CurrentBlue Cross Blue Shield - IowaPolicy N/A

Miscellaneous Treatments for Varicose Veins/Venous Insufficiency

This policy governs coverage and evidence assessment for several nonstandard or emerging treatments for varicose veins/venous insufficiency (e.g., cryoablation, mechanochemical ablation, coil embolization, KAVS) and guidance on ultrasound use for sclerotherapy; it applies to Wellmark/Blue Cross Blue Shield members and providers using Wellmark authorization procedures.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyMiscellaneous Treatments for Varicose Veins/Venous Insufficiency

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateAug 1, 2014

Next Review DateN/A

Key ActionObtain prior approval when indicated and document duplex-confirmed saphenous vein insufficiency, prior conservative therapy, and a follow-up imaging plan.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5+treatment modalities

4 RCTsMOCA RCTs

InvestigationalInvestigational status

RequiredPrior approval

Yes

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Procedure codes listed

Coverage Criteria and Evidence Summary

Not Medically Necessary and Investigational — Policy Statements

Guideline-based coverage recommendations and policy statements regarding procedures for symptomatic varicose veins/venous insufficiency.

The following treatments are considered investigational because the evidence is insufficient to determine they improve net health outcomes: Coil embolization; Cryoablation (cryostripping); Endomechanical ablative approaches using rotating catheter (e.g., ClariVein) including mechanochemical endovenous ablation (MOCA), mechanic-chemical endovenous ablation (MCEA), mechanically enhanced endovenous chemical ablation (MEECA); Endovenous catheter-directed chemical ablation with balloon isolation (e.g., KAVS procedure); VenoValve. ALL Category III codes will be considered investigational unless the code is explicitly addressed as a covered service in a Wellmark BlueCross BlueShield Medical Coverage Policy.

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Therapy-specific Evidence Summaries

Therapy-specific evidence summaries relevant to coverage determinations:

Cryoablation: Two randomized controlled trials suggest cryoablation is inferior or ineffective compared with available alternatives (conventional stripping or endovenous laser ablation). Reported outcomes included higher residual vein rates and worse disease-specific scores for cryoablation.

Mechanochemical Ablation (MOCA/ClariVein): Multiple RCTs (four identified) and cohort studies show mixed results. MOCA may reduce intraprocedural pain compared with thermal ablation but has demonstrated lower anatomic (occlusion) success rates at 6 months to 2 years in several trials. Long-term durability is uncertain; cohort data with follow-up up to 8 years suggest possibility of later clinical recurrence. Comparative evidence is limited and of low-to-moderate quality; longer-term RCT follow-up is needed.

KAVS (Catheter-assisted Vein Sclerotherapy): Evidence is limited to case series and no comparative studies versus conservative care; available data are insufficient to establish safety and efficacy and the procedure is not widely accepted in practice.

Coverage Considerations from Society Guidelines

Coverage considerations based on clinical guideline recommendations (Society for Vascular Surgery, American Vein and Lymphatic Society, and American Venous Forum):

Phlebectomy or sclerotherapy are recommended to treat varicose tributaries.

Selective treatment of perforating vein incompetence in patients with simple varicose veins is not recommended; treatment of pathologic perforating veins (outward flow ≥500 ms and diameter ≥3.5 mm) located under healed or active ulcers (CEAP class C5–C6) is recommended.

For reflux in accessory great saphenous veins, either thermal or nonthermal ablation is suggested (weak recommendation, low-quality evidence). Recommend against concomitant initial ablation and treatment of incompetent perforating veins for reflux in the great or small saphenous vein.

Persistent or recurrent symptoms after previous complete ablation: treatment of perforating vein incompetence is suggested.

Coverage Criteria — Operational Rules and Exclusions

Operational coverage rules and exclusions:

Ultrasound or radiological guidance solely to guide the needle or introduce sclerosant into varicose veins is excluded as not medically necessary.

Procedure and Billing Codes

Category III / Temporary CodesmixedExperimental

Category III (T) codes

Temporary codes for emerging technologies; to be used when available instead of an unlisted or deleted Category I code; generally considered experimental unless explicitly covered.

Covered CPT Codes (mechanochemical and venous embolization)CPTCovered

36473	Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring percutaneous, mechanochemical; first vein treated (Mechanochemical Ablation [MCA; MOCA] (ClariVein System).
36474	Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring percutaneous, mechanochemical; subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure) (Mechanochemical Ablation [MCA; MOCA] (ClariVein System).
37241	Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural road mapping, and imaging guidance necessary to complete the intervention; venous, other than hemorrhage (e.g., congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles) (may be utilized for coil embolization).

Unlisted / miscellaneous procedure and guidance codesmixed

0524T	Unlisted procedure, vascular surgery (may be utilized for Transilluminated Powered Phlebectomy [TIPP, TriVex]; or cryostripping).
0744T	Unlisted procedure, vascular surgery (may be utilized for Transilluminated Powered Phlebectomy [TIPP, TriVex]; or cryostripping).
76942	Ultrasonic guidance for needle placement, imaging supervision and interpretation.
77002	Fluoroscopic guidance for needle placement (List separately in addition to code for primary procedure).

Unlisted vascular procedure mappingsmixed

37799	Unlisted procedure, vascular surgery (may be utilized for Trannsilluminated Powered Phlebectomy [TIPP, TriVex] or cryostripping).
0524T	Mapped from 37799 in this document context
0744T	Mapped from 37799 in this document context
76942	Ultrasonic guidance for needle placement (imaging supervision and interpretation) — mapped from 37799 context
77002	Fluoroscopic guidance for needle placement — mapped from 37799 context

Unlisted CPTCPT

37799

Unlisted procedure, vascular surgery (may be utilized for Trannsilluminated Powered Phlebectomy [TIPP, TriVex] or cryostripping [cryoablation, cryofreezing and transilluminated cryosurgery]).

inv-19: Use of Category III codes

Policy requirementIf a Category III (temporary 'T') code exists for a service, providers must use the Category III code instead of an unlisted or deleted Category I code.

RationaleCategory III codes enable data collection for emerging technologies and indicate services that may be experimental or not widely performed.

Coverage presumptionUnless a Category III code is explicitly addressed as covered by specific policy criteria, it is generally considered experimental/investigational.

Implication for billingDo not submit unlisted or deleted Category I codes when a relevant Category III code is available; use the designated T-code for reporting.

inv-20: Place of Service — Outpatient/Inpatient

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Prior Authorization and Denial Risk

Prior approval is required for certain varicose vein treatment modalities. Refer to the Wellmark Authorization Table to determine which modalities require prior approval and to the InterQual® clinical criteria for medical necessity. Procedures lacking sufficient comparative or long-term evidence (for example, some mechanochemical ablation [MOCA] and KAVS uses) may be denied if documentation does not justify medical necessity.

Prior approval requirement: check payer authorization table and InterQual® criteria.
Evidence insufficiency may trigger denial: limited long-term durability or comparative data for MOCA/KAVS could lead to denial without strong supporting documentation.

Prior Authorization

Prior Authorization Recommended for Device-Based Nonthermal Procedures

Procedures utilizing devices cleared via FDA 510(k) (eg, ClariVein, KAVS catheter) may still require prior authorization. Provide comparative evidence and longer-term follow-up when available to support medical necessity.

510(k) regulatory status does not obviate need for clinical justification.

Clinical Background

Venous reflux of the lower extremity can arise from superficial (great and small saphenous), deep, or perforator veins and may produce varicosities, itching, heaviness, pain, thrombophlebitis, leg ulceration, or hemorrhage. Treatment options range from conservative measures (compression therapy) to surgical ligation and stripping, endovenous thermal ablation, sclerotherapy, cryotherapy, and newer mechanical or catheter-directed chemical techniques. Clinical classification commonly uses the CEAP system to describe severity from class 0 (no visible sign) to class 6 (active ulceration).

Definitions and Procedural Descriptions

inv-42: CEAP classification

DefinitionCEAP (Clinical Etiology Anatomy Pathophysiology) classifies chronic venous disease by clinical, etiologic, anatomic, and pathologic characteristics from class 0 (no visible sign) to class 6 (active ulceration).

Clinical useCEAP class is used to describe disease severity (e.g., C5 = healed venous ulcer, C6 = active venous ulcer) and guide management decisions.

Anatomic contextCEAP complements anatomic descriptions of superficial, deep, and perforator venous systems when documenting reflux and interventions.

inv-43: Mechanochemical ablation (MOCA)

Procedure descriptionMechanochemical ablation (MOCA) combines mechanical lumen abrasion by a rotating intraluminal wire and infusion of a liquid sclerosant (e.g., sodium tetradecyl sulfate) to occlude the vein.

Mechanism

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyMiscellaneous Treatments for Varicose Veins/Venous Insufficiency

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateAug 1, 2014

Next Review DateN/A

Key ActionObtain prior approval when indicated and document duplex-confirmed saphenous vein insufficiency, prior conservative therapy, and a follow-up imaging plan.

SourceLink

On This Page

Place of service optionsOutpatient or Inpatient (procedures such as transilluminated powered phlebectomy or cryostripping may be performed in either setting).

Type of serviceSurgery (procedures reported with unlisted vascular surgery codes such as 37799 are categorized as surgical services).

Billing implicationWhen billing unlisted vascular procedure codes (e.g., 37799), indicate the appropriate place of service (Outpatient/Inpatient) per coding guidance.

MOCA (ClariVein) and KAVS lack robust long-term comparative evidence; prior authorization may be recommended.

Billing Rule

Procedure Coding and Category III Requirement

Mechanochemical ablation (MOCA) should be reported with the specific CPT codes for mechanochemical ablation; use Category III codes when applicable and avoid unlisted Category I codes if a Category III (T) code exists.

Report MOCA using CPT 36473 for the first treated vein and 36474 for subsequent veins.
If a Category III (T) code exists for a service, that code must be used instead of an unlisted or deleted Category I code.

Billing Rule

Unlisted Vascular Procedure Coding (37799)

When no specific CPT/HCPCS code applies, providers may bill using unlisted vascular procedure code 37799. Map 37799 to the appropriate temporary or guidance code in documentation and submit full operative and device-specific details for review.

37799 may be used for procedures such as TIPP/TriVex, cryostripping, or KAVS when no specific code exists.
When billing 37799, include crosswalk to applicable temporary codes (eg, 0524T, 0744T, 76942, 77002 where relevant) and thorough operative report and device details to support reimbursement.

Step Therapy

Conservative Therapy and Step-Therapy Preference

Conservative therapy (eg, compression therapy) is recommended as initial management for venous ulceration and symptomatic varicose veins in many cases; ablation is recommended to reduce ulcer recurrence and is preferred over long-term compression for axial reflux of the great or small saphenous veins.

Compression therapy is primary for venous ulcer healing; combine ablation with compression to decrease recurrence.
For reflux in great/small saphenous veins, superficial venous intervention (eg, endovenous ablation) is preferred over long-term compression stockings.

Documentation Required

Documentation to Support Medical Necessity

Providers should document clinical indications, prior conservative treatments, duplex ultrasound confirmation of reflux, and follow-up/anatomic outcome data to support medical necessity, especially for procedures with limited evidence.

Suggested documentation: clinical indication (eg, saphenous vein reflux, CEAP class), prior conservative therapy and responses, duplex ultrasound findings, and post-procedure follow-up documenting anatomic success and any reinterventions.
Insufficient documentation of indication, conservative therapy trial, or lack of comparative/long-term outcome data may lead to denial for investigational procedures.

Note

No Explicit Automatic Authorization/Denial Trigger

There is no explicit automatic authorization or denial trigger stated for many of the investigational or device-based procedures; decisions will be based on the submitted documentation, evidence of clinical benefit, and applicable prior authorization rules.

No automatic approval or denial: each case evaluated individually against payer authorization requirements and medical necessity criteria.
Provide complete operative notes, device identifiers, and follow-up outcome data when requesting authorization for newer or unproven procedures.

A motorized catheter rotates a wire (about 3500 rpm) to abrade the lumen while concurrent sclerosant infusion enhances vein closure without requiring tumescent anesthesia.

Proposed benefitsMay reduce intraprocedural pain and risk of nerve injury compared with thermal ablation; evidence on long-term anatomic durability is limited and mixed.

inv-44: Coil embolization

Procedure descriptionCoil embolization involves catheter placement into a calf or leg vein and insertion of a small coil to occlude the vein, often with adjunct injection of alcohol or foamed sclerosant.

Evidence summaryPublished literature is scant with small series reporting limited technical and clinical success and high recanalization rates.

Use considerationNot widely accepted for lower extremity varicose veins absent stronger comparative evidence; may be considered investigational.

inv-45: KAVS procedure

Procedure descriptionKAVS is catheter-assisted vein sclerotherapy using a catheter with a distal balloon to temporarily block blood flow in a target vein segment prior to injection of sclerosant.

Regulatory noteThe KAVS catheter received FDA 510(k) clearance (2005), but clinical comparative evidence is limited (no RCTs identified).

Evidence implicationLack of comparative studies means KAVS is not widely accepted; additional justification and documentation recommended if used.

inv-46: Cryoablation (cryostripping)

TechniqueCryoablation (cryostripping) applies extreme cold via a probe (temperatures down to about -80°C) to adhere tissue to the probe and mediate vein removal or ablation.

Procedure deliveryProbe is inserted through a small incision or applied externally to the vessel wall to produce cryoapplication effects resulting in tissue adherence for stripping or ablation.

Evidence summaryRandomized trials have suggested cryoablation may be inferior to conventional stripping or endovenous laser ablation for varicose veins.

inv-47: Mechanochemical endovenous ablation (MOCA)

DefinitionMechanochemical endovenous ablation (MOCA) is a nonthermal technique using a rotating intraluminal wire plus infusion of liquid sclerosant (e.g., sodium tetradecyl sulfate) via a catheter (e.g., ClariVein) to abrade and chemically occlude the vein.

Key featuresPerformed under ultrasound guidance; typically does not require tumescent anesthesia; combines mechanical and chemical mechanisms for vein closure.

Evidence noteRCTs show mixed results with lower anatomic occlusion rates versus thermal ablation; durability beyond 2 years remains uncertain.

inv-48: KAVS catheter procedure

Procedure descriptionKAVS catheter procedure is catheter-directed chemical ablation with balloon isolation: a distal balloon temporarily blocks flow to the targeted vein segment to permit injection of sclerosant.

Regulatory statusKAVS catheter cleared by FDA 510(k) in 2005 for temporary inhibition of blood flow in isolated peripheral vein sections to permit medication injection.

Evidence limitationNo comparative studies were identified; efficacy and safety relative to standard care remain inadequately evaluated.

inv-49: Cryoablation (cryostripping)

TechniqueCryoablation (cryostripping) uses cryosurgical devices/units capable of cryofreezing to ablate veins and facilitate stripping (cryostripping).

Device clearanceModified cryosurgical units (e.g., Erbe Erbokryo) have FDA 510(k) clearance listing cryostripping among indications.

Coding noteCryostripping and similar cryosurgery procedures may be billed using unlisted vascular procedure codes with specified mappings in coding guidance.

inv-50: MOCA

Short definitionMOCA (mechanochemical ablation) — combines mechanical abrasion of the lumen with liquid sclerosant infusion to occlude target superficial veins.

Representative deviceClariVein infusion catheter is an example of a mechanochemical ablation device cleared by FDA (2008).

Clinical evidenceIncludes multiple RCTs and cohort studies; mixed results on anatomic occlusion and limited long-term durability data.

inv-51: KAVS

Short definitionKAVS (catheter-assisted vein sclerotherapy) — a catheter with a distal balloon to isolate a vein segment for sclerotherapy allowing localized sclerosant injection.

Evidence statusSingle case series reported early closure rates but no comparative trials; overall evidence insufficient for broad acceptance.

Regulatory noteKAVS catheter received FDA 510(k) clearance in 2005 but lack of comparative evidence limits clinical uptake.

inv-52: Superficial truncal veins

Included veinsSuperficial truncal veins: great saphenous vein, small saphenous vein, anterior accessory great saphenous vein, and posterior accessory great saphenous vein.

Clinical relevanceThese truncal veins are the typical targets for interventions addressing superficial venous reflux and varicose disease.

Guideline contextJoint SVS/AVLS/AVF guidance on duplex scanning and truncal reflux focuses on these defined superficial truncal veins.

inv-53: CEAP

AcronymCEAP = Clinical Etiology Anatomy Pathophysiology (classification for chronic venous disease).

PurposeProvides standardized descriptors for clinical presentation, etiology, anatomic location, and pathophysiology to guide management and reporting.

Severity rangeRanges from class 0 (no visible sign) to class 6 (active ulceration), used in study inclusion criteria and clinical documentation.

inv-54: Transilluminated Powered Phlebectomy

ProcedureTransilluminated Powered Phlebectomy (TIPP, TriVex) — removal of varicose veins using transillumination and powered phlebectomy devices.

Coding noteMay be billed using unlisted vascular procedure codes (e.g., 37799) with mappings to temporary codes (e.g., 0524T, 0744T) in the document guidance.

Place/type of serviceDocument place of service (Outpatient/Inpatient) and type (Surgery) when submitting claims for TIPP or similar procedures.

inv-55: Cryostripping / Cryosurgery

TechniqueCryostripping/cryosurgery involves cryoablation or cryofreezing techniques used to strip or ablate incompetent veins using cryosurgical devices.

Device clearanceFDA-cleared cryosurgical units (e.g., modified Erbe Erbokryo) list cryostripping among indications for use.

Coding guidanceThese procedures may be reported with unlisted vascular surgery codes and mapped to temporary or guidance codes per the policy coding table.