ModifiedUnitedHealthcarePolicy CS117NE.AC

Surgical and Ablative Procedures for Venous Insufficiency and Varicose Veins (for Nebraska Only)

Clinical coverage policy for surgical and ablative treatments of venous insufficiency and varicose veins applicable to Nebraska members and providers.

Policy Summary

PayerUnitedHealthcare

PolicySurgical and Ablative Procedures for Venous Insufficiency and Varicose Veins (for Nebraska Only)

Policy CodePolicy CS117NE.AC

Change TypeDocumentation language added; reference link removed; prior version archived

Effective DateDecember 1, 2025

Next Review DateN/A

Key ActionEnsure the patient's medical record includes legible history, physical exam, and duplex ultrasound results that support medical necessity and make these records available upon request.

SourceLink

POLICY UPDATE CHANGES

Added language to indicate the patient's medical record must contain documentation that fully supports the medical necessity for the requested services, including relevant history, exam, and diagnostic results

Removed reference link to the guidelines titled Medical Records Documentation Used for Reviews

Archived previous policy version CS117NE.AB

≥ 3 mmGSV/SSV diameter threshold

≥ 500 msReflux duration threshold

3.5 mmPerforator diameter

Nebraska

12/01/2025Policy effective

Coverage Criteria — Surgical and Ablative Procedures for Venous Insufficiency

Thermal and Non-Thermal Treatments - GSV/SSV/Accessory Veins

Covered when ALL of the following are met:

Primary coverage criteria: Individual has one of the listed Functional or Physical Impairments: skin ulceration; documented frank bleeding from a varicose vein due to erosion or trauma; documented superficial thrombophlebitis; venous stasis dermatitis causing functional or physical impairment; or moderate to severe pain causing functional or physical impairment.

Venous size

GSV: Great Saphenous Vein (GSV) diameter ≥ 3 mm when measured at the proximal thigh immediately below the saphenofemoral junction via duplex ultrasonography.≥ 3 mm
SSV or Accessory Vein: Small Saphenous Vein (SSV) or Accessory Vein diameter ≥ 3 mm when measured immediately below the appropriate junction via duplex ultrasonography.≥ 3 mm

Reflux measurement: Duplex ultrasound performed in standing or reverse Trendelenburg position demonstrates reflux duration ≥ 500 milliseconds for the GSV, SSV, or Accessory Veins (interpretations describing 'moderate to severe reflux' are acceptable).≥ 500 ms

Allowed procedures: Thermal (EVLA/RFA) or non-thermal (cyanoacrylate adhesive, endovenous foam sclerotherapy) ablation, stripping with ligation and excision, and concomitant tributary treatments are considered reconstructive and medically necessary when the above criteria are met.

Perforator Vein Ablation

Covered when ALL of the following are met:

Perforator ablation criteria: Recent duplex ultrasound in standing or reverse Trendelenburg demonstrates perforator venous insufficiency with perforator vein diameter ≥ 3.5 mm and outward reflux duration ≥ 500 milliseconds; the perforator lies beneath or adjacent to a healed or active venous stasis ulcer; and the condition is not secondary to acute deep vein thrombosis.diameter ≥ 3.5 mm; reflux ≥ 500 ms

Endovenous foam sclerotherapy or cyanoacrylate adhesive for isolated perforator treatment is considered unproven and not medically necessary in the absence of supportive evidence.

Ligation Procedures

Covered when ALL of the following are met:

Saphenofemoral ligation for thrombophlebitis: Ligation at the saphenofemoral junction as a stand-alone procedure is medically necessary when performed to prevent propagation of an active clot to the deep venous system in patients with ascending superficial thrombophlebitis who fail or are intolerant of anticoagulation therapy.

Other ligation procedures: Ligation of the GSV, SSV, or Accessory Veins as stand-alone procedures, and ligation at the saphenofemoral junction as an adjunct to endovenous ablation, are considered unproven and not medically necessary for treatment of venous reflux.

These are listed as unproven/not medically necessary in policy exclusions.

Coverage criteria informed by pivotal trials

Clinical trial–derived inclusion and outcome measures that inform coverage decisions:

Trial-style inclusion for CAC vs RFA: Duplex-confirmed GSV reflux ≥ 0.5 seconds; symptomatic CEAP class C2–C5; absence of common trial exclusions (e.g., SSV/AAGSV reflux, prior GSV treatment, symptomatic peripheral arterial disease, history of DVT/PE, aneurysm of target GSV > 12 mm, BMI > 35, active anticoagulation, sensitivity to cyanoacrylate).

Based on Alhewy et al. (2024) and VeClose trial enrollment criteria.

Primary outcome requirement for effectiveness assessment: Documented complete closure (occlusion) of the target vein on duplex ultrasound at 3 months (primary endpoint) with continued closure documented at longer-term timepoints (e.g., 12, 24, 36 months) for durability assessment.3 months primary; 24–36 months secondary

Coverage stance by modality

Coverage stance based on available evidence:

Cyanoacrylate adhesive (CAC/VenaSeal): Randomized trials and cohort studies report high short- and mid-term closure rates (≈95–99% at 3–12 months) with sustained closure in many followed patients up to 24–60 months; limitations include loss to follow-up and some single-arm reports. CAC is considered an effective nonthermal option relative to RFA in pivotal trials.

Endovenous foam sclerotherapy (PEM/Varithena): PEM demonstrates symptom and occlusion benefits versus placebo and mixed comparative results versus EVTA; network meta-analysis found no statistically significant difference for occlusion versus EVTA, but evidence quality and longer-term durability remain uncertain.

Treatment of perforator veins with CAC or foam: Evidence is limited and heterogeneous for isolated perforator treatment with CAC or foam; current data are insufficient to demonstrate superiority over established therapies and more robust RCTs are needed before broad endorsement.

Mechanochemical ablation (MOCA):

Coverage implications from evidence and guidelines

Evidence synthesis and guideline-summary based coverage implications:

Preferred first-line: Endovenous thermal ablation (EVTA: EVLA or RFA) is recommended as first-line treatment for GSV and SSV incompetence per multiple society guidelines.

Acceptable alternatives when EVTA unsuitable: Ultrasound-guided foam sclerotherapy (UGFS), cyanoacrylate adhesive closure (CAC), or mechanochemical ablation (MOCA) may be considered when EVTA is unsuitable or contraindicated, with counseling about differences in occlusion rates and durability.

Perforator vein treatment: Endovenous ablation or percutaneous approaches (EVTA or UGFS) are recommended for pathologic perforator veins associated with ulcers or symptomatic disease; isolated CAC/foam for perforators lacks robust evidence.

Guidelines and wound care recommendations support ablation of both superficial and perforator veins in selected C4–C6 patients.

Investigational devices:

Initial and procedural coverage criteria

Covered when ALL of the following are met (summary of guideline/AUC recommendations):

Primary coverage criteria: Symptomatic patients with varicose veins and documented axial reflux in the targeted truncal vein (GSV, SSV, AAGSV, PAGSV) on duplex ultrasound with reflux duration ≥ 500 ms; CEAP class documented (C2–C6) as applicable.reflux ≥ 500 ms

Appropriate treatments: Appropriate interventions include thermal ablation (EVLA/RFA), nonthermal ablation (CAC, MOCA), high ligation and stripping when endovenous treatment is unavailable or contraindicated, and ultrasound-guided foam sclerotherapy for tributaries; choice depends on anatomy, guideline recommendations, clinician expertise, and patient preference.

Adjunctive and perforator considerations: Concomitant phlebectomy or UGFS for varicosities is appropriate when indicated; treatment of pathologic perforator veins may be considered for C4–C6 or recurrent symptomatic cases when perforator reflux (≥ 500 ms) and diameter (≥ 3.5 mm) are documented and anatomy supports intervention.perforator reflux ≥ 500 ms; diameter ≥ 3.5 mm

The policy identifies specific procedures considered unproven and not medically necessary because available evidence does not demonstrate sufficient efficacy. Examples include ligation of the GSV, SSV, or accessory veins as stand‑alone procedures, and ligation at the saphenofemoral junction when used as an adjunct to radiofrequency or endovenous laser ablation. Endovenous mechanochemical ablation (MOCA) and porcine bioprosthetic valve implantation (e.g., VenoValve) are also listed as unproven. These determinations reflect insufficient peer‑reviewed evidence to support routine coverage for treatment of venous reflux.

Treatments for spider veins/telangiectasias are considered cosmetic and excluded from coverage. CPT code 36468 (sclerotherapy for spider veins/telangiectasia) is explicitly identified as cosmetic and not medically necessary. Additionally, endovenous ablation of reticular or telangiectatic veins is described as not reconstructive and therefore excluded. For non‑telangiectatic varicosities, sclerotherapy CPT codes (36470/36471) have limits described elsewhere in the policy.

The policy notes several exclusion criteria used in pivotal trials that may be reasonable clinical exclusions in authorization or coverage decisions. Examples include reflux of the SSV or AAGSV, prior treatment of the target GSV, history of DVT or PE, BMI > 35, active anticoagulation, GSV aneurysm > 12 mm, and sensitivity to cyanoacrylate adhesives. These trial‑based exclusions inform which patients were studied and help identify situations where evidence is limited.

The policy characterizes isolated indications with limited evidence as investigational. Specifically, perforator‑only treatment using cyanoacrylate adhesive (CAE/CAC) or endovenous foam sclerotherapy, and MOCA for venous insufficiency are described as having insufficient high‑quality evidence from randomized trials and long‑term follow‑up to support routine coverage. These isolated indications therefore lack definitive endorsement and may be considered investigational pending robust RCT data.

VenoValve is described as investigational. Published evidence is limited to very small early human series (reports of roughly 11 participants in early reports) and the device is not yet FDA‑approved; ongoing trials such as the SAVVE trial are noted. Because of limited sample size and follow‑up, routine coverage is not supported until FDA approval and more robust randomized controlled trial evidence are available.

FDA approval status is presented for informational context only and is not determinative of coverage. The policy explicitly states that FDA approval alone does not constitute a basis for coverage decisions. For example, vein ligation is a surgical procedure and not an FDA‑regulated device intervention; device approvals (e.g., ClariVein K071468, VenaSeal P140018) are noted for reference but do not by themselves establish medical necessity.

Endovenous foam sclerotherapy and cyanoacrylate‑based adhesive for treatment of incompetent perforator veins are described as having limited and heterogeneous evidence. The policy states that ablation of perforator veins using endovenous foam sclerotherapy or cyanoacrylate adhesive is unproven and not medically necessary for routine use due to insufficient high‑quality data and the need for additional robust randomized trials and longer‑term outcomes.

The policy explicitly excludes endovenous ablation of reticular or telangiectatic veins and other procedures intended solely for cosmetic improvement. Cosmetic sclerotherapy (including treatment for spider veins/telangiectasias) is excluded, and CPT code 36468 is identified as cosmetic and not medically necessary. These exclusions apply when procedures do not address a Functional, Physical, or physiological Impairment.

A Hayes Health Technology Assessment (2022) concluded that evidence for some cyanoacrylate embolization (CAE) devices, including VenaSeal, is of low quality and that benefits are potentially present but remain unproven beyond one year. The assessment highlighted limited comparative studies and short follow‑up as important evidence gaps.

Procedures directed at perforator veins and mechanochemical ablation (MOCA) are described as supported by limited evidence. The policy cites systematic reviews and primary studies indicating MOCA has less favorable anatomical occlusion and VCSS outcomes in some analyses compared with established modalities, and that perforator procedures have small, heterogeneous studies that do not establish clear superiority over standard approaches.

Because evidence is limited, the policy indicates that endovenous foam sclerotherapy for perforator veins and MOCA should not be considered equivalent first‑line alternatives to endovenous thermal ablation (EVTA) without supporting data. Submissions proposing these techniques as replacements for EVTA should include clinical justification and high‑quality evidence; absent such evidence, they may be considered not medically necessary or investigational.

Guideline recommendations caution against using truncal vein diameter alone to determine need for ablation in symptomatic CEAP C2 patients. The Society for Vascular Surgery and collaborating societies make a weak suggestion against basing ablation decisions solely on diameter, emphasizing clinical symptoms and duplex reflux assessment as primary determinants.

Procedure and device codes listed in the policy are provided for reference and to facilitate authorization and billing workflows; inclusion of a code does not imply coverage. Providers should verify benefit and prior authorization requirements for listed codes (for example, sclerotherapy codes 36465/36466/36470/36471, mechanochemical ablation codes 36473/36474, thermal ablation codes 36475–36479, cyanoacrylate codes 36482/36483, and ligation/stripping codes 37700–37785). Documentation requirements and clinical criteria in the policy determine medical necessity, not the mere presence of a code.

Coding — Procedure and Device Codes

Referenced Procedure CodesCPT

36465	Injection of non-compounded foam sclerosant with ultrasound compression maneuvers; single incompetent extremity truncal vein.
36466	Injection of non-compounded foam sclerosant with ultrasound compression maneuvers; multiple incompetent truncal veins, same leg.
36468	Injection(s) of sclerosant for spider veins (telangiectasia), limb or trunk.
36470	Injection of sclerosant; single incompetent vein (other than telangiectasia).
36471	Injection of sclerosant; multiple incompetent veins (other than telangiectasia), same leg.
36473	Endovenous ablation therapy, percutaneous, mechanochemical; first vein treated.
36474	Endovenous ablation therapy, mechanochemical; subsequent vein(s) treated in single extremity.
36475	Endovenous ablation therapy, percutaneous, radiofrequency; first vein treated.
36476	Endovenous ablation therapy of incompetent vein, percutaneous, radiofrequency; subsequent vein(s) in single extremity.
36478	Endovenous ablation therapy, percutaneous, laser; first vein treated.

1–10 of 22

1/3

Device FDA approvals referencedmixed

K071468	ClariVein infusion catheter FDA 510(k) approval reference
P140018	VenaSeal Closure System PMA reference

Duplex reflux and diameter thresholds — GSV/SSV/accessory and perforator veins

Truncal/Accessory diameter thresholdGSV, SSV, or accessory vein diameter ≥ 3 mm measured by duplex ultrasound (GSV measured proximal thigh immediately below the saphenofemoral junction; SSV/accessory measured immediately below the appropriate junction)

Reflux duration threshold (truncal/accessory)Duplex reflux duration ≥ 500 ms for GSV, SSV, or accessory veins

Perforator diameter thresholdPerforator vein diameter ≥ 3.5 mm on duplex ultrasound

Perforator reflux thresholdPerforator venous reflux duration ≥ 500 ms on duplex ultrasound

Sclerotherapy session limit

Provider Actions — Authorization, Documentation, and Denial Risk

Prior Authorization

Code reference and prior authorization implication

The code lists in this policy are provided for reference only. Inclusion of a code does not guarantee coverage, authorization, or payment. Prior authorization requirements may apply even when a code is listed; submission of a code is not a substitute for documentation of medical necessity.

Listing a code does not imply the service is covered or payable
Per AMA guidance, only one primary endovenous ablation code per extremity and one add-on per extremity for additional veins (see coding clarifications)
CPT codes 36470/36471: up to three sclerotherapy sessions per leg within a rolling 12-month period

Prior Authorization

Prior authorization and excluded services

Background and Evidence Summary

Varicose veins result from venous valve incompetence leading to reflux and venous pooling. Duplex ultrasound is the diagnostic gold standard to evaluate venous reflux and anatomy, and CEAP clinical classification (C0–C6) is used to describe severity. Diagnostic duplex parameters (reflux duration and vessel diameter) are essential to document when justifying procedural interventions.

Definitions and Terminology

Great Saphenous Vein (GSV) definition

AnatomyGreat Saphenous Vein (GSV) is a superficial vein that ascends along the medial leg and thigh and joins the common femoral vein at the saphenofemoral junction

Location detailOriginates from the medial side of the dorsal pedal venous arch and courses to the saphenofemoral junction

Clinical relevanceGSV is a primary truncal vein assessed by duplex ultrasound when evaluating axial reflux and eligibility for truncal ablation

Varicose Veins definition (CEAP C2)

Size criterionVaricose veins defined as dilated subcutaneous tributaries ≥ 3 mm in diameter

CEAP associationVaricose veins correspond to CEAP clinical class C2

Revision History

2025-12-01policy_revisionLatest

Added explicit medical record documentation requirement specifying that records must fully support medical necessity (history, exam, diagnostic results) and be legible, maintained, and made available upon request; removed the reference link to the 'Medical Records Documentation Used for Reviews' guideline and archived prior policy version CS117NE.AB.

Policy Summary

PayerUnitedHealthcare

PolicySurgical and Ablative Procedures for Venous Insufficiency and Varicose Veins (for Nebraska Only)

Policy CodePolicy CS117NE.AC

Change TypeDocumentation language added; reference link removed; prior version archived

Effective DateDecember 1, 2025

Next Review DateN/A

Key ActionEnsure the patient's medical record includes legible history, physical exam, and duplex ultrasound results that support medical necessity and make these records available upon request.

SourceLink

On This Page

MOCA has limited peer-reviewed evidence and some meta-analyses report lower occlusion rates compared with EVTA; MOCA is considered to have limited/insufficient evidence for routine first-line use.

Porcine bioprosthetic venous valve (VenoValve) remains investigational with very limited early human data and is not FDA-approved for routine coverage pending robust RCTs and regulatory approval.

Up to 3 sessions per leg within a rolling 12‑month period for CPT 36470/36471; a session is one date of service

Exceeding session limitMore than three sessions per leg within 12 months is considered cosmetic and excluded

Relevant CPT codesCPT 36470, 36471 (sclerotherapy of incompetent veins, non-telangiectasia)

Reflux duration threshold

Reflux duration definitionReflux (reversed flow) defined as duration ≥ 500 milliseconds (ms) on duplex ultrasound

Vein categories referencedThreshold applies to superficial truncal veins (GSV, SSV, accessory) and selected perforator veins as specified

Diagnostic positionDuplex performed in standing or reverse Trendelenburg position for reflux measurement

Perforator vein diameter threshold

Perforator diameterPathologic perforating vein defined as diameter ≥ 3.5 mm on duplex ultrasound

Associated reflux requirementPerforator must also demonstrate outward flow duration ≥ 500 ms to meet pathologic definition

Context for treatmentPerforator ablation coverage criteria require diameter ≥ 3.5 mm and reflux ≥ 500 ms and other clinical conditions (e.g., lies beneath healed or active venous ulcer)

Prior authorization is generally required for many endovascular and ablation procedures addressed in this policy. Certain services are explicitly excluded and will not be authorized (for example, cosmetic sclerotherapy and procedures to treat spider veins/telangiectasias). Verify benefit plan terms before requesting authorization.

Cosmetic sclerotherapy (e.g., treatment for spider veins/telangiectasias) is excluded
Endovenous ablation of reticular or telangiectatic veins is excluded
Prior authorization decisions are subject to applicable federal, state, and contractual requirements

Prior Authorization

Prior authorization: duplex-confirmed GSV reflux and follow-up schedule

Authorization requests for ablation of the great saphenous vein (GSV) should include duplex ultrasound confirmation of pathologic reflux (reversed flow > 500 ms). Trials and pivotal studies typically documented duplex-confirmed reflux and prespecified follow-up visits (e.g., day 3; 1, 3 months; then periodic longer-term assessments). Include documentation of follow-up duplex results when available.

Duplex ultrasound demonstrating reflux (>500 ms) is expected to support medical necessity (see imaging documentation)
Follow-up timepoints used in pivotal studies: day 3; 1 month; 3 months; then 6, 12, 24, 36 months where applicable
Document closure status on follow-up duplex when available

Prior Authorization

VenoValve — prior authorization expectations due to investigational status

The VenoValve porcine bioprosthetic valve is investigational with limited peer-reviewed evidence and is being evaluated in early trials. Prior authorization requests for VenoValve procedures should include trial identifiers, detailed supporting clinical evidence, and will be reviewed rigorously; coverage is unlikely outside of approved clinical study protocols.

VenoValve is not yet FDA-approved for general commercial use; evidence limited to small early studies
Include clinical trial identifiers (e.g., SAVVE trial NCT04943172) and all available follow-up data when requesting authorization
Expect denials or requests for supplemental evidence when proposed outside of an approved clinical trial

Prior Authorization

MOCA — prior authorization guidance given evidence limitations

Mechanochemical ablation (MOCA) has lower reported occlusion rates versus established EVTA modalities in pooled analyses. Prior authorization submissions for MOCA should include rationale for device selection and supporting evidence; expect requests for comparative justification to EVTA alternatives.

MOCA has been associated with lower GSV occlusion rates compared with EVLA, RFA, and CAC in meta-analyses
Provide documentation explaining why EVTA (e.g., RFA/EVLA) is not suitable if MOCA is requested
Anticipate additional documentation or prior authorization denial if comparative evidence is lacking

Documentation Required

Prior authorization: document AUC concordance

When Appropriate Use Criteria (AUC) apply, document concordance with the AUC scenario(s) in the authorization submission. Explicitly reference relevant AUC statements (e.g., ablation for axial GSV reflux in symptomatic patients, CEAP 2–6) and include clinical details that map to the rated scenario.

If claiming appropriateness per AUC, cite the specific AUC scenario number or description
Provide clinical details (CEAP class, symptoms, duplex findings) that align with the AUC rating

Note

Verify benefit plan requirements before authorization

Before requesting authorization, verify the member's benefit plan, including federal, state, or contractual variations that may override this policy. Benefit plan terms govern coverage decisions and may impose additional requirements.

Check the member’s contract for any mandated coverage or exclusions that differ from this policy
State or federal mandates may require coverage even if policy classifies a service as investigational or excluded

Denial Risk

Trial-based exclusion criteria (potential denial triggers)

Prior authorization may be denied if trial- or study-based exclusion criteria apply (these also serve as useful clinical denial triggers). Common exclusionary or denial-trigger conditions observed in trials include prior treatment of the target GSV, history of DVT or PE, BMI > 35, active hypercoagulable disorder, or large target vein aneurysm (e.g., > 12 mm).

Prior treatment of the target truncal vein (e.g., prior GSV ablation) may preclude coverage for the same target
History of DVT or PE, active hypercoagulable state, anticoagulation use, large aneurysm (>12 mm), or BMI > 35 were common exclusion criteria in pivotal studies and may prompt denial or require additional justification

Denial Risk

Evidence limitations may trigger denials

Evidence limitations for certain procedures (e.g., CAE for perforator veins, endovenous foam sclerotherapy for perforator veins, and some nonthermal techniques) may lead to denial or request for supplemental information. Where evidence is limited or low quality, include robust clinical rationale and relevant supporting data.

CAE for incompetent perforator veins: peer-reviewed evidence is limited and may not support coverage
Endovenous foam sclerotherapy (UGFS/PEM) for perforator veins: limited evidence and may be considered investigational
When evidence is limited, prior authorization reviewers may deny or request additional documentation such as long-term outcomes or comparative data

Prior Authorization

Endovenous foam sclerotherapy — limited evidence and prior authorization expectations

Endovenous foam sclerotherapy (including physician-compounded foam) has variable evidence versus EVTA. Proprietary PEM (Varithena) has RCT data but overall evidence for foam in perforator veins or as superior to EVTA is limited. Prior authorization for foam procedures should include specific evidence of indication and why EVTA is not appropriate.

PEM (Varithena) has RCT evidence but comparative effectiveness and long-term durability relative to EVTA remain uncertain
Physician-compounded foam (PCF) has lower closure rates versus PEM and EVTA in some analyses
For perforator vein treatment with foam, available data are limited and may be considered investigational

Documentation Required

Medical record requirements

The member's medical record must contain documentation that fully supports medical necessity. Documentation should be legible, maintained in the medical record, and made available upon request. Lack of adequate documentation may result in denial or delay.

Include relevant medical history, focused physical exam, and results of pertinent diagnostic tests (e.g., duplex ultrasound)
Medical records must be retrievable and presented upon request for review
Insufficient or missing documentation is a common reason for denial

Documentation Required

Required imaging and follow-up documentation

Required imaging and follow-up documentation should be submitted with the authorization request when available. Duplex ultrasound is the diagnostic test of choice and should document reflux severity, vein diameter, and anatomic location. Follow-up duplex documentation of closure status (when available) strengthens the case for medical necessity.

Preoperative duplex ultrasound showing reflux duration (>500 ms) and vein anatomy is expected
Document vein diameter and specific segments treated (GSV, SSV, accessory veins, perforators)
Submit follow-up duplex results (e.g., day 3, 1 month, 3 months, and later timepoints if available) to demonstrate closure or need for reintervention

Documentation Required

Recommended supporting clinical documentation

When available, include validated outcome measures used in studies to support benefit. Use of standardized severity and quality-of-life instruments in the medical record at baseline and follow-up bolsters the authorization review.

Provide baseline and follow-up VCSS or rVCSS scores when possible
Include AVVQ or VEINES-QOL/SD symptom scores and EQ-5D if collected
Document procedural pain scores, adverse events, and return-to-activity timelines when relevant

Documentation Required

Training and governance documentation

Follow standard clinical governance, consent, and training expectations for newer techniques (e.g., CAC, MOCA). Per professional guidance, clinicians performing these procedures should have appropriate training in venous ultrasound and participate in outcome audit and governance.

Ensure operators have documented training and experience in venous duplex ultrasound and the specific procedure
Maintain local audit, consent processes, and clinical governance records to support quality of care
Documentation of training and governance may be requested during authorization review

Documentation Required

Imaging documentation

Duplex ultrasound is the imaging modality of choice. Reflux is commonly defined as reversed flow duration > 500 ms on duplex interrogation; document the location (SFJ/SFJ competence, GSV, SSV, accessory veins) and reflux measurements.

Record reflux duration and vein diameters in the duplex report
Note whether SFJ/SFJ competence or prior interruptions are present
For perforator veins, document outward flow duration and diameter when relevant

Step Therapy

Step therapy / EVTA preferred and preferred treatment sequencing

Guideline and comparative-evidence context favors EVTA (e.g., EVLA, RFA) as first-line therapy in most patients. Prior authorization reviewers will expect justification if non-EVTA modalities are proposed first-line.

EVTA (EVLA/RFA) is recommended as first-choice treatment for symptomatic GSV/SSV incompetence when available
If proposing CAC, MOCA, foam, or surgery instead of EVTA, provide clinical rationale why EVTA is unsuitable for this patient (anatomic constraints, prior procedures, patient preference with documented informed consent)
Document prior conservative care and prior procedures as applicable

Clinical featuresAppearing as enlarged, twisted, bulging veins typically in the lower extremities and associated with venous reflux

CEAP classification — overview

RangeCEAP clinical classification ranges from C0 (no signs) to C6 (active venous ulcer)

PurposeUsed to describe clinical severity of chronic venous disorders and guide management

C component focusThe 'C' (clinical) component (C0–C6) is commonly used in practice to rate disease severity

CEAP classification (C component) — C0–C6

C0No visible or palpable signs of venous disease

C1Telangiectasis (spider veins) or reticular veins

C2Varicose veins (diameter > 3 mm)

C3Edema

C4a/C4bSkin changes: C4a = pigmentation/eczema; C4b = lipodermatosclerosis/atrophie blanche

C5/C6C5 = healed venous ulcer; C6 = active venous ulcer

Novel endovenous modalities — CAE, CAC, NBCA, MOCA, PEM

CAE/CAC/NBCA overviewEndovascular embolization techniques that use cyanoacrylate-based adhesive (commercial systems include VenaSeal and NBCA formulations) to seal incompetent truncal veins; typically non‑thermal and may not require tumescent anesthesia

MOCA overviewMechanochemical ablation (MOCA) combines mechanical endothelial injury (rotating wire) with direct sclerosant infusion to induce vein sclerosis without thermal energy or tumescent anesthesia

PEM/Varithena noteEndovenous foam sclerotherapy uses pharmaceutical-grade polidocanol microfoam to sclerose veins under ultrasound guidance

Complete closure / occlusion — duplex absence of flow definition and endpoint timing

DefinitionComplete closure/occlusion: absence of flow in the treated target vein on duplex ultrasound at specified follow-up timepoint

Common primary endpoint timingPrimary endpoint commonly assessed at 3 months post‑treatment in pivotal trials (e.g., VeClose)

Follow-up windowsDurability is assessed with continued duplex follow-up at intervals such as 12, 24, 36 months and beyond in published studies

CAE / CAC / NBCA / VenaSeal definitions

CAC / VenaSealEndovenous cyanoacrylate adhesive closure systems (e.g., VenaSeal) that deliver medical adhesive into the truncal vein to seal it; reported not to require tumescent anesthesia in some studies

NBCAn‑butyl‑2‑cyanoacrylate (NBCA) formulations used for endovascular embolization of truncal veins in some studies and series

CAE generalThese adhesive techniques are non‑thermal, non‑sclerosant closure methods used for symptomatic truncal vein incompetence

CAC / VenaSeal — adhesive closure system definition and tumescent anesthesia note

Adhesive closure systemCyanoacrylate adhesive closure systems (CAC/VenaSeal) deliver medical adhesive into the target truncal vein to achieve occlusion; trials report high short‑term closure rates

Tumescent anesthesia noteCAC/VenaSeal has been reported in trials to not require tumescent anesthesia, unlike thermal ablation techniques

Clinical useUsed as a non‑thermal alternative to EVTA for treatment of symptomatic GSV incompetence

PEM / Varithena definition

AgentPEM/Varithena = pharmaceutical‑grade polidocanol injectable microfoam (polidocanol 1% microfoam) used for ultrasound‑guided endovenous foam sclerotherapy

MechanismFoam sclerosant damages the endothelium leading to scarring and vein closure; intended for truncal and tributary varicose veins under ultrasound guidance

Regulatory/Study contextStudied in randomized controlled trials versus placebo and compared with EVTA in meta‑analyses; longer‑term comparative data remain limited

MOCA definition — mechanochemical ablation

MechanismMOCA uses a rotating wire to cause mechanical endothelial injury combined with infusion of a sclerosant to induce vein sclerosis without thermal energy or tumescent anesthesia

Device exampleClariVein‑style infusion catheter is a commonly described implementation of MOCA

Evidence noteEvidence for MOCA is limited; systematic reviews show lower GSV closure odds versus RFA/EVLA in some analyses

EVTA definition (EVLA, RFA)

DefinitionEndovenous thermal ablation (EVTA) includes endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) that use thermal energy to seal incompetent saphenous veins

RoleEVTA is recommended as first‑line treatment for GSV and SSV incompetence by multiple society guidelines

Comparison notesEVTA typically requires tumescent anesthesia and is widely studied with robust long‑term outcome data compared with some non‑thermal options

MOCA alternative definition entry (ClariVein‑style)

ClariVein‑style MOCADescribed as a flexible infusion catheter with a rotating wire tip that mechanically abrades the endothelium while delivering sclerosant to induce occlusion (ClariVein example)

Non‑thermalMOCA is performed without thermal energy and often without tumescent anesthesia

Evidence caveatNo large RCTs conclusively demonstrating parity with EVTA; pooled anatomical success reported but some analyses show inferior closure versus EVTA

VenoValve definition — investigational porcine bioprosthetic venous valve

Device descriptionVenoValve is a porcine bioprosthetic venous valve implanted in the femoral vein intended to act as a permanent functional valve to reduce venous hypertension in chronic venous insufficiency

Investigational statusEvidence limited to small first‑in‑human cohorts; device is not yet FDA‑approved and is under investigation (SAVVE trial)

Clinical contextStudied in severe chronic venous insufficiency (C4b‑C6) with limited sample sizes and early follow‑up reports

Reflux definition — reversed flow duration > 500 ms

Reflux definitionReflux defined as reversed flow duration ≥ 500 ms in superficial truncal veins and selected deep/perforator veins on duplex ultrasound

Clinical applicationUsed to determine pathologic venous insufficiency for truncal and perforator treatment eligibility

Measurement positionDuplex measurements obtained in standing or reverse Trendelenburg position per policy and guidelines

Pathologic perforating vein — diameter and reflux criteria

Pathologic perforating vein criteriaPerforator vein with diameter ≥ 3.5 mm and outward flow (reflux) duration ≥ 500 ms on duplex ultrasound

Treatment considerationPerforator ablation coverage requires these duplex findings plus clinical context (e.g., lies beneath a healed/active venous stasis ulcer)

Guideline citationSVS/AVF/AVLS/SIR Good Practice Statement recognizes these thresholds for pathologic perforators

Axial reflux — uninterrupted retrograde flow from groin to calf

Axial reflux definitionAxial reflux is uninterrupted retrograde venous flow from the groin to the calf (for GSV) or knee to ankle (for SSV)

Measurement requirementDocumented on duplex ultrasound and used to identify candidates for truncal ablation

Clinical implicationPresence of axial reflux in symptomatic patients (CEAP C2–C6) supports endovenous ablation per guideline recommendations