Are codes 36465 and 36466 medically necessary for a patient with bilateral varicose veins and significant saphenous vein reflux, who has tried compression stockings and lifestyle modifications, and has a history of previous vein treatment?

Medical Necessity Assessment for CPT Codes 36465 and 36466

Direct Answer

Based on the insurance criteria provided and current ultrasound documentation, codes 36465 (Varithena injection) and 36466 (ultrasound guidance) are NOT medically necessary at this time because the patient lacks documented prior treatment of saphenofemoral junction (SFJ) reflux, which is a mandatory requirement. The insurance policy explicitly states that Varithena is only medically necessary as adjunctive treatment when the patient "is being treated or has previously been treated" for incompetence at the SFJ or saphenopopliteal junction 1.

Critical Missing Documentation

Mandatory Criteria Not Met

• The insurance policy requires that junctional reflux must be treated with procedures such as ligation, division, stripping, VNUS procedure, or EVLT before Varithena can be considered medically necessary 1.
• The clinical documentation states the patient had vein procedures "about 15 years ago while living in [STATE] (unsure specifics at this time)," which fails to establish whether SFJ reflux was actually treated 1.
• Without confirmation that the previous treatment addressed SFJ reflux, the mandatory insurance criterion cannot be satisfied 1, 2.

Required Ultrasound Measurements Missing

• The ultrasound report must explicitly document reflux duration ≥500 milliseconds at the saphenofemoral junction with exact anatomic landmarks 1, 3.
• The provided ultrasound data shows reflux times but lacks clear documentation of whether these measurements were obtained at the SFJ specifically 1.
• Vein diameter measurements at specific anatomic sites are required, with minimum 2.5mm diameter for Varithena treatment 1.

Evidence-Based Treatment Algorithm

Step 1: Confirm Previous Treatment History

• Obtain operative reports or medical records from the procedures performed 15 years ago to verify whether SFJ reflux was treated 1.
• If SFJ reflux was NOT previously treated, the patient requires endovenous thermal ablation (radiofrequency or laser) as first-line treatment before Varithena can be considered 1, 3.

Step 2: Obtain Proper Diagnostic Documentation

• Order repeat venous duplex ultrasound with explicit instructions to document:
  • Reflux duration at bilateral SFJs with measurements ≥500 milliseconds 1, 3
  • Exact vein diameters at specific anatomic landmarks for all veins proposed for treatment 1
  • Assessment of deep venous system patency 1
  • Location and extent of all refluxing segments 1

Step 3: Implement Conservative Management

• Document a 3-month trial of medical-grade gradient compression stockings (20-30 mmHg minimum pressure) 1, 2.
• The patient reports using compression stockings, but documentation must confirm prescription-grade stockings with adequate pressure and duration of trial 1.

Step 4: Determine Appropriate Treatment Sequence

If SFJ reflux was NOT previously treated:

• Endovenous thermal ablation (RFA or laser) is mandatory first-line treatment for bilateral GSV reflux with documented SFJ incompetence 1, 3.
• Technical success rates for thermal ablation are 91-100% at 1 year, with superior long-term outcomes compared to sclerotherapy alone 1, 3.
• Treating tributary veins with Varithena without addressing upstream SFJ reflux causes persistent downstream pressure, leading to recurrence rates of 20-28% at 5 years 1, 2.

If SFJ reflux WAS previously treated:

• Varithena becomes appropriate for residual refluxing segments, tributary veins, and accessory saphenous veins with diameter ≥2.5mm 1.
• Foam sclerotherapy demonstrates 72-89% occlusion rates at 1 year for appropriately selected veins 1.

Clinical Rationale for Insurance Requirements

Why Junctional Treatment Must Precede Tributary Sclerotherapy

• Multiple studies demonstrate that chemical sclerotherapy alone has worse outcomes at 1-, 5-, and 8-year follow-ups compared to thermal ablation of main trunks 1.
• Untreated junctional reflux creates persistent venous hypertension that causes rapid recurrence even after successful tributary treatment 1, 2.
• The American College of Radiology explicitly states that treating junctional reflux with thermal ablation provides better long-term outcomes than foam sclerotherapy alone, with success rates of 85% at 2 years 1, 2.

Vein Size Requirements

• Vessels less than 2.0mm in diameter treated with sclerotherapy had only 16% primary patency at 3 months compared with 76% for veins greater than 2.0mm 1.
• The insurance policy requires minimum 2.5mm diameter measured by recent ultrasound 1.

Common Pitfalls to Avoid

Critical Error in Varicose Vein Treatment

• The most critical error is performing sclerotherapy on tributary veins without treating upstream junctional reflux 2.
• This leads to rapid recurrence from persistent downstream venous hypertension, need for repeat procedures within 6-12 months, and poor long-term outcomes 1, 2.

Documentation Failures

• Assuming previous treatment addressed SFJ reflux without verification through operative reports 1.
• Failing to document exact vein diameter measurements at specific anatomic landmarks 1, 3.
• Inadequate documentation of conservative management trial with prescription-grade compression 1, 2.

Recommended Next Steps

Immediate Actions Required

1. Obtain operative reports from procedures performed 15 years ago to verify whether SFJ reflux was treated 1.

2. Order repeat venous duplex ultrasound with specific measurements:

   • Reflux duration at bilateral SFJs (must be ≥500ms) 1, 3
   • Exact diameters of all veins proposed for Varithena treatment (must be ≥2.5mm) 1
   • Comprehensive assessment to confirm absence of occult saphenous or perforator reflux 2

3. Document 3-month trial of prescription-grade compression stockings (20-30 mmHg) with symptom diary 1, 2.

If SFJ Reflux Was NOT Previously Treated

• Schedule bilateral GSV endovenous thermal ablation as first-line treatment 1, 3.
• Varithena can be performed as adjunctive treatment for tributary veins during the same session or subsequently 1.
• This approach satisfies the insurance requirement that junctional reflux be treated concurrently with tributary sclerotherapy 1, 2.

Strength of Evidence

• American College of Radiology Appropriateness Criteria (2023) provide Level A evidence that junctional reflux must be treated before or concurrently with tributary sclerotherapy 1, 2.
• American Family Physician guidelines (2019) provide Level A evidence that endovenous thermal ablation is first-line treatment for symptomatic varicose veins with documented valvular reflux 1, 3.
• Multiple meta-analyses provide Level A evidence that thermal ablation of main trunks has superior long-term outcomes compared to isolated tributary treatment 1, 2.