Medical Necessity Determination for Varithena (CPT 36465 x3)
Varithena sclerotherapy is NOT medically necessary for this patient because the critical prerequisite of treating saphenofemoral junction reflux with endovenous thermal ablation or surgical ligation has not been met, which is required to reduce the risk of varicose vein recurrence.
Critical Missing Criterion
The Aetna policy explicitly requires that if a patient has incompetence at the saphenofemoral junction, the junctional reflux must be treated by one or more endovenous ablation procedures (radiofrequency ablation, endovenous laser ablation, or surgical ligation/stripping) BEFORE or concurrent with sclerotherapy to reduce the risk of varicose vein recurrence. 1, 2
Evidence-Based Treatment Algorithm
The established treatment sequence for varicose veins with saphenofemoral junction incompetence follows this hierarchy:
- First-line treatment: Endovenous thermal ablation (radiofrequency or laser) for the great saphenous vein or small saphenous vein with documented reflux at the saphenofemoral junction 1, 3
- Second-line/adjunctive treatment: Foam sclerotherapy (including Varithena) for tributary veins and residual varicosities AFTER treating the main truncal reflux 1, 2
- Third-line treatment: Surgical ligation and stripping when endovenous techniques are not feasible 3
Why This Sequence Matters
- Multiple studies demonstrate that chemical sclerotherapy alone has significantly worse outcomes at 1-, 5-, and 8-year follow-ups compared to thermal ablation or surgery, with higher rates of recurrent great saphenous vein reflux and saphenofemoral junction failure 1
- Treating the saphenofemoral junction with thermal ablation or ligation provides better long-term outcomes than foam sclerotherapy alone, with success rates of 85% at 2 years versus 72-89% for foam alone 1
- The treatment plan must include treatment of saphenofemoral junction reflux to meet medical necessity criteria, as recommended by the American College of Radiology with moderate strength of evidence 1
Criteria This Patient DOES Meet
The patient satisfies several important criteria for varicose vein treatment:
- Vein size requirement: Veins ≥2.5 mm diameter measured by ultrasound (medial saphenous veins documented on 9/25/25) 1, 2
- Symptomatic criteria: Severe and persistent pain, swelling, aching, fatigue/heaviness interfering with activities of daily living (cannot sit or stand for extended periods) 1, 2, 3
- Conservative management failure: Documented trial of 20-30mmHg compression therapy for >3 months with minimal relief, plus exercise and over-the-counter analgesics without significant improvement 1, 2, 3
- Appropriate clinical presentation: Bilateral varicose veins with complications (I83.893), progressive symptoms over several years, moderate interference in daily activities 2, 3
What Should Happen Instead
The appropriate treatment plan should be:
Initial treatment: Endovenous thermal ablation (radiofrequency ablation or endovenous laser ablation) of the great saphenous vein or small saphenous vein to address the saphenofemoral junction incompetence 1, 3
Subsequent treatment: Varithena sclerotherapy for residual tributary veins and varicosities 4-6 weeks after the primary ablation procedure 1, 2
FDA-Approved Indications for Varithena
The FDA label for polidocanol (Asclera/Varithena) indicates it is approved for sclerosing uncomplicated spider veins (≤1 mm diameter) and uncomplicated reticular veins (1-3 mm diameter) in the lower extremity, and specifically states "Asclera has not been studied in varicose veins more than 3mm in diameter" 4. While Varithena (the microfoam formulation) has been studied in larger veins with saphenofemoral junction incompetence, the clinical trials demonstrate efficacy when used as part of a comprehensive treatment approach 5, 6.
Common Pitfall to Avoid
Do not proceed directly to sclerotherapy alone when saphenofemoral junction incompetence is present. This approach leads to higher recurrence rates and suboptimal long-term outcomes because the underlying source of reflux remains untreated 1, 3. The presence of documented reflux at the saphenofemoral junction is significant and requires treatment with thermal ablation or surgical intervention to prevent recurrence 1.
Recommendation for Authorization
Deny the current request for Varithena x3 sessions as submitted. Instead, recommend authorization for:
- Endovenous thermal ablation (radiofrequency or laser) of the bilateral great saphenous veins or small saphenous veins (whichever demonstrates saphenofemoral junction incompetence on the 9/25/25 ultrasound) 1, 3
- Subsequent Varithena sclerotherapy sessions for residual tributary veins can be reconsidered 4-6 weeks after successful completion of the primary ablation procedure, with repeat ultrasound documentation 1, 2
This approach aligns with evidence-based guidelines from the American College of Radiology and American Academy of Family Physicians, which emphasize treating the saphenofemoral junction first to reduce recurrence risk and optimize long-term outcomes 1, 3.