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    v1.0.28
    OpenPayerPolicy UpdatesGastroenterologyAetna contact dissolution coverage update | OpenPa…
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    CurrentAetnaPolicy 0509

    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.

    Policy Summary
    PayerAetna
    PolicyContact Dissolution for Gallstones
    Policy CodePolicy 0509
    Change TypeNo material change
    Effective DateJun 12, 2001
    Last ReviewMay 27, 2027
    Next Review DateMay 27, 2027
    Key ActionDo not request coverage for contact dissolution; document rationale and alternatives since the procedure is considered experimental and will be denied.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    InvestigationalPolicy classification
    Not approvedAgents not FDA-approved
    2001Effective
    2026-08-06Last review

    Coverage Determination

    Not covered — investigational

    Aetna coverage stance

    Policy statement: Contact dissolution (direct solvent dissolution/litholysis) for treatment of gallstones is considered experimental, investigational, or unproven.

    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

    Policy Summary
    PayerAetna
    PolicyContact Dissolution for Gallstones
    Policy CodePolicy 0509
    Change TypeNo material change
    Effective DateJun 12, 2001
    Last ReviewMay 27, 2027
    Next Review DateMay 27, 2027
    Key ActionDo not request coverage for contact dissolution; document rationale and alternatives since the procedure is considered experimental and will be denied.
    SourceLink
    On This Page
    Coverage DeterminationCodingProvider Actions and ExpectationsBackgroundDefinitions

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    ICD-10 Codes mentionedICD-10
    K80.00 - K80.81Cholelithiasis

    Provider Actions and Expectations

    Prior Authorization

    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).
    Step Therapy

    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 Required

    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

    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

    Contact dissolution (direct solvent dissolution / litholysis) — definition and examples
    DefinitionIntroduction of an organic solvent (eg, ethyl propionate (EP), isopropyl acetate (IA), methyl tertiary butyl ether (MTBE)) into the gallbladder via a percutaneous transhepatic catheter to dissolve gallstones by infusion and drainage of solvent and removal of stone fragments.
    Procedure routePercutaneous transhepatic catheter placed under fluoroscopic or ultrasonographic guidance; catheter connected to a peristaltic pump to deliver small amounts of solvent continuously.
    Examples of solvents usedEthyl propionate (EP); isopropyl acetate (IA); methyl tertiary butyl ether (MTBE).
    Typical duration and clearanceStones can usually be cleared in hours to days with continuous, slow solvent instillation and drainage.
    Key safety considerationLimit contact time between instillation and drainage to avoid discharge of the solvent into the bile duct or duodenum, which may cause transient abdominal pain and duodenitis.