- Renal artery. This includes: renovascular hypertension (see “Renal Arteries” section below) and insufficiency; mesenteric ischemia; post-transplant renal, pancreatic or hepatic ischemia; or arterial dissection. Stenting of renal arteries is covered only when angioplasty of the vessel 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. In these situations, PTA and stent placement should be considered an alternative to surgery and not an addition to medical management.
- Lower extremity arteries (abdominal aorta, iliac, superficial femoral, subpopliteal arteries). This includes: lifestyle-limiting claudication, focal hemodynamically significant lesion, ischemic rest pain, non-healing tissue ulceration and focal gangrene. Peripheral vascular stenting is covered for symptomatic patients with occlusive disease of the arterial or venous system. Vascular stents are utilized either following a suboptimal or failed PTA, or as a planned adjunct to PTA (so-called primary stenting). When PTA of the vessel without stenting is not expected to or has not been sufficient to restore sufficient blood flow in symptomatic patients for whom surgery is the likely alternative, PTA with stent placement is indicated as an alternative to surgery – not simply an addition to medical management.
- Hemodialysis access graft/fistula. This includes: stenosis, restenosis and occlusion.
- Superior vena cava. This includes: superior vena cava syndrome, post-radiation venous stenosis and congenital stenosis.
- Brachiocephalic arteries. This includes: subclavian steal syndrome, upper extremity claudication, ischemic rest pain of the arm and hand, non-healing tissue ulceration and focal gangrene.
- Iliac veins and inferior vena cava. Stenting in these areas should be rare and would be considered at the review level with supporting documentation.
- Venous occlusive disease. This includes: superior vena cava syndrome, venous occlusions and stenoses, post-radiation venous stenosis, congenital stenoses or webs, extrinsic venous compression (iliac artery compression syndrome - May Thurner syndrome) and symptomatic post-traumatic venous stenosis.
- 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.
- Used for the FDA-approved indications;
- Used for the above indications supported by the peer medical literature.
- An inadequate angiographic and/or hemodynamic result as defined by a 30 percent or greater residual stenosis post-PTA, lesion recoil or intimal flaps.
- Flow limiting dissections post-PTA.
- A 5 mm Hg or greater mean trans-stenotic pressure gradient post-PTA.
- Acute occlusion of the vessel post-PTA.
- Significant recurrence of a lesion at the prior PTA site within 12 months.
- Arterial or venous occlusions that carry a high risk for distal embolization or rapid recurrence.
- 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 stenoses.
Renal artery angioplasty meets coverage criteria for patients with rapidly progressive renal insufficiency due to atherosclerotic stenosis of = 75 percent obstruction. Stenting meets coverage criteria for ostial lesions, for angioplasty with suboptimal results and dissection.
Renal artery angioplasty meets coverage criteria for patients with recurrent acute pulmonary edema without cardiac cause, who have stenosis of the renal artery(s) of = 60 percent. Stenting meets coverage criteria for ostial lesions, angioplasty with suboptimal results and dissection.
Renal artery angioplasty meets coverage criteria for patients with renal artery stenosis of = 50 percent in a transplanted kidney. Stenting meets coverage criteria for ostial lesions, angioplasty with suboptimal results and dissection.
Renal artery angioplasty with or without stenting does not meet coverage criteria for patients with renal artery atherosclerosis or stenosis but who do not have any of the conditions mentioned above.
- 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.
- 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.
- 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.
- 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, which 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 need.
- At least as beneficial as an existing and available medically appropriate alternative.
Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web.
Transcath iv stent, percut
Transcath iv stent/perc addl
Transcath iv stent, open
Transcath iv stent/open addl
Iliac revasc w/stent
Iliac revasc w/stent add-on
Fem/popl revasc w/stent
Fem/popl revasc stnt & ather
Tib/per revasc w/stent
Tib/per revasc stent & ather
Revsc opn/prq tib/pero stent
Tib/per revasc stnt & ather
Transcath iv stent rs&i
Hypertensive chronic kidney disease, malignant, with chronic kidney disease stage I through stage IV, or unspecified
Hypertensive chronic kidney disease, malignant, with chronic kidney disease stage V or end stage renal disease
Hypertensive heart and chronic kidney disease, malignant, with heart failure and with chronic kidney disease stage I through stage IV, or unspecified
Hypertensive heart and chronic kidney disease, malignant, without heart failure and with chronic kidney disease stage V or end stage renal disease
Hypertensive heart and chronic kidney disease, malignant, with heart failure and with chronic kidney disease stage V or end stage renal disease
Malignant renovascular hypertension
Dissection of renal artery
Acute edema of lung unspecified
Complications of transplanted kidney
Kidney replaced by transplant
Aftercare following organ transplant
Chronic kidney disease, stage IV (severe)
Chronic kidney disease, stage V
End stage renal disease
Mechanical complication of other vascular device implant and graft
Other complications due to renal dialysis device implant and graft
Other complications due to other vascular device implant and graft
Compression of vein
Other anomalies of great veins
Swelling mass or lump in head and neck
Effects of radiation unspecified
Subclavian steal syndrome
Atherosclerosis of native arteries of the extensions
Arterial embolism and thrombosis of upper extremity
Acute vascular insufficiency of intestine
Chronic vascular insufficiency of intestine
Unspecified insufficiency of intestine
Peripheral vascular complications
Diabetes with peripheral circulatory disorders
Atherosclerosis of aorta
Atherosclerosis of native arteries of the extremities
Dissection of aorta abdominal
Other arterial dissection
Peripheral vascular disease unspecified
Arterial embolism and thrombosis of arteries of the extremities
Arterial embolism and thrombosis of other specified artery
Atresia and stenosis of aorta
- The medical record must contain information indicating which FDA-approved stent was placed.
- Documentation must reflect an effort to establish a cause-and-effect relationship between the lesion to be treated and the presenting symptoms and/or other objective findings (e.g., hypertension secondary to renal artery stenosis versus essential hypertension with incidental renal stenosis).
- Claim documentation for IDE services includes modifiers Q0, Q1 and the FDA-issued identifier number.
- The claim(s) should be submitted with an ICD-9-CM diagnosis code, coded to the highest level of specificity, which reflects one of the specified “covered” indications found in this policy. Claims submitted without such evidence will be denied as not medically necessary.