CurrentAetnaPolicy 0509

Contact Dissolution for Gallstones

Defines Aetna's coverage stance for contact (direct solvent) dissolution of gallstones and the clinical context for its use; applies to providers submitting claims for this procedure under Aetna plans.

Policy Summary

PayerAetna

PolicyContact Dissolution for Gallstones

Policy CodePolicy 0509

Change TypeNo material changes

Effective DateJun 12, 2001

Next Review DateMay 23, 2024

Key ActionDo not authorize contact dissolution using EP, IA, or MTBE because it is considered experimental and investigational.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

ExperimentalCoverage stance

3Agents listed

Up to 92%Reported dissolution

High riskSafety concerns

2001Original year

Coverage Determination

Not covered — investigational

Aetna coverage determination:

Contact dissolution (direct solvent dissolution, litholysis) for gallstones is considered experimental and investigational.

None of the solvents (ethyl propionate, isopropyl acetate, methyl tertiary butyl ether) are FDA‑approved for this indication and safety and effectiveness have not been established.

Use of ethyl propionate (EP), isopropyl acetate (IA), or methyl tertiary butyl ether (MTBE) for contact (direct solvent) dissolution of gallstones is excluded because these agents are not approved by the U.S. Food and Drug Administration for this indication and the safety and effectiveness have not been established.

Contact dissolution (direct solvent dissolution or litholysis) for gallstones is considered investigational and not medically necessary because the solvents used (EP, IA, MTBE) lack FDA approval for this indication and evidence of safety and effectiveness is insufficient. In addition, MTBE is no longer available because of concerns regarding toxicity.

Relevant Codes

ICD-10 Codes referencedICD-10

K80.00 - K80.81

Cholelithiasis

Policy Summary

PayerAetna

PolicyContact Dissolution for Gallstones

Policy CodePolicy 0509

Change TypeNo material changes

Effective DateJun 12, 2001

Next Review DateMay 23, 2024

Key ActionDo not authorize contact dissolution using EP, IA, or MTBE because it is considered experimental and investigational.

SourceLink

On This Page

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Provider Requirements and Implications

Denial Risk

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

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

Step Therapy

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)

Documentation Required

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

Background and Context

Gallstones (cholelithiasis) are common. Standard management for symptomatic gallstone disease is surgical removal of the gallbladder, typically by laparoscopic cholecystectomy. For selected patients who are not surgical candidates, noninvasive oral bile acid therapy with ursodiol has been used as an alternative. Contact dissolution refers to percutaneous transhepatic instillation of an organic solvent (for example, EP, IA, or MTBE) into the gallbladder via catheter to dissolve cholesterol stones; although some reports showed high complete dissolution rates in selected patients, the procedure is technically complex, associated with significant complication risk and high recurrence, and has been largely abandoned with the availability of laparoscopic cholecystectomy.

Definitions and Terminology

Contact dissolution (direct solvent dissolution, litholysis) — percutaneous instillation definition

DefinitionPercutaneous instillation of an organic solvent into the gallbladder via a transhepatic catheter (inserted under fluoroscopic or ultrasonographic guidance) to dissolve gallstones; solvent is delivered continuously by pump with concurrent drainage to remove fragments.

Typical techniqueCatheter placed through small needle puncture into gallbladder, connected to a computerized peristaltic pump that delivers small amounts of solvent continuously to dissolve stones over hours to days.

Key procedural cautionLimit contact time between instillation and drainage to avoid discharge of solvent into the bile duct or duodenum, which can cause transient abdominal pain and duodenitis.

Common complicationsRisks include procedure-related puncture complications and solvent-related toxicities if drainage into duodenum occurs (hemolytic anemia, erosive/hemorrhagic duodenitis, aspiration pneumonia, somnolence).

Common solvents referenced (EP, IA, MTBE) and regulatory status

Agents referencedEthyl propionate (EP), isopropyl acetate (IA), methyl tertiary butyl ether (MTBE).

Regulatory statusNone of these agents (EP, IA, MTBE) is approved by the U.S. Food and Drug Administration for treatment of gallstones.

Availability noteMTBE is no longer available due to concerns regarding toxicity.

Clinical contextThese solvents were used historically for high‑risk patients unable to undergo surgery but the technique is now considered investigational and largely abandoned due to complexity, side effects, and recurrence risk.