Currentsierra health and lifePolicy 2026T0447RR

Surgical and Ablative Procedures for Venous Insufficiency and Varicose Veins

Medical necessity and coding guidance for surgical and endovenous (thermal and non-thermal) treatments of venous insufficiency and varicose veins for UnitedHealthcare Commercial and Individual Exchange plans.

Policy Summary

Payersierra health and life

PolicySurgical and Ablative Procedures for Venous Insufficiency and Varicose Veins

Policy CodePolicy 2026T0447RR

Change TypeMinor / no material change

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain and document duplex ultrasound confirming reflux duration and vein diameter alongside clinical impairment to support medical necessity for ablation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=3 mmmin vein diameter (GSV/SSV/accessory)

>=500 msmin duplex reflux duration

3.5 mmperforator diameter threshold

up to 3sclerotherapy sessions/leg/yr

36468excluded cosmetic code

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~95%VenaSeal reported 24–36 mo closure

Coverage Criteria — Indications, Limits, and Exclusions

Primary treatment coverage criteria

Thermal and non-thermal treatments of GSV, SSV, and accessory veins are considered reconstructive and medically necessary when ALL of the following are met:

Clinical impairment: Individual must have one of: skin ulceration; documented frank bleeding of the varicose vein due to skin erosion or trauma; documented superficial thrombophlebitis; documented venous stasis dermatitis causing functional or physical impairment; or moderate to severe pain causing functional or physical impairment.

Vein size: GSV must be >= 3 mm when measured at the proximal thigh immediately below the saphenofemoral junction by duplex ultrasonography; SSV or accessory veins must be >= 3 mm immediately below the appropriate junction.

Duplex reflux: Duplex ultrasound (standing or reverse Trendelenburg) demonstrates reflux duration >= 500 milliseconds for the GSV, SSV, or accessory veins.

Perforator vein ablation criteria

Ablation of incompetent perforator veins using radiofrequency or endovenous laser ablation is considered reconstructive and medically necessary when ALL of the following are met:

Duplex evidence: Recent duplex ultrasound performed in standing or reverse Trendelenburg position documents perforator venous insufficiency.

Perforator size: Perforator vein diameter is >= 3.5 mm on duplex ultrasonography.

Perforator reflux duration: Perforating vein reflux duration is >= 500 milliseconds on duplex ultrasonography.

Ulcer relation: The perforating vein lies beneath a healed or active venous stasis ulcer.

Not DVT-related: Perforator insufficiency is not secondary to acute deep vein thrombosis.

Ligation and other procedures

Specific ligation and other procedures stance:

Proven ligation indication: Ligation at the saphenofemoral junction as a stand‑alone procedure is medically necessary to prevent propagation of an active clot to the deep venous system in individuals with ascending superficial thrombophlebitis who fail or are intolerant of anticoagulation therapy.

Unproven ligation: Ligation of the GSV, SSV, or accessory veins as stand‑alone procedures, and ligation at the saphenofemoral junction as an adjunct to RFA or endovenous laser ablation of the main saphenous veins, are unproven and not medically necessary for treating venous reflux due to insufficient evidence of efficacy.

Other unproven procedures: Endovenous mechanochemical ablation (MOCA) and porcine bioprosthetic valve implantation (e.g., VenoValve) are unproven and not medically necessary for venous reflux treatment.

Exclusions / Not covered

Excluded procedures and general coverage framing

Exclusion criteria: Procedures that correct an anatomic congenital anomaly without improving or restoring physiologic function are cosmetic and excluded; treatments for spider veins and telangiectasias are excluded; cosmetic sclerotherapy is excluded. Endovenous ablation (radiofrequency and/or laser) of reticular or telangiectatic veins is not reconstructive and not medically necessary and therefore excluded.

From Coverage Limitations and Sclerotherapy sections.

Clinical evidence basis and trial-derived inclusion/exclusion

Summary of evidence and typical inclusion criteria used in referenced trials

Trial-style inclusion examples: Many randomized trials enrolled symptomatic GSV incompetence with duplex‑confirmed reflux (typically >= 0.5 seconds) and CEAP C2–C5; common exclusion criteria in trials included prior GSV treatment, symptomatic SSV or accessory GSV reflux, BMI > 35, active anticoagulation or hypercoagulable state, history of DVT/PE, and CEAP C6 in some studies.clinical trial eligibility

These are trial enrollment criteria cited in multiple studies and may inform clinical appropriateness assessments.

Outcome measures used to establish efficacy: Primary anatomic endpoint in trials is typically complete closure of the target vein at three months by duplex ultrasound; secondary measures include VCSS, AVVQ, EQ‑5D, pain scores, procedural complications and longer‑term closure up to 24–60 months.timepoints: primary at 3 months; follow‑up up to 60 months

Examples: VeClose, Alhewy, and other RCTs and extensions.

CAC / VenaSeal - Supported coverage criteria

Covered when ALL of the following are met (evidence-supported scenarios):

CAC (VenaSeal) - evidence-supported indications: 1) Symptomatic truncal vein incompetence (e.g., GSV) demonstrated by duplex ultrasound; 2) Candidate for endovenous therapy; 3) Provider documents baseline symptom/QOL measures (e.g., VCSS, AVVQ, EQ‑5D) and a planned duplex follow‑up schedule (eg, 3, 12, 24 months). Rationale: multicenter RCTs (VeClose) and meta‑analyses report similar closure rates and sustained QOL improvements through mid‑ to long‑term follow‑up.

Limitations in some studies include loss to follow‑up and lack of blinding.

PEM / Varithena - Supported coverage criteria

Covered when ALL of the following are met:

PEM (Varithena) - evidence-supported indications: 1) Symptomatic, visible varicose veins associated with truncal reflux confirmed by duplex ultrasound; 2) Baseline patient‑reported symptom measures documented (e.g., VVSymQ, VCSS, VEINES‑QOL); 3) Treatment planned within studied dosing limits (for single administration ≤ 15 mL as in VANISH/VANISH‑2) with follow‑up for symptom and safety assessment. Rationale: randomized trials demonstrate symptom and appearance benefit versus placebo; comparative data vs thermal ablation are limited but systematic reviews show similar short‑term occlusion rates.

Document adverse event monitoring and follow‑up per trial schedules.

CAE for perforator veins — insufficient evidence / Not supported

Not supported / considered investigational when ANY of the following apply:

CAE for isolated incompetent perforator veins: Use of endovascular cyanoacrylate embolization specifically for isolated incompetent perforator veins lacks robust randomized controlled trial evidence and long‑term outcomes; current peer‑reviewed literature is limited to small, retrospective or mixed‑method studies and does not establish safety and durability—coverage is not supported outside of research protocols or compelling new data.

Prasad et al. and systematic reviews note limited quality evidence and need for RCTs.

Preferred treatments and situational exceptions

Guideline-based preferences and conditions to consider

EVTA preferred: Endovenous thermal ablation (EVLA/RFA) is recommended as first‑choice treatment for GSV and SSV incompetence when available and appropriate.

ESVS guideline recommendation (De Maeseneer et al., 2022).

When non-thermal options may be considered: Non‑thermal options (UGFS/PEM, cyanoacrylate adhesive closure, or MOCA) may be considered for saphenous trunks <6 mm, for tortuous or recurrent varices where cannulation is challenging, or when a non‑thermal technique is preferred by patient/anatomic considerations; documentation of rationale and clinical governance is expected.saphenous trunk diameter < 6 mm (UGFS consideration)

ESVS and NICE guidance; NICE requires clinical governance, training, consent and audit for CAC and MOCA.

MOCA performance considerations

Comparative effectiveness considerations affecting coverage

MOCA vs EVTA findings: Systematic reviews and meta‑analyses report lower anatomical occlusion and mid‑term GSV closure rates for MOCA compared with thermal EVTA in several analyses; heterogeneity and limited long‑term data are noted as limitations.

Bontinis et al., Lim et al., Witte et al. summarize comparative performance concerns.

VenoValve (investigational) criteria

Investigational/early device considerations

VenoValve investigational: VenoValve porcine bioprosthetic venous valve implantation has very limited human evidence (first‑in‑human series ≈ 11 subjects) with short‑term follow‑up; device is not FDA‑approved and is considered investigational pending results of larger, controlled trials.

Hayes emerging technology report and small case series report limited data and ongoing SAVVE trial.

Covered with clinical criteria

Coverage considerations aligned with society guidelines (summarized):

Ablation for symptomatic truncal reflux: Ablation of refluxing superficial truncal veins (GSV, SSV, accessory saphenous veins) is recommended for symptomatic patients (CEAP C2–C6) with duplex‑proven reflux (reflux threshold > 500 ms); choice of thermal versus non‑thermal modality depends on expertise, anatomy, and patient preference.duplex reflux > 500 ms

Supported by SVS/AVF/AVLS/SIR AUC and guideline statements.

UGFS vs EVTA: Ultrasound‑guided foam sclerotherapy (UGFS) may be considered for saphenous trunks <6 mm or when endovenous ablation is unsuitable; EVTA is generally preferred when durable occlusion is a priority.saphenous trunk diameter < 6 mm (UGFS consideration)

ESVS, NICE, and SVS guidance; preference based on long‑term outcomes.

Cyanoacrylate and MOCA: Cyanoacrylate adhesive closure and MOCA may be considered as non‑thermal alternatives; cyanoacrylate glue is supported by NICE conditional guidance provided clinical governance, provider training, consent, and audit arrangements are in place.

The evidence base does not support ultrasound-guided foam sclerotherapy (UGFS) or cyanoacrylate adhesive (CAE) as proven primary treatments when targeted to perforator veins alone. The policy notes that ablation of incompetent perforator veins using endovenous foam sclerotherapy and/or cyanoacrylate-based adhesive is considered unproven and not medically necessary due to insufficient evidence of efficacy, and that published studies are limited, often small, and lack robust randomized long-term outcomes to establish safety and effectiveness for isolated perforator treatment.

Treatments directed solely at cosmetic concerns—such as spider veins or telangiectasias—are framed as non-reconstructive. The policy explicitly classifies sclerotherapy for spider veins/telangiectasias (CPT 36468) as cosmetic and excluded, and excludes procedures that do not restore physiologic function. Providers should therefore consider these interventions as cosmetic when submitted for coverage.

Randomized trials and comparative studies cited in the evidence typically applied exclusion criteria that are informative for interpreting applicability. Common trial exclusions included patients with CEAP class 6 (active, non-healed ulcers), prior GSV treatment of the target vein, symptomatic SSV or accessory reflux, BMI > 35, and current anticoagulation or active hypercoagulable treatment. These trial-derived exclusions reflect populations that were not studied and may affect the generalizability of results.

Clinical trials often limited or prohibited adjunctive and concomitant procedures within the study protocol, and many reported the need for tributary or adjunctive treatments at predefined follow-up visits. For example, WAVES and other CAC studies disallowed concomitant procedures during the index treatment and recorded adjunctive treatments at three months. The absence of comparative data for combined or unrestricted adjunctive approaches means payers should evaluate claims that include multiple concurrent procedures against the trial protocols that established device-specific outcomes.

The evidence does not support treating UGFS or MOCA as universally equivalent to thermal EVTA for all patients. Meta-analyses and systematic reviews report lower mid-term anatomic occlusion and GSV closure rates for MOCA compared with EVTA, and UGFS/foam techniques have shown lower long-term occlusion in some comparative studies. For isolated perforator treatment, the policy highlights limited and inconsistent data for UGFS and advises that isolated perforator-only UGFS or nonthermal approaches lack robust evidence compared with established ablation methods.

NICE guidance supports cyanoacrylate glue occlusion only when appropriate clinical governance, consent, audit, and operator training are in place and suggests offering UGFS only if endovenous ablation is unsuitable. The policy notes NICE does not provide an exhaustive list of explicit procedural exclusions here, but emphasizes the need for documented governance and operator competence when using CAE or MOCA.

This Medical Policy is intended to assist interpretation of standard plan benefits but does not replace the member-specific benefit plan document. Coverage for any procedure is ultimately governed by the member's plan terms and any applicable federal or state mandates; in cases of conflict the member-specific document controls.

The policy lists several procedures as unproven or not medically necessary for treating venous reflux, including stand-alone ligation of the GSV, SSV, or accessory veins and ligation used as an adjunct to endovenous ablation. It also identifies MOCA (endovenous mechanochemical ablation), porcine bioprosthetic valve implantation (e.g., VenoValve), and certain uses of sclerotherapy beyond approved indications as unproven. Additionally, cosmetic sclerotherapy (CPT 36468) and endovenous ablation of reticular/telangiectatic veins are excluded from coverage.

Endovenous ablation of reticular or telangiectatic veins is explicitly characterized as not reconstructive and not medically necessary. Such procedures—and treatments aimed primarily at reticular or telangiectatic veins—are excluded from coverage because they do not restore physiologic function.

A Hayes Health Technology Assessment concluded that the body of evidence for some cyanoacrylate endovenous (CAE) systems is of low quality with uncertainty about longer-term effectiveness. The assessment judged VenaSeal to have potential for high closure rates at one year but noted substantial uncertainty due to limited comparative studies and follow-up beyond one year.

Use of cyanoacrylate adhesive as the primary treatment for isolated incompetent perforator veins is considered not medically necessary in this policy because peer-reviewed evidence is limited, largely nonrandomized, and insufficient to establish long-term safety and efficacy for this specific indication.

MOCA may be less appropriate in settings where durable anatomic occlusion is the priority: multiple meta-analyses and RCT pooled analyses report lower occlusion/anatomic success rates for MOCA compared with thermal EVTA (RFA/EVLA) at mid-term follow-up. Where evidence favors greater durability with EVTA, MOCA should not be considered equivalent for routine first-line management.

Several specialty society guidelines and consensus statements favor endovenous thermal ablation (EVLA/RFA) over physician-compounded UGFS when long-term occlusion and durability are prioritized. ESVS and SVS/AVF guidance suggest UGFS may be appropriate for small-diameter trunks (< 6 mm) or when anatomy or patient preference makes EVTA unsuitable, but they recommend EVTA or surgery over physician-compounded UGFS for patients placing a high priority on long-term outcomes.

Coding — Applicable Codes, Clarifications, and Thresholds

Applicable CPT CodesCPT

0744T	Insertion of bioprosthetic valve, open, femoral vein, including duplex ultrasound imaging guidance, when performed.
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 mechanochemical ablation; first vein treated.
36474	Endovenous mechanochemical ablation; subsequent vein(s) treated in a single extremity.
36475	Endovenous ablation therapy, percutaneous, radiofrequency; first vein treated.
36476	Endovenous ablation therapy, percutaneous, radiofrequency; subsequent vein(s) treated in a single extremity.

1–10 of 20

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Coding clarifications (EVTA - RFA first vein)CPT

36476

Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; first vein treated

Coding clarifications (EVTA - RFA subsequent veins)CPT

36477

Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure).

Coding clarifications (EVTA - laser and adhesive)CPT

36478	Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, laser; first vein treated
36479	Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, laser; subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure).
36482	Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (e.g., cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring, percutaneous; first vein treated.
36483	Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (e.g., cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring, percutaneous; subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure).

Coding clarifications (surgical ligation/stripping)CPT

37700	Ligation and division of long saphenous vein at saphenofemoral junction, or distal interruptions.
37718	Ligation, division, and stripping, short saphenous vein.
37722	Ligation, division, and stripping, long (greater) saphenous veins from saphenofemoral junction to knee or below.
37735	Ligation and division and complete stripping of long or short saphenous veins with radical excision of ulcer and skin graft and/or interruption of communicating veins of lower leg, with excision of deep fascia.
37780	Ligation and division of short saphenous vein at saphenopopliteal junction (separate procedure).
37785	Ligation, division, and/or excision of varicose vein cluster(s), 1 leg

Procedure and device references (no codes specified)mixed

not listed

No explicit CPT/HCPCS/ICD-10 codes appear in these chunks; clinical trials and reviews are described without billing code lists.

Covered/Referenced procedures (no explicit codes listed in these chunks)mixed

No codes listed

FDA device approvals / referencesmixed

K071468	FDA document number for ClariVein infusion catheter (informational)
P140018	FDA PMA number for VenaSeal Closure System (informational)

Sclerosing agents (FDA references)mixed

NDC/Drug labels referenced

Asclera (polidocanol) NDA documents and Varithena labeling referenced (informational)

inv-35: Duplex reflux duration — Reflux thresholds used for eligibility

Duplex reflux duration for superficial trunks>= 500 ms (GSV, SSV, accessory veins)

Perforator vein reflux threshold>= 500 ms (perforator veins)

Deep vein reflux threshold (definition)1.0 sec (deep veins) as noted in definitions

inv-36: Vein diameter thresholds — GSV/SSV/accessory >= 3 mm; perforator >= 3.5 mm

Truncal vein minimum diameter (GSV/SSV/accessory)

Provider Actions — Authorization, Documentation, and Billing Guidance

Prior Authorization

Code-based authorization note — verify member coverage

Procedures in the Applicable Codes section may require verification of member-specific coverage; pre-service review is recommended to confirm benefits and any prior authorization requirements.

Verify member-specific benefits before scheduling.
Pre-service review recommended when codes in Applicable Codes are billed.

Documentation Required

Coding and medical necessity verification

Ensure documentation supports the coded procedure and medical necessity. Confirm that coding matches the documented clinical criteria (eg, CEAP class, duplex ultrasound measurements, reflux duration) and the actual procedure performed.

Confirm duplex ultrasound report with reflux ≥500 ms and vein diameter thresholds (GSV/SSV/accessory ≥3 mm; perforator ≥3.5 mm).
Match CPT/HCPCS codes to the specific procedure performed and the number of veins treated per extremity (see AMA guidance for add-on code limits).

Background and Scope

Endovenous approaches and surgical options for superficial venous insufficiency include thermal endovenous ablation (radiofrequency ablation and endovenous laser ablation), surgical ligation and stripping, sclerotherapy (liquid or foam), and cyanoacrylate adhesive closure. These techniques are used to close or remove incompetent truncal and tributary veins and are chosen based on anatomy, clinical severity, patient factors, and available evidence; some nonthermal options (CAE, PEM, MOCA) are considered alternatives in specific situations but have differing levels of comparative evidence supporting durability and safety.

Definitions and Key Terms

inv-73: Axial reflux — definition and anatomy references

Axial reflux definitionUninterrupted retrograde venous flow along the vein segment (GSV: groin to upper calf; SSV: knee to ankle; accessory veins: between measurements >=5 cm apart)

Clinical significanceAxial reflux identifies continuous truncal incompetence guiding truncal ablation decisions

Assessment methodDefined and assessed by duplex ultrasonography in standing or reverse Trendelenburg position

inv-74: Duplex Ultrasonography — definition and recommended positioning

Duplex ultrasonography definitionNoninvasive imaging combining B-mode and Doppler to assess venous anatomy and reflux

Recommended patient positioningPerform studies in standing or reverse Trendelenburg position for accurate reflux assessment

Revision History

01/01/2026revisionLatest

Template update and creation of a shared policy version to support application to Oxford plan membership (Policy history entry).

Policy Summary

Payersierra health and life

PolicySurgical and Ablative Procedures for Venous Insufficiency and Varicose Veins

Policy CodePolicy 2026T0447RR

Change TypeMinor / no material change

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain and document duplex ultrasound confirming reflux duration and vein diameter alongside clinical impairment to support medical necessity for ablation.

SourceLink

On This Page

clinical governance/training documented

NICE and other society statements referenced.

Perforator vein treatment: For pathologic perforator veins associated with symptomatic disease or leg ulcers, endovenous ablation or ultrasound‑guided sclerotherapy is suggested over open perforator surgery; pathologic perforators are defined by duplex as reflux >= 500 ms and diameter >= 3.5 mm.perforator reflux >= 500 ms and diameter >= 3.5 mm

SVS/AVF/AVLS/SIR guidance and good practice statements.

>= 3 mm measured immediately below the appropriate junction on duplex ultrasound

Perforator vein minimum diameter>= 3.5 mm on duplex ultrasound

Measurement positionMeasure GSV at proximal thigh immediately below the saphenofemoral junction; SSV/accessory immediately below appropriate junction

inv-37: CEAP diameter threshold — Varicose veins defined as diameter > 3 mm (C2)

CEAP varicose vein diameter criterionVaricose veins defined as diameter > 3 mm (CEAP clinical class C2)

CEAP clinical useCEAP C2–C6 used to grade severity and inform treatment decisions

Diagnostic modalityDiameter assessed by duplex ultrasound as part of CEAP classification

inv-38: Vein diameter — Treated veins reported up to 20 mm in WAVES study (context)

Maximum treated vein diameter reported (WAVES study)Treated veins up to 20 mm in diameter reported in WAVES case series of CAE

Vein types includedGSV, SSV, and accessory saphenous veins included in WAVES study reports

Follow-up visits reportedFollow-up at one week and one month in WAVES series

inv-39: Saphenous trunk diameter — < 6 mm for UGFS consideration per ESVS guideline

ESVS guideline UGFS saphenous trunk considerationUGFS may be considered for saphenous trunks with diameter < 6 mm

PEM (Varithena) contextPharmaceutical-grade polidocanol microfoam (Varithena) is an UGFS option evaluated in VANISH trials

Evidence noteGuidelines note UGFS less effective long-term than EVLA/RFA; consider anatomy and patient factors

inv-40: Reflux duration threshold — > 500 ms

Primary reflux duration threshold for intervention> 500 ms (reversed flow) for superficial truncal and perforator veins

Acceptable duplex reporting languageDuplex interpretations describing 'moderate to severe reflux' are acceptable equivalents to numeric thresholds

Role in trial inclusionMany RCTs used reflux >= 0.5 sec as enrollment criterion for symptomatic truncal reflux

inv-41: Pathologic perforator diameter — >= 3.5 mm

Pathologic perforator diameter threshold>= 3.5 mm (on duplex ultrasound)

Associated reflux durationPerforator reflux >= 500 ms required to define pathologic perforator

Clinical contextPerforator criteria applied when perforator lies beneath a healed or active venous stasis ulcer for ablation consideration

Note

No explicit prior authorization requirement stated — check plan

No explicit prior authorization requirement is stated in this excerpt; however, verify the member-specific benefit plan and any employer or state/federal mandates as these govern authorization rules.

Check member plan document for any plan-level prior authorization requirements.
Absence of a stated requirement in this policy does not preclude plan-level prior auth.

Prior Authorization

Prior authorization: require baseline reflux documentation and follow-up plan

If prior authorization is required, include baseline duplex ultrasound documentation showing reflux duration and vein diameter, CEAP classification, symptoms/functional impairment, prior conservative therapy, and a follow-up plan with scheduled duplex assessments.

Baseline duplex with reflux ≥500 ms for targeted truncal veins and diameter measurements (GSV/SSV/accessory ≥3.0 mm; perforator ≥3.5 mm).
Clinical documentation of CEAP class, symptoms, and prior conservative therapy.
Proposed follow-up schedule and assessment plan (eg, duplex and clinical follow-up at 3, 12, 24, 36, and when applicable 60 months per trial schedules).
For sclerotherapy, include VVSymQ, VCSS, VEINES-QOL when available.

Prior Authorization

Prior authorization for VenoValve / investigational valve

Prior authorization for investigational devices such as the VenoValve should require documentation of clinical trial enrollment or the research protocol; if used off-study, submit rationale, prior conservative treatments, and detailed safety monitoring plans.

If device is investigational or not FDA-approved, attach trial protocol and informed consent.
Document attempts at standard treatments and reason investigational device is being considered.

Note

Device/agent approval and utilization note

Devices and agents (eg, Varithena, VenaSeal, ClariVein) noted in the FDA section are FDA-approved for specific indications; authorizations may reference device-specific labeling and intended-use restrictions.

Varithena (polidocanol foam) — FDA indication scope.
VenaSeal — PMA indications for permanent closure of superficial truncal veins.
ClariVein — infusion catheter cleared for use with specified medicaments.

Prior Authorization

Check member plan and mandates

Always verify member-specific benefits and applicable federal/state mandates before rendering a coverage decision; the member-specific plan governs in the event of any conflict.

Reference the member specific benefit plan document.
Check for state or federal mandates that may alter coverage.

Denial Risk

Cosmetic sclerotherapy exclusion and session limits

CPT code 36468 for treatment of telangiectasia/spider veins is considered cosmetic and excluded from coverage. Cosmetic sclerotherapy and more than three sclerotherapy sessions per leg within a rolling 12-month period are excluded.

CPT 36468 — cosmetic, not covered.
CPT 36470/36471 — limited to up to three sessions per leg within a rolling 12-month period; a session = one date of service.
>3 sessions per leg in 365 days considered cosmetic and excluded.

Note

None explicitly stated in this excerpt

No additional explicit provider actions were stated in this excerpt beyond documentation and coding guidance; ensure requirements above are met to avoid denials.

If requested documentation is missing, claim or authorization may be denied.
Provide complete medical records to support medical necessity.

Denial Risk

MOCA comparative effectiveness concern

MOCA has shown lower anatomical occlusion and VCSS improvement compared with EVTA in meta-analyses; when alternatives (EVTA/CAC/RFA) are available and appropriate, document rationale if selecting MOCA and be prepared for potential payer preference for EVTA.

Document vein diameter and why MOCA is chosen if EVTA is feasible.
Be aware of comparative effectiveness concerns and include evidence of constrained options or contraindications to EVTA.

Documentation Required

Governance and training expectations (NICE)

Per NICE guidance, ensure clinical governance, appropriate training in venous ultrasound, informed consent, and audit arrangements are in place for cyanoacrylate glue occlusion and for MOCA; include operator training credentials when relevant to prior authorization.

Document operator training and experience with venous ultrasound and the specific technique.
Confirm local governance, consent processes, and audit/monitoring plans for cyanoacrylate use.

Documentation Required

Required clinical assessments in studies — follow-up intervals

Clinical trials and device studies commonly require and report standardized clinical assessments and duplex outcomes at specified intervals; authorizations and post-procedure monitoring plans should reference these intervals.

Typical follow-up schedule: day 3, 1 month, 3 months, then every 6–12 months up to 24–60 months as applicable.
Use duplex ultrasound to confirm vein closure/occlusion at each interval and document patient-reported outcomes (VCSS, AVVQ/VEINES-QOL, VVSymQ).

Documentation Required

Required clinical assessments and documentation

Authorization and ongoing documentation should include both clinical assessments and imaging: duplex-confirmed anatomic occlusion/closure at standardized intervals and patient-reported outcome measures to support continued coverage or adjudicate outcomes.

Document duplex results (closure/occlusion) at 3, 12, 24, 36, and when available 60 months.
Include VCSS, VEINES-QOL/AVVQ, VVSymQ where collected.

Documentation Required

Required clinical documentation for PEM (foam) sclerotherapy

For foam sclerotherapy (PEM/Varithena), include trial-relevant outcome measures in documentation when available: VVSymQ, VCSS, VEINES-QOL, and duplex findings used in studies to demonstrate clinical benefit and support medical necessity.

Attach VVSymQ and VCSS scores pre- and post-treatment when available.
Include duplex evidence of occlusion at follow-up intervals.

Documentation Required

Required clinical documentation for MOCA

When MOCA is performed, include duplex-confirmed anatomic occlusion/closure at standardized intervals and patient-reported outcomes (VCSS, VEINES-QOL/AVVQ) consistent with study follow-up to support claims and durability.

Duplex at baseline, 1, 3, 12 months and yearly as available.
Document any recanalization and subsequent interventions.

Documentation Required

Duplex ultrasound documentation — key parameters

Duplex ultrasound reports must document reflux duration and vein diameter thresholds to support medical necessity: reflux ≥500 ms for truncal veins and perforator reflux/dimensions per guideline thresholds.

Reflux duration: ≥500 ms for GSV/SSV/accessory and perforators (per policy/guidelines).
Vein diameter: GSV/SSV/accessory ≥3.0 mm; perforator ≥3.5 mm. Include measurement location and patient position (standing or reverse Trendelenburg).

Prior Authorization

Documentation of member benefits

Reference and document member-specific plan terms when making coverage decisions; the member benefit document supersedes this policy if discrepancies exist.

Attach member benefit verification to authorization requests.
Note any plan exclusions or mandates that alter standard coverage.

Billing Rule

Sclerotherapy session limit

CPT codes 36470 and 36471 are limited to up to three sclerotherapy sessions per leg within a rolling 12-month (365-day) period; a session is defined as a single date of service.

Three-session limit applies per leg per rolling 365 days.
More than three sessions per leg in 12 months is considered cosmetic and excluded.

Step Therapy

No mandated step therapy sequence in this excerpt — check plan

No formal step therapy sequence is mandated in this policy excerpt; clinical guideline evidence favors EVTA as first-line in many cases but document clinical rationale when selecting alternative treatments.

If deviating from EVTA (preferred first-line), document contraindications or anatomical reasons.
Payer-level step therapy protocols, if any, must be checked separately.

Step Therapy

Step therapy consideration between PEM and EVTA

Consider preferring EVTA over PEM when evidence supports superior long-term anatomical closure for patients prioritizing durability; document rationale if PEM is selected, especially where EVTA is available.

PEM may be considered in specific anatomical configurations or when EVTA is unsuitable.
Document comparative rationale, patient preference, and prior conservative therapies.

Note

Preferred first-line treatments per guideline

Guidelines (ESVS, SVS/AVF/AVLS/SIR) generally recommend endovenous thermal ablation (EVTA: EVLA or RFA) as first-choice treatment for GSV/SSV incompetence; UGFS and non-thermal options may be appropriate in select situations (eg, small-diameter veins, tortuous anatomy, or patient preference).

EVTA preferred for symptomatic GSV/SSV incompetence.
UGFS may be considered for trunks <6 mm or when endovenous cannulation is challenging.
Cyanoacrylate adhesive closure may be considered when non-thermal technique preferred.

Purpose in policyDuplex is required to document vein diameter and reflux duration to support medical necessity

inv-75: Varicose Veins — definition (>=3 mm, CEAP C2)

Varicose veins definitionDilated subcutaneous tributaries >= 3 mm in diameter, CEAP Class C2

Clinical featuresMay cause pain, itching, skin changes, clotting, or ulcers; graded by CEAP C0–C6

Diagnostic standardDuplex ultrasound is gold standard for diagnosing superficial venous incompetence

inv-76: Endovenous ablation (EVTA) — definition and modalities (RFA, EVLA, CAE, MOCA)

Endovenous ablation (EVTA) definitionMinimally invasive closure of incompetent truncal veins using thermal energy (RFA, EVLA) or non-thermal methods (cyanoacrylate, MOCA), performed under ultrasound guidance

Modalities listedRFA, EVLA (laser), cyanoacrylate adhesive closure (CAC), and mechanochemical ablation (MOCA)

Typical settingPerformed percutaneously with imaging guidance and monitoring; tumescent anesthesia used with thermal techniques

inv-77: UGFS — definition and description (polidocanol foam)

UGFS definitionInjection of polidocanol microfoam under ultrasound guidance to damage endothelium and induce vein occlusion (PEM/Varithena)

Proprietary preparationVarithena (pharmaceutical-grade polidocanol endovenous microfoam) is cited as a tested PEM product

Indications notedUsed for symptomatic, visible varicose veins and for trunks/tortuous veins when endovenous cannulation is challenging

inv-78: MOCA (ClariVein) — mechanochemical ablation description

MOCA descriptionMechanochemical ablation uses a rotating wire/catheter to mechanically disrupt endothelium combined with sclerosant infusion to induce sclerosis and occlusion (e.g., ClariVein)

Non-thermal categorizationMOCA is a non-thermal endovenous technique combining mechanical injury with chemical sclerosant

Evidence noteSystematic reviews report lower occlusion rates for MOCA versus thermal EVTA in several analyses

inv-79: Complete target vein closure — duplex-based endpoint definition used in trials

Complete target vein closure endpointAbsence of flow in the treated GSV on duplex ultrasound at predefined follow-up (primary endpoint commonly at 3 months)

Use in trialsPrimary anatomic endpoint used in VeClose and other RCTs with follow-up at day 3, 1, 3, 6, 12, 24, 36 months

Assessment methodDuplex ultrasound evaluation by study schedule to determine closure/noninferiority

inv-80: Anatomical success / recurrent reflux — definitions and measurement locations

Anatomical success / recurrent reflux definitionPatency or recurrence of reflux at specific junctions (e.g., SFJ/SPJ) assessed by duplex and reported as anatomical success or recurrent reflux rates

Measurement locationsAssess at saphenofemoral junction, saphenopopliteal junction, and along truncal segments as appropriate

Trial reportingReported as pooled rates in meta-analyses comparing modalities (EVLA, RFA, UGFS, CAC, MOCA)

inv-81: CAC / VenaSeal — brief device definition

CAC / VenaSeal definitionCyanoacrylate adhesive endovenous closure system used to occlude incompetent truncal veins without routine tumescent anesthesia (eg, VenaSeal)

Regulatory noteVenaSeal received FDA PMA (P140018) referenced in policy; evidence includes VeClose RCT and extension studies

Clinical contextUsed for symptomatic GSV incompetence as a non-thermal alternative to thermal EVTA

inv-82: PEM / Varithena — brief definition

PEM / Varithena definitionPharmaceutical-grade polidocanol endovenous microfoam (Varithena) used for ultrasound-guided foam sclerotherapy of varicose veins

Trial evidenceEvaluated in VANISH-1 and VANISH-2 and other RCTs showing symptom and appearance benefit versus placebo

Dosing contextTrials evaluated single administrations up to 15 mL; follow trial dosing and safety parameters

inv-83: MOCA — non-thermal technique definition

MOCA non-thermal techniqueA non-thermal technique using mechanical endothelial disruption plus sclerosant infusion to ablate the vein (eg, ClariVein)

Procedure componentsRotating wire/catheter to cause mechanical injury with simultaneous liquid sclerosant delivery

Comparative evidenceMeta-analyses indicate MOCA may have lower mid-term occlusion rates compared with thermal EVTA

inv-84: PEM (polidocanol microfoam) — definition and VANISH-2 reference

PEM (polidocanol microfoam) definitionPolidocanol foam sclerosant evaluated in VANISH-2 and VANISH-1 for treatment of GSV and major accessory vein reflux

Indications in trialsUsed for symptomatic, visible varicose veins associated with truncal reflux

Safety observationsAdverse events in VANISH-2 were mostly mild/moderate; longer-term comparative data versus EVTA limited

inv-85: VenoValve — porcine bioprosthetic venous valve definition; investigational

VenoValve descriptionPorcine bioprosthetic venous valve implanted to treat chronic venous insufficiency; early human data only and not FDA-approved

Regulatory statusDevice under investigation (SAVVE trial); not FDA approved at time of policy

Evidence volumePublished experience limited (≈11 individuals) with short-term outcomes reported

inv-86: Reflux — duplex definition (reversed flow > 500 ms)

Reflux duplex definitionReflux defined as reversed flow duration > 500 ms in superficial truncal and other venous segments on duplex ultrasound

Perforator and superficial thresholdsPerforator and superficial venous reflux thresholds set at >= 500 ms; deep veins use 1.0 sec

Use in coverage criteriaPolicy requires duplex-documented reflux > 500 ms to meet ablation eligibility for truncal and perforator veins

inv-87: Pathologic perforating vein — definition (>=500 ms and >=3.5 mm)

Pathologic perforating vein definitionPerforating veins with outward flow duration >= 500 ms and diameter >= 3.5 mm on duplex ultrasound

Clinical applicationThese criteria are used to define pathologic perforators when considering ablation, particularly if associated with ulceration

Measurement positionAssess perforator reflux and diameter on duplex in standing or reverse Trendelenburg position