CurrentAetnaPolicy 0413

Varicocele: Selected Treatments

This policy governs Aetna's coverage determinations for selected treatments of varicocele (embolization, ligation, microsurgical varicocelectomy) including which procedures are considered medically necessary or experimental/investigational and the applicable diagnosis and procedure codes.

Policy Summary

PayerAetna

PolicyVaricocele: Selected Treatments

Policy CodePolicy 0413

Change TypeNo material change

Effective DateMay 4, 2000

Next Review DateApr 25, 2024

Key ActionSubmit embolization or ligation procedure codes with supporting clinical documentation that the patient meets the listed medical necessity criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4Indications meeting medical necessity

5Procedures experimental/investigational

37241Key CPT codes

06/07/2023Last review

Coverage Criteria and Evidence Summary

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Aetna considers percutaneous embolization or ligation medically necessary for the treatment of varicocele when ANY of the following are met:

Medical necessity for embolization or ligation: 1) Adolescents with grade 2 or 3 varicoceles associated with ipsilateral testicular growth retardation; OR 2) Males with infertility who have decreased sperm motility and lower sperm concentrations; OR 3) Post-surgical (ligation) recurrence of varicoceles; OR 4) Scrotal pain associated with varicoceles.any of the listed conditions

Microsurgical varicocelectomy is an acceptable alternative when any of these criteria is met.

Experimental and Investigational

Aetna considers the following procedures experimental and investigational (effectiveness not established):

Experimental/Investigational procedures: 1) Addition of a sclerosant agent to coil embolization to improve outcomes; 2) Endoluminal occlusion devices (e.g., the ArtVentive endoluminal occlusion system); 3) Endovenous laser ablation (EVLA) of the spermatic vein; 4) Surgical treatment (ligation, embolization) for subclinical varicocele; 5) Varicocelectomy for non-obstructive azoospermia.all listed are considered experimental/investigational

These procedures are not considered established treatments per the policy.

Guideline-based consideration for varicocelectomy

Clinical guidance and evidence-based recommendations summarized:

AUA guideline recommendation context: American Urological Association guideline: consider surgical varicocelectomy in men attempting to conceive who have palpable varicocele(s), infertility, and abnormal semen parameters (except azoospermic men).Moderate Recommendation; Grade B

Guideline cited in document (AUA).

Antioxidant supplementation evidence

Evidence summary regarding antioxidant supplementation in subfertile men (contextual to varicocele management):

Antioxidant supplementation outcomes: Cochrane review (48 RCTs, 4,179 men) found low- to very-low-quality evidence that antioxidants may increase live birth and clinical pregnancy rates but results are limited by small trials, methodological issues, and imprecision (e.g., live birth OR 4.21 based on 4 small RCTs, 277 men).low to very low quality evidence

Authors conclude further large well-designed RCTs are needed to clarify these results.

Microsurgical vs laparoscopic varicocele repair

Comparative surgical approaches evidence:

Microsurgery vs laparoscopic outcomes: Meta-analysis of RCTs (23 studies; 1,178 microsurgery vs 1,069 laparoscopic patients) reported microsurgery decreased complication rate (RR 0.40), decreased hospital stay (WMD -0.53), increased post-op sperm concentration (WMD 3.00), and decreased recurrence rate (RR 0.35); no significant difference in operation time or sperm motility.statistically significant on listed outcomes

Findings support microsurgery as a favorable alternative to laparoscopic approach.

Percutaneous embolization materials

Embolization materials and outcomes:

Embolic material comparative outcomes: Systematic reviews and cohort studies show technical success >90% across embolic materials. At ~1 year, glue (e.g., Glubran2) had the lowest reported recurrence (~4.2%), coils ~9.1%, and sclerosants alone higher (~11%); adding sclerosants to coils did not clearly reduce recurrence. Safety profiles were similar across agents.variable by agent and follow-up

Evidence largely retrospective; authors call for RCTs and cost-effectiveness analyses.

Experimental or limited-evidence techniques

Emerging or uncertain interventions:

Endovenous laser ablation and sperm DNA fragmentation: EVLA of the spermatic vein has been reported as feasible and safe in a small prospective series (n=11) with short-term technical success, but is not listed in major reviews/UpToDate as a standard option. Evidence regarding varicocelectomy's effect on sperm DNA fragmentation is under investigation with protocols and meta-analyses ongoing; current evidence is limited and heterogeneous.limited evidence; small studies or protocols

Not established as standard therapy.

Varicocelectomy for NOA

Varicocelectomy in non-obstructive azoospermia (NOA):

Outcomes in NOA: Retrospective cohorts and systematic reviews report that varicocelectomy may result in return of sperm to the ejaculate in a subset of men (average ~27% primary spermatogenesis), may improve sperm retrieval rates for subsequent microTESE (SRR higher vs untreated), and may increase live-birth rates compared with NOA patients without varicocele; evidence is heterogeneous and primarily retrospective.variable; dependent on histopathology subtype

Further prospective studies are needed to confirm benefits and identify predictors of success.

The policy lists specific CPT and HCPCS entries related to endovenous laser ablation and various sclerosant agents as not covered for the indications in this bulletin. Notably, Endovenous laser ablation (EVLA) of the spermatic vein is identified without a specific CPT code and is included among procedures and technologies not covered for the listed indications. The HCPCS/drug entries and devices called out as not covered include the ArtVentive endoluminal occlusion system and multiple listed sclerosants (for example, Sodium tetradecyl sulfate, Polidocanol, Sodium morrhuate, hypertonic saline preparations, chromated glycerin) as well as the injectable agent J1430 (ethanolamine oleate, 100 mg).

For subclinical varicoceles the evidence and guidance are uncertain: a systematic review and meta-analysis found no clear consensus and concluded there was insufficient high-quality evidence to draw final conclusions. An UpToDate review cited in the policy states that the role of surgical ligation for subclinical varicoceles associated with subfertility is not clear. Endovenous laser ablation is not presented in major treatment reviews as a standard option for subclinical varicocele.

Within the provided excerpts there are no additional explicit, formal coverage exclusion statements beyond those already summarized (for example, procedural items and device/drug entries listed as not covered in the coding section). The policy history and metadata present in these chunks do not add further exclusion language.

The policy states that percutaneous embolization or ligation performed for patients who do not meet the listed medical necessity criteria are considered experimental and investigational. In operational terms, procedures performed when the stated selection criteria are not met may be treated as not covered and are at risk for denial.

The document summarizes that current evidence is insufficient to support treating subclinical varicoceles to improve fertility. A meta-analysis of randomized trials specific to subclinical varicocele showed low-quality evidence and no statistically significant improvement in pregnancy rates, leading the authors to conclude further research is required before recommending treatment for fertility.

The cited sections contain bibliographic references and guideline citations relevant to varicocele management (AUA/ASRM guidelines, systematic reviews, and studies of embolization and surgical techniques). These reference lists and guideline citations do not themselves include explicit 'not medically necessary' declarations beyond the policy’s main coverage and investigational statements.

Billing Codes and Diagnosis Mapping

Covered CPT Codes (if selection criteria are met)CPTCovered

37241

Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; venous, other than hemorrhage (eg, congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles).

Other related CPT codesCPT

37799

Unlisted procedure, vascular surgery

Surgical CPT Codes (not covered for subclinical varicocele)CPTCovered

55530-55540	Excision of varicocele or ligation of spermatic veins for varicocele
55550	Laparoscopy, surgical, with ligation of spermatic veins for varicocele

HCPCS / Drug codes mentionedHCPCS

J1430

Injection, ethanolamine oleate, 100 mg

ICD-10 Codes (covered if selection criteria are met)ICD-10

E29.1	Testicular hypofunction
I86.1	Scrotal varices
N46.023	Azoospermia due to obstruction of efferent ducts
N46.11 - N46.129	Oligospermia

ICD-10 Codes not coveredICD-10Not Covered

N46.01 - N46.022, N46.024 - N46.029

Azoospermia [excluding obstruction of efferent ducts]

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior authorization / Coding headline — Submit codes with supporting clinical documentation

Submit appropriate codes with supporting clinical documentation that selection criteria are met. When prior authorization is required, include clinical notes, test results, and rationale demonstrating the member meets the medical necessity criteria in this policy.

Include documentation of indication (e.g., infertility with abnormal semen analysis, ipsilateral testicular growth retardation in adolescents, recurrent post-surgical varicocele, or scrotal pain).
When applicable, provide semen analysis, sperm DNA fragmentation testing (if performed), and ultrasound/Color Doppler assessment results as cited in clinical trials and reviews.
If procedure is performed without meeting listed medical necessity criteria, claim may be denied as experimental/investigational or not covered.

Prior Authorization

Prior authorization for procedures/devices — Policy text does not list specific codes requiring prior authorization

The policy text does not list a broad set of codes that universally require prior authorization; however, procedures/devices discussed (e.g., percutaneous embolization using coils, glue, sclerosants, or endoluminal occlusion devices) may be subject to authorization based on coverage criteria and device-specific coverage determinations.

Percutaneous embolization (CPT 37241) is covered only if selection criteria are met.
Endovenous laser ablation (EVLA) of the spermatic vein and certain devices (e.g., ArtVentive endoluminal occlusion system) are considered experimental/investigational for varicocele and are not covered for the indications in this bulletin.
Confirm device-specific coverage and any payor enrollment or authorization processes before scheduling.

Note

Prior authorization not specified in this excerpt — Verify plan-level requirements

No explicit prior authorization process or universal prior-authorization-only codes are specified in the excerpt. Providers should verify plan-specific preauthorization requirements and follow standard authorization workflows when unsure.

Check the member's benefit plan and prior authorization portal for any payer-specific requirements.
When in doubt, obtain pre-service review to reduce risk of claim denial.

Denial Risk

Denial risk for not meeting criteria

Procedures performed without meeting the policy's medical necessity criteria are at risk for denial. Treatments considered experimental/investigational (e.g., adding sclerosant to coil embolization to improve outcomes, EVLA, endoluminal occlusion devices, surgical treatment for subclinical varicocele, varicocelectomy for non-obstructive azoospermia) are not covered for the listed indications.

If documentation does not demonstrate one of the medical necessity indications (adolescent with testicular growth retardation; male infertility with decreased motility/lower concentration; post-surgical recurrence; scrotal pain), the claim may be denied.
Procedures labeled experimental/investigational in this policy should not be submitted as covered services.

Prior Authorization

Authorization triggers and cautions

Authorization triggers and cautions: treatment of subclinical varicoceles is uncertain and generally not supported by high-quality evidence; exercise caution and document rationale when treating subclinical cases.

Subclinical varicocele treatment lacks consensus and is considered experimental in this policy — provide clear documentation if treatment is pursued.
When novel devices or techniques (e.g., ArtVentive EOS, EVLA) are proposed, include evidence of medical necessity and any supporting literature; these are listed as experimental/investigational.

Documentation Required

Coding and supporting documentation — Use listed codes and ensure documentation supports coverage

Coding and supporting documentation — Use the CPT/HCPCS/ICD-10 codes referenced and ensure clinical documentation supports that selection criteria for coverage are met before billing.

Covered CPT when criteria met: 37241 (vascular embolization/occlusion, venous).
Other relevant CPTs listed in bulletin: 37799 (unlisted vascular procedure); 55530-55540 and 55550 for varicocele excision/ligation (not covered for subclinical varicocele).
HCPCS / supply codes for certain devices or sclerosants may be not covered as noted (e.g., ArtVentive EOS, sclerosing agents). J1430 (injection, ethanolamine oleate) is listed among agents.
ICD-10 codes referenced: E29.1 (Testicular hypofunction), I86.1 (Scrotal varices), N46.023 (as applicable) — submit diagnosis codes that support medical necessity.
Retain operative reports, imaging (Color Doppler ultrasound), semen analyses, and other diagnostic test results to substantiate the indication.

Step Therapy

Step therapy for embolization materials — No step therapy requirements described

Step therapy for embolization materials — No step therapy rules are described in this policy; comparative outcomes for embolic materials are discussed but do not establish a required sequence of therapies or materials.

Systematic reviews report differences in recurrence rates among glue, coils, and sclerosants, but the policy does not mandate a step-wise use of materials.
No payer-imposed step-therapy or prior trial requirements for specific embolic materials are provided in this excerpt.

Billing Rule

Provider actions not provided in these chunks — Verify operational details with payer

Provider actions not provided in these chunks — Certain administrative items (e.g., specific prior authorization forms, payer web portals, or preauthorization codes) are not detailed here; contact the payer or consult plan-specific resources for operational steps.

Policy history and review dates are documented but do not replace plan-specific authorization instructions.
If additional billing guidance is needed (modifiers, global period queries), use payer resources or provider services.

Clinical Background

Varicoceles are dilations of the pampiniform venous plexus most commonly found on the left side and are associated with impaired fertility in about 30% of men with infertility. Grading ranges from Grade 1 (small, palpable only with Valsalva) to Grade 3 (large, visible); ultrasonography with color Doppler is the most practical noninvasive diagnostic method. Established treatments include embolization and surgical ligation/varicocelectomy, which can improve semen parameters and, in adolescents, testicular size.

Clinical Definitions and Devices

Grade 1 varicocele

DefinitionGrade 1 varicocele: small — palpable only during a Valsalva maneuver.

Clinical detectionMay be detected on physical exam only with Valsalva maneuver; ultrasonography can aid diagnosis.

RelevanceIncluded in the clinical grading system used to determine treatment candidacy (grade 1 = subclinical/small).

Grade 2 varicocele

DefinitionGrade 2 varicocele: moderate — palpable without the need for a Valsalva maneuver.

Clinical detectionEasily palpable on routine physical examination without special maneuvers.

RelevancePart of the 3-grade clinical system used to stratify varicoceles for management decisions.

Grade 3 varicocele

DefinitionGrade 3 varicocele: large — visible.

Clinical detectionVisible on inspection of the scrotum; readily identified without palpation in many cases.

RelevanceRepresents the most severe clinical grade in the standard classification influencing treatment consideration.

ArtVentive EOS (Endoluminal occlusion system)

Device descriptionArtVentive EOS is an endoluminal occlusion system comprised of an implantable occlusion device and a delivery catheter for percutaneous peripheral arterial and venous occlusion.

Intended useDeveloped to occlude peripheral arteries and veins, including the spermatic vein for varicocele treatment.

Device sizesTwo device sizes: size 1 for target vessels 3.5–5.5 mm; size 2 for target vessels 5.5–8.5 mm.

Clinical findingsInitial study (Venbrux et al) reported 100% acute occlusion in 9 of 9 treated vessels and sustained occlusion at 30 days in the small cohort.

Endovenous laser ablation (EVLA) of the spermatic vein

DefinitionEndovenous laser ablation (EVLA) of the spermatic vein: a percutaneous laser-based technique to ablate the spermatic vein for varicocele treatment.

Evidence statusEarly feasibility study (Basile et al, n=11) reported technical success in all cases with disappearance of varicocele on color Doppler ultrasound at 1 and 3 months and symptom/ spermiographic improvements.

LimitationsPublished data are limited (small, early series); EVLA is not mentioned as a standard option in an UpToDate review of male infertility.

Policy history / definitions

Policy history linkPolicy history and last review dates are documented (Last review 06/07/2023; Effective 05/04/2000; Next review 04/25/2024).

Definitions linkPolicy references a Definitions page (Definitions link provided in policy history section) but clinical definitions are presented elsewhere in the document.

Content noteThis chunk records administrative metadata (review dates and links) rather than additional clinical definitions.

Policy Dates and History

2000-05-04policy_effective

Policy became effective.

2023-06-07last_review

Policy was last reviewed.

2024-04-25next_review_scheduledLatest

Next scheduled policy review date.

Policy Summary

PayerAetna

PolicyVaricocele: Selected Treatments

Policy CodePolicy 0413

Change TypeNo material change

Effective DateMay 4, 2000

Next Review DateApr 25, 2024

Key ActionSubmit embolization or ligation procedure codes with supporting clinical documentation that the patient meets the listed medical necessity criteria.

SourceLink

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