37215   Transcatheter placement of intravascular stent(s), cervical carotid artery, open or percutaneous, including angioplasty, when performed, and radiological supervision and interpretation; with distal embolic protection

37216         without distal embolic protection

The revascularization or  the stent placement procedure codes includes the work of accessing and selectively catheterizing of the vessel. So, here above CPT code 37215 and 37216 includes all the ipsilateral selective carotid catheterization and all the diagnostic imaging for ipsilateral, cervical and cerebral carotid arteriography. 

Also these procedures includes all the related radiological supervision and interpretation. 

37236 Transcatheter placement of an intravascular stent(s) (except lower extremity artery(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; initial artery

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. This LCD does not address carotid artery stenting, which is subject to National Coverage Determination 20.7, nor does it address intracranial events or stent placement for hemodialysis access.

Stenting of vessels is covered only when all of the following conditions are met:

• Angioplasty alone would not suffice.
• The patient has undergone prior thorough medical evaluation and management of symptoms for which PTA and stent are therapeutic.
• Surgical intervention would otherwise be considered as an alternative treatment for the patient.
• Condition(s) exists for which there is evidence of equal outcomes with renal artery intervention and medical therapy when compared with outcome of medical or surgical management.

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. 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), ostial renal artery stenoses or restenosis of prior stented areas.

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 Stents

• 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) or renal insufficiency as well as post-transplant renal artery stenosis, arterial aneurysm 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 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.

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, or American Society of Diagnostic and Interventional Nephrology. 

For those providers who would not have had formal training, ie before 2000, 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. Substantiation of the training may include ongoing CME and Training events, Medical Staff privileges in order to do the procedures, or attestation by peers.

Note: 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.