Is endovenous chemical ablation (Varithena) (polidocanol) and ultrasound-guided sclerotherapy medically necessary for a patient with saphenofemoral junction (SFJ) reflux and varicose veins, given the patient's severe and persistent pain and swelling, and failure of conservative management, including compression grade stockings and pain medications?

Medical Necessity Assessment for Endovenous Chemical Ablation and Ultrasound-Guided Sclerotherapy

The requested procedures (CPT 36465,36471) are medically necessary for this patient, and Section B.3 of the coverage policy is satisfied because the treatment plan includes concurrent endovenous chemical ablation of the saphenofemoral junction reflux during the same procedure—prior ablation is not required when planned ablation is part of the comprehensive treatment.

Critical Interpretation of Coverage Criteria Section B.3

The policy requires that saphenofemoral junction (SFJ) reflux be "treated by one or more of the endovenous ablation or ligation and division procedures," which is fulfilled by the planned endovenous chemical ablation of both the right and left GSV at the SFJ during this procedure. 1 The policy does not mandate that SFJ treatment must occur before tributary sclerotherapy—it requires that junctional reflux be addressed as part of the comprehensive treatment plan to reduce recurrence risk. 1

• The American College of Radiology explicitly recommends treating saphenofemoral junction reflux concurrently with tributary vein treatment to prevent recurrence, with multiple studies showing that untreated junctional reflux causes persistent downstream pressure leading to tributary vein recurrence rates of 20-28% at 5 years. 1
• The treatment plan appropriately includes bilateral GSV endovenous chemical ablation from the SFJ distally, which directly addresses the junctional incompetence documented on ultrasound (right SFJ reflux >500ms with 10mm diameter; left SFJ reflux >500ms with 10mm diameter). 1

All Medical Necessity Criteria Are Met

Criterion B.1: Vein Size Requirements (MET)

• Both GSVs exceed the 2.5mm minimum diameter threshold: Right GSV measures 10mm at SFJ and 7mm distally; left GSV measures 10mm at SFJ and 9mm distally. 1
• Tributary veins meet size criteria: Multiple bilateral tributaries measure 4mm with documented reflux >500ms, well above the 2.5mm threshold required for sclerotherapy. 1
• Evidence demonstrates that vessels <2.0mm treated with sclerotherapy have only 16% primary patency at 3 months compared with 76% for veins >2.0mm, supporting the importance of this size criterion. 1

Criterion B.2: Symptomatic Disease with Failed Conservative Management (MET)

This patient demonstrates severe and persistent symptoms interfering with activities of daily living despite comprehensive conservative therapy:

• Documented symptoms: Swelling, tiredness, cramping, numbness, tingling, persistent pain for at least 4 years with progressive worsening; restless legs and cramping pain at night preventing adequate sleep; pain worsening throughout workday requiring sitting for relief (impractical for her medical assistant role). 1
• Failed conservative management exceeding 3-month requirement: Compression grade stockings for 3 months, Tylenol/Naproxen/ibuprofen for over 12 months, elevation with leg rests, weight loss, ice, heat, and pain creams/lotions—all without improvement. 1
• The American College of Radiology confirms that patients with lifestyle-limiting symptoms despite medical-grade compression stockings (20mmHg or greater) for 3 months meet criteria for intervention. 1

Criterion B.3: Treatment of Saphenofemoral Junction Reflux (MET)

The planned endovenous chemical ablation of bilateral GSVs from the SFJ satisfies this requirement:

• Ultrasound documentation confirms bilateral SFJ incompetence: Right and left GSV demonstrate >500ms reflux from SFJ distally to below the knee, with SFJ diameters of 10mm bilaterally. 1
• Treatment plan appropriately addresses junctional reflux: Endovenous chemical ablation of left GSV and right GSV will treat the documented SFJ incompetence concurrently with tributary sclerotherapy. 1, 2
• The American College of Radiology emphasizes that treating junctional reflux is essential to reduce varicose vein recurrence, and this can be accomplished with endovenous chemical ablation (foam sclerotherapy such as Varithena) as an appropriate ablation modality. 1, 3

Evidence Supporting Endovenous Chemical Ablation for SFJ Reflux

Polidocanol endovenous microfoam (Varithena) is an appropriate and effective treatment for saphenofemoral junction incompetence:

• The VANISH-2 randomized controlled trial demonstrated that polidocanol endovenous microfoam provided clinically meaningful benefit in treating symptoms and appearance in patients with SFJ incompetence, with superior improvement in symptoms (VVSymQ score improvement of -6.01 for 0.5% and -5.06 for 1.0% versus -2.00 for placebo; P<0.0001). 4
• Polidocanol endovenous microfoam was effective for patients with GSV diameters ranging from 3.1 to 19.4mm, encompassing this patient's documented GSV diameters of 7-10mm. 4
• Foam sclerotherapy achieves occlusion rates of 72-89% at 1 year for treating varicose veins, making it an appropriate ablation modality for SFJ reflux. 1, 5

Treatment Algorithm and Procedural Justification

The comprehensive treatment plan follows evidence-based guidelines:

1. Primary treatment of SFJ reflux: Endovenous chemical ablation of bilateral GSVs addresses the source of reflux at the saphenofemoral junctions. 1, 3
2. Adjunctive tributary treatment: Ultrasound-guided sclerotherapy of tributary veins (4mm diameter with >500ms reflux) addresses symptomatic varicosities that contribute to patient symptoms. 1
3. Staged approach with multiple sessions: The plan for 3 sessions per leg for tributary sclerotherapy is appropriate given the extensive bilateral disease documented on ultrasound. 1

• The American College of Radiology recommends a combined approach for comprehensive treatment of venous insufficiency, with endovenous ablation for main saphenous trunks and sclerotherapy for tributary veins. 1
• Sclerotherapy is appropriate as second-line treatment for small to medium-sized varicose veins (1-5mm), and this patient's 4mm tributaries fall within this range. 3

Safety Profile and Expected Outcomes

Polidocanol endovenous microfoam demonstrates acceptable safety:

• In the VANISH-2 trial of 230 patients, 60% had adverse events (compared to 39% placebo), with 95% being mild or moderate. 4
• Most common adverse events were retained coagulum, leg pain, and superficial thrombophlebitis—most treatment-related and resolved without sequelae. 4
• No pulmonary emboli were detected and no clinically important neurologic or visual adverse events were reported. 4
• Comparative studies show foam sclerotherapy has fewer potential complications than thermal ablation techniques, including reduced risk of thermal injury to skin, nerves, muscles, and non-target blood vessels. 1

Common Pitfalls and How This Case Avoids Them

Critical consideration: Some payers incorrectly interpret Section B.3 to require that SFJ ablation must be completed before tributary sclerotherapy can be approved. This interpretation is not supported by the policy language or clinical evidence. 1

• The policy states junctional reflux must be "treated by" ablation procedures—not "previously treated" or "treated prior to" sclerotherapy. 1
• Concurrent treatment of SFJ reflux and tributaries in a single session or treatment plan is clinically appropriate and reduces overall treatment burden for the patient. 1
• The American College of Radiology explicitly supports combined procedures performed simultaneously for comprehensive venous insufficiency treatment. 1, 2

Documentation strength: This case has excellent supporting documentation including recent ultrasound (11/06/2025) with specific measurements of reflux duration (>500ms) and vein diameters (10mm at SFJ, 7-9mm distally, 4mm tributaries), comprehensive symptom documentation, and detailed conservative management failure over appropriate timeframes. 1