Brachiocephalic arteries:
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.
Pulmonary artery: Stenting may be indicated for balloon angioplasty for certain people with congenital pulmonary stenosis.
Renal artery: Stenting may be indicated for renal artery stenosis causing renovascular hypertension (see below) and/or renal insufficiency as well as post-transplant renal artery stenosis, arterial aneurysm and/or dissection. Renal artery angioplasty with or without stenting is covered for renal artery stenosis manifested by at least one of the following conditions:
Renovascular hypertension (all criteria must be met):
Hypertension is not controlled (lowest blood pressure recorded by a physician of 160 mm Hg systolic or 90 mm Hg diastolic or 160 mm Hg in patients with isolated systolic hypertension despite documented adherence to treatment with maximum accepted doses of three or more antihypertensive medications.
Renal artery stenosis demonstrated by renal arteriography with luminal cross-sectional area reduction of 75 percent or vessel diameter narrowing greater than 50 percent. Stenting of renal artery stenosis of less than 75 percent reduction of luminal cross-sectional area/50 percent reduction of vessel diameter may be indicated when renal vein renin studies clearly indicate renal artery stenosis to be the cause of the elevated blood pressure.
Recurrent (“flash”) pulmonary edema without cardiac or other obvious etiology and with renal artery stenosis of greater than or equal to 60 percent of the vessel diameter.
Rapidly progressive renal insufficiency or acute renal failure in patients at risk for renal artery stenosis when another cause for renal deterioration has been sought and is not present, and with renal artery stenosis of greater than or equal to 75 percent of the vessel diameter and with one of the following in addition to progressive renal insufficiency:
Coexisting diffuse atherosclerotic vascular disease.
Acute renal failure precipitated by antihypertensive therapy, particularly angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers.
Renal artery dissection.
Renal artery aneurysm.
Renal artery stenosis greater than or equal to 50 percent in a transplanted kidney.
Lower extremity arteries (abdominal aorta, iliac, superficial femoral and infrapopliteal arteries): This includes: lifestyle-limiting claudication, focal hemodynamically significant lesion, ischemic rest pain, non-healing tissue ulceration and focal gangrene. Stent placement in infrapopliteal vessels is not expected to be often indicated and in those cases the rationale for stent placement must be exquisitely explained in the record.
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 have multiple comorbidities 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 and occlusion
Venous Stents
Superior vena cava and subclavian veins stents are covered for superior vena cava syndrome, post-radiation venous stenosis, congenital stenosis, and thrombosis and embolism, including acute thrombophlebitis.
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 stenoses 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 initial procedure may be followed at the same encounter by a sequential, usually “more invasive,” procedure. There may be separate CPT /HCPCS codes describing each service. 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 its (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: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
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. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
Safe and effective.
Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, that meet the requirements of the Clinical Trials NCD are considered reasonable and necessary).
Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
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.
Furnished in a setting appropriate to the patient's medical needs and condition.
Ordered and furnished by qualified personnel.
One that meets, but does not exceed, the patient's medical needs.
At least as beneficial as an existing and available medically appropriate alternative.
Note: Bill Type and Revenue Codes DO NOT apply to Part B.
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