![]() | Medical Policy |
| Subject: | Treatment of Varicose Veins (Lower Extremities) | ||
| Policy #: | SURG.00037 | Current Effective Date: | 07/15/2009 |
| Status: | Revised (Coding Updated 10/01/2009) | Last Review Date: | 05/21/2009 |
| Description/Scope |
This document addresses various modalities for the treatment of valvular incompetence of the greater or lesser saphenous veins (i.e., reflux) and associated varicose tributaries and "spider veins."
| Position Statement |
Medically Necessary:
Patient selection criteria: Treatment of varicose veins is medically necessary when:
The following treatment methods are medically necessary when the above patient selection criteria are met:
Not Medically Necessary:
Endoluminal radiofrequency ablation, (also known as VNUS® Closure® System), endoluminal laser ablation (also known as EVLT™ or ELAS), sclerotherapy and echosclerotherapy are each considered not medically necessary when above patient selection criteria are not met.
Investigational and Not Medically Necessary:
Note: COMPASS is an acronym for Comprehensive Objective Mapping, Precise Image-guided Injection, Antireflux Positioning and Sequential Sclerotherapy.
Cosmetic and Not Medically Necessary:
Treatment using sclerotherapy or various laser treatments (including tunable dye or pulsed dye laser, e.g., PhotoDerm™, VeinLase™, Vasculite™) of the telangiectatic dermal veins, which may be described as "spider veins" or "broken blood vessels," is considered cosmetic and not medically necessary.
| Rationale |
Endoluminal radiofrequency ablation (thermal heating) (VNUS® Closure® System):
The VNUS® Closure® System has been evaluated as an alternative to vein ligation and stripping or stripping alone, for the treatment of valvular incompetence (i.e. reflux) of the greater or lesser saphenous veins. Endoluminal radiofrequency ablation of the saphenous vein is based on the principle of treating reflux disease by control of the point of reflux and isolation of the refluxing saphenous vein from circulation. The current evidence suggests that this procedure has success rates similar to those reported for surgical ligation and stripping with less postoperative pain and faster postoperative recovery. The use of this procedure outside the patient population specified in the position statement criteria has not been adequately evaluated to allow conclusions regarding efficacy (Lurie, 2005; Rautio, 2002). No literature addressing endoluminal radiofrequency for refluxing saphenous tributaries was found.
Endovenous laser ablation (Endovenous Laser Treatment or EVLT™):
EVLT™ of the greater saphenous vein has been studied in two large-scale case series studies and several smaller case series studies. These studies demonstrate lower relapse rates when compared to ligation and stripping, as well as comparable symptom relief and complication rates similar to endoluminal radiofrequency ablation. With respect to long-term outcomes and head-to-head comparison to other therapies, including ligation and stripping or radiofrequency ablation, the data is not adequate to make sufficient comparisons. The use of this procedure outside the patient population specified in the position statement criteria has not been adequately evaluated to allow conclusions regarding efficacy (Min, 2003; Darwood, 2008; Rasmussen, 2007). Endovenous laser ablation has been considered for treatment of refluxing saphenous tributaries. A literature search returned one small study of 18 patients (Bush, 2007) and a case report of 2 patients (Theivacumar et al, 2007).
Peden et al (2007) and Elias et al (2007) addressed the feasibility of endoluminal radiofrequency and endovenous laser ablation for refluxing perforator veins. They concluded that clinical studies are needed to validate these treatment techniques.
Sclerotherapy:
There is sufficient evidence in the peer-reviewed medical literature to support the use of sclerotherapy when used adjunctively for the treatment of symptomatic varicose tributaries when done either at the same time as surgical ligation and stripping, endoluminal radiofrequency ablation, or endoluminal laser ablation of the saphenous vein or for the treatment of residual or recurrent symptomatic varicose tributaries following the above procedures. (Tissi et al, 2006).
Sclerotherapy as the sole treatment of symptomatic varicose tributaries of the greater saphenous vein is not indicated in the presence of saphenofemoral or saphenopopliteal junctional reflux. The published studies indicate that such treatment, without definitive treatment of valvular incompetence (i.e., reflux) of the saphenous veins with stripping and ligation or other surgical treatments (e.g., endoluminal radiofrequency ablation, or endoluminal laser ablation), provides little long-term benefit and leads to high recurrence rates. Individuals who undergo definitive treatment as well as adjunctive sclerotherapy of the varicose tributaries have been shown to have better long-term results, lower rates of recurrence, and better quality of life scores.
The overwhelming majority of varicosities of the saphenous tributaries are related to co-existing valvular incompetence (i.e. reflux) of the greater or lesser saphenous veins. However, a small subset of patients may be symptomatic in the absence of underlying reflux. Sclerotherapy as a sole therapy has been proposed for these patients. However, a literature search identified only one controlled study of this group. In this randomized study of 25 patients, those receiving sclerosant reported a higher obliteration rate compared to those receiving normal saline at a 12 week follow up. The study does not address the key issue of long term symptom resolution (Kahle, 2004).
Sclerotherapy directed at the underlying refluxing saphenous veins (as opposed to the visible varicosities of the tributary veins) requires ultrasound guidance. This procedure may be referred to as echosclerotherapy or ultrasound-guided sclerotherapy. Controlled studies have shown that sclerotherapy/echosclerotherapy of the underlying refluxing greater or lesser saphenous veins is associated with a higher rate of recurrence compared to the gold standard of ligation and stripping. Additionally, sclerotherapy of the saphenous vein raises issues regarding both the appropriate volume and concentration of the sclerosant and the ability to provide adequate post-procedure compression (Belcaro et al, 2003).
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. The literature in support of this technique, in particular the study published by Belcaro and colleagues (2003), suffers from flaws in design, including a failure to address specific information in regard to patient selection criteria, no description of the randomization process, and a failure to randomize against standard surgical treatment consisting of vein stripping and ligation. In addition, one of the surgical reference arms was not a part of the randomization process but was actually a retrospective historical control group, limiting its ability to be adequately compared to the rest of the prospective data collected. Additionally, the re-treatment as a result of ongoing ultrasound monitoring is regarded as a continuation of the initial therapy in the "COMPASS" protocol, thus eliminating the consideration that such occurrences represent recurrences or treatment failures. This aspect of the "COMPASS" protocol may be responsible for the low "recurrence rate" being reported in the published studies. With the "COMPASS" protocol, patients are viewed as being in the latter "phases" of therapy for prolonged periods of time. Some reports indicate that patients have received therapy in excess of one year. This is in contrast to alternative treatment methods, including standard surgical techniques, laser ablation or radiofrequency ablation procedures that report completion of treatment within a week to 10 days.
PhotoDerm™, VeinLase™, and Vasculite™, are laser devices primarily used in treating telangiectatic dermal veins and other skin related applications. There is no compelling evidence that these conditions have any significantly negative health impact and as such fail to meet the criteria for medical necessity. However, there is adequate evidence that these treatment methods do significantly decrease the appearance of superficial spider nevi. Therefore these techniques are considered cosmetic in nature.
| Background/Overview |
Some form of venous disorder affects approximately 80 million Americans and varicose veins are present in about 30% of women and 10 to 20 percent of men. Often, varicose veins present as a cosmetic concern but they may cause symptoms such as cramping, throbbing, burning, swelling, feeling of heaviness or fatigue, and may interfere with activities of daily living. There is frequent confusion between varicose veins and "spider veins," which are small blue or red veins at the surface of the skin. Spider veins, also known as telangiectatic dermal veins, spider nevi, or broken blood vessels, while potentially unattractive, are not associated with any physical symptoms and are a benign condition.
The veins located in the lower extremities consist of the superficial (including the greater and lesser saphenous veins and their tributaries) and deep veins (including the popliteal and femoral veins). These two parallel systems are interconnected via perforator veins. One-way valves are present at the junctions between the bifurcation point of the deep and superficial veins, i.e., the saphenofemoral and the saphenopopliteal junction.
Varicose veins are abnormally enlarged and unusually shaped blood vessels close to the surface of the skin that develop when the venous valves fail to function properly and allow blood to reflux, or flow in a backward direction. Reflux of blood back into the vein causes dilation of the vessel, restriction of adequate blood flow to portions of the leg, and in some cases, discomfort or pain. Varicose veins are found most often on the back of the calf or on the inside of the leg between the groin and ankle, and are commonly the result of reflux through the valve at the junction between the greater saphenous vein and the common femoral vein. An imaging technique called ultrasound or duplex scanning can be used to identify whether venous reflux is in the superficial, deep or perforating veins. It also can help determine whether reflux is confined to veins above or below the knee. This information is important in diagnosing the cause of this condition and in the planning of treatment.
Treatment for symptomatic varicose veins includes conservative measures such as frequent elevation of affected leg(s), walking, weight reduction and avoidance of prolonged sitting, analgesics and the use of compression stockings. The key to treatment of varicose veins is prevention of reflux in the short and long saphenous veins that connect to the major veins in the hip and pelvic area (femoral veins), a condition referred to as saphenofemoral reflux. When this non-invasive approach fails to relieve symptoms, several invasive options exist, as described below.
Standard procedures:
Surgical ligation and stripping
The traditional therapy for venous reflux in the saphenous vein is surgical ligation and stripping. This begins with an incision in the groin region to expose the saphenous vein. The surgeon then ligates (ties off) the saphenous vein and small veins in the area. A second incision is made either just below the knee or at the ankle for the same purpose. Once both ends of the vein are free, a wire-like instrument is threaded through the vein from the groin to the second incision and secured to the vein. The vein is then pulled out (or "stripped") and removed from the leg.
Microphlebectomy
Also known as ambulatory phlebectomy or stab avulsion, microphlebectomy is a technique to remove varicose veins. In this procedure, several tiny incisions are made in the skin through which the varicosed vein is removed. This technique is best suited for tortuous varicosities where passage of a probe or catheter cannot be accomplished.
Hook phlebectomy
Hook phlebectomy, also known as avulsion phlebectomy or small incision avulsion, is a surgical procedure performed alone or together with vein stripping. During avulsion phlebectomy, the surgeon makes a series of tiny incisions in the leg to remove varicose veins with a hook. Historically, hook phlebectomy has been performed as a blind procedure involving multiple incisions.
Trans-Illuminated Powered Phlebectomy (TIPP):
This technique uses the TRIVEX™ System. Through a small incision, a fiber optic illuminator is positioned by the varicose vein. A resector with a rotating blade is then guided through the skin next to the vein. Suction draws the vein into the tip of the vein resector. The vein fragments are removed by suction.
Alternative procedures:
Several alternative therapies have been proposed that use minimally invasive approaches with laser and radiofrequency energy. These techniques use devices that allow treatment of the saphenous vein from inside the refluxing vein, resulting in smaller incisions in the skin, potentially less pain and shorter recovery periods. Such techniques are collectively referred to as endovenous or endoluminal ablation treatments and are distinct from catheter techniques (sclerotherapy) for the injection of sclerosing agents through hollow catheters.
Endoluminal radiofrequency ablation(VNUS® Closure® System
Also known as radiofrequency endovenous occlusion, endoluminal radiofrequency ablation is typically performed by using a thin catheter inserted into the saphenous vein through a small opening in the skin. Radiofrequency energy is then delivered through the end of the catheter to heat the saphenous vein wall, causing it to collapse, scar and seal shut. The Food and Drug Administration (FDA) approved modifications to this device to include use in vessel and tissue coagulation, including treatment of incompetent (i.e., refluxing) perforator and tributary veins (FDA, 2006). However, there is a lack of clinical evidence that demonstrates clinical efficacy for vessels other than the saphenous vein.
Endovenous Laser Treatment (EVLT™):
Endovenous laser ablation of the saphenous vein utilizes a small laser fiber that is inserted through a small incision in the skin into the vein. Pulses of laser light are emitted inside the vein, heating the vein wall causing it to collapse, scar and seal shut. A bandage or compression hose is placed on the treated leg following the treatment.
Sclerotherapy:
Sclerotherapy of varicose tributaries may be used adjunctively with stripping and ligation, radiofrequency ablation or endovenous laser ablation of the greater saphenous vein and this procedure is typically performed in a physician's office. During this procedure a chemical known as a sclerosing agent, typically a 0.5%-3% solution of sodium tetradecyl sulfate (STS), is injected into the vein to collapse its walls so it can no longer transport blood. Following the procedure, pressure is applied to the vein through padding and compression stockings worn for 7 to 10 days. This continuous pressure allows a scar to form between the two walls of the vein preventing the further development of varicosities. Response to each injection can vary and it typically requires one to three injections to obliterate any vessel. Echosclerotherapy is a term used to describe ultrasound guided sclerotherapy where the veins are injected under direct ultrasound visualization.
A variation of ultrasound-guided sclerotherapy, Comprehensive Objective Mapping, Precise Image-guided Injection, Antireflux Positioning and Sequential Sclerotherapy; also known as the COMPASS protocol, has also been proposed as a treatment for varicose veins. This therapy proposes the use of ultrasound-guided sclerotherapy followed by multiple diagnostic ultrasound imaging procedures and sclerotherapy treatments for the treatment of subsequent varicose veins. This therapy may involve several weeks or months of treatment.
Note: The term "varicose veins" does not apply to the telangiectatic dermal veins, also known as "spider veins" or "broken blood vessels." Similar to varicose veins, telangiectasias (spider veins) are created when the valves that control the blood flow in the veins weaken. This causes the formerly small veins located just below the skin to become engorged with blood. As a result, the veins widen and become visible. While spider veins may appear anywhere, they most often appear on the legs in spiderweb-like patterns. Visible subcuticular veins (i.e., spider angiomas, and telangiectasias) less than 2 mm in size have not been known to be associated with pain, bleeding, ulceration, or other medical problems and their treatment is purely cosmetic. A common treatment method for this condition uses laser light to destroy small spider veins.
| Definitions |
Anti-Embolism Hose (also called elastic stockings or compression stockings): a type of stocking worn to prevent the formation of blood clots in the legs (thromboses); assisting in the return flow of the blood to the heart, and prevention of pooling in the veins; there are three support grades of prescription hose; mild to severe support (15-20, 20-30, 30-40 mmHg) which are generally used to assist with a medical condition and light support (8-15 mmHg) that may be used as a preventive measure
Arteriovenous Fistulae: a condition where a vein and artery are directly connected without the usual intervening small vessels
Catheter Ablation: a technique involving the application of either radiofrequency or laser energy through an endovenous catheter for the purpose of ablating varicose vein tissue of the greater saphenous vein. This does not include the "closure" or ablation of a vein using the injection of a sclerosing agent through a hollow catheter
Deep-Vein Thrombosis: a condition where blood clots form in the deep veins of the thigh and lower leg; these clots block blood flow to portions of the leg, and may break off and travel to the brain, lungs, heart or other organs and cause serious damage
Echosclerotherapy (also known as ultrasound-guided sclerotherapy): the direct ultrasonic visualization of refluxing or varicose veins during injection of a sclerosing agent
Endoluminal Laser Ablation (Endovenous Laser Treatment or EVLT™, also known as endovenous laser ablation of the saphenous vein or ELAS): a proposed treatment for varicose veins using lasers to destroy affected veins from the inside
Endoluminal Radiofrequency Ablation (also known asradiofrequency endovenous occlusion, VNUS® Closure® System or endoluminal radiofrequency thermal heating): a treatment for varicose veins using radiofrequency energy to heat the vessel wall from the inside, causing vein shrinkage or occlusion
Ligation and Stripping: a treatment for varicose veins, which involves surgically closing and removing varicose veins
PhotoDerm: a pulsed laser light treatment to aesthetically treat a specific area of leg telangiectasis
Perforator Veins: connect the superficial veins to the deep veins
Saphenofemoral Reflux: backflow of blood in the veins causing varicose vein symptoms and bulging
Saphenous Vein: a vein that serves as the principal blood vessel returning blood from the surface of the leg back to the trunk
Sclerotherapy: a treatment for varicose veins in which a chemical is injected into the vein, which causes the vein to shrink and close
Stasis dermatitis: a condition caused by too little circulation in the legs; it begins with swelling of the ankles and progresses to tan-colored skin, patchy reddening, tiny, round, purplish-red spots, and hardening of the skin
Telangiectatic Dermal Veins (also known as spider veins, spider nevi or broken blood vessels): small enlarged blood vessels just below the surface of the skin that occur most commonly on the legs, but may also occur on the face and other locations
Thrombophlebitis: inflammation of a vein, along with the formation of a clot; this occurs most commonly as the result of injury to the vessel wall, abnormal increased clotting capacity of the blood (hypercoagulability), infection, or a chemical irritation
Tributary Vein: a superficial vein branch that flows into larger veins
Varicose Vein: veins that are abnormally swollen or enlarged due to weakening in the vein's wall
Venous Insufficiency: is an abnormal circulatory condition marked by decreased return of venous blood from the legs to the trunk of the body
| Coding |
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services may be Medically Necessary when criteria are met:
| CPT | |
| 36470 | Injection of sclerosing solution; single vein |
| 36471 | Injection of sclerosing solution; multiple veins, same leg |
| 36475 | Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; first vein treated |
| 36476 | Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; second and subsequent veins treated in a single extremity, each through separate access sites |
| 36478 | Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, laser; first vein treated |
| 36479 | Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, laser; second and subsequent veins treated in a single extremity, each through separate access sites |
| HCPCS | |
| S2202 | Echosclerotherapy |
| ICD-9 Procedure | |
| 39.92 | Injection of sclerosing agent into vein |
| ICD-9 Diagnosis | |
| 448.0 | Hereditary hemorrhagic telangiectasia |
| 451.0-451.2 | Phlebitis and thrombophlebitis of vessels of lower extremities |
| 453.6 | Venous embolism and thrombosis of superficial vessels of lower extremity |
| 454.0-454.8 | Varicose veins of lower extremities [with complications] |
| 459.11-459.19 | Postphlebitic syndrome [with complications] |
| 459.81 | Venous (peripheral) insufficiency, unspecified |
| 459.89 | Other specified disorders of circulatory system (phlebosclerosis) |
| 707.10-707.19 | Ulcer of lower limbs, except decubitus |
| 729.5 | Pain in limb |
| 729.81 | Swelling of limb |
| 747.64 | Other anomalies of peripheral vascular system, lower limb vessel anomaly |
| 782.3 | Edema |
| 785.4 | Gangrene |
| V12.51 | Personal history of venous thrombosis and embolism |
| V12.52 | Personal history of thrombophlebitis |
When services are Not Medically Necessary:
For the procedure and diagnosis codes listed above, when criteria are not met, and for the following diagnosis
| ICD-9 Diagnosis | |
| 454.9 | Asymptomatic varicose veins |
When services are Investigational and Not Medically Necessary:
For the procedure codes listed above, for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
When services are also Investigational and Not Medically Necessary:
| CPT | |
| No specific code for COMPASS protocol | |
| ICD-9 Diagnosis | |
| All diagnoses |
When services are Cosmetic and Not Medically Necessary:
| CPT | |
| 36468 | Single or multiple injections of sclerosing solutions, spider veins (telangiectasia); limb or trunk |
| ICD-9 Diagnosis | |
| All diagnoses |
| References |
Government Agency, Medical Society and Other Authoritative Publications:
| Web Sites for Additional Information |
| Index |
Closure Procedure
COMPASS
Endosaphenous Radiofrequency or Laser Ablation for Primary Venous Insufficiency
EVLT™
Laser Ablation for Primary Venous Insufficiency
PhotoDerm®
Photothermal sclerosis
Primary Venous Insufficiency, Endosaphenous Radiofrequency or Laser Ablation for
Radiofrequency Ablation for Primary Venous Insufficiency
Spider Veins
Telangiectatic Dermal Veins
Trans-Illuminated Powered Phlebectomy (TIPP)
TRIVEX™ System
Varicose Veins
Vasculite™
VeinLase™
VNUS® Closure® Catheter Systems
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
| Document History |
| Status | Date | Action |
| 10/01/2009 | Updated coding section with 10/01/2009 ICD-9 changes; removed ICD-9 diagnosis code 453.8 (no longer applicable). | |
| Revised | 05/21/2009 | Medical Policy & Technology Assessment Committee (MPTAC) review. Vein anatomy clarified in position statement. Background updated to address standard therapies. References updated. |
| Revised | 11/20/2008 | MPTAC review. Criteria updated to address saphenous vein tributaries and extensions. Rationale, background, coding and references updated. |
| Revised | 11/29/2007 | MPTAC review. Criteria for perforator ligation clarified. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary" and the phrase "cosmetic/not medically necessary" was clarified to read "cosmetic and not medically necessary." References updated. |
| Revised | 12/07/2006 | MPTAC review. Minimal pressure criteria (30mmHg) for compression stockings deleted. Coding updated; removed HCPCS S2130, S2131 deleted 12/31/2004. |
| Revised | 03/23/2006 | MPTAC review. |
| 11/21/2005 | Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD). | |
| Revised | 04/28/2005 | MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. |
| Pre-Merger Organizations | Last Review Date | Document Number | Title |
| Anthem, Inc. | 10/28/2004 | SURG.00037 | Treatment of Varicose Veins (lower extremities) |
| WellPoint Health Networks, Inc. | 03/11/2004 | 3.01.23 | Endosaphenous Radiofrequency or Laser Ablation for Treatment of Primary Venous Insufficiency |
| 09/23/2004 | Clinical Guideline | Sclerotherapy-Varicose Veins | |
| 12/02/2004 | Clinical Guideline | Treatment of Refluxing Saphenous Vein in Patients with Varicose Veins |