LCD L37893: Endovenous Stenting

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Chronic venous disease (CVD) is prevalent in the United States of America (USA) affecting more than 6 million adults. 1 CVD may be defined as any morphological and functional abnormality of the venous system of long duration manifested either by symptoms and/or signs indicating the need for investigation and/or care. 2 Symptoms of progression may include leg heaviness, aching, fatigue, edema, and ulceration.

A common feature in chronic venous disease is the formation of progressive venous hypertension in which inflammatory and pro-thrombotic mechanisms are triggered. While the pathophysiology of venous disease is largely related to stasis and reflux, the sequelae of same may ultimately lead to subsequent obstruction resulting in the partial or total occlusion of a vein.

Venous thrombosis is the formation of a blood clot in any segment of the deep or superficial venous system. Venous obstruction is considered to be a partial or complete blockage of venous flow in any venous segment. The blockage may be a result of an internal thrombosis or external compression of a vein.

Deep Venous Thrombosis (DVT) refers to the formation of blood clots in at least one deep vein, usually of the lower or upper extremities. The Centers for Disease Control and Prevention (CDC) estimates 20-50% of people who experience DVT develop long-term complications. 3 Post-thrombotic syndrome (PTS), manifesting itself with a myriad of symptoms, is recognized as the most common long-term complication of DVT.

After DVT is objectively diagnosed, clinical tools used to help define PTS may include the Villalta scale, Ginsberg measure or the Brandjes scale. Other tools developed for general chronic venous disease include the Clinical, Etiological, Anatomic, Pathophysiological (CEAP) classification, Venous Clinical Severity Score (VCSS) and the Widmer scale. 4

Venous stenosis is an abnormal narrowing in a vein. Venous stenosis most commonly affects the axillary, brachial, cephalic, or brachiocephalic veins of the upper extremities, or the superior vena cava, but can also affect the central veins in the abdomen and the pulmonary artery and veins. Common causes are extrinsic compression, thrombosis from various etiologies including, but not limited to, trauma and stenosis from placement of central venous catheters, pacemaker leads or hemodialysis catheters.

Noninvasive conservative management of venous disease and stenosis includes treatment that improves venous circulation and reduces lower extremity edema (e.g., elevation, analgesics, diuretics, weight management, exercise, tobacco cessation or compression and anticoagulant therapy) to prevent thromboembolic complications.

Failed conservative management of clinically significant symptomatic venous stenosis may include angioplasty and placement of an endovenous stent. An endovenous stent may be defined as a synthetic tubular structure implanted in native or graft vasculature to provide mechanical radial support and enhance vessel patency. Percutaneous transluminal angioplasty (PTA) delivers the stent under radiographic guidance to the intended location, where it is expanded within the luminal space using either a balloon catheter or a self-expanding mechanism.

In the infancy of stenting, intravascular stents were developed for arterial obstructions to restore and maintain arterial perfusion. Early venous stenting extrapolated these indications from arterial use and applied balloon-expandable and self-expandable stents to veins as an off-label use.

As an initial therapeutic intervention, angioplasty may be performed on near-obstructed veins to alleviate symptomatic areas of stenosis. In general, the determination of success for angioplasty is evaluated by using the degree of residual stenosis, the appearance of the vessel wall, and the absence of a complication. 5

Clinical experience has shown advantages and disadvantages of the different stent types. Compared to the self-expanding type, balloon-expandable stents tend to have higher radial force but will not re-expand if crushed or bent. On the other hand, self-expanding stents, available in larger lengths and diameters, are reported to conform better to curvatures and deploy easily. Venous stent technologies are emerging with many questions still unanswered. 6

In the search for the optimal endovenous stent, various types, each with their unique characteristics, have been tried in search of the optimal desired outcome.

Nitinol stents have also been developed as an adjunct for treatment of venous stenosis.

Several different stents are currently used in the medical community.

Coverage for placement of endovenous stents depends on the use of a U.S. Food and Drug Administration (FDA) approved stent. Neither FDA classification and marketing indication nor American Medical Association (AMA) Current Procedural Terminology (CPT) category descriptors determine that a product meets Medicare reasonable and necessary requirements. Each device has specific indications described by the FDA for approved market uses. All products with FDA clearance/approval used in accordance with the individualized product application guidelines will be considered for the purpose of this LCD. Stent placement is covered by Medicare only when an FDA-approved stent is used for the FDA-approved indications or for off-label indication(s) supported by the peer reviewed medical literature. For more details please see the FDA website at http://www.fda.gov/.

It is the responsibility of the treating physician/practitioner to:

• Determine and comply with FDA approval and specific designation for use of any agent or device utilized for the procedure or treatment planned

• Comply with all applicable State and Federal regulations, laws and licensure related to the use of the agents and devices utilized

The central focus of this Local Coverage Determination (LCD) will be on the indications for placement of stents in a severely symptomatic patient with a vein which may be partially or near occluded.

Covered Indications

Failed conservative management of CVD may include the need for Percutaneous Transluminal Angioplasty (PTA). Placement of endovenous stents may be considered as a planned adjunct to suboptimal or failed angioplasty.

A suboptimal or failed angioplasty is defined as dilation judged by the physician to be suboptimal or failed due to the presence of unfavorable lesion morphology such as:

• Residual stenosis of more than 30 percent for a vein measured at the narrowest point of the vascular lumen at the site of angioplasty or more than 50 percent reduction of luminal diameter. 5(p59)

• A tear that interrupts the integrity of the intima or lumen causing hemorrhage.

• Abrupt persistent occlusion or dissection at the site of angioplasty, occlusion elastic recoil or refractory spasm.

A stent may be placed as a planned adjunct to angioplasty rather than in response to a suboptimal or failed angioplasty.

Primary endovenous stenting is justified for situations where angioplasty alone is not expected to provide a durable result.

Endovenous stents may be placed for patients with severely symptomatic venous obstructions due to any of the following:

• Iliac vein compression syndrome also known as May-Thurner or Cockett syndrome.

• Iliocaval obstruction.

• Iliofemoral obstruction for patients with venous leg ulceration(s) not relieved by conservative therapies and compression. Progression of symptoms may lead to Phlegmasia Cerulea Dolens (PCD), acute inferior vena cava (IVC) thrombosis, and rapid thrombus extension despite anticoagulation as well as anatomically extensive DVT affecting the common femoral and/or iliac vein, or post-thrombotic stenosis with ankle edema of venous origin (i.e., minimum CEAP score 3).

• Superior or Inferior Vena Caval Thrombosis including Superior Vena Cava syndrome.

• Post-thrombotic syndrome (PTS).

• As an adjunct to catheter-directed thrombolysis for acute femoroiliocaval deep vein thrombosis when post thrombolysis imaging identifies symptomatic residual stenosis.

• Post radiation venous stenosis.

• Symptomatic post-traumatic venous stenosis including those resulting from central venous catheters or transvenous device (e.g., pacemakers, defibrillators,) pacemaker leads or a history of abdominal and/or pelvic surgery.

• Salvage of thrombosed or stenotic symptomatic or limited function arteriovenous dialysis access fistulae or grafts with compromised venous outflow, failed angioplasty rapid restenosis, or vessel perforation. This may include treatment of trapping a life threatening thrombus, an aneurysm or pseudoaneurysm that threatens the viability of the AV fistula or graft, or the treatment of a hemodialysis vascular access rupture that cannot be controlled through balloon tamponade.

• Thrombotic obstruction of major hepatic veins (Budd-Chiari syndrome).

• Transvenous decompression of portosystemic shunts.

• Post-operative stenosis or venous narrowing due to repair of congenital cardiac disease, e.g. sinus venosus Atrial Septal Defect (ASD), discordant atrioventricular connection status post Mustard or Senning repair of Transposition of the Great Arteries (TGA).

• Pulmonary vein stenosis resulting from congenital malformation, extrinsic compression, sequelae of radiofrequency ablation (RFA), lung transplantation, or status post repair of Total Anomalous Pulmonary Vein Return (TAPVR).

Limitations

The following are considered not medically reasonable and necessary:

• All other uses of endovenous stents not listed as a covered indication in this LCD.

• The placement of a stent in a vein for which there is no objective-related symptom or limitation of function is considered to be preventive and, therefore, not covered by Medicare.

• Presence of local or systemic infection is a relative contraindication to venous stenting except under unusual circumstances where the benefit of placing the stent may outweigh the risks. In these circumstances, the documentation should reflect the provider's rationale.

• Use of stents without U.S. FDA approval.

• Stenting of popliteal or tibial veins.

• Venous stenosis less than or equal to 50% of diameter of vein or residual stenosis of less than 30% measured after angioplasty.

• Venous stenting for idiopathic intracranial hypertension (IIH) is considered investigational and may be considered only in select isolated and unique circumstances upon individual redetermination.

• A 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. Coverage 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.

Provider Qualifications

Services will be considered reasonable and necessary only if performed by appropriately trained physicians.

• Physicians who perform endovenous 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. Physicians 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, nephrology, 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 physicians who would not have had formal training, i.e. before 2000, Medicare expects that any physician who seeks and receives payment for these services is prepared to substantiate his/her 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.

A qualified physician for this service/procedure is defined as:

• Physician (MD or DO) properly enrolled in Medicare, Licensed by the State with full scope of practice, with

• Training and experience acquired through tenured practice or within the framework of an accredited residency and/or fellowship training program in the applicable specialty/subspecialty in the United States, reflecting equivalent education, training and expertise endorsed by an academic institution or specialty society in the United States.

Notice: 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.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.

Technology Assessment

Agency for Healthcare Research and Quality (AHRQ) Jones, et al. 7 in conjunction with CMS proposed a technology assessment (TA) on treatment strategies for lower extremity chronic venous disease (LECVD). This systematic review includes a narrative review of diagnostic testing modalities and assesses the comparative effectiveness of exercise training, medical therapy, weight reduction, mechanical compression therapy, and invasive procedures (i.e., surgical and endovascular procedures) in patients with LECVD. Eight studies were included for treatment of adult patients with lower extremity chronic venous thrombosis/obstruction. In seven of the studies, all patients were symptomatic at baseline; in one study only a small minority had unclear symptom severity. Three studies were randomized controlled trials representing a total of 109 patients. The sample size of the five observational studies ranged from 20 to 216 patients. All studies assessed the comparative effectiveness of exercise training, medical therapy, weight reduction, compression therapy, skin/wound care, endovenous intervention and/or surgical intervention on functional outcomes, quality of life, and safety events in patients with lower extremity chronic venous obstruction/thrombosis. Studies that assessed individual treatment modalities or combinations of treatment modalities were analyzed; however differences in the treatment comparisons, outcome measures, and follow-up time points eliminated the possibility that study results could be pooled for analysis of direct comparisons. There were no studies reporting results by the following subgroups: age, race/ethnicity, sex, body weight, CEAP classification, VCSS classification, severity of disease, anatomic segment affected, presence of ulcer, and known malignancy. Unfortunately given the small number of studies, heterogeneity in outcomes and interventions assessed, diverse populations evaluated, and inconsistency in findings, the evidence was insufficient to support any findings.

Evidence-Based / Professional Society Guidelines

The American College of Phlebology, in their practice guidelines on chronic deep venous obstruction of the femoroiliocaval venous system 8 recommend venous balloon angioplasty and stenting as an adjunct to catheter-directed thrombolysis for acute femoroiliocaval deep vein thrombosis in order to maintain vein patency and flow when a residual stenosis is found on post thrombolysis imaging. The guidelines state there is robust clinical evidence in the peer-reviewed medical literature that alleviating venous obstruction utilizing balloon angioplasty and stenting is feasible in the vast majority of patients with good to excellent results in terms of stent patency, relief of symptoms, and recurrent stenosis. The evolution of balloon angioplasty and stenting of the femoroiliocaval vein obstructions over the past 20 years has established it as the technique of choice for most severely symptomatic patients.