surgical management via open or laparoscopic cholecystectomy remain the mainstay treatments.
- Oral ursodiol (Actigall) therapy may be appropriate for selected patients.
- Open or laparoscopic cholecystectomy is the primary treatment for symptomatic gallstones.
Documentation expectations — rationale required when proposing alternatives
Document clinical rationale when proposing alternatives to standard care because contact dissolution is considered investigational; include patient-specific risk factors (for example, high surgical risk or contraindications to anesthesia) and prior therapies tried.
- Record why standard surgical management is not appropriate or feasible (e.g., patient too ill for surgery).
- Document prior therapies and clinical factors supporting consideration of alternative management.
Denial risk — contact dissolution considered experimental/investigational
Requests for contact dissolution of gallstones will be denied as experimental, investigational, or unproven because the agents used (EP, IA, MTBE) are not FDA‑approved for this indication and safety and effectiveness have not been established.
- Policy classifies contact dissolution (direct solvent dissolution/litholysis) as investigational.
- Agents cited: ethyl propionate (EP), isopropyl acetate (IA), methyl tertiary butyl ether (MTBE); none approved by the FDA for gallstone treatment.
Background
Background: Gallstone disease historically has been addressed primarily with surgical removal of the gallbladder (open or laparoscopic cholecystectomy). Noninvasive oral dissolution with agents such as ursodiol may be appropriate for selected patients. Contact dissolution refers to percutaneous transhepatic catheter instillation of organic solvents (for example, EP, IA, MTBE) into the gallbladder to dissolve stones; however, this technique carries a significant risk of complications related to the percutaneous puncture and solvent exposure (for example, hemolytic anemia, erosive or hemorrhagic duodenitis, aspiration pneumonia, somnolence). Although there is some preliminary evidence of efficacy for cholesterol stones, contact dissolution is considered investigational and has largely been abandoned with the advent of laparoscopic cholecystectomy.
Definitions
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