Is Varithena (polidocanol) medically necessary for a patient with left-sided varicosities and chronic venous insufficiency who has persistent symptoms despite wearing prescription compression stockings?

Medical Necessity Assessment for Varithena in Left-Sided Varicosities

Primary Determination

Varithena (polidocanol endovenous microfoam) is NOT medically necessary as a standalone treatment for this patient because the insurance criteria explicitly require concurrent treatment of saphenofemoral junction (SFJ) reflux with endovenous thermal ablation or surgical ligation when junctional incompetence is present. 1

Critical Analysis of Insurance Criteria vs. Clinical Presentation

Criteria Met

• Vein diameter requirement: Left GSV measures 3.5mm proximally and 3.1-3.3mm mid-calf, exceeding the 2.5mm minimum threshold 1, 2
• Reflux duration: Left GSV demonstrates 6 seconds (6000ms) of reflux proximally and 3.3 seconds (3300ms) mid-calf, far exceeding the 500ms threshold 1, 2
• Conservative management: Patient wears prescription thigh-high compression stockings, meeting the 3-month trial requirement 2
• Symptomatic disease: Chronic venous insufficiency with varicosities causing functional impairment 1, 2

Critical Criterion NOT Met

• The insurance policy explicitly states: "If [patient] has incompetence (i.e., reflux) at the saphenofemoral junction, the junctional reflux is being treated by one or more of the endovenous ablation or ligation and division procedures" 1
• The ultrasound report does NOT document SFJ reflux measurements or diameter at the saphenofemoral junction 1, 3
• Without documented SFJ measurements, medical necessity cannot be established 1, 3

Evidence-Based Treatment Algorithm

Step 1: Obtain Complete Diagnostic Documentation

Before ANY treatment approval, a comprehensive duplex ultrasound must document: 1, 2

• Exact reflux duration at the saphenofemoral junction (SFJ) with anatomic landmarks
• GSV diameter measured immediately below the SFJ
• Assessment of deep venous system patency
• Specific location and extent of all refluxing segments

The current ultrasound is INCOMPLETE because it lacks SFJ measurements 1, 3

Step 2: Determine Appropriate Treatment Based on Complete Ultrasound

If SFJ Reflux ≥500ms AND GSV Diameter ≥4.5mm at SFJ:

Endovenous thermal ablation (radiofrequency or laser) is the REQUIRED first-line treatment 1, 2, 3

• Technical success rates: 91-100% occlusion at 1 year 1, 3
• Varithena may be added as adjunctive therapy for tributary veins AFTER or CONCURRENT with thermal ablation 1
• Varithena alone without treating junctional reflux results in 20-28% recurrence rates at 5 years 1

If SFJ Reflux ≥500ms BUT GSV Diameter 2.5-4.4mm:

Foam sclerotherapy (Varithena) becomes appropriate as primary treatment 1, 2

• Expected occlusion rates: 72-89% at 1 year 1
• However, junctional reflux must still be addressed to prevent recurrence 1

If NO Significant SFJ Reflux (<500ms):

Varithena alone may be appropriate for isolated mid-calf GSV reflux 1, 2

• This scenario would meet insurance criteria without requiring thermal ablation 1

Why This Criterion Exists: Clinical Rationale

Untreated saphenofemoral junction reflux creates persistent downstream venous hypertension that causes tributary vein recurrence even after successful sclerotherapy 1

• Multiple studies demonstrate that chemical sclerotherapy alone has worse outcomes at 1-, 5-, and 8-year follow-ups compared to thermal ablation or surgery 1
• The treatment sequence is critical: thermal ablation for junctional reflux FIRST, then sclerotherapy for residual tributaries 1, 2
• Treating tributaries without addressing the upstream source of reflux leads to predictable treatment failure 1

Common Pitfalls and How to Avoid Them

Pitfall #1: Incomplete Ultrasound Documentation

The most common reason for denial is missing SFJ measurements 1, 3

• Solution: Request repeat ultrasound specifically documenting SFJ reflux duration and GSV diameter at the SFJ 1, 3

Pitfall #2: Attempting Varithena as Sole Treatment When Thermal Ablation is Required

Insurance will deny if GSV diameter ≥4.5mm at SFJ with documented junctional reflux 1, 2

• Solution: Submit for combined procedure (thermal ablation + Varithena) rather than Varithena alone 1

Pitfall #3: Assuming Mid-Calf Measurements Substitute for SFJ Measurements

Reflux and diameter measurements must be obtained at the saphenofemoral junction specifically 1, 3

• Mid-calf measurements (3.3s reflux, 3.1-3.5mm diameter) do NOT establish medical necessity for junctional treatment 1, 3

Specific Recommendation for This Case

DENY Varithena as currently requested. Require the following before resubmission: 1, 2, 3

1. Repeat duplex ultrasound documenting:

   • Reflux duration at the left saphenofemoral junction (must be ≥500ms for treatment) 1, 2
   • Left GSV diameter measured immediately below the SFJ 1, 3
   • Deep venous system patency 2

2. If repeat ultrasound shows SFJ reflux ≥500ms with GSV diameter ≥4.5mm:

   • Approve endovenous thermal ablation (radiofrequency or laser) as primary treatment 1, 2, 3
   • Consider Varithena as adjunctive therapy for residual tributaries 1

3. If repeat ultrasound shows SFJ reflux ≥500ms with GSV diameter 2.5-4.4mm:

   • Varithena becomes appropriate as primary treatment 1, 2
   • Must still address junctional reflux to meet insurance criteria 1

4. If repeat ultrasound shows NO significant SFJ reflux (<500ms):

   • Varithena alone may be approved for isolated mid-calf GSV reflux 1, 2

Strength of Evidence

• American College of Radiology Appropriateness Criteria (2023) provide Level A evidence that junctional reflux must be treated before or concurrent with tributary sclerotherapy 1
• American Family Physician guidelines (2019) provide Level A evidence that endovenous thermal ablation is first-line treatment for documented junctional reflux with GSV diameter ≥4.5mm 1, 2
• Society for Vascular Surgery/American Venous Forum (2011) guidelines provide Grade 1B recommendation for endovenous thermal ablation over surgical stripping 4

Expected Outcomes If Criteria Are Eventually Met

With Appropriate Treatment Sequencing:

• Thermal ablation of SFJ reflux: 91-100% occlusion at 1 year 1, 3
• Adjunctive Varithena for tributaries: 72-89% occlusion at 1 year 1
• Combined approach provides comprehensive treatment with lowest recurrence rates 1

Risks to Counsel Patient About:

• Thermal ablation: ~7% risk of temporary nerve damage, 0.3% DVT risk, 0.1% PE risk 1, 3
• Varithena: 35.4% superficial thrombophlebitis (generally mild), contusion, limb discomfort 5, 6
• Recent data suggests 5 days of apixaban 5mg twice daily may reduce DVT risk after Varithena from 16.7% to 1.98% 7