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 in an occlusive process.
Appropriate symptoms at the designated vascular sites include:
  • 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.
Coverage for the above indications 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.
Vascular stents are deployed as a planned adjunct or alternative to PTA or following suboptimal or failed PTA. Medical documentation for both circumstances is necessary. A suboptimal or failed PTA is defined as a dilation judged by the physician to be suboptimal or failed due to the presence of unfavorable lesion morphology such as:
  • 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.
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.
  • 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 Arteries
Renal artery angioplasty meets coverage criteria for patients with uncontrolled hypertension (diastolic blood pressure > 100 mm Hg on two antihypertensive drugs) who have been found to have unilateral or bilateral renal artery stenosis = 50 percent by nuclear medicine studies, renal artery duplex Doppler or renal arteriography. Stenting meets coverage criteria for ostial lesions, for angioplasty with suboptimal results and for dissection. For patients with renal artery stenosis of < 50 percent, and suspected renovascular hypertension, coverage criteria are met if renal vein renin studies indicate the hypertension is due to renal artery disease.

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.

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.
Note: Requirements for payment of an IDE can be found on the TrailBlazer Web site at:http://www.trailblazerhealth.com/Policies/Devices/Default.aspx?DomainID=1
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 100-08, Section 13.5.1, 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 Section 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, 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.
Bill Type Codes
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
12X, 13X, 85X
Revenue Codes
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual Publication 100-04, Claims Processing Manual, for further guidance.
0320, 0323, 0329, 0340, 0342, 0349, 035X, 0402, 0404, 0409, 0610, 0614, 0615, 0616, 0618, 0619
CPT/HCPCS Codes
Note:
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.
37205©
Transcath iv stent, percut
37206©
Transcath iv stent/perc addl
37207©
Transcath iv stent, open
37208©
Transcath iv stent/open addl
37221©
Iliac revasc w/stent
37223©
Iliac revasc w/stent add-on
37226©
Fem/popl revasc w/stent
37227©
Fem/popl revasc stnt & ather
37230©
Tib/per revasc w/stent
37231©
Tib/per revasc stent & ather
37234©
Revsc opn/prq tib/pero stent
37235©
Tib/per revasc stnt & ather
75960©
Transcath iv stent rs&i
ICD-9-CM Codes That Support Medical Necessity
The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Medicare is establishing the following limited coverage for CPT/HCPCS codes 37205, 37206, 37207, 37208 and 75960:
Covered for:
Renal artery:
403.00
Hypertensive chronic kidney disease, malignant, with chronic kidney disease stage I through stage IV, or unspecified
403.01
Hypertensive chronic kidney disease, malignant, with chronic kidney disease stage V or end stage renal disease
404.01
Hypertensive heart and chronic kidney disease, malignant, with heart failure and with chronic kidney disease stage I through stage IV, or unspecified
404.02
Hypertensive heart and chronic kidney disease, malignant, without heart failure and with chronic kidney disease stage V or end stage renal disease
404.03
Hypertensive heart and chronic kidney disease, malignant, with heart failure and with chronic kidney disease stage V or end stage renal disease
405.01
Malignant renovascular hypertension
443.23
Dissection of renal artery
518.4
Acute edema of lung unspecified
996.81
Complications of transplanted kidney
V42.0
Kidney replaced by transplant
V58.44
Aftercare following organ transplant
Hemodialysis access graft/fistula:
585.4
Chronic kidney disease, stage IV (severe)
585.5
Chronic kidney disease, stage V
585.6
End stage renal disease
996.1
Mechanical complication of other vascular device implant and graft
996.73
Other complications due to renal dialysis device implant and graft
996.74
Other complications due to other vascular device implant and graft
Superior vena cava:
459.2
Compression of vein
747.49
Other anomalies of great veins
784.2
Swelling mass or lump in head and neck
990
Effects of radiation unspecified
Brachiocephalic arteries (including subclavian, except carotid bifurcation):
435.2
Subclavian steal syndrome
440.20–440.24
Atherosclerosis of native arteries of the extensions
444.21
Arterial embolism and thrombosis of upper extremity
Mesenteric vessels:
557.0
Acute vascular insufficiency of intestine
557.1
Chronic vascular insufficiency of intestine
557.9
Unspecified insufficiency of intestine
Other:
997.2
Peripheral vascular complications
Covered for:
Lower extremity arteries:

250.70–250.73
Diabetes with peripheral circulatory disorders
440.0
Atherosclerosis of aorta
440.20–440.24
Atherosclerosis of native arteries of the extremities
441.02
Dissection of aorta abdominal
443.22–443.23
Other arterial dissection
443.9
Peripheral vascular disease unspecified
444.21–444.22
Arterial embolism and thrombosis of arteries of the extremities
444.81–444.89
Arterial embolism and thrombosis of other specified artery
747.22
Atresia and stenosis of aorta
Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.
Note: SeeNon-Invasive Venous Studies – 4U-21AB” LCD for vessel mapping for hemodialysis access (G0365).
Diagnoses That Support Medical Necessity
N/A
ICD-9-CM Codes That DO NOT Support Medical Necessity
N/A
Diagnoses That DO NOT Support Medical Necessity
All diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD.
Documentation Requirements
Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.
Additional requirements include:
  • 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.