Is Varithena (polidocanol) chemo ablation of the left Great Saphenous Vein (GSV) medically necessary for a patient with chronic venous insufficiency, severe multilevel reflux, and lifestyle-limiting symptoms, given the unavailability of radiofrequency and laser ablation?

Medical Necessity Assessment for Varithena Chemo Ablation of Left GSV

Recommendation

Varithena (polidocanol foam sclerotherapy) alone for the left GSV is NOT medically necessary as first-line treatment for this patient, because the documentation confirms severe saphenofemoral junction reflux (5.1 seconds) with a large-diameter GSV (1.3 cm at SFJ), which mandates endovenous thermal ablation as first-line therapy—however, since radiofrequency and laser ablation are unavailable at this facility, Varithena may be approved as an alternative treatment modality for the main GSV trunk, provided the facility documents why thermal ablation cannot be arranged at another facility and acknowledges the inferior long-term outcomes compared to thermal ablation. 1

Critical Analysis of Documentation

Criteria Met for Intervention

• Saphenofemoral junction reflux: 5.1 seconds (significantly exceeds the 500ms threshold required for medical necessity) 1
• GSV diameter: 1.3 cm (13mm) at the saphenofemoral junction, well above the 4.5mm minimum for thermal ablation 1
• Failed conservative management: 30-40mmHg compression stockings for 2 years, frequent elevation, and venous exercises 1
• Lifestyle-limiting symptoms: Swelling, heaviness, throbbing ache, paresthesias, tender varicosities interfering with work and daily activities 1
• Physical examination: Mild pitting edema and prominent tender varicosities on left lower extremity 1

The Treatment Hierarchy Problem

The fundamental issue is that this patient requires thermal ablation, not sclerotherapy, as first-line treatment. 1

• The American College of Radiology explicitly recommends endovenous thermal ablation (radiofrequency or laser) as first-line treatment for GSV reflux when the vein diameter is ≥4.5mm with documented saphenofemoral junction reflux >500ms 1
• This patient's GSV measures 13mm at the SFJ with 5.1 seconds of reflux—these measurements strongly indicate thermal ablation as the appropriate modality 1
• Chemical sclerotherapy alone has worse outcomes at 1-, 5-, and 8-year follow-ups compared to thermal ablation, with recurrence rates of 20-28% at 5 years 1

Evidence-Based Treatment Algorithm

Step 1: Why Thermal Ablation is Preferred

• Endovenous thermal ablation demonstrates 91-100% occlusion rates at 1 year for GSV reflux 1, 2
• Thermal ablation has largely replaced surgical ligation and stripping due to similar efficacy with fewer complications and faster recovery 1, 2
• Treating saphenofemoral junction reflux with thermal ablation provides better long-term outcomes than foam sclerotherapy alone 1

Step 2: Varithena as Alternative When Thermal Ablation Unavailable

• The American College of Radiology recognizes foam sclerotherapy as appropriate treatment when "radiofrequency or laser ablation is contraindicated, not available, or not feasible" 1
• Foam sclerotherapy (including Varithena) demonstrates 72-89% occlusion rates at 1 year—notably lower than thermal ablation's 91-100% 1, 2
• Varithena is FDA-approved for treatment of incompetent GSV and requires ultrasound guidance with maximum dosing of 5mL per injection and 15mL per treatment session 1

Step 3: Specific Veins Requiring Treatment

The documentation identifies these refluxing segments requiring treatment:

• Left GSV from saphenofemoral junction through mid-calf (severe multilevel reflux with times ranging from 4.4-6.2 seconds) 1
• Left distal calf perforator vein (4.6 seconds of reflux) 1
• The treatment plan should address the entire incompetent GSV trunk from SFJ distally, as untreated junctional reflux causes persistent downstream pressure leading to tributary vein recurrence 1

CPT Code Analysis for Medical Necessity

Why 36465 x 2 and 36466 x 2 May Not Be Appropriate

The requested codes (36465 - injection non-compounded sclerosant single vein, 36466 - multiple veins) suggest treatment of tributary veins, but this patient requires treatment of the main GSV trunk. 1

• For main truncal vein treatment with Varithena, the appropriate code is typically 36465 for the GSV trunk itself, not multiple units for tributaries 1
• The American College of Radiology recommends treating the saphenofemoral junction reflux first, then addressing tributary veins as adjunctive therapy 1
• Sclerotherapy of tributary veins without first treating junctional reflux leads to 20-28% recurrence rates at 5 years 1

Clinical Caveats and Common Pitfalls

Critical Documentation Gap

• The facility must document why the patient cannot be referred to another facility with thermal ablation capabilities 1
• Simply stating "not available in our facility" is insufficient—the medical record should address whether referral to another facility was considered and why it was not feasible 1

Expected Outcomes with Varithena vs. Thermal Ablation

• Varithena for main GSV trunk: 72-89% occlusion at 1 year (lower than thermal ablation) 1, 3
• Thermal ablation: 91-100% occlusion at 1 year 1, 2
• Long-term recurrence: Foam sclerotherapy has higher rates of recurrent GSV reflux and saphenofemoral junction failure at 5- and 8-year follow-ups compared to thermal ablation 1

Common Side Effects of Varithena

• Phlebitis, new telangiectasias, and residual pigmentation at treatment sites 1
• Deep vein thrombosis is rare (approximately 0.3%) but requires early postoperative duplex scanning 1
• Transient visual disturbances and neurological symptoms can occur but are typically self-limited 4

Strength of Evidence Assessment

• American College of Radiology Appropriateness Criteria (2023): Level A evidence that endovenous thermal ablation is first-line treatment for GSV reflux with diameter ≥4.5mm and SFJ reflux >500ms 1
• American Family Physician guidelines (2019): Level A evidence supporting thermal ablation over sclerotherapy for main truncal veins 1
• Cochrane systematic review (2021): Moderate-certainty evidence that thermal ablation has comparable or superior technical success and recurrence rates compared to foam sclerotherapy 2

Final Determination

Approve Varithena treatment of the left GSV as an alternative to thermal ablation ONLY if:

1. The facility documents why referral to a facility with thermal ablation is not feasible 1
2. The patient is counseled about the lower long-term success rates (72-89% vs. 91-100%) and higher recurrence rates compared to thermal ablation 1, 2
3. The treatment plan specifies treatment of the entire incompetent GSV trunk from saphenofemoral junction distally, not just tributary veins 1
4. The patient understands that additional treatments may be needed due to the higher recurrence rates with foam sclerotherapy 1

The specific CPT codes requested (36465 x 2,36466 x 2) require clarification regarding which specific vein segments will be treated with each injection to ensure appropriate coding and medical necessity determination. 1