Medical Necessity Assessment for Varithena (Polidocanol Endovenous Microfoam)

Primary Recommendation

Varithena is NOT medically necessary for this patient because critical medical necessity criteria are not met, specifically: (1) the diagnosis codes indicate "asymptomatic" varicose veins (I83.90), which directly contradicts medical necessity requirements, (2) the documentation fails to specify symptom duration and severity, and (3) most importantly, the patient's bilateral GSVs and SSVs have already been successfully ablated, meaning the saphenofemoral junction reflux—which is mandatory to treat before tributary sclerotherapy—has already been addressed. 1

Critical Analysis of Medical Necessity Criteria

Criterion 1: Vein Size Requirements (MET)

The insurer requires vein diameter ≥2.5 mm measured by recent ultrasound 1
This criterion is clearly met: Right and left saphenofemoral junction diameters are 6.8 mm and 8.2 mm respectively, with GSV proximal thigh measurements of 6.6 mm (right) and 6.1 mm (left), and multiple tributary veins measuring 4.5-5.0 mm 1
The American College of Radiology confirms that vessels <2.0 mm have only 16% primary patency at 3 months with sclerotherapy, compared to 76% for veins >2.0 mm, supporting the 2.5 mm threshold 1

Criterion 2: Clinical Indications (NOT MET)

The insurer requires ONE of the following:

Option A: Intractable ulceration secondary to venous stasis

Not documented in this case 1

Option B: Hemorrhage from ruptured varicosity

Not documented in this case 1

Option C: Symptoms persisting despite 3-month conservative trial

The insurer specifically requires EITHER recurrent superficial thrombophlebitis OR severe and persistent pain/swelling interfering with activities of daily living 1
CRITICAL DEFICIENCY: The documentation states "Symptoms and how long: not stated" 1
CRITICAL DEFICIENCY: The diagnosis code I83.90 explicitly states "asymptomatic varicose veins" which directly contradicts any claim of symptomatic disease requiring intervention 1
While the documentation mentions "help with comfort and quality of life," this vague statement does not meet the specific requirement for "severe and persistent pain and swelling interfering with activities of daily living" 1

Criterion 3: Treatment of Saphenofemoral Junction Reflux (ALREADY COMPLETED)

This is the most critical issue: The insurer explicitly requires that "if member has incompetence at the saphenofemoral junction, the junctional reflux is being treated by one or more of the endovenous ablation or ligation and division procedures" 1
The documentation clearly states: "Patient's bilateral GSVs with SSVs have been successfully ablated" 1
The American College of Radiology emphasizes that treating saphenofemoral junction reflux is mandatory BEFORE tributary sclerotherapy to prevent recurrence, with untreated junctional reflux causing 20-28% recurrence rates at 5 years 1
Since the junctional reflux has already been successfully treated, the current request for additional Varithena represents treatment of residual tributary veins, which is appropriate ONLY if symptomatic criteria are clearly met 1

Evidence-Based Treatment Algorithm Analysis

What Should Have Been Done (And Apparently Was)

First-line treatment: Endovenous thermal ablation of main saphenous trunks 1
- The American College of Radiology recommends radiofrequency ablation or endovenous laser ablation as first-line treatment for GSV reflux with diameter ≥4.5 mm and documented saphenofemoral junction reflux ≥500 ms 1
- This was completed: "Patient's bilateral GSVs with SSVs have been successfully ablated" 1
- Technical success rates for thermal ablation are 91-100% at 1 year 1
Second-line treatment: Foam sclerotherapy for residual tributary veins 1
- The American College of Radiology recognizes foam sclerotherapy as appropriate adjunctive treatment for tributary veins following primary saphenous trunk ablation 1
- Foam sclerotherapy achieves 72-89% occlusion rates at 1 year for tributary veins 1
- However, this is only medically necessary if symptoms persist despite successful trunk ablation 1

Why Varithena Was Chosen Over RFA for Current Treatment

The documentation states: "The reason we have performed Varithena over RFA is because the patient will not be able to tolerate the RFA procedure due to tortuous veins" 1
This is clinically appropriate reasoning, as tortuous veins are technically challenging for catheter-based thermal ablation 1
The FDA label for Varithena (polidocanol) does not restrict use based on vein tortuosity, making it suitable for this anatomic consideration 2

Critical Documentation Deficiencies

Missing Essential Information

Symptom documentation: "Symptoms and how long: not stated" 1
- The American College of Radiology requires documented symptoms with specific duration to establish medical necessity 1
- The insurer requires symptoms to be "severe and persistent" and "interfering with activities of daily living" 1
Contradictory diagnosis coding: I83.90 "asymptomatic varicose veins" 1
- This diagnosis code directly contradicts any claim of symptomatic disease requiring intervention 1
- The American Family Physician guidelines require symptomatic presentation for medical necessity determination 1
Post-ablation assessment: No documentation of post-ablation duplex ultrasound results 1
- The American College of Radiology recommends early postoperative duplex scans (2-7 days) after endovenous ablation to detect complications, and longer-term imaging (3-6 months) to assess treatment success 1
- Without documented assessment of the previously ablated GSVs/SSVs, it's impossible to confirm that junctional reflux remains adequately treated 1

Safety Considerations for Varithena

FDA-Approved Indications and Limitations

The FDA label for Asclera (polidocanol) states it is indicated for spider veins ≤1 mm and reticular veins 1-3 mm in diameter 2
CRITICAL LIMITATION: "Asclera has not been studied in varicose veins more than 3 mm in diameter" 2
This patient's veins measure 4.5-8.2 mm, which exceeds the FDA-studied range for standard polidocanol formulations 2
However, Varithena (polidocanol endovenous microfoam 1%) has been studied in larger veins with saphenofemoral junction incompetence in clinical trials 3

Documented Risks and Complications

Thrombus extension into deep venous system: Reported following Varithena treatment, though adjunctive techniques can reduce this risk to 1.5% 4
Common adverse events: Contusion, incision-site hematoma, limb discomfort, phlebitis (14.8%), and postoperative pain (15.6%) 4, 3
Serious complications are rare: No pulmonary emboli, neurologic events, or visual disturbances in recent series using adjunctive techniques 4
Anaphylaxis risk: The FDA label warns that severe allergic reactions, including fatal anaphylaxis, have been reported, particularly with volumes >3 mL 2

Prior Authorization History

Previous approvals: The patient had 36466 x8 approved in one session and 36466 x6 approved in another session 1
Current request: 36466 x5 (3 right side, 2 left side) 1
Pattern of repeated treatments: This suggests either incomplete initial treatment, recurrence, or progressive disease 1
The American College of Radiology notes that recurrence rates for varicose veins are 20-28% at 5 years even with appropriate treatment 1

Common Pitfalls in This Case

Pitfall 1: Assuming Prior Approvals Guarantee Current Approval

Previous approvals do not establish medical necessity for subsequent treatments without updated documentation of persistent symptoms 1
Each treatment session requires independent justification with current clinical findings 1

Pitfall 2: Vague Symptom Documentation

Statements like "help with comfort and quality of life" do not meet the specific requirement for "severe and persistent pain and swelling interfering with activities of daily living" 1
The American College of Radiology requires explicit documentation of symptom severity and functional impairment 1

Pitfall 3: Contradictory Diagnosis Codes

Using I83.90 "asymptomatic varicose veins" while claiming symptomatic disease creates an insurmountable documentation contradiction 1
The correct codes should reflect symptomatic disease if that is the clinical reality 1

What Would Be Required for Medical Necessity

Essential Documentation Needed

Correct diagnosis coding: Replace I83.90 (asymptomatic) with appropriate symptomatic codes 1
Detailed symptom documentation: 1
- Specific symptoms (pain, heaviness, swelling, etc.)
- Duration of symptoms
- Severity assessment (mild/moderate/severe)
- Functional impairment (specific activities affected)
- Frequency (daily, intermittent, constant)
Post-ablation assessment: 1
- Recent duplex ultrasound (within 6 months) documenting:
  - Status of previously ablated GSVs/SSVs
  - Confirmation that saphenofemoral junction reflux remains adequately treated
  - Identification of specific tributary veins requiring treatment
  - Reflux duration ≥500 ms in tributary veins
Conservative management documentation: 1
- Specific duration of compression stocking use (requires 3 months minimum)
- Compliance assessment
- Response to conservative treatment
- Reason for treatment failure

Alternative Approaches

If Symptoms Are Truly Present But Poorly Documented

Resubmit with corrected documentation addressing all deficiencies noted above 1
Consider formal venous clinical severity score (VCSS) assessment to objectively quantify symptoms 3
Document specific functional limitations using validated instruments like VEINES-QOL/Sym 3

If Symptoms Are Minimal or Absent

Continue conservative management with compression stockings 1
The American College of Radiology notes that compression therapy is the cornerstone of conservative management for chronic venous insufficiency 1
Schedule follow-up assessment in 3-6 months to monitor for symptom progression 1

Strength of Evidence Assessment

American College of Radiology Appropriateness Criteria (2023): Level A evidence that saphenofemoral junction reflux must be treated before tributary sclerotherapy 1
American Family Physician guidelines (2019): Level A evidence requiring documented symptoms for medical necessity determination 1
FDA label requirements: Regulatory standard for polidocanol use and safety monitoring 2
Clinical trial data for Varithena: Moderate-quality evidence showing efficacy in symptomatic patients with 30.7-point improvement in HASTI symptom scores versus 16.7 points for placebo (p=0.0009) 3

Is endovenous chemical ablation (Varithena) (polidocanol) medically necessary for a patient with symptomatic saphenous veins and varicose veins, despite not meeting all criteria for medical necessity?

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