Summary Of Evidence

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Analysis of Evidence

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Vascular stents are used to enhance primary patency in arteries and veins, usually at the site of stenotic or occlusive lesions. Stents also may be used as an adjunct to technically inadequate Percutaneous Transluminal Angioplasty (PTA) or in cases where PTA alone will not be expected to provide a durable result. Peripheral vascular stenting may be indicated for patients with symptomatic arterial and venous disease resulting from an occlusive process. This LCD does not address carotid artery stenting, which is subject to National Coverage Determination 20.7.

PTA and stenting of vessels is covered only when all of the following conditions are met:

• The patient has undergone prior thorough medical evaluation and management of symptoms. See below under specific categories for guidelines on medical evaluation and management recommendations.
• Surgical intervention would otherwise be considered as an alternative treatment for the patient.
• A stent may be placed as a planned adjunct to PTA rather than in response to a suboptimal or failed PTA (so-called primary stent deployment). Primary stenting is justified for situations where PTA alone is not expected to provide a durable result, such as arterial or venous occlusions that carry a high risk for distal embolization or rapid recurrence OR occlusive lesions known to be unfavorable for PTA alone such as significantly calcified lesions, eccentric lesions, lesions related to external compression (e.g., May-Thurner syndrome and malignant compression of the superior vena cava), or ostial renal artery stenosis.

Coverage for non-coronary vascular stents depends on the use of an FDA-approved stent. Several different stents are currently used in the medical community. Each device has specific indications described by the FDA for approved market uses. Stent placement is covered by Medicare only when an FDA-approved stent is:

• Used for the FDA-approved indications, OR
• Used for the above indications supported by the peer medical literature.

Specific Arterial Indications for PTA and Stenting

• Brachiocephalic arteries: PTA and stenting may be indicated for treatment of flow-limiting stenosis resulting in conditions such as subclavian steal syndrome, upper extremity claudication, ischemic rest pain of the arm and hand, non-healing tissue ulceration and focal gangrene. Stenting of the inflow arteries, such as the innominate or subclavian when they are the inflow vessels of an arteriovenous fistula for chronic hemodialysis and are significantly stenotic, is often useful.
• Pulmonary artery: PTA and stenting may be indicated for certain people with congenital pulmonary artery stenosis.
• Renal artery: PTA and stenting may be indicated for renal artery stenosis. The following guidelines should be followed when making determination for RAS:
  
  Renal artery stenting is considered appropriate for renal artery dissection; renal artery aneurysm and renal artery atherosclerosis greater than 50% in a transplanted kidney. 
  
  Renal artery stenting is considered appropriate under the following conditions:
  Flash pulmonary edema or acute coronary syndrome (ACS) with severe hypertension;
  Resistant HTN (Uncontrolled hypertension with failure of maximally tolerated doses of at least three antihypertensive agents, one of which is a diuretic, or intolerance to medications); or
  Ischemic nephropathy with chronic kidney disease (CKD) with eGFR < 45 cc/min and global renal ischemia (unilateral significant renal artery stenosis with a solitary kidney or bilateral significant renal artery stenosis ) without other explanation.
  
  Renal artery stenting may be considered appropriate under the following conditions:
  Unilateral renal artery stenosis with CKD (eGFR < 45cc/min).
  Unilateral renal artery stenosis with prior episodes of congestive heart failure (Stage C).
  Anatomically challenging or high-risk lesion (early bifurcation, small vessel, severe concentric calcification, and severe aortic atheroma or mural thrombus).
  
  Renal artery stenting is rarely considered appropriate under the following conditions:
  Unilateral, solitary, or bilateral renal artery stenosis with controlled BP and normal renal function.
  Unilateral, solitary, or bilateral renal artery stenosis with kidney size < 7cm in pole-to-pole length.
  Unilateral, solitary, or bilateral renal artery stenosis with chronic end stage renal disease on hemodialysis > 3 months.
  Unilateral, solitary, or bilateral renal artery chronic total occlusion.
• Lower extremity arteries (aorto-iliac, superficial femoral and infra-popliteal arteries): PTA and stent placement in infra-popliteal vessels is not expected to be often indicated and in those cases the rationale for stent placement must be thoroughly explained in the record.
  
  PTA and stenting for critical limb ischemia is considered appropriate under the following conditions: Limb threatening lower extremity ischemia.
  
  PTA and stenting for claudication may be appropriate under the following conditions: Individuals who have failed medical management and home exercise program and continue to have significant activity limiting disease, with an anatomically suitable lesion for intervention. Medical management of peripheral artery disease (PAD) should include Class I recommendations for antiplatelet therapy, statins, home exercise program, smoking cessation including planning, counseling or behavior modification and pharmacotherapy if needed.
• Mesenteric vessels: This includes acute mesenteric ischemia, chronic mesenteric ischemia, mesenteric thrombosis, dissection, or any other vascular insufficiency resulting in gastrointestinal symptoms. Stenting of the mesenteric vessels is covered only when angioplasty of the vessels would not suffice and after the patient has had a thorough medical evaluation and management of symptoms, and for whom surgical intervention is the likely alternative. The eligible patients will be required to have multiple comorbidities documented making them poor candidates for open surgical procedures. In these situations, PTA and stent placement should be considered an alternative to surgery and not an addition to medical management.
• Hemodialysis access graft/fistula: This includes stenosis, restenosis, occlusion and pseudoaneurysm.

Specific Venous Stents

• Superior vena cava and subclavian/innominate veins stents: PTA and stenting are covered for superior vena cava syndrome, post-radiation venous stenosis, congenital stenosis, and thrombosis and embolism, including acute thrombophlebitis. Stenting of the veins, such as the innominate, subclavian, or superior vena cava when they are the outflow vessels of an arteriovenous fistula for chronic hemodialysis and are significantly stenotic, is often useful.
• Inferior vena cava and iliofemoral veins: This includes vena caval and iliofemoral venous occlusions and stenosis due to the following: post-radiation venous stenosis, congenital stenosis or webs, extrinsic venous compression (May-Thurner syndrome), thrombophlebitis, and symptomatic post-traumatic venous stenosis.

Sequential Procedures
Vascular obstructions may be caused by thrombosis, embolism, atherosclerosis, or other conditions and may be multifocal in a single vascular family or in multiple vascular families. Management options to maintain or re-establish the patency of a vessel in a particular vascular family include surgery, thrombectomy, embolectomy, endarterectomy, thrombolysis, atherectomy, angioplasty, and stent placement. These procedures may be performed alone or in sequence. The subsequent procedure(s) is necessary because the initial approach was unsuccessful or only partially successful in accomplishing the intended goal (that is, to maintain or re-establish the patency of a vessel). An example of this situation is when an atherectomy is followed by an angioplasty and the angioplasty followed by the placement of a stent.
Limitations

1. The placement of a stent in a vessel for which there is no objective-related symptom or limitation of function is considered to be preventive, and therefore, not covered by Medicare.
2. Use of non-coronary vascular stents is covered only after the patient has had a thorough evaluation and treatment of symptoms and when PTA of the vessel alone has not, or is not expected to sufficiently resolve the symptoms making surgery the likely alternative.
3. A non-coronary intravascular stent(s) that carries an Investigational Device Exemption (IDE) may be covered under Medicare. Medicare coverage of IDE devices is predicated, in part, upon their status with the FDA. Payment will cease in the event a manufacturer loses (or violates relevant IDE requirements necessitating FDA’s withdrawal of) IDE approval. The FDA issues a special identifier number that corresponds to each device or stent(s) granted an IDE.

Training and Competency Requirements

Physicians who perform vascular stent procedures must possess the knowledge, skills, training, and experience necessary to properly select suitable patients who will benefit from and not be harmed by stent therapy as opposed to other intervention, perform the procedures safely, and recognize and handle complications of stent placement. Practitioners who perform and report these services for Medicare payment must have satisfied training and competency guidelines in peripheral vascular medicine and intervention as part of a formal postgraduate training program in radiology, cardiology, or general/vascular surgery. Alternatively, physicians must have completed supervised training in vascular medicine and intervention as published by a recognized specialty organization of the same stature as the American College of Radiology, American College of Cardiology or American College of Surgery.

Medicare expects that any provider who seeks and receives payment for these services is prepared to substantiate his training and experience if asked to do so by Medicare.

Notice: As published in CMS IOM Pub.100-08, Section 13.5.1, in order to be covered under Medicare, a service shall be reasonable and necessary. The service provided should have an appropriate duration and frequency in terms of whether it is:

1. Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member.
2. Furnished in a setting appropriate to the patient's medical needs and condition.
3. Ordered and furnished by qualified personnel.
4. One that meets but does not exceed, the patient's medical needs and at least as beneficial as an existing and available medically appropriate alternative.