Is Varithena (polidocanol) medically necessary for a 55-year-old patient with varicose veins and pain, who has incompetence at the saphenofemoral junction and has not met the CPB (Clinical Policy Bulletin) criteria for previous treatment of reflux?

Medical Necessity Determination: Varithena for Right SSV Reflux

Varithena (polidocanol foam sclerotherapy) for the right small saphenous vein is NOT medically necessary at this time because the patient has documented saphenofemoral junction (SFJ) reflux bilaterally that has not been treated, which violates the explicit insurance policy requirement and evidence-based treatment sequencing guidelines.

Critical Unmet Criterion

The insurance Clinical Policy Bulletin explicitly states that if a member has incompetence (reflux) at the saphenofemoral junction, the junctional reflux MUST be treated by endovenous ablation or ligation procedures to reduce the risk of varicose vein recurrence before foam sclerotherapy can be approved. 1

Documented Bilateral SFJ Reflux Requiring Treatment First

• Right SFJ: 825 ms reflux time with 3.64 mm diameter - This exceeds the 500 ms threshold for pathologic reflux and meets criteria for thermal ablation 1, 2
• Left SFJ: 508 ms reflux time with 6.5 mm diameter - This also exceeds the 500 ms threshold and the 4.5 mm diameter requirement for radiofrequency ablation 1, 2

Evidence-Based Treatment Algorithm

Step 1: Treat Saphenofemoral Junction Reflux FIRST (Currently Not Done)

Endovenous thermal ablation (radiofrequency or laser) must be performed for bilateral GSV reflux originating from the SFJ before any tributary or SSV sclerotherapy. 1, 2

• The American College of Radiology explicitly states that treating junctional reflux with thermal ablation is essential before tributary sclerotherapy to prevent recurrence 1
• Multiple studies demonstrate that chemical sclerotherapy alone has worse outcomes at 1-, 5-, and 8-year follow-ups compared to thermal ablation, with recurrence rates of 20-28% at 5 years when junctional reflux is not addressed 1, 3
• Untreated junctional reflux causes persistent downstream pressure, leading to tributary and SSV vein recurrence even after successful sclerotherapy 1

Step 2: Varithena for Right SSV (After SFJ Treatment)

Only after bilateral SFJ reflux is treated with thermal ablation can Varithena be considered medically necessary for the right SSV. 1, 2

• The right SSV meets size criteria (2.92 mm diameter exceeds the 2.5 mm minimum) 1, 2
• The right SSV meets reflux criteria (725 ms exceeds the 500 ms threshold) 1, 2
• Foam sclerotherapy demonstrates 72-89% occlusion rates at 1 year for appropriately selected veins 1, 3

Why This Sequence Matters Clinically

The treatment sequence is not arbitrary—it is based on hemodynamic principles and long-term outcome data. 1, 2

• The SFJ serves as the primary source of venous hypertension in this patient's venous system 1
• Treating downstream veins (SSV, tributaries) without addressing upstream junctional reflux results in persistent high pressure that causes rapid recurrence 1
• Studies show that when SFJ reflux remains untreated, sclerotherapy of tributary veins has a 20-28% recurrence rate at 5 years 1, 3

Approved Procedure: Left GSV Radiofrequency Ablation

The left GSV radiofrequency ablation (CPT 36475) DOES meet all medical necessity criteria and should be certified. 1, 2

• Left SFJ reflux: 508 ms (exceeds 500 ms threshold) ✓ 1
• Left GSV diameter: 6.5 mm at SFJ, 4.57 mm proximal thigh (exceeds 4.5 mm threshold) ✓ 1
• Symptomatic disease with severe persistent pain and swelling interfering with ADLs ✓ 1
• Conservative management failure: 3+ months compression stockings ✓ 2
• CEAP Class 4 with skin changes (C1, C2, s, Ep, As, P) ✓ 1

Recommended Clinical Pathway

Immediate Authorization

1. Certify LEFT GSV radiofrequency ablation (CPT 36475) - All criteria met 1, 2

Require for Future Varithena Authorization

1. RIGHT GSV radiofrequency ablation must be performed first to address the right SFJ reflux (825 ms, 3.64 mm) 1, 2
2. After bilateral SFJ treatment is completed and documented, resubmit authorization request for right SSV Varithena with post-ablation ultrasound showing successful SFJ occlusion 1

Common Pitfall to Avoid

Do not approve sclerotherapy procedures when documented SFJ reflux exists and has not been treated, even if the target vein (SSV) meets size and reflux criteria independently. 1, 2

• The insurance policy explicitly requires SFJ treatment first, and this requirement is supported by Level A evidence from the American College of Radiology Appropriateness Criteria (2023) 1
• Approving Varithena without prior SFJ treatment will likely result in treatment failure and need for repeat procedures 1

Strength of Evidence

• Level A evidence from American College of Radiology Appropriateness Criteria (2023) supports mandatory treatment of SFJ reflux before tributary/SSV sclerotherapy 1
• Level A evidence from American Family Physician guidelines (2019) confirms endovenous thermal ablation as first-line treatment for SFJ reflux with diameter ≥4.5 mm and reflux ≥500 ms 2
• Insurance policy requirement explicitly states junctional reflux must be treated before foam sclerotherapy approval 1