Medical Policy: 02.01.54
Original Effective Date: August 2014
Reviewed: May 2020
Revised: May 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Sclerotherapy is a non-surgical procedure used to eradicate varicose veins and/or improve the appearance of the leg. This involves injection of a sclerosant/foam directly into the vein resulting in changes to the lining of the vein wall. The vein is then considered sclerosed or thrombosed and no longer able to serve as a conduit for venous blood flow.
In Echosclerotherapy, the use of duplex ultrasound is being utilized during sclerotherapy to guide injections. Ultrasound imaging is used to guide a needle into the abnormal vein and deliver medication to destroy the lining of the blood vessel and seal it shut. Ultrasound guided sclerotherapy (echosclerotherapy) is primarily used to treat large veins beneath the surface of the skin.
During echosclerotherapy, duplex ultrasound is said to enhance the precision of the therapy. Echosclerotherapy is also called aimed sclerotherapy, duplex sclerotherapy, or sonographic sclerotherapy. Ultrasound-monitored or duplex-guided techniques for sclerotherapy have not been shown to definitively increase the effectiveness or safety of this procedure. Ultrasound- or radiologically guided or monitoring techniques are of no proven value when performed solely to guide the needle or introduce the sclerosant into the varicose veins.
The COMPASS procedure represents a distinct sclerotherapy protocol for the treatment of valvular incompetence (i.e. reflux) of the greater or lesser saphenous veins. COMPASS is an acronym for Comprehensive Objective Mapping, Precise Image-guided Injection (i.e., echosclerotherapy), Antireflux Positioning and Sequential Sclerotherapy.
This technique is also referred to as Endomechanical ablation, mechanico-chemical endovenous ablation (MCEA) and mechanically enhanced endovenous chemical ablation (MEECA). Mechanochemical endovenous ablation utilizes both sclerotherapy and mechanical damage to the lumen. Following ultrasound imaging, a disposable catheter with a motor drive is inserted into the distal end of the target vein and advanced to the saphenofemoral junction. As the catheter is pulled back, a wire rotates within the lumen of the vein, abrading the lumen. At the same time, a liquid sclerosant (sodium tetradecyl sulphate) is infused near the rotating wire. It is proposed that mechanical ablation allows for better efficacy of the sclerosant, without the need for the tumescent anesthesia used in radiofrequency ablation or endovenous laser ablation. The ClariVein® Infusion Catheter is utilized to perform MOCA and received 510(k) approval by the U.S. Food and Drug Administration (FDA) in February 2008. The system includes an infusion catheter, motor drive, stopcock and syringe and is intended for the infusion of physician-specified agents in the peripheral vasculature.
Pelvic venous congestion syndrome is most commonly recognized as the persistence of noncyclical chronic pelvic pain for longer than 6 months in the absence of known pelvic pathology. Under fluoroscopic guidance, an interventional radiologist guides a catheter to the affected vein, and inserts inert embolic agents to completely seal the vein. As a result, blood flow is rerouted, thereby reducing pressure within the targeted veins. Several types of embolic agents may be used, and include, but are not limited to, metal coils, sclerosing agents, and gelatin sponges. These agents may either be temporary or permanent. Since the Ovarian Veins and Internal Iliac Veins are in close proximity, embolization of the Internal Iliac Veins may also be necessary. Considering the difficulty of making the diagnosis clinically and radiologically, outcomes are also difficult to assess (often anecdotal), and there remains a lack of evidence to robustly assess clinical efficacy of treatment.
Cryoablation uses extreme cold to cause injury to the vessel. The objective of endovenous techniques is to cause injury to the vessel, causing retraction and subsequent fibrotic occlusion of the vein. A modified Erbe Erbokryo® cryosurgical unit (Erbe USA) received FDA clearance for marketing in 2005. A variety of clinical indications are listed, including cryostripping of varicose veins of the lower limbs.
TIPP is an alternative to stab avulsion or hook phlebectomy. This procedure uses 2 instruments: an illuminator, which also provides irrigation, and a resector, which has an oscillating tip and can perform suction. Following removal of the saphenous vein, the illuminator is introduced via a small incision in the skin and tumescence solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity.
The resector is then inserted under the skin from the opposite direction, and the oscillating tip is placed directly beneath the illuminated veins to fragment and loosen the veins from the supporting tissue. Irrigation from the illuminator is used to clear the vein fragments and blood through aspiration and additional drainage holes. The illuminator and resector tips may then be repositioned, thereby reducing the number of incisions needed when compared with stab avulsion or hook phlebectomy. It has been proposed that TIPP might result in decreased operative time, decreased complications such as bruising, and faster recovery compared with the established procedures.
Cyanoacrylate adhesive is a clear, free-flowing liquid that polymerizes in the vessel via an anionic mechanism (ie, polymerizes into a solid material on contact with body fluids or tissue). The adhesive is gradually injected along the length of the vein in conjunction with ultrasound and manual compression. The acute coaptation halts blood flow through the vein until the implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the treated vein. Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of indications, including gastrointestinal bleeding, embolization of brain arteriovenous malformations, and to seal surgical incisions or other skin wounds. The low-quality body of evidence suggests that the VenaSeal ClosureSystem may result in reduced symptom severity, improved quality of life and similar occlusion rates when compared with radiofrequency ablation however, substantial uncertainly remains regarding its effectiveness due to the lack of well-designed comparative studies. A large part of the supporting literature includes a product that is not FDA approved for use in the United States. The current literature for use of the FDA approved product in the United States includes:
The VeinGogh Ohmic Thermolysis System generates a tiny, regulated, high frequency current delivered to the vessel via a hair-thin probe. A "microburst" of energy selectively heats the vein, coagulating the blood and collapsing the vessel wall, which is reabsorbed into the body. This can be used in smaller veins that would be too small for sclerotherapy.
Endovascular catheter-directed chemical ablation with balloon isolation (i.e., balloon sclerotherapy) describes treatment of varicose veins in an extremity by incorporating two familiar procedures: sclerotherapy and balloon catheterization as a minimally invasive and cost-effective treatment option. Traditional catheter-based endovenous sclerotherapy can often have negative effects to the overall body system resulting from the combination of air and the sclerosing agent. The physician uses a double lumen balloon catheter as a means of separating or isolating venous blood, allowing the physician to use the minimal amount of sclerosing agent needed while removing the excess amounts and subsequently limiting the potential for systemic risk. Vein occlusion occurs when the physician carefully retracts the expanded balloon containing the captured sclerotherapeutic agent in between. The KAVS [catheter-assisted vein sclerotherapy] procedure involves an intravascular catheter that is introduced into the vein for short-term therapeutic use. The catheter has a balloon at the distal end that will temporarily block the blood flow to that segment of the vein being targeted for sclerotherapy. Evidence evaluating the safety and efficacy of sclerotherapy in conjunction with balloon isolation as a treatment of varicose veins has not been proven at this time.
The National Institute for Health and Clinical Evidence issued guidance on endovenous mechanochemical ablation in 2013, concluding that current evidence on the safety and efficacy of endovenous mechanochemical ablation for varicose veins is inadequate in quantity and quality and the procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
The Society for Vascular Surgery and the American Venous Forum published clinical practice guidelines in 2011 (Gloviczki, 2011). The recommendations are rated as strong=1 or weak=2, based on a level of evidence that is either high quality=A, moderate quality=B, or low quality=C, and include the following:
An ECRI Health Technology Assessment on the VenaSeal Closure System reviewed 5 studies. One randomized controlled trial and 1 nonrandomized comparative study showed that the VenaSeal is as safe and effective as radiofrequency ablation in achieving vein closure, resolving symptoms and improving quality of life. Three additional case series showed high vein closure success. However, the report states that additional randomized controlled trials comparing VenaSeal with other treatment modalities and reporting on longer-term follow-up are needed. The current available literature is minimal and of low quality with a high degree of loss to follow up within the studies.
Evidence limitations: The RCT is at risk of bias due to use of subjective outcome measures (e.g., pain, QOL) and lack of blinding. The retrospective comparison study and case series are at risk of bias due to two or more of the following: short follow-up, single-center focus, lack of randomization and controls, retrospective design, and subjective outcomes. RCTs comparing VenaSeal with other treatment modalities (e.g., endovenous laser ablation, thermal ablation, sclerotherapy) and reporting patient-oriented outcomes at long-term follow-up (≥2 years) would be useful to validate findings.
In 2015, the VenaSeal Closure System (Sapheon, part of Medtronic) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval (P140018) process for the permanent closure of clinically significant venous reflux through endovascular embolization with coaptation. The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent. FDA product code: PJQ.
In 2013, Varithena<99>(formerly Varisolve), a sclerosant microfoam made with a proprietary gas mix, was approved by the FDA under a new drug application (205-098) for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee.
The following devices were cleared for marketing by the FDA through the 501(k) process for endovenous treatment of superficial vein reflux:
In 1999, the VNUS Closure<99> System, a radiofrequency device, was cleared by the FDA through the 510(k) process for "endovascular coagulation of blood vessels in patients with superficial vein reflux." In 2005, the VNUS RFS<99> and RFSFlex<99>devices were cleared by the FDA for "use in vessel and tissue coagulation including treatment of incompetent (ie, refluxing) perforator and tributary veins." In 2008, the modified VNUS ClosureFast<99> Intravascular Catheter was cleared by the FDA through the 510(k) process. FDA product code: GEI.
In 2002, the Diomed 810 nm surgical laser and EVLT<99> (endovenous laser therapy) procedure kit were cleared by the FDA through the 510(k) process "...for use in the endovascular coagulation of the great saphenous vein of the thigh in patients with superficial vein reflux." FDA product code: GEX.
In 2005, a modified Erbe Erbokryo cryosurgical unit (Erbe USA) was approved by the FDA for marketing. A variety of clinical indications are listed, including cryostripping of varicose veins of the lower limbs. FDA product code: GEH.
In 2003, the Trivex system (InaVein), a device for transilluminated powered phlebectomy, was cleared by the FDA through the 510(k) process for "ambulatory phlebectomy procedures for the resection and ablation of varicose veins." FDA product code: DNQ.
In 2008, the ClariVein Infusion Catheter (Vascular Insights) was cleared by the FDA through the 510(k) process (K071468) for mechanochemical ablation. The FDA determined that this device was substantially equivalent to the Trellis Infusion System (K013635) and the Slip-Cath Infusion Catheter (K882796). The system includes an infusion catheter, motor drive, stopcock, and syringe, and is intended for the infusion of physician-specified agents in the peripheral vasculature. FDA product code: KRA
High intensity focused ultrasound with the ECHOPULSE device for the treatment of varicose veins is considered investigational (see policy 02.01.53 High Intensity Focused Ultrasound)
Treatment of asymptomatic varicose veins are considered not medically necessary.
Treatment using sclerotherapy (including but not limited to Asclera), various laser treatments or microwave energy (including tunable dye or pulsed dye laser, for example, PhotoDerm®, VeinLase™, Vasculite™, Veinwave) of the telangiectatic dermal veins (for example, reticular, capillary, venule or any vein less than 3mm in diameter), which may be described as "spider veins" or "broken blood vessels" is considered not medically necessary.
Treatment with the VeinGogh Thermolysis System is considered not medically necessary. The effectiveness has only been shown in veins less than 3mm in diameter and the treatment of veins this size are considered not a medical necessity.
Cyanoacrylate adhesive (e.g. VenaSeal®) of any vein is considered investigational.
Currently the short term process has been studied, longer term follow-up and higher quality evidence is needed to permit conclusions on the durability of this procedure. Substantial uncertainty remains regarding its effectiveness due to the lack of well-designed comparative studies.
Echosclerotherapy is considered investigational.
There is no evidence that ultrasound makes a significant difference in optimizing outcome or decreasing complications from sclerotherapy for varicose veins, when compared to non-ultrasound-guided techniques. There is very little published medical literature on the use of echosclerotherapy, and no large long-term outcomes have been reported.
Mechanochemical Ablation (i.e. The ClariVein®) is considered investigational for all veins.
Endovenous Cryoablation is considered investigational for all veins.
There is minimal evidence on the safety and long-term results for mechanochemical ablation and endovenous cryoablation at this time. There is also a lack of improvement on health outcomes in comparison to standard procedures at this time.
Intense pulsed-light source (also known as PhotoDerm, VeinLase or Vasculite or in general, photothermal sclerosis) treatment of a varicose vein is considered investigational for all veins.
Transilluminated powered phlebectomy (TIPP, TriVex™) treatment of a varicose vein is considered investigational when used as the sole treatment for varicose vein (without prior or concurrent treatment of saphenous veins).
Coil embolization is considered investigational as a treatment of lower extremity veins (e.g. pelvic embolization (sclerotherapy)).
Sclerotherapy or echosclerotherapy is considered investigational when used in conjunction with a balloon catheter (e.g. KAVS procedure).
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
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