Currentsierra health and lifePolicy 2025T0247Z

Lithotripsy for Salivary Stones

Defines coverage stance and evidence summary for extracorporeal and endoscopic intracorporeal lithotripsy for salivary stones for UnitedHealthcare Commercial and Individual Exchange plans.

Policy Summary

Payersierra health and life

PolicyLithotripsy for Salivary Stones

Policy CodePolicy 2025T0247Z

Change TypeNo material change

Effective DateMay 1, 2025

Next Review Date

Key ActionConfirm prior authorization requirements with the member's benefit plan before submitting claims or scheduling the procedure.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2techniques discussed

67%-100%reported success range

97%gland preservation rate

1154largest case series

Coverage Determinations

inv-01: Not medically necessary — ESWL and intracorporeal laser

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Not medically necessary interventions: Extracorporeal shock wave lithotripsy (ESWL) and endoscopic intracorporeal laser lithotripsy are considered unproven and not medically necessary for treating salivary stones due to insufficient evidence of efficacy and/or safety.

Based on limited quality evidence (primarily single-arm studies) and lack of well-designed randomized controlled trials.

inv-02: Clinical evidence summary

Evidence from observational studies:

study_outcomes: One retrospective study reported complete fragmentation/extraction in most treated stones but was limited by lack of control group and small size; investigators reported all patients symptom free after pneumatic lithotripsy (Koch et al.). Another series reported complete success (stone and symptom free) in 47.15% (67/142), partial success in 34.5% (49/142), and failure in 18.3% (26/142); effectiveness varied by gland and depended mainly on stone size.

Available evidence is primarily single-arm and nonrandomized; studies lack long-term follow-up and adequate control groups.

Coding and Product Codes

Applicable CPT Codes (reference)CPT

42699

Unlisted procedure, salivary glands or ducts

FDA product codesmixed

FFK	FDA product code referenced for lithotripter devices (informational)
GEX	FDA product code referenced for laser powered devices (informational)

Study size threshold — stone size influences effectiveness (no exact numeric threshold reported)

Influence on effectivenessStone size is reported as the main determinant of lithotripsy effectiveness; larger stones are less likely to be eradicated.

Numeric thresholdNo exact numeric stone-size threshold is reported in the evidence or policy text.

Study limitationsAvailable study cited lacked a comparison group and long-term follow-up, limiting precision of size-based recommendations.

Reported outcomes linked to sizeComplete success and failure rates varied by gland and were described in the study, reflecting size-dependent effectiveness (example: overall complete success 47.15%).

Provider Requirements and Billing Guidance

Prior Authorization

Prior Authorization / Benefit Verification

Prior authorization may be required per the member-specific benefit plan. Confirm prior authorization and eligibility with the member's plan before scheduling or performing procedures.

Verify prior authorization status with the member's plan prior to service.
If prior authorization is required, obtain and document the approval number on the claim.

Denial Risk

Denial Triggers

Procedures listed below are considered unproven and not medically necessary for treating salivary stones due to insufficient evidence of efficacy and/or safety; claims for these procedures may be denied.

Denial trigger: Extracorporeal shock wave lithotripsy (ESWL) — may be denied as not medically necessary.
Denial trigger: Endoscopic intracorporeal laser lithotripsy — may be denied as not medically necessary.

Billing Rule

Coding and FDA Note

Report procedure and diagnosis codes exactly as submitted on claims. Inclusion of a code in this policy is informational and does not guarantee coverage or payment. FDA approvals are informational only and do not determine coverage.

Procedure code referenced in this policy: CPT 42699.
FDA device approvals are informational — coverage decisions rely on member plan and policy criteria.

Documentation Required

Member-Specific Plan Documentation

Coverage decisions must be based on the member-specific benefit plan document and any applicable federal or state mandates. In the event of a conflict between this policy and the member's benefit plan, the member plan governs.

Always check the member's benefit plan for coverage, limitations, and applicable mandates before rendering services.
Document verification of the member's plan provisions in the medical record and on the claim.

Note

Multimodal Treatment Sequencing (Clinical Context)

When lithotripsy or related modalities are considered in complex sialolithiasis, they are often used as part of a multimodal, minimally invasive, gland-preserving treatment approach (for example ESWL followed by intraductal or transoral techniques). Document prior treatments, rationale for sequencing, and why alternatives are not appropriate.

If a multimodal approach is used, document the sequence (e.g., ESWL before intraductal pneumatic lithotripsy), clinical indications for each step, and expected benefit.
Use clinical records to justify why standard, proven techniques are insufficient or not feasible for the member prior to using unproven modalities.

Clinical Background

Sialolithiasis is the formation of salivary stones (calculi) from crystallization of minerals in saliva that can obstruct salivary ducts and cause painful inflammation. It most commonly affects the submandibular gland, though the parotid gland may also be involved. Smaller stones may pass spontaneously; larger or symptomatic stones often require intervention.

Definitions

Extracorporeal shock wave lithotripsy (ESWL) definition

DefinitionExtracorporeal shock wave lithotripsy (ESWL) is a minimally invasive approach that uses high-energy shock waves generated outside the body to pulverize or crush salivary stones, facilitating their passage or removal.

GoalReduce size of sialoliths to enable spontaneous clearance with salivation or removal during endoscopic procedures.

Clinical contextUsed as a gland-preserving, minimally invasive technique for salivary stones, most commonly in submandibular and parotid glands.

Intracorporeal laser lithotripsy definition

DefinitionIntracorporeal laser lithotripsy is an endoscopic technique using a probe (laser, pneumatic, electro-hydraulic, or electrokinetic) inserted into the salivary duct to directly fragment stones at their surface.

MechanismProbe delivers energy (e.g., laser beams) directly to the stone under endoscopic guidance to produce fragmentation for subsequent removal or passage.

Device informationFDA has approved several lithotripter and laser-powered devices; product codes referenced for these devices include FFK and GEX (informational only).

lithotripter (FFK/GEX product codes)

FFKFDA product code referenced for lithotripter devices (informational).

GEXFDA product code referenced for laser-powered devices (informational).

Use noteFDA approvals are informational and do not alone establish coverage decisions.