Medical Policy: 02.01.54
Original Effective Date: August 2014
Reviewed: May 2018
Revised: May 2018
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.
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 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.
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:
Treatment of asymptomatic varicose veins is 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 (including VenaSeal®) of any vein is considered investigational. Longer term follow-up is needed to permit conclusions on the durability of this procedure.
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.
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).
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
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