ModifiedUnitedHealthcarePolicy CS117PA.Z

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

Medical policy governing indications, coverage criteria, and coding for surgical and endovenous treatments of venous insufficiency and varicose veins for UnitedHealthcare Community Plan in Pennsylvania; affects providers requesting coverage for these procedures in Pennsylvania.

Policy Summary

PayerUnitedHealthcare

PolicySurgical and Ablative Procedures for Venous Insufficiency and Varicose Veins (PA)

Policy CodePolicy CS117PA.Z

Change TypeModified coverage criteria and exclusions

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain standing or reverse Trendelenburg duplex ultrasound showing reflux ≥ 500 ms and document functional impairment to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Language indicating ligation, subfascial, endoscopic surgery for treatment of perforating veins associated with chronic venous insufficiency is proven and medically necessary in certain circumstances was removed.

Language stating endovascular embolization of varicose veins using cyanoacrylate-based adhesive is unproven and not medically necessary for treating venous reflux was removed.

Ablation of incompetent perforator veins using endovenous foam sclerotherapy and/or cyanoacrylate-based adhesive is unproven and not medically necessary due to insufficient evidence of efficacy.

Expanded the list of acceptable initial and subsequent treatments for GSV, SSV, and Accessory veins to include endovenous foam sclerotherapy and cyanoacrylate-based adhesive alongside radiofrequency ablation, endovenous laser ablation, stripping with ligation and excision.

Changed duplex ultrasound wording to allow interpretations describing reflux ≥ 500 ms for accessory veins (in addition to GSV/SSV/principal tributaries).

Replaced prior general statement that ablation of perforator veins is proven/medically necessary with a narrower statement that ablation of incompetent perforator veins using radiofrequency ablation or endovenous laser ablation is reconstructive and medically necessary when criteria are met.

Revised duplex ultrasound criterion language to require the study be performed in the standing or reverse Trendelenburg position showing reflux ≥ 500 ms for GSV, SSV, or Accessory Veins.

For incompetent perforator veins, added requirement that the veins are not secondary to acute deep vein thrombosis.

Updated ambulatory phlebectomy references and removed older InterQual phlebectomy references for certain subtypes (mini phlebectomy, stab avulsion, stab phlebectomy).

Added definitions for Superficial Vein, Telangiectasias/Spider Veins, and Tributary Vein; removed several prior definitions including Cosmetic Procedures and Reconstructive Procedures.

Removed CPT codes 37500 and 37799 from applicable codes and updated coding notations including referral to CPT 36465/36466 guidance and changes to coverage statements for sclerotherapy CPT codes.

Updated supporting sections: Description of Services, Clinical Evidence, FDA, and References to current information.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

3GSV/SSV/Accessory min diameter (mm)

>=500Duplex reflux threshold (ms)

3.5Perforator min diameter (mm)

up to 3Sclerotherapy sessions/leg/year

08/01/2025Policy revision date

94%Two-year NBCA occlusion

Coverage Criteria for Surgical and Endovenous Treatments

Initial/Surgical and Endovenous Ablation Coverage Criteria

Thermal and Non-Thermal Treatments for GSV, SSV, and Accessory Veins are considered reconstructive and medically necessary when ALL of the following are met:

Functional or Physical Impairment: Individual must have one of: skin ulceration; documented episode(s) of frank bleeding of the varicose vein due to erosion or trauma to the skin; 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 ≥ 3.0 mm when measured at the proximal thigh immediately below the saphenofemoral junction by duplex ultrasonography; SSV or Accessory veins must be ≥ 3.0 mm measured immediately below the appropriate junction by duplex ultrasonography.GSV/SSV/Accessory >= 3 mm

Duplex reflux: Duplex ultrasound study performed in the standing or reverse Trendelenburg position must show duration of reflux ≥ 500 milliseconds for the GSV, SSV, or Accessory veins (interpretations describing moderate to severe reflux are acceptable).>= 500 ms

Duplex must document location and measured reflux duration.

Perforator Vein Ablation Criteria

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

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

Perforator size: Perforator vein diameter ≥ 3.5 mm on duplex ultrasound.>= 3.5 mm

Perforator reflux: Perforating vein reflux duration ≥ 500 milliseconds on duplex ultrasound.>= 500 ms

Ulcer relation: Perforating vein lies beneath a healed or active venous stasis ulcer (when applicable).

Coverage and Exclusions (documented statements)

Coverage stance and limits (as stated in this section of the document):

General coverage principles: Procedures to treat symptomatic varicose veins and superficial venous incompetence (including endovenous ablation, adhesive embolization, mechanochemical ablation, foam sclerotherapy for truncal veins, ligation/stripping, phlebectomy, and perforator ablation) are supported by clinical evidence; duplex ultrasound is used for evaluation and CEAP classification guides severity assessment.

Diagnostic duplex required to document reflux and vein anatomy.

Explicit exclusions: Treatments for spider veins/telangiectasias and cosmetic sclerotherapy are excluded from coverage; endovenous ablation of reticular or telangiectatic veins is not reconstructive and not medically necessary.

CPT 36468 and cosmetic sclerotherapy excluded; see sclerotherapy session limits for truncal/non-telangiectasia treatments.

Evidence-derived procedural eligibility and outcome measures

Study eligibility and outcome measures commonly used in trials (may inform coverage criteria):

Diagnostic confirmation: Duplex ultrasound documenting target GSV (or other truncal vein) reflux ≥ 0.5 seconds (500 ms) as used in randomized trials.>= 0.5 seconds

Used as an inclusion criterion in RCTs (e.g., Alhewy 2024, VeClose).

Prior treatments/exclusions: Common trial exclusions included prior treatment of the target GSV, active anticoagulation, BMI > threshold, and history of DVT/PE.varies

May affect applicability of trial results to individual patients.

Follow-up for efficacy: Anatomic closure assessed at 3 months is a common primary endpoint; longer-term follow-up (12–60 months) commonly reported as secondary endpoints.

Evidence summaries

Findings from randomized trials, cohort studies, and systematic reviews supporting clinical effectiveness and limitations

CAC (VenaSeal) evidence summary: Randomized trials (VeClose) and meta-analyses report high short- and mid-term GSV closure rates for cyanoacrylate adhesive closure (CAC), often noninferior to RFA, with sustained symptom and QOL improvements reported through available follow-up (up to 60 months) though limited by loss to follow-up and lack of blinding.

VeClose and pooled analyses show comparable closure and symptom outcomes to RFA; limitations include follow-up attrition and study design.

PEM (Varithena) evidence summary: Randomized trials and systematic reviews demonstrate PEM (polidocanol endovenous microfoam) improves symptoms and appearance versus placebo and in some analyses is not statistically different from EVTA for vein closure; longer-term head-to-head comparisons are limited.

Safety profile includes thrombophlebitis and minor adverse events; larger RCTs with longer follow-up needed.

MOCA and non-thermal limitations: Systematic reviews and meta-analyses indicate lower occlusion/anatomic success for mechanochemical ablation (MOCA) compared with thermal EVTA in several analyses, though pain and nerve injury may be reduced with non-thermal techniques.

Coverage-relevant conclusions

Summary coverage-relevant conclusions from evidence and guidelines in these chunks

EVTA preferred: Guidelines and comparative data support EVTA (endovenous thermal ablation) as the preferred first-line treatment for GSV and SSV incompetence due to higher occlusion rates and favorable outcomes compared with some non-thermal techniques.

ESVS and other society guidance cited.

Non-thermal acceptable scenarios: Non-thermal techniques (e.g., CAC, UGFS, MOCA, PEM) may be considered when anatomy, inability to cannulate, patient preference, or contraindications to thermal techniques exist; however, MOCA demonstrates lower occlusion rates in several analyses.

Use non-thermal approaches selectively when clinically indicated.

Perforator vein treatment conclusion: Evidence is limited for endovenous foam sclerotherapy for perforator veins and does not clearly demonstrate benefit over established techniques; thermal ablation (RFA/EVLA) may be more reliable for perforator closure in available observational data.

Policy treats foam sclerotherapy and CAC for perforators as unproven.

Guideline-based coverage criteria

Guideline-based recommendations and appropriate-use determinations from major societies

Ablation for symptomatic axial truncal reflux (GSV/SSV/AAGSV/PAGSV): Ablation of refluxing superficial truncal veins is recommended for symptomatic patients with axial reflux (CEAP C2–C6) after duplex ultrasound diagnosis; EVTA is preferred when available though both thermal and non-thermal ablation may be acceptable depending on expertise and patient preference.

Society guidelines (ESVS, SVS/AVF/AVLS/SIR) support this recommendation.

When UGFS is appropriate: UGFS (including Varithena/PEM) may be considered for saphenous trunks < 6 mm or when endovenous cannulation/ablation is technically challenging; foam sclerotherapy is appropriate for tortuous or recurrent tributaries.< 6 mm for consideration of UGFS

ESVS guidance references diameter consideration.

Cyanoacrylate (CAC/VenaSeal) considerations: Cyanoacrylate adhesive closure may be considered as a non-thermal option for GSV incompetence; NICE and specialty societies note use is acceptable provided governance, consent, and audit are in place, and additional data are needed for broader applications (e.g., perforator veins).

Modality-specific medical necessity criteria

Covered when ALL of the following are met (modality-specific):

GSV/SSV/Accessory Veins: Reconstructive and Medically Necessary Treatments: Initial and subsequent treatment of the GSV, SSV, and Accessory veins with radiofrequency ablation, endovenous laser ablation, stripping with ligation and excision, endovenous foam sclerotherapy (PEM/Varithena), and/or cyanoacrylate-based adhesive (CAC/VenaSeal) are considered reconstructive and medically necessary when all listed general criteria are met (functional impairment, vein size ≥ 3 mm, duplex reflux ≥ 500 ms in standing or reverse Trendelenburg).duplex reflux >= 500 ms (standing or reverse Trendelenburg)

Policy expansion explicitly includes foam sclerotherapy and cyanoacrylate-based adhesive among covered modalities when criteria are satisfied.

Incompetent Perforator Veins: Medically Necessary Treatments: Ablation of incompetent perforator veins using radiofrequency ablation or endovenous laser ablation is considered reconstructive and medically necessary when all listed criteria are met: duplex in standing/reverse Trendelenburg showing perforator reflux ≥ 500 ms, perforator diameter ≥ 3.5 mm, vein lies beneath or is associated with a healed or active venous stasis ulcer when applicable, and findings are not secondary to acute DVT.perforator reflux >= 500 ms

Endovenous mechanochemical ablation (MOCA) is specifically identified in the policy as an unproven technique for treating varicose veins. The policy lists MOCA among procedures described as lacking sufficient evidence of efficacy and therefore considered not medically necessary for venous reflux management. This designation is supported by systematic-review data showing lower occlusion and clinical-improvement outcomes for MOCA compared with several thermal and adhesive techniques. (See policy statements and evidence syntheses regarding mechanochemical ablation and comparative outcomes.)

CPT code 36468 (injections of sclerosant for spider veins/telangiectasia) is designated in the policy as cosmetic and excluded from coverage because it does not address a functional, physical, or physiological impairment. The document therefore treats procedures billed with 36468 as cosmetic services and not reconstructive therapies.

The policy limits coverage for sclerotherapy: CPT codes 36470 and 36471 (sclerotherapy for non-telangiectatic veins) are covered for up to three sessions per leg within a 12‑month (rolling) period. The policy explicitly states that more than three sessions per leg in a year is considered cosmetic and excluded. A session is defined as a single date of service.

Treatments directed solely at spider veins/telangiectasias or reticular veins are considered cosmetic and excluded from coverage. The policy reiterates that cosmetic sclerotherapy is excluded and that endovenous ablation of reticular or telangiectatic veins is not reconstructive and therefore not medically necessary. CPT 36468 is specifically called out as cosmetic.

Clinical trials and comparative studies informing the policy commonly excluded certain populations and applied device‑specific restrictions. Typical exclusions reported in trials include patients with CEAP class 6 (active ulceration), prior treatment of the target GSV, history of DVT/PE, anticoagulant use, high BMI, or anatomic features such as aneurysmal target veins. Device‑specific notes and study entry criteria (for example in CAC and RFA trials) therefore imply that similar factors may affect eligibility in clinical practice and authorization decisions.

The policy notes that available peer‑review evidence for cyanoacrylate‑based adhesive (cyanoacrylate embolization) when used to treat incompetent perforator veins is limited. Published series are small, often retrospective, and confounded by concomitant treatments; the document concludes that robust randomized controlled trials with longer follow‑up are needed to establish safety and efficacy for this indication.

The porcine bioprosthetic venous valve (VenoValve) is described in the policy as investigational: available clinical evidence is limited to very small early series (approximately 11 subjects reported in first‑in‑human reports), and the device is not currently FDA‑approved. The policy therefore treats VenoValve as investigational until there are larger, longer‑term controlled studies and regulatory approval.

Certain chunks do not state explicit blanket coverage exclusions for every modality; instead, guideline context and anatomy‑based recommendations guide decisions. For example, guideline statements emphasize using duplex ultrasound and CEAP classification to inform whether ablation is appropriate and note that when endovenous ablation is not feasible due to anatomy or unavailable expertise, ligation and stripping may be reasonable. The policy revisions clarify duplex positioning requirements and apply reflux thresholds to accessory veins, but do not create new, universal exclusions beyond those explicitly listed.

The policy explicitly states that ablation of perforator veins using endovenous foam sclerotherapy and/or cyanoacrylate adhesive is considered unproven and not medically necessary due to insufficient evidence of efficacy. This statement is reiterated in the policy’s not‑medically‑necessary/exclusion language and is intended to guide denial risk for these specific techniques when proposed for isolated perforator treatment.

Standalone ligation of the GSV, SSV, accessory veins, or ligation performed as an adjunct to ablation is described in the policy as unproven and not medically necessary for treatment of venous reflux, except for a limited, proven indication to prevent clot propagation in ascending superficial thrombophlebitis when anticoagulation is not tolerated. The general statement treats routine isolated ligation for reflux as unsupported by sufficient evidence.

The policy reiterates that endovenous foam sclerotherapy and cyanoacrylate adhesive for perforator vein ablation remain unproven. Multiple evidence summaries referenced in the document describe limited sample sizes, retrospective designs, and short follow‑up for these approaches in perforator applications, supporting the policy’s conservative stance.

Endovenous ablation procedures directed at isolated reticular or telangiectatic veins are considered cosmetic and not reconstructive. The policy reinforces that treating these small superficial tributaries with ablation is not intended to correct physiologic impairment and therefore is excluded from coverage as cosmetic care. Clinical society guidance supports targeted sclerotherapy or phlebectomy for telangiectasias and reticular veins rather than ablation.

The policy identifies use of devices or systems that are not cleared or approved by the U.S. Food and Drug Administration (for example, VariClose in other countries) as investigational. Use of non‑cleared devices is characterized as under research and not approved for marketing in the U.S., and such use would be treated as investigational/not covered in the policy. Device approval status (e.g., ClariVein, Varithena, VenaSeal) is referenced elsewhere for informational purposes but does not replace the investigational designation for non‑cleared products.

The Hayes assessments cited in the policy characterize the evidence for PEM (polidocanol endovenous microfoam) as low‑quality but potentially beneficial: PEM may relieve symptoms and produce vein occlusion in some trials, but uncertainty remains regarding comparative durability and optimal patient selection. The Hayes summaries therefore describe PEM as having potential but unproven benefits pending larger, well‑designed RCTs and longer follow‑up.

The policy and cited evidence do not support recommending MOCA or PEM as preferred first‑line therapy over established thermal endovenous techniques for typical GSV incompetence. Meta‑analyses and RCT data summarized in the policy show lower long‑term anatomic closure or occlusion rates for MOCA compared with EVLA/RFA, and the PEM evidence base is of limited quality—together supporting guideline preference for EVTA as first‑line therapy when appropriate.

Clinical society guidance cited in the policy warns against using truncal vein diameter alone to determine the need for ablation in patients with CEAP class C2 disease. The SVS/AVF/AVLS/SIR statements recommend basing treatment decisions primarily on symptoms and duplex‑documented reflux rather than diameter alone, and therefore the policy cautions that diameter by itself is not an adequate indication for ablation in C2 disease.

The policy revision history documents removal of a prior statement that described cyanoacrylate embolization as unproven; this historical note is captured in the summary of changes. The revision log therefore records that some earlier NMN language was removed or updated during the policy change process.

Procedure and Coding Guidance

Applicable Procedure CodesCPT | HCPCS

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, radiofrequency; first vein treated.
36476	Endovenous ablation therapy, radiofrequency; subsequent vein(s) treated in a single extremity.

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Covered CPT Codes (endovenous ablation - laser first vein)CPT

36478

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

Covered CPT Codes (endovenous ablation - laser subsequent veins)CPT

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

Covered CPT Codes (adhesive embolization)CPT

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.

Covered CPT Codes (ligation, stripping, phlebectomy)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.
37765	Stab phlebectomy of varicose veins, 1 extremity; 10-20 stab incisions.
37766	Stab phlebectomy of varicose veins, 1 extremity; more than 20 incisions.
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.

Device approvals / identifiersmixed

K071468	ClariVein infusion catheter FDA submission number (device information).
P140018	VenaSeal Closure System PMA identifier.

Applicable Sclerotherapy CPT Codes and GuidanceCPT

36465	Sclerotherapy: Injection of non-compounded foam sclerosant with ultrasound compression maneuvers for a single incompetent extremity truncal vein (refer to CPT 36465 guidance).
36466	Sclerotherapy: Injection of non-compounded foam sclerosant with ultrasound compression maneuvers for multiple incompetent truncal veins, same leg (refer to CPT 36466 guidance).
36470	Injection of sclerosant; single incompetent vein (other than telangiectasia). Covered up to three sessions per leg per year for non-truncal, non-telangiectasia sclerotherapy.
36471	Injection of sclerosant; multiple incompetent veins (other than telangiectasia), same leg. Covered up to three sessions per leg per year for non-truncal, non-telangiectasia sclerotherapy.

Removed CPT CodesCPTNot Covered

37500	Removed from applicable codes
37799	Removed from applicable codes

Vein diameter and reflux thresholds — Key numeric thresholds

GSV/SSV/Accessory minimum diameter3.0 mm (measured at proximal thigh immediately below the saphenofemoral junction for GSV; immediately below the appropriate junction for SSV/Accessory)

Perforator vein minimum diameter3.5 mm

Duplex reflux duration threshold (superficial/truncal)>= 500 milliseconds (0.5 sec)

Eggen RCT inclusion (reflux)Reflux > 0.5 seconds (used in trial eligibility)

Duplex position for measurementStudy performed in standing or reverse Trendelenburg position

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Code list and prior authorization applicability

Prior authorization may be required per state or contract rules for the procedures listed below; the code list is provided for reference only. Providers should verify member-specific benefit and PA requirements before scheduling.

Prior authorization applicability varies by state/contract — check eligibility and authorizations prior to service.
Code lists in this policy are informational and do not guarantee coverage or payment.

Prior Authorization

Prior authorization for specified procedure codes

Prior authorization applies to endovenous ablation and related procedural codes. When submitting PA requests include target vein(s), laterality, and planned CPT(s).

Common CPTs referenced (for PA routing/reference): 36475 (RFA, first vein), 36476 (RFA, subsequent/add-on), 36478/36479 (EVLA first/subsequent), 36482/36483 (cyanoacrylate adhesive first/subsequent), 37700–37785 (ligation/stripping/phlebectomy), 36470/36471/36465/36466 (sclerotherapy codes).

Background and Clinical Context

Venous reflux (venous insufficiency) occurs when retrograde flow develops in superficial, deep, or perforator veins, producing dilated varicose veins, skin changes, edema, and in severe cases ulceration. Duplex ultrasound—performed in the standing or reverse Trendelenburg position—is the diagnostic standard to document reflux duration and vein diameter prior to intervention, and these clinical features guide the policy’s reconstructive versus cosmetic determinations.

Definitions and Terminology

Duplex Ultrasonography — Definition and role

Duplex Ultrasonography definitionNoninvasive imaging using B-mode and Doppler to assess blood flow and reflux in leg veins

Role in evaluationGold-standard diagnostic test to document reflux duration and vein diameter prior to treatment

Measurement conditionsPerformed in standing or reverse Trendelenburg position for reflux assessment

Varicose Veins — Definition

DefinitionDilated subcutaneous tributaries >= 3 mm in diameter consistent with CEAP Class C2

Clinical implicationVaricose veins (CEAP C2) may cause symptoms that justify reconstructive treatment when accompanied by reflux and impairment

Policy Revision History and Changes

2025-08-01policy_revisionLatest

Expanded modalities considered reconstructive and medically necessary (added endovenous foam sclerotherapy and cyanoacrylate-based adhesive for GSV/SSV/Accessory veins) and revised duplex reflux wording to include accessory veins; added new NOT medically necessary statement that ablation of incompetent perforator veins using endovenous foam sclerotherapy and/or cyanoacrylate-based adhesive is unproven and not medically necessary; removed prior proven/medically necessary language for certain ligation/subfascial/endoscopic perforator procedures.

Policy Summary

PayerUnitedHealthcare

PolicySurgical and Ablative Procedures for Venous Insufficiency and Varicose Veins (PA)

Policy CodePolicy CS117PA.Z

Change TypeModified coverage criteria and exclusions

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain standing or reverse Trendelenburg duplex ultrasound showing reflux ≥ 500 ms and document functional impairment to support medical necessity.

SourceLink

On This Page

Not DVT secondary: Findings are not secondary to an acute deep vein thrombosis.

3 months primary endpoint; up to 60 months follow-up

Duplex-confirmed closure at month 3 frequently used as primary outcome in RCTs.

MOCA generally shows lower one-year occlusion rates compared with EVTA.

Perforator ablation evidence: Small prospective trials (e.g., SeCure) report high short-term technical closure rates for laser perforator ablation with improvements in QOL and ulcer metrics, but limitations include lack of comparators and small sample sizes.

Longer-term comparative data are limited.

Evidence limitations: Across modalities many studies lack blinding, have variable follow-up durations, and include single-arm series; authors recommend larger, longer RCTs to establish comparative durability and safety.

These limitations affect certainty of long-term comparative effectiveness.

VenoValve investigational: Porcine bioprosthetic venous valve (VenoValve) remains investigational with very limited human data and is not FDA approved; considered experimental pending further evidence.

Small first-in-human series and Hayes assessment noted.

Guidelines note evidence supports CAC for truncal veins but is limited for other uses.

Perforator vein treatment (guideline): For pathologic perforating veins (defined as ≥ 500 ms reflux and ≥ 3.5 mm diameter) associated with ulceration or symptomatic varicosities, endovenous ablation, division/ligation, or ultrasound-guided sclerotherapy are recommended options, with percutaneous techniques preferred over open surgery in compromised skin.>= 500 ms and >= 3.5 mm

SVS/AVF guidance and AUC consider perforator ablation appropriate in specified scenarios.

Diagnostic requirement: Duplex ultrasound scanning is the diagnostic test of choice to evaluate venous reflux prior to treatment decisions (strong recommendation).

Grade one (strong) recommendation in guidelines.

Policy excludes use of foam sclerotherapy and cyanoacrylate adhesive for perforator veins as unproven and not medically necessary.

Varicose vein diameter

Varicose vein size defining CEAP C2>= 3 mm (dilated subcutaneous tributaries >= 3 mm)

Clinical relevanceCEAP C2 corresponds to varicose veins (diameter > 3 mm) used in severity classification

Measurement methodDiameter assessed by duplex ultrasonography

Inclusion criterion for Eggen RCT

Eggen RCT saphenous reflux criterionGSV reflux > 0.5 seconds on ultrasound

Eggen RCT diameter requirementGSV diameter >= 3 mm (and <= 15 mm as reported in trial)

Trial contextInclusion required reflux > 0.5 sec over an intrafascial length >= 15 cm from SFJ

Reflux duration threshold

Diagnostic reflux threshold (policy)> 500 ms (0.5 seconds) reversed flow duration on duplex ultrasound

Vein groups covered by thresholdApplies to GSV, SSV, Accessory Veins and selected perforating veins per policy

Testing positionDuplex performed in standing or reverse Trendelenburg position

Pathologic perforator diameter threshold

Pathologic perforator diameter>= 3.5 mm

Associated reflux requirementPerforating vein reflux >= 500 ms

Clinical contextDefinition applied in patients with varicose veins (CEAP C2) and in perforator treatment criteria

UGFS saphenous trunk diameter consideration

UGFS saphenous trunk considerationUGFS (foam sclerotherapy) may be considered for saphenous trunks < 6 mm

Guideline basisESVS guidance notes UGFS is an option for trunks <6 mm or challenging anatomy

Evidence notePEM (Varithena) trials show symptom and appearance improvement but longer-term comparative durability data limited

Duplex reflux duration

Required duplex reflux duration>= 500 milliseconds (0.5 sec) for diagnostic confirmation of reflux on duplex ultrasound

Acceptable wordingInterpretations describing 'moderate to severe' reflux are acceptable if consistent with the numeric threshold

Positioning requirementDuplex study must be performed in standing or reverse Trendelenburg position

Per AMA guidance only one primary endovenous ablation code may be billed per extremity and only one add-on code per additional vein per extremity (see coding clarifications).

Documentation Required

Diagnostic confirmation and CEAP class

Prior authorization requests must document diagnostic confirmation of reflux and CEAP clinical class when applicable. Include the duplex ultrasound report (standing or reverse Trendelenburg) with measured reflux durations and vein diameters at the relevant anatomic points.

Duplex performed standing or in reverse Trendelenburg showing reflux ≥ 500 ms for target truncal or accessory veins; perforator reflux ≥ 500 ms and diameter ≥ 3.5 mm when applicable.
CEAP clinical class (C2–C6) should be documented; clinical impairment such as ulceration, bleeding, thrombophlebitis, venous stasis dermatitis, or moderate-to-severe pain must be noted.
For perforator vein ablation, document that perforator lies beneath a healed or active venous stasis ulcer if claiming medical necessity.

Prior Authorization

Prior authorization status not specified in excerpt

The evidence excerpt does not explicitly specify payer-wide prior authorization sequencing (step therapy) or which treatments must be preauthorized in every contract. Operational PA requirements should be confirmed against state/contract rules and employer group benefits.

No uniform step-therapy sequence is specified in this excerpt.
Verify PA and step requirements with UnitedHealthcare contract/state-specific rules.

Prior Authorization

MOCA prior authorization rationale

Mechanochemical ablation (MOCA) may require stronger justification on PA due to evidence showing lower anatomic (occlusion) success compared with thermal EVTA; include rationale why MOCA is chosen over EVTA and documentation of prior treatment attempts or contraindications to EVTA when applicable.

Studies show MOCA has lower occlusion rates vs RFA/EVLA; reference RCT/meta-analysis evidence in the justification.
If requesting MOCA, document contraindications to thermal techniques (e.g., nerve proximity, patient comorbidity, anesthesia risk) or patient preference after informed discussion.

Note

Device approvals — informational

Device approvals are provided for informational/billing purposes only and are not by themselves a basis for coverage. Include device name and model in the submission when used.

ClariVein (infusion catheter) FDA K071468 — informational.
Varithena (polidocanol injectable foam) FDA-approved (Nov 25, 2013) — informational.
VenaSeal Closure System PMA P140018 (Feb 20, 2015) — informational.
FDA approval is informational; coverage depends on medical necessity criteria and contract terms.

Denial Risk

Unproven perforator ablation methods

Ablation of perforator veins using endovenous foam sclerotherapy or cyanoacrylate adhesive is considered unproven and not medically necessary in this policy due to insufficient evidence. Such requests should be denied unless robust, contract-allowable justification and supporting evidence are provided.

Ablation of incompetent perforator veins using endovenous foam sclerotherapy and/or cyanoacrylate-based adhesive is listed as unproven and not medically necessary.
Radiofrequency or laser ablation of perforator veins may be medically necessary when policy criteria are met (document duplex, size, reflux, and relationship to ulcer).

Denial Risk

Exclusions that trigger denial

Requests for treatments that are explicitly excluded (cosmetic or non-reconstructive) should be denied. Include clear clinical documentation when medical necessity is claimed to avoid denial.

Treatments for spider veins/telangiectasias (C1) and cosmetic sclerotherapy (e.g., CPT 36468 for spider veins) are excluded and considered cosmetic.
Endovenous ablation of reticular or telangiectatic veins is excluded as not reconstructive and not medically necessary.

Documentation Required

Trial eligibility implies potential coverage restrictions

Eligibility criteria used for clinical trials (e.g., CEAP limits, prior treatment exclusions) may reflect coverage boundaries — when trial populations excluded certain patients, similar exclusions may inform medical necessity decisions.

Some RCTs limited CEAP classes or excluded prior-treated veins; document prior interventions and how the member aligns with clinical criteria.
If a requested service mirrors trial settings (e.g., CEAP C2–C5 for CAC/RFA trials), include corresponding clinical documentation to support coverage.

Prior Authorization

Not specified in this excerpt — operational PA triggers

The excerpt does not state explicit payer-wide prior authorization triggers for all modalities; clinical documentation expectations (duplex, CEAP, symptoms) are prominent but operational PA rules must be checked with the payer.

No single explicit PA trigger list is provided in the evidence excerpt for every modality.
Providers should include complete clinical and imaging documentation with any PA to facilitate review.

Denial Risk

Limited evidence for perforator vein foam sclerotherapy

Evidence for endovenous foam sclerotherapy (UGFS/PEM) for perforator veins is limited and does not demonstrate clear benefit versus established therapies; PA requests for perforator UGFS should include supporting evidence and rationale.

VANISH trials support PEM for truncal/visible varicosities but long-term comparative data vs EVTA are limited.
For perforator treatment using UGFS, document why standard ablation (RFA/EVLA) is not appropriate and include duplex findings.

Documentation Required

Governance and training expectations

NICE and other guidance recommend that procedures (especially newer techniques like CAC or MOCA) be performed only after appropriate training and with arrangements for clinical governance, consent, and audit. PA submissions may be strengthened by documenting provider training and local governance arrangements.

Document operator training and venous ultrasound competency when using CAC, MOCA, or other newer technologies.
Confirm local policies for consent and audit are followed and note this in the submission if applicable.

Documentation Required

Required clinical impairment documentation

The policy lists specific documentation requirements to support medical necessity: clinical impairment (ulceration, bleeding, thrombophlebitis, venous stasis dermatitis, or moderate-severe pain) and duplex ultrasound findings. Include these in PA submissions.

Document functional/physical impairment (ulceration, bleeding, thrombophlebitis, venous stasis dermatitis, or significant pain).
Include duplex measurements: vein diameter (GSV/SSV/accessory ≥ 3 mm; perforator ≥ 3.5 mm) and reflux duration (≥ 500 ms).

Documentation Required

Recommended follow-up assessments (evidence basis)

Follow-up assessments and outcome measures used in trials (e.g., duplex at predefined intervals, VCSS, VVSymQ, AVVQ, and QOL measures) can support efficacy documentation in PA or appeals.

Typical trial follow-up: day 3, 1 month, 3 months, then every 6–12 months up to 24–60 months — include planned follow-up imaging/timepoints.
Use validated measures (VCSS, VVSymQ, AVVQ, EQ-5D) where available to document symptomatic improvement.

Documentation Required

Clinical trial outcome documentation

Clinical trials (e.g., VANISH, VeClose, VeClose extension studies) used outcome measures such as VVSymQ, VCSS, AVVQ, duplex-defined closure, and patient satisfaction. Including these outcomes in prior authorization or post-procedure reporting aligns with the evidence base.

Primary trial endpoints often include duplex-confirmed vein closure at 3 months and patient-reported symptom scores (VVSymQ).
Secondary outcomes include VCSS, AVVQ, EQ-5D, adverse events, and procedural pain.

Documentation Required

Consent and audit documentation

Ensure informed consent addresses options, device-specific risks, and alternatives. Maintain documentation of consent and be prepared for audit. Include evidence of shared decision-making when requesting non-standard therapies.

Document discussion of all reasonable treatment options and rationale for chosen therapy.
Retain signed informed consent and note adherence to institutional audit and monitoring policies.

Documentation Required

Duplex ultrasound requirement (reiteration)

Ensure duplex ultrasound reports in the PA clearly state patient position (standing or reverse Trendelenburg), measured reflux duration (≥ 500 ms threshold), and vein diameter at specific anatomic points to meet policy criteria.

Required duplex elements: patient position, vein diameter (GSV/SSV/accessory ≥ 3 mm; perforator ≥ 3.5 mm), and reflux duration in milliseconds (≥ 500 ms).
Acceptable duplex language includes statements describing 'moderate to severe reflux' if quantitative values are provided or interpretable.

Billing Rule

Endovenous RFA coding constraint

Coding and billing must follow AMA guidance: only one primary endovenous ablation code per extremity and only one add-on code per additional vein per extremity. Ensure claims reflect this guidance to avoid denials.

Example: CPT 36475 may be used once per extremity as the primary code; CPT 36476 (add-on) may be billed once per extremity for subsequent veins as applicable.
Validate modifier and laterality use per payer billing rules.

Documentation Required

Preferred modalities based on long-term efficacy

Long-term evidence suggests EVLA and high ligation with stripping have higher anatomic success than UGFS at five years; consider these durability data when justifying modality selection in PA requests.

EVLA and high ligation with stripping show higher long-term anatomic success versus UGFS—reference five-year outcomes when appropriate.
UGFS/foam may be reasonable for small-diameter trunks, tortuous anatomy, or when endovenous cannulation is not feasible; document rationale.

Step Therapy

Step therapy not specified

No explicit step-therapy sequencing is mandated by the policy excerpt; clinical judgment and documented contraindications should guide therapy choice. Verify any plan- or contract-specific step requirements.

Policy does not mandate that EVTA must be attempted before adhesive or foam in all cases.
If a payer-specific step-therapy program exists, follow that process.

Documentation Required

Preferred first-line therapy

Guideline-supported preference is for endovenous thermal ablation (EVTA/RFA/EVLA) as first-line therapy for truncal vein incompetence in most patients; document why an alternative is selected when requesting non-preferred modalities.

EVTA is recommended as first choice for GSV/SSV incompetence; UGFS may be considered for trunks < 6 mm or tortuous anatomy.
If selecting cyanoacrylate or MOCA, document contraindications to thermal techniques or patient-centered reasons.

Measurement methodDiameter assessed by duplex ultrasonography

Functional or Physical Impairment — Definition

DefinitionFunctional or Physical Impairment: significant limitation in physical function or daily activities due to ulceration, bleeding, thrombophlebitis, dermatitis, or moderate to severe pain

Policy usePresence of one listed impairment is required for reconstructive medical necessity for truncal vein treatments

Reference instrumentModerate to severe pain described by VCSS criteria

Endovenous ablation (EVTA) — Definition

DefinitionEndovenous ablation (EVTA): minimally invasive thermal (laser, radiofrequency) or non-thermal (adhesive, chemical) procedures to close incompetent superficial truncal veins

ExamplesEVLA (laser), RFA (radiofrequency), cyanoacrylate adhesive embolization (VenaSeal), and foam sclerotherapy (PEM/Varithena)

Clinical intentTo achieve duplex-confirmed occlusion of the target truncal vein as reconstructive therapy

CEAP C-class — Classification

CEAP C-class rangeC0 (no signs) through C6 (active ulcer)

C2 definitionVaricose veins: diameter > 3 mm

UseCEAP clinical class used to stratify disease severity and guide treatment eligibility

Mechanochemical ablation — Definition

DefinitionMechanochemical ablation (ClariVein): rotating wire mechanically disrupts endothelium while liquid sclerosant is infused to induce sclerosis and occlusion

Device exampleClariVein infusion catheter

Evidence noteMOCA has shown short- to mid-term anatomic success but lower occlusion rates than thermal techniques in some analyses

Complete closure (anatomic success) — Definition

Complete closure (anatomic success)Duplex-confirmed occlusion of the target vein at reported follow-up timepoints (commonly 3, 12, 24, 36, 60 months)

Primary endpoint in trialsThree-month duplex closure commonly used as primary endpoint (VeClose, Alhewy) with longer-term extensions reported

Clinical relevanceAnatomic closure correlated with symptom and QOL improvements in many studies but follow-up duration affects durability assessment

CAE / CAC — Definition

Cyanoacrylate embolization (CAE/CAC)Endovascular sealing of a truncal vein using cyanoacrylate glue (e.g., VenaSeal) without tumescent anesthesia

Clinical featuresNon-thermal, non-sclerosant technique often not requiring compression or tumescent anesthesia; reported high short- and mid-term closure rates

Evidence noteRCTs (VeClose, Alhewy) and meta-analyses support efficacy versus RFA in selected populations

Closure outcome timepoints

Common follow-up timepointsDay 3, 1 month, 3 months, then periodic visits at 6, 12, 24, 36, and 60 months depending on study

PurposeDuplex ultrasound and validated outcome instruments are used at these timepoints to assess anatomic closure and clinical outcomes

Trial practiceMany pivotal trials used month 3 as primary endpoint with extension studies reporting 12–60 month outcomes

Outcome instruments — Validated tools

Validated instrumentsVCSS, AVVQ, EQ-5D, HASTI, VVSymQ

UseUsed in trials to quantify symptom severity, appearance, and QOL improvement after interventions

ExamplesVVSymQ used as primary symptom endpoint in VANISH trials; VCSS and AVVQ used across CAC trials

PEM (polidocanol endovenous microfoam) — Definition

PEM (Varithena) definitionPharmaceutical-grade polidocanol endovenous microfoam used for ultrasound-guided foam sclerotherapy (Varithena) in VANISH trials

Clinical contextShown in RCTs to improve symptoms and appearance versus placebo; longer-term head-to-head durability data limited

AdministrationUltrasound-guided injection of up to 15 mL in trials; reported dose concentrations 0.5%–2%

MOCA (ClariVein) — Definition

MOCA (ClariVein) definitionMechanochemical ablation combining mechanical endothelial disruption via a rotating wire with infusion of liquid sclerosant (ClariVein device)

MechanismMechanical injury plus chemical sclerosant induces sclerosis and occlusion without thermal energy

Evidence noteReported short- to mid-term anatomic success; RCT comparisons with thermal ablation are limited and meta-analyses show lower closure odds

VenoValve — Definition and status

VenoValve definitionPorcine bioprosthetic venous valve implanted into the femoral vein to treat deep venous reflux; investigational with limited human data

Regulatory statusNot yet FDA approved; evidence limited to small first-in-human series and ongoing trials (SAVVE NCT04943172)

Evidence implicationConsidered investigational until larger RCTs and regulatory approval available

Reflux — Diagnostic definition

Reflux definition> 500 ms reversed flow duration on duplex ultrasound for superficial truncal and selected deep/perforating veins

Trial and policy useUsed both as trial inclusion (e.g., Alhewy, VeClose) and policy diagnostic threshold

Measurement positionStanding or reverse Trendelenburg duplex required for accurate reflux assessment

Pathologic perforating vein — Definition

Pathologic perforating veinPerforating veins with outward flow duration >= 500 ms and diameter >= 3.5 mm on duplex ultrasound (in CEAP C2 patients)

Clinical implicationThis definition supports eligibility for perforator-targeted interventions when symptomatic or associated with ulceration

Policy applicationPerforator treatment criteria require duplex evidence and exclusion of DVT-related secondary causes

Superficial Vein — Glossary addition

Superficial Vein (glossary)Veins located above the muscular fascia

Policy noteAdded as a glossary definition in the policy revision

RelationIncludes GSV, SSV, accessory and tributary veins relevant to coverage criteria

Telangiectasias/Spider Veins — Glossary addition

Telangiectasias/Spider Veins — definitionDilated small superficial veins < 1 mm in diameter, predominantly in the lower extremities

Coverage implicationTreatment of telangiectasias/spider veins (CPT 36468) is considered cosmetic and excluded

DistinctionThese are smaller than varicose veins (varicose >= 3 mm) and classified as CEAP C1

Tributary Vein — Glossary addition

Tributary Vein — definitionSmall superficial veins in the legs that run close to the skin within the superficial subcutaneous plane

Clinical roleTributary veins (including tributaries >=3 mm) may be treated adjunctively when truncal reflux addressed

MeasurementDiameter assessed by duplex ultrasonography; tributaries >=3 mm meet varicose vein definition