Is injection therapy of veins, specifically sclerotherapy with Varithena (polidocanol), medically necessary for a patient with symptomatic varicose veins (I83.812) of the left lower extremity, severe and persistent pain, and swelling, despite previous treatments, including endovenous ablation and conservative management with medical grade compression stockings, and normal saphenofemoral junction findings on ultrasound?

Medical Necessity Assessment: Sclerotherapy for Varicose Veins Without Saphenofemoral Junction Reflux

Sclerotherapy is NOT medically necessary for this patient because the saphenofemoral junction (SFJ) is normal on ultrasound, which is a critical exclusion criterion that must be addressed before tributary vein treatment can be considered appropriate.

Critical Missing Criterion: Saphenofemoral Junction Treatment Requirement

The most significant barrier to medical necessity is the documented normal saphenofemoral junction findings. Multiple guidelines explicitly state that if saphenofemoral junction incompetence exists, it must be treated with endovenous ablation or surgical ligation before or concurrent with tributary sclerotherapy to prevent recurrence 1. The policy criteria specifically require: "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.

Why This Criterion Exists

• Untreated junctional reflux causes persistent downstream pressure, leading to tributary vein recurrence rates of 20-28% at 5 years even after successful sclerotherapy 1.
• Chemical sclerotherapy alone has inferior long-term outcomes at 1-, 5-, and 8-year follow-ups compared to thermal ablation when junctional reflux is present 1.
• The treatment sequence is critical for long-term success: endovenous thermal ablation for main truncal veins first, followed by sclerotherapy for tributaries 1, 2.

Clinical Context for This Patient

The ultrasound documents normal saphenofemoral junction findings, which creates an unusual clinical scenario. The patient has:

• Previous left GSV and left SSV ablations (documented in history) 1
• Current varicose veins with reflux >500msec and diameter >4.5mm 1
• Normal SFJ on current ultrasound 1

This raises a critical question: Where is the source of the current reflux? The policy assumes that if varicose veins are present with normal SFJ, either:

1. The reflux originates from incompetent perforators
2. The reflux represents residual or recurrent disease in previously ablated segments
3. There is accessory saphenous vein reflux not adequately documented

Additional Unmet Criteria

Lack of Severe Qualifying Conditions

The policy requires varicosities result in one of the following severe conditions 1:

• Intractable ulceration secondary to venous stasis - NOT documented in this case
• More than 1 episode of minor hemorrhage from ruptured varicosity, or single significant hemorrhage requiring transfusion - NOT documented in this case

Conservative Management Documentation Gap

While the patient reports symptoms "for years" and mentions "post ablation" status, the policy requires documented failure of a 3-month trial of medical-grade gradient compression stockings (20 mmHg or greater) for the current episode of symptoms 1, 3. The documentation does not clearly establish:

• When the current symptoms began relative to previous ablations
• Whether a formal 3-month trial of compression therapy was attempted for these specific symptoms
• Compliance with compression therapy and symptom persistence despite proper use

Vein Size Criteria Assessment

The documented veins DO meet size criteria for sclerotherapy:

• Policy requires vein diameter ≥2.5 mm 1
• Ultrasound documents reflux >500msec and veins >4.5mm 1
• FDA labeling for polidocanol (Asclera) indicates approval for veins 1-3mm diameter, though Varithena foam formulations may be used for larger veins 4

Symptom Severity Assessment

The patient's symptoms appear to meet severity criteria:

• Reports persistent lower leg itching interfering with clothing choices 1
• Standing causes aching 1
• Reports difficulty with prolonged standing and walking limiting daily activity levels 1
• Symptoms documented "for years" 1

However, symptom severity alone is insufficient without meeting the other mandatory criteria, particularly the requirement for either severe complications (ulceration/hemorrhage) OR proper junctional reflux treatment 1.

Evidence-Based Treatment Algorithm When Criteria Are Not Met

Step 1: Obtain Complete Diagnostic Documentation

• Request clarification on the source of current reflux with normal SFJ 1
• Document exact anatomic location of refluxing segments (GSV remnant, accessory saphenous, perforators) 1
• Confirm whether previously ablated veins have recanalized 1

Step 2: Implement or Document Conservative Management Trial

• Prescribe medical-grade gradient compression stockings (20-30 mmHg minimum) for documented 3-month trial 1, 3
• Include leg elevation, exercise, weight loss if applicable 1
• Document symptom persistence despite full compliance 1

Step 3: Address Source of Reflux Before Tributary Treatment

• If recanalized GSV or SSV: Endovenous thermal ablation is first-line treatment with 91-100% occlusion rates at 1 year 1
• If incompetent perforators: These should be addressed with ablation or subfascial endoscopic perforator surgery 1
• If accessory saphenous veins: Thermal ablation for veins ≥4.5mm diameter, sclerotherapy for 2.5-4.4mm 1

Common Pitfalls in This Clinical Scenario

Pitfall 1: Treating Tributaries Without Addressing Upstream Source

The most common error is performing sclerotherapy on visible varicose veins without identifying and treating the source of venous hypertension 1. This leads to rapid recurrence and patient dissatisfaction 1.

Pitfall 2: Inadequate Ultrasound Documentation

The current ultrasound documents "varicose veins" and "reflux more than 500msec more than 4.5mm" but does not specify the exact anatomic segments with these measurements 1. Medical necessity requires documentation of:

• Exact vein diameter at specific anatomic landmarks 1
• Reflux duration at saphenofemoral junction with precise measurements 1
• Assessment of deep venous system patency 1
• Location and extent of all refluxing segments 1

Pitfall 3: Misunderstanding Post-Ablation Anatomy

After previous GSV and SSV ablations, the venous anatomy is altered and requires careful mapping to identify the current source of symptoms 1. The normal SFJ finding suggests either:

• Successful ablation of the main truncal veins with residual tributary disease
• Development of new incompetent pathways (neovascularization, accessory veins)
• Incompetent perforators as the primary source

Strength of Evidence Assessment

• 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 for treatment sequencing: thermal ablation first-line for main trunks, sclerotherapy second-line for tributaries 1, 2
• FDA labeling for polidocanol specifies approved indications for veins ≤3mm diameter, with larger veins requiring foam formulations 4

Recommendation for Authorization Decision

DENY the current request for sclerotherapy (CPT 36471) as NOT medically necessary because:

1. The saphenofemoral junction is documented as normal, yet the policy requires treatment of junctional reflux when present to prevent recurrence 1
2. The source of current reflux is not adequately identified - requires additional diagnostic workup to determine if recanalized previously ablated veins, incompetent perforators, or accessory saphenous veins are responsible 1
3. No documentation of ulceration or hemorrhage (the severe complications that would override other requirements) 1
4. Insufficient documentation of 3-month conservative management trial for current symptoms 1, 3

Required Actions Before Resubmission

• Obtain updated duplex ultrasound with specific anatomic mapping of all refluxing segments, exact diameter measurements, and identification of the source of venous hypertension 1
• Document 3-month trial of medical-grade compression stockings (20-30 mmHg) with symptom diary showing persistence despite compliance 1, 3
• If recanalized veins or incompetent perforators identified: treat these with appropriate thermal ablation first 1
• Only after addressing the source of reflux should tributary sclerotherapy be considered 1, 2