Appeal type: Medical necessity
Decision: Overturned in Part

Diagnosis: Varicose Veins
Treatment: Endovenous ablation therapy of incompentent vein, extremity inclusive of all imaging guidance and monitoring percutaneous, laser, first vein treated, left-side (36478-LT) 
The insurer denied the Endovenous ablation therapy of incompentent vein, extremity inclusive of all imaging guidance and monitoring percutaneous, laser, first vein treated, left-side (36478-LT) 
The denial is overturned, in part.

The patient is a female with left leg pain. The patient's provider performed ablation of the left greater saphenous vein (GSV) on two occasions for this patient with symptomatic varicose veins. The patient presented with left leg pain, cramping and other symptoms. She had failed a trial of compression stockings.

The procedures were denied coverage by the health plan on the basis of existing medical policy, because the policy has a size threshold of 4.5 mm (millimeters) for approving GSV (greater saphenous vein) ablation. This denial is being appealed.

Yes, in part. The Endovenous ablation therapy of incompentent vein, extremity inclusive of all imaging guidance and monitoring percutaneous, laser, first vein treated, left-side (36478-LT), was medically necessary, in part.
A single ablation procedure was medically necessary. The second procedure was not medically necessary.

The provider performed ablation of the left greater saphenous vein (GSV) on two occasions for this patient with symptomatic varicose veins. The patient presented with left leg pain, cramping and other symptoms. She had failed a trial of compression stockings.

To evaluate medical necessity of the procedure, widely accepted criteria to assess the medical necessity of the procedures will be applied.

Under widely accepted criteria based on randomized trials and cohort studies [1-7], endovenous ablation of the axial saphenous vein and/or perforator veins is medically necessary when:

1) The patient has venous insufficiency symptoms severe enough to affect normal function
2)  The patient has failed a trial of prescription compression stockings
3) The patient has duplex-proven reflux that correlate with the patient's symptoms.

Requirement 1 has been met. The submitted records show that the patient had symptoms of varicose vein disease (pain, cramping, etc.), and that the symptoms were severe enough to adversely affect her normal function. The provider's H&P (history and physical) describes the patient's symptoms in enough detail to show that the symptoms cause substantial adverse impact on the patient's function.

Requirement 2 has been met. The records indicate that the patient failed a monitored trial of compression stockings before undergoing ablation.

Requirement 3 has been met. The reflux study showed severe reflux (> (greater than)500 milliseconds) in the left GSV (greater saphenous vein) at multiple levels.

Therefore, the patient meets published, well-accepted criteria for left GSV (greater saphenous vein) ablation. A single ablation procedure was medically necessary. However, there was no medical necessity of the second ablation procedure.

Note: The previous denial was based on the fact that the policy has a 4.5 mm (millimeters) threshold size for the GSV (greater saphenous vein). In this case, the patient's vein below the saphenofemoral junction measured 4.4 mm (millimeters). The size was 8.3 mm (millimeters) at the junction itself, but the policy threshold applies to the vein size below the junction.

However, published data demonstrate that vein size does not correlate with patient symptoms [8] and that treatment of small axial veins results in clinical improvement to the same degree observed when treating large axial veins [9]. Thus, there are no data to support having a size threshold for treatment of incompetent axial veins.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient, in part.
The previous denial of both procedures was based on the fact that the policy has a 4.5 mm (millimeters) threshold size for the GSV (greater saphenous vein). In this case, the patient's vein below the saphenofemoral junction measured 4.4 mm (millimeters). The size was 8.3 mm (millimeters) at the junction itself, but the policy threshold applies to the vein size below the junction.

However, published data demonstrate that vein size does not correlate with patient symptoms [8] and that treatment of small axial veins results in clinical improvement to the same degree observed when treating large axial veins [9]. Thus, there are no data to support having a size threshold for treatment of incompetent axial veins.