This document addresses the use of peripheral vascular angioplasty, with and without stenting, and with or without atherectomy, for the treatment of occlusive peripheral arterial disease (PAD) of the lower extremities.

Note: The following procedures are NOT addressed in this document:

• Procedures for venous peripheral vascular disease
• Open bypass procedures

Note: Please see the following document for additional information:

• CG-THER-RAD-07 Intravascular Brachytherapy (Coronary and Non-Coronary)
• TRANS.00035 Therapeutic use of Stem Cells, Blood and Bone Marrow Products

Clinical Indications

Medically Necessary:

A.  Treatment of Claudication

For individuals with claudication due to lower extremity occlusive arterial disease, the use of either percutaneous or open exposure angioplasty is considered medically necessary for individuals who meet ALL of the following criteria:

1. Presence of severe disability (inability to perform usual work or life-style activities) due to intermittent claudication; and
2. There has been an inadequate response to at least 6 months of conservative treatment including lifestyle initiatives for known risks (for example, smoking cessation and dietary changes), including supervised exercise training, and pharmacological therapy (for example, anti-platelet, cilostazol) unless contraindicated; and
3. The targeted lesion has one of the following anatomic characteristics:
   1. Common iliac artery: unilateral or bilateral lesions of any length; or
   2. External iliac: unilateral or bilateral lesions less than or equal to 3 cm in length; or
   3. Femoral or popliteal artery: a single stenosis less than or equal to 10 cm in length or a single occlusion less than or equal to 5 cm in length; and
4. There is an absence of other conditions that would limit activity even if the claudication were improved (for example, angina or chronic pulmonary disease) with the endovascular intervention.

For individuals with claudication due to lower extremity occlusive arterial disease, the use of either percutaneous or open exposure primary stent placement is considered medically necessary, when the following criteria have been met:

1. Criteria above for angioplasty have been met; and
2. Stenosis or occlusion is present in the common iliac artery, external iliac artery; or
3. Stenosis or occlusion of intermediate-length (5-15 cm) is present in the femoropopliteal artery.

For individuals with claudication due to aortoiliac occlusive disease (AIOD), the use of covered stent devices is considered medically necessary in the presence of severe calcification or aneurysmal changes where the risk of rupture may be increased after unprotected dilation.

B.  Salvage (Provisional) Therapy for Claudication

For individuals with claudication due to lower extremity occlusive arterial disease, the use of either percutaneous or open exposure stents or atherectomy devices as salvage (provisional) therapy for a suboptimal or failed result from balloon angioplasty is considered medically necessary when the residual stenosis or occlusion is present in either the femoral, popliteal, or tibial artery and ANY of the following criteria have been met:

1. Residual diameter stenosis greater than 50%; or
2. Persistent translesional pressure gradient; or
3. Flow-limiting dissection is present.

C.  Critical Limb Ischemia (CLI)

For individuals with limb threatening CLI due to lower extremity occlusive arterial disease (ischemic rest pain and/or impending limb loss with skin ulceration, gangrene, infection) of the lower extremity, the use of endovascular procedures (angioplasty, stent placement, or atherectomy) is considered medically necessary as initial or salvage therapy for inflow (aorto-iliac) and outflow (infrainguinal) occlusive vascular disease.

Note: The optimal strategy for the management of an individual with CLI is determined on a case by case basis by the treating physician and influenced by the urgency of the limb threat, comorbidities, and the individual’s arterial anatomy.

Not Medically Necessary:

The use of percutaneous or open exposure angioplasty, with or without stent placement, and with or without atherectomy for the treatment of individuals with claudication due to lower extremity occlusive arterial disease is considered not medically necessary when the criteria above have not been met, including its use as prophylactic therapy in an asymptomatic individual with lower extremity PAD, or for claudication due to isolated infrapopliteal artery disease.

The use of primary stent placement for the treatment of claudication caused by isolated lesions in the infrapopliteal or tibial arteries is considered not medically necessary.

The use of peripheral vascular angioplasty, with or without stenting, and with or without atherectomy, is considered not medically necessary for treatment of occlusive arterial disease of the deep femoral artery (profunda femoris).

The use of endovascular procedures (angioplasty, stent placement, or atherectomy) for the treatment of CLI due to lower extremity occlusive arterial disease is considered not medically necessary as initial or salvage therapy for inflow (aorto-iliac) and outflow (infrainguinal) occlusive vascular disease in the absence of clinical symptoms of limb threatening CLI or when the medically necessary criteria for treatment of claudication above are not met.