Is Varithena (polidocanol) treatment medically necessary for a patient with bilateral painful varicose veins, who has tried compression stockings (20-30 mmHg) for 4 years with minimal relief, despite no evidence of reflux and vein size less than 4.5 mm on the Great Saphenous Vein (GSV)?

Varithena Treatment Does Not Meet Medical Necessity Criteria

This patient does NOT meet medical necessity criteria for Varithena (CPT 36465,36466) because there is no documented reflux at the saphenofemoral junction and the GSV diameter is below the required 4.5 mm threshold. 1

Critical Missing Criteria

Absence of Junctional Reflux

• The insurance policy explicitly requires "incompetence at the saphenofemoral junction or saphenopopliteal junction documented by recent Doppler or duplex ultrasound scanning" with "ultrasound documented junctional reflux duration of 500 milliseconds (ms) or greater." 1
• The ultrasound report clearly states "GSVJUN Reflux Absent" bilaterally, which is an absolute contraindication to proceeding with Varithena under this policy. 1
• Without junctional reflux, treating tributary veins with sclerotherapy alone results in 20-28% recurrence rates at 5 years because the upstream source of venous hypertension remains untreated. 1

Insufficient Vein Diameter

• The policy requires "vein size is 4.5 mm or greater in diameter measured by ultrasound below the saphenofemoral or saphenopopliteal junction" for saphenous vein treatment. 1
• The patient's GSV measurements show 3.0 mm (right) and 4.0 mm (left) at the junction, with even smaller diameters distally (0.8-1.1 mm), all falling below the 4.5 mm threshold. 1
• For sclerotherapy specifically, the policy requires "vein size is 2.5 mm or greater in diameter," and while some of the tributary veins meet this criterion (3.0-4.0 mm), they cannot be treated without addressing junctional reflux first. 1

Why These Criteria Exist

Evidence-Based Treatment Sequencing

• The American College of Radiology emphasizes that treating junctional reflux with thermal ablation or ligation 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 or surgery when junctional reflux is present. 1
• The treatment algorithm requires: (1) endovenous thermal ablation for main saphenous trunks with documented junctional reflux, followed by (2) sclerotherapy for tributary veins. 1

Vein Diameter Predicts Treatment Outcomes

• Vessels less than 2.0 mm treated with sclerotherapy had only 16% primary patency at 3 months compared with 76% for veins greater than 2.0 mm. 1
• The 4.5 mm threshold for saphenous veins ensures appropriate patient selection for endovenous procedures, reduces recurrence rates, and decreases complication rates. 1

What This Patient Actually Has

Tributary Vein Reflux Without Junctional Incompetence

• The patient has isolated tributary vein reflux with reflux times ranging from 0.72 to 5.08 seconds in various superficial tributary veins. 1
• However, the absence of GSV junctional reflux and the hypoplastic/non-visualized GSV segments indicate this is NOT classic saphenous vein insufficiency requiring endovenous ablation. 1
• The bilateral GSV hypoplasia from knee to proximal calf and non-visualization from proximal to mid-thigh suggests congenital anatomical variation rather than acquired valvular incompetence. 1

Alternative Treatment Approach

Conservative Management Should Continue

• The patient has used 20-30 mmHg compression stockings for 4 years with "partial/transient relief," which does not constitute treatment failure. 2
• The policy requires "severe and persistent pain and swelling interfering with activities of daily living" despite a 3-month trial of conservative management. 1
• While the patient reports pain affecting exercise and prolonged standing, this represents CEAP C2 disease (varicose veins without skin changes), which is symptomatic but not advanced disease. 1

Why Compression Alone May Be Insufficient But Still Required

• Compression stockings have limited evidence for treating varicose veins themselves, but insurance policies require documented compliance before approval of interventional treatments. 1
• However, compression therapy alone has inadequate evidence for C2-C4 disease, though it has value in C5-C6 disease (with ulceration). 1
• The patient's 4-year trial with "minimal relief" suggests compression is not adequately controlling symptoms, but without junctional reflux, interventional options are limited. 1, 2

What Would Be Required for Approval

For Varithena to Meet Medical Necessity

1. Documented reflux ≥500 milliseconds at the saphenofemoral or saphenopopliteal junction (currently absent). 1
2. Vein diameter ≥2.5 mm for tributary veins (some veins meet this criterion at 3.0-4.0 mm). 1
3. If saphenofemoral junction reflux were present, it must be treated with thermal ablation or ligation concurrently to reduce recurrence risk (not applicable here). 1

Alternative Consideration: Direct Tributary Treatment

• Some insurance policies may allow sclerotherapy of isolated tributary veins ≥2.5 mm without junctional reflux, but this specific policy explicitly requires junctional treatment when junctional incompetence exists. 1
• The policy states: "If member 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
• Since this patient has NO junctional incompetence, this requirement technically does not apply, but the policy does not explicitly address isolated tributary treatment without junctional disease. 1

Clinical Pitfalls to Avoid

Common Documentation Errors

• Exact vein diameter measurements at specific anatomic landmarks are mandatory to avoid inappropriate treatment selection. 1
• Reflux duration must be documented in milliseconds, not just as "present" or "absent." 1
• The policy requires ultrasound performed within the past 6 months before interventional therapy. 1, 3

Misunderstanding Treatment Algorithms

• Treating tributary veins without addressing upstream junctional reflux (when present) leads to high recurrence rates. 1
• In this case, junctional reflux is absent, but the GSV hypoplasia and small diameter suggest these tributaries may not respond well to sclerotherapy alone. 1
• Foam sclerotherapy demonstrates 72-89% occlusion rates at 1 year for appropriately selected veins ≥2.5 mm, but outcomes are worse when anatomical prerequisites are not met. 1

Recommendation for This Case

Request denial of the Varithena procedure based on failure to meet medical necessity criteria: (1) absence of saphenofemoral junction reflux, and (2) GSV diameter below 4.5 mm threshold. 1

Suggest the provider consider:

• Continued optimization of conservative management with properly fitted medical-grade compression stockings (20-30 mmHg minimum). 1, 2
• Reassessment with repeat duplex ultrasound in 6-12 months to document any progression of disease. 1
• If symptoms remain severe and lifestyle-limiting despite optimal conservative management, consider peer-to-peer review to discuss whether isolated tributary sclerotherapy without junctional treatment might be appropriate given the unique anatomical findings (GSV hypoplasia). 1
• Alternative consideration: ambulatory phlebectomy for larger tributary veins (>4 mm) may be more appropriate than sclerotherapy for these isolated varicosities. 1