Download Varicose Vein Treatments and Therapies - Providers

Clinical Policy Title: Varicose Vein Treatments and Therapies
Clinical Policy Number: 16.03.06
Effective Date:
Initial Review Date:
Most Recent Review Date:
Next Review Date:
January 1, 2014
August 20, 2014
August 19, 2015
August, 2016
Policy contains:
 Varicose veins.
 Treatments and therapies.
Related policies:
None.
ABOUT THIS POLICY: Keystone First has developed clinical policies to assist with making coverage determinations. Keystone First’s clinical policies
are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies,
the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies
along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific
definition of “medically necessary,” and the specific facts of the particular situation are considered by Keystone First when making coverage
determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements,
the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Keystone First’s clinical policies are for informational
purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the
treatment decisions for their patients. Keystone First’s clinical policies are reflective of evidence-based medicine at the time of review. As medical
science evolves, Keystone First will update its clinical policies as necessary. Keystone First’s clinical policies are not guarantees of payment.
Coverage policy
Keystone First considers varicose vein treatments and therapies to be clinically proven and, therefore,
medically necessary when the following criteria are met:


The patient has documented varicose veins, which are symptomatic (e.g., aching and/or edema,
not responsive to elevation and/or analgesics).
Compression stockings are the initial treatment for varicose veins.
o Graded compression stockings may be indicated for all of the following:

 Venous stasis ulcer.
 Following an invasive procedure on a saphenous vein, for example:
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

 Saphenous vein stripping.
 Laser ablation of the saphenous vein.
 Radiofrequency ablation (RFA) of saphenous vein.
 Deep venous thrombosis of a lower extremity.
 Prevention or treatment of post-thrombotic syndrome.
o Contraindications have been excluded, including all of the following :
 Untreated cellulitis.
 Arterial insufficiency.
 Severe cardiac failure.
Compression therapy (pressure 20 – 30mm Hg) are a second order therapy under the following
conditions:
o Patients with symptomatic varicose veins.
o As the primary treatment to aid healing of venous ulceration.
o In addition to ablation of incompetent superficial veins to decrease the recurrence of
venous ulcers.
o This therapy is not recommended as the primary treatment if the patient is a candidate for
saphenous vein ablation.
Prior to consideration of ablative or surgical approaches, an ultrasound or duplex scan must be
performed to determine the extent and configuration of varicose veins. Documentation from the
studies must demonstrate both of the following:
o Absence of deep venous thrombosis.
o Greater and/or lesser saphenous vein valvular incompetence/reflux that correlates with the
patient’s symptoms.
Varicose vein ablative and stripping procedures that fail conservative therapy, including:
Invasive
procedure
Endovascular
laser ablation,
radiofrequency
ablation,
stripping, ligation
and excision of
the great
saphenous vein
and small
saphenous
Indications




Saphenofemoral valve incompetence
documented by duplex scan or
ultrasound test.
The saphenofemoral junction.
The great saphenous vein in the
thigh.
The saphenopopliteal junction
o The small saphenous vein in
the calf.
o Perforators that remain
incompetent only after
ablation of the incompetent
saphenous system and all the
following criteria are met:
 Perforator vein size is
Comment



Deep venous thrombosis
ruled out by duplex
ultrasound or other
imaging test.
No evidence of clinically
significant lower extremity
arterial disease.
Symptoms of saphenous
venous insufficiency
causing a clinically
significant functional
impairment, including one
or more of the following:

Leg pain
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




3.5mm or greater.
Outward flow
duration is ≥ 500
milliseconds.
Perforating vein is
located underneath a
healed or active
venous stasis ulcer
(CEAP class C-5-C6).
(See glossary.)


Ambulatory
phlebectomy or
transilluminated
powered
phlebectomy

Leg fatigue.
Leg edema.
Persistent or
recurrent venous
stasis ulcer.
Persistent or
recurrent
superficial
thrombophlebitis.
No significant symptomatic
improvement in response
to a three-month trial of
fitted elastic support hose.
Symptomatic saphenous veins,
varicose tributaries, accessory and
perforator veins 2.5 mm or greater in
diameter for persons who meet the
medical necessity criteria for varicose
vein treatment in sections I and II
above and who are being treated or
have previously been treated by one
or more of the procedures noted in
section I and II above for
incompetence (i.e., reflux) at the
saphenofemoral junction or
saphenopopliteal junction.
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Liquid or foam
sclerotherapy
(endovenous
chemical
ablation).



Symptomatic saphenous veins,
varicose tributaries, accessory, and
perforator veins 2.5 mm or greater in
diameter for persons who meet
medical necessity criteria for varicose
vein treatment in section I and II
above and who are being treated or
have previously been treated by one
or more of the procedures noted in
section II above for incompetence
(i.e., reflux) at the saphenofemoral
junction or saphenopopliteal
junction.
No evidence of saphenofemoral valve
incompetence documented by duplex
ultrasound or other imaging test.
One or more of the following is or are
present:
o
o
o
o
Subfascial
endoscopic
perforator vein
surgery (SEPS)
Valvular
reconstruction
Recurrent or residual
symptomatic superficial
varicosities after vein stripping.
Superficial varices from venous
malformations for which surgery
is not advisable.
Emergency treatment for
bleeding, ruptured superficial
varicose veins.
Large superficial varices around
skin ulcer.
The number of medically necessary
sclerotherapy injection sessions
varies with the number of
anatomical areas that have to be
injected, as well as the response to
each injection. Usually one to three
injections are necessary to
obliterate any vessel, and 10 to 40
vessels, or a set of up to 20
injections in each leg, may be
treated during one treatment
session. Initially, up to two sets of
injections of sclerosing solution in
multiple veins in each affected leg
(i.e., four sets of injections if both
legs are affected) are considered
medically necessary when criteria
are met. (A set of injections is
defined as multiple sclerotherapy
injections during a treatment
session.) Additional sets of
injections of sclerosing solution are
considered medically necessary for
persons with persistent or
recurrent symptoms.
Medically necessary for the treatment of
members with advanced chronic venous
insufficiency secondary to primary valvular
incompetence of superficial and perforating
veins, with or without deep venous
incompetence, when conservative
management has failed.
Is considered medically necessary for chronic
venous insufficiency.
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Limitations:
All other uses of therapies and/or treatments for varicose veins are not medically necessary.
Keystone First considers any of the following varicose vein therapies and/ or treatments to be cosmetic and
not clinically proven, therefore not medically necessary:







Sclerotherapy or various laser treatments (including tunable dye or pulsed dye laser like
PhotoDerm®, VeinLase™, Vasculite™) of the telangiectatic dermal veins (e.g., reticular, capillary,
venule), which may be described as "spider veins" or "broken blood vessels."
Endoluminal radiofrequency ablation and endoluminal laser ablation, are considered investigational
and not medically necessary for all other uses in the lower extremities including, but not limited to:
o As an alternative to perforator vein ligation.
o As treatment of saphenous vein tributaries or extensions (e.g., anterolateral thigh, anterior
accessory saphenous and Giacomini veins)
o As an alternative to adjunctive sclerotherapy or echosclerotherapy of symptomatic varicose
tributaries.
Endoluminal cryoablation is investigational and not medically necessary.
Mechanochemical ablation of any vein is investigational and not medically necessary because it has
not been proven to be as effective as established alternatives.
Sclerotherapy or echosclerotherapy is considered investigational and not medically necessary:
o As the sole* treatment of symptomatic varicose tributary or extension or perforator veins
in the presence of valvular incompetence of the greater or lesser saphenous veins (by
Doppler or duplex ultrasound scanning).
o As the sole treatment of symptomatic varicose tributary or perforator veins in the absence
of saphenous vein reflux or major saphenous vein tributary reflux.
o For the treatment of secondary varicose veins resulting from deep-vein thrombosis or
arteriovenous fistulae when used to treat valvular incompetence (i.e., reflux) of the greater
or lesser saphenous veins, with or without associated ligation of the saphenofemoral
junction.
o When performed as part of other protocols for sclerotherapy, including, but not limited to
the COMPASS protocol, for the treatment of valvular incompetence (i.e., reflux) of the
greater or lesser saphenous veins.
Photothermal sclerosis (also referred to as an intense pulsed light source, like the PhotoDerm
VascuLight, VeinLase), used to treat small veins such as small varicose veins and spider veins, is
considered cosmetic because such small veins do not cause pain, bleeding, ulceration or other
medical problems.
Transdermal laser treatment is considered experimental and investigational for the treatment of
large varicose veins because it has not been proven in direct comparative studies to be as effective
as sclerotherapy and/or ligation and vein stripping in the treatment of the larger varicose veins
associated with significant symptoms (pain, ulceration, inflammation). (Note: Although transdermal
Nd:YAG laser has been shown to be effective for the treatment of telangiectasias and reticular
veins, treatment of these small veins is considered cosmetic.)
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

Polidocanol injection (Asclera) is considered cosmetic, it has been approved by the United States
Food and Drug Administration for the treatment of telangiectasias and reticular veins less than
3mm in diameter (treatment of these small veins is considered cosmetic).
Subfascial endoscopic perforator vein surgery (SEPS) is considered experimental and investigational
for the treatment of patients with postthrombotic syndrome, varicose veins and other indications
because its effectiveness has not been established.
* Note for patients receiving anticoagulant therapy: If the decision is made to proceed with the service, the
medical record should clearly support that the benefit outweighs the risk and the justification to proceed
with the service should be given.


Ambulatory phlebectomy or transilluminated powered phlebectomy is considered experimental
and investigational for treatment of junctional reflux as these procedures have not been proven to
be effective for these indications. Ambulatory phlebectomy is considered cosmetic for veins less
than 2.5mm in diameter and all other indications.
Repeated procedures for venous ablation (e.g., VNUS, ELAS), performed more than twice, on the
same area of the same vein, in separate surgical procedures, are considered not medically
necessary.
Contraindications:



Pregnant women.
Patients on anticoagulant therapy.*
The inability to tolerate compressive bandages or stockings.



Severe distal arterial occlusive disease.
Obliteration of deep venous system.
Allergy to the sclerosant.
Alternative covered services:
Consultation with treating physician or specialist.
Background
Varicose veins are widened veins that twist and turn and are visible under the skin of the leg. These
abnormally enlarged vessels develop when the thin flaps of the venous valves no longer meet in the
midline, which allows blood to reflux, or flow backwards away from the heart, causing discoloration.
Backward blood flow introduces increased pressure into veins that are intended to function as a lowpressure system, which leads to progressive distension, dilation and tortuosity of the vein. Since the
superficial veins lack muscle support and lie close to the surface of the skin, they become visible with
increased intravascular pressure. The condition is further aggravated as the walls of the affected vein
weaken. Larger varicose veins are found most often on the back of the calf or on the inside of the leg
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between the groin and ankle, and are commonly the result of reflux through the valve at the junction
between the great saphenous vein (GSV) and the common femoral vein, but can also result from
enlargements of the perforating veins. Some form of venous disorder affects approximately 80 million
Americans. Women are more likely to suffer from varicose veins then men, with as many as 50 percent
affected.
Varicose veins generally do not cause medical problems, although many sufferers seek medical advice as
they are often a cosmetic concern. Symptoms that may occur include pain, ankle swelling, tired legs,
restless legs, night cramps, heaviness and itching. Initially, these symptoms may not warrant medical
intervention but they can become clinically important when symptoms such as cramping, throbbing,
burning, swelling, feeling of heaviness or fatigue and alterations in skin pigmentation become pronounced.
Severe varicosities may be associated with dermatitis, ulceration, and thrombophlebitis, which result when
metabolic waste products are no longer removed due to pooling of venous blood and increased hydrostatic
pressure.
The four main causes of these abnormalities are heredity, female sex, gravitational hydrostatic forces and
hemodynamic muscular compartment pressure. There are clear indications and goals for intervention.
Genetic predisposition is the primary contributing factor causing varicose veins. Hormonal factors,
associated with puberty, pregnancy, menopause, the use of birth control pills, estrogen, and progesterone
may also contribute to the condition. Varicose veins may also be the result of increased hydrostatic
pressure from: standing occupations, obesity, ultraviolet or chronic X-ray exposure, thrombophlebitis or
deep vein thrombosis, chronic lower extremity infection, anoxia or traumatic injury. The degeneration of
smooth muscles and loss of elastic support, which is associated with advanced age, is also a contributing
factor.
Another common cause is chronic venous insufficiency (CVI), a venous disorder affecting at least 25 million
Americans. CVI is a disorder in which veins fail to pump blood back to the heart adequately. It can cause
varicose veins, skin ulcers, and superficial or deep vein thrombosis in the legs. GSV reflux, a form of CVI, is
most commonly responsible for the development of varicose veins.
Traditionally, varicose veins are first treated with conservative management techniques that attempt to
treat the underlying cause of the defect. Conservative therapies may include: weight reduction, elevation of
the legs, walking or compression hosiery. Compression stockings are often the first line of treatment and
come in a variety — knee-length to full tights — and apply different pressures to support the flow of blood
in the veins. There are three types of compression stockings that offer increasing levels of pressure,
including support pantyhose, over-the-counter compression hose and prescription-strength compression
hose. Although compression stockings may not prevent the emergence of varicose veins, they can reduce
the risk of GSV reflux and the worsening of symptoms.
Varicose veins are often treated with surgery to remove the veins, by stripping them to the level of the
knee (so-called high ligation and stripping), particularly if there is severe discomfort, ulceration,
thrombosis, ligation, excision or ablation of the affected veins may be indicated. New less invasive
treatments seal the main leaking vein in the thigh using laser (endovenous laser therapy), RFA or foam
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sclerotherapy. These techniques may result in less pain after the procedure, fewer complications and a
quicker return to work and normal activities, with improved patient quality of life, as well as avoiding the
need for general anesthesia.
Saphenous vein ablation, radiofrequency:
RFA, also called obliteration, is a form of endovenous thermal ablation. Under duplex (Doppler) scan
guidance, radiofrequency energy is directed at the specified varicose vein. This controlled heating of the
vein wall results in closure of the vein due to contraction of collagen in the wall. Providing saphenous vein
closure rates around 85 percent to 90 percent, RFA may have a somewhat lower closure rate when directly
compared with vein stripping and ligation. Possible complications include vessel perforation, pulmonary
embolism, phlebitis, hematoma, infection, paresthesia and skin burns. RFA has been shown in a prospective
nonrandomized trial to be more effective than foam sclerotherapy for closure of the GSV at one year follow
up. RFA offers a less invasive alternative to surgical stripping and ligation for patients with symptomatic
varicose veins. Post-RFA patients can return to work sooner with less pain and fewer infections.
Sclerotherapy:
Injection sclerotherapy can be used for superficial varicose veins, residual or recurring varicose veins
following surgery and thread veins to obliterate veins. An irritant liquid such as sodium tetradecyl sulphate
(STD) is injected into the faulty blood vessel. The solution obliterates the lumen through irritating the vein
until it shrinks, becoming scar tissue and fading. Possible complications of sclerotherapy include formation
of blood clots, skin staining, inflammation, ulcers and tissue damage, and reactions to the sclerosing agent.
Currently sclerotherapy is usually limited to treatment of recurrent varicose veins following surgery, and
thread veins.
Varicose vein and venous insufficiency/ligation tripping cryostripping:
Ligation is a surgical technique where veins are tied off proximally; this usually results in atrophy of veins.
This prevents the pooling of blood or backwards flow that can lead to discoloration. Ligation is sometimes
preformed in conjunction with stripping of the vein, which is actual removal of the specified vein. The
stripping technique surgically removes the truncal vein. This is used for both the initial treatment and for
the prevention of future varicose veins. Usually preformed as an outpatient procedure, these surgical
treatment options of varicose veins are consistently successful.
Cryoablation uses extreme cold to injure the vessel. Cryostripping of the GSV may be considered an
alternative approach to traditional ligation and stripping. During this procedure, a cryoprobe is passed
through the GSV, the probe freeze attaches to the GSV and stripping is performed by pulling back the
probe. Results of cryotherapy procedures for treatment of varicose veins in the published scientific
literature are mixed and do not lend strong support to improved clinical outcomes when compared to more
conventional methods of varicose vein treatment. Further studies are needed to demonstrate safety,
efficacy and the clinical utility of cryostripping.
Ambulatory phlebectomy/stab phlebectomy:
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Ambulatory phlebectomy is also widely accepted as an alternative to sclerotherapy, performed for the
treatment of secondary branch varicose veins. It is also referred to as miniphlebectomy, hook phlebectomy
or stab avulsion. In ambulatory phlebectomy, multiple small incisions are made, and the varicose veins are
grasped with a small hook or hemostat. The entire varicosity can be extracted with multiple small incisions.
Effectiveness is dependent on the type of vein treated. Phlebectomy is a treatment of choice for smaller
veins such as the lateral accessory veins and that for larger veins such as the saphenous veins, phlebectomy
may not provide the same level of success as sclerotherapy.
Transilluminated powered phlebectomy (TIPP):
TIPP, which is similar to ambulatory phlebectomy, is another minimally invasive alternative to standard
surgery for the treatment of symptomatic varicosities. Also known as the TriVex™ procedure, TIPP involves
endoscopic resection and ablation of the superficial varicosity.
Subcutaneous transillumination and tumescent anesthesia help visualize and locate the varicosity, while
subcutaneous vein ablation is performed using a powered resector to obliterate the vein. Tumescent
anesthesia involves the infusion of large amounts of saline and lidocaine to reduce hemorrhage and of
epinephrine to delay absorption of the lidocaine. TIPP is intended for patients who are suitable candidates
for conventional ambulatory phlebectomy, and may also be used as an adjunctive method to other varicose
vein treatments (e.g., ligation and stripping).
Several treatment options are available for the treatment of symptomatic varicose veins, including ligation
and stripping, subfascial endoscopic surgery and ablative procedures. Procedures such as sclerotherapy and
phlebectomy are effective for treatment of secondary varicose tributaries when performed either at the
same time or following an initial invasive procedure. The peer-reviewed scientific literature supports safety
and efficacy of these procedures, with most patients obtaining improvement in clinical outcomes. While
varicose vein surgery is a very common surgical procedure, there is no general consensus regarding the best
surgical approach. Additionally, recurrences have been reported requiring second treatment sessions for
some procedures. Evidence in the medical literature evaluating procedures such as transilluminated
powered phlebectomy, endomechanical ablative approaches and cryoablative procedures is primarily in the
form of case series, lack randomization and controls, and involve small sample populations evaluating
short-term outcomes. Strong evidence-based conclusions cannot be made regarding safety, efficacy and
improvement of net health outcomes. Further clinical studies are needed to support the safety and efficacy
of these procedures.
Searches
Keystone First searched PubMed and the databases of:
 UK National Health Services Centre for Reviews and Dissemination.
 Agency for Healthcare Research and Quality’s National Guideline Clearinghouse and other evidencebased practice centers.
 The Centers for Medicare & Medicaid Services (CMS).
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We conducted searches in January 2014 and August 2015. Search terms were: "varicose veins" or free-text
terms “varicose”[Mesh].
We included:
 Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater
precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined
transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are
thus rated highest in evidence-grading hierarchies.
 Guidelines based on systematic reviews.
 Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost
studies), reporting both costs and outcomes — sometimes referred to as efficiency studies — which
also rank near the top of evidence hierarchies.
Findings
A review of available randomized, controlled trials that compared the new techniques such as RFA to
surgery in the treatment of varicosities in the great saphenous vein found only five trials, with a combined
total of 450 patients, which met inclusion criteria. Three trials compared laser therapy with surgery and two
trials compared RFA with surgery. Laser therapy was associated with less technical failure but a trend to
higher rates of reopening of the treated vein (recanalization) compared with surgery. No results were
available to compare the rates of recurrence. It was found that RFA was associated with trends for fewer
technical failures and less new vein growth (neovascularization) compared with surgery; the trend was for
more recanalization within four months with no demonstrated difference in recurrence of varicose veins.
The results in the study reports were presented as either the number of legs or number of patients, where
some patients had varicose veins in both legs. The outcomes were also measured at different times after
the procedures for the different trials. This limited the findings of our review. Currently available clinical
trial evidence suggests RFA and endovenous laser ablation (EVLT) are at least as effective as surgery in the
treatment of (GSV). There are insufficient data to comment on ultrasound-guided sclerotherapy (USGS).
Further randomized trials are needed.
Seventeen randomized controlled trials involving over 3,300 people were included in the review. One study
comparing sclerotherapy to compression stockings in pregnancy found that sclerotherapy improved
symptoms and cosmetic appearance. There was no overall benefit from using alternative agents to STD, or
any evidence that a foam was superior to liquid. Adding local anesthetic to the sclerosing agent reduced the
pain of injection in one study. Neither the type, nor duration of elastic compression or type of pressure pad
after sclerotherapy had any clear effect on the effectiveness of sclerotherapy, on varicose vein recurrence
rates, cosmetic appearance or symptomatic improvement, or on complications. There were no controlled
trials comparing sclerotherapy for thread veins with either laser treatment or simple observation;
hypertonic dextrose had similar efficacy in terms of sclerosis to STD in one study.
10
Given its success rates and minimally invasive approach in an outpatient setting, UGFS may offer an
attractive, alternative treatment option for patients before conventional surgical stripping and ligation
(phlebectomy), which are inherently more invasive procedures that carry greater morbidity.
Evidence from a number of randomized comparative trials and prospective studies suggests
that EVLA effectively provides venous occlusion to treat symptomatic varicose veins due to GSV reflux in
adult patients. Several studies of moderate-to-good quality that evaluated the relative efficacy of EVLA
compared with conventional surgical techniques report comparable or superior clinical results of EVLA, with
rates of recurrence generally less than 5 percent. The evidence also suggests that patients who underwent
EVLA experienced less postoperative morbidity, with less need for extended analgesics to address pain, and
experienced faster recovery, compared with conventional surgical techniques. Patient-reported health
outcomes, including cosmesis, quality of life, and overall patient satisfaction, were generally comparable
between EVLA and conventional surgical treatments.
Summary of clinical evidence
Citation
Content, methods, recommendations
Wright, et al. (2006)
Key points:
Rasmussen, et al.
(2011)
Lurie, et al. ( 2003)
Comparing the safety and efficacy of USGS using polidocanol 1% microfoam formulation (Varisolve)
with surgery for the treatment of primary or recurrent varicose veins and trunk vein incompetence
(n=710):
 Patients had either GSV or SSV incompetence, and were assigned to receive either
surgery (n=311) or sclerotherapy (n=399) based on the severity of the disease and
physician preference. Within the surgery group, patients were randomized to receive
Varisolve (n=210) or surgery (n=101); within the sclerotherapy group, patients were
randomized to receive Varisolve (n=274) or conventional sclerotherapy (n=125).
 The primary outcome measure was treatment response at three months of follow up,
defined as the complete occlusion of the incompetent trunk veins viewed on duplex
scanning.
 Secondary outcomes included postprocedure pain (measured using a visual analog scale)
, time to return to normal activity, the number of treatment sessions required and the
response rate at 12 months.
Key points:
Comparing four treatments for varicose GSVs (n=500 consecutive patients; 580 legs).
 Patients were randomized to EVLA, RFA, USGS or surgical stripping with local anesthesia
with light sedation. Patients treated by foam sclerotherapy experienced the highest failure
rate (GSV that was open and refluxing) (16%) compared with EVLA (6%), RFA (5%) and
surgical stripping (5%). (P<0.001 for each comparison). Secondary outcomes included
pain, return to activity, VCSS, AVVSS and SF-36.
 Foam sclerotherapy resulted in a significantly greater number of patients with phlebitis
(n=17) compared with EVLA postoperative pain than patients treated with EVLA or
stripping (P<0.001 for each comparison).
Key points:
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This study was designed as a randomized comparison of procedure-related complications, patient
recuperation and quality of life outcomes between patients undergoing vein stripping with high
ligation and patients (SandL) undergoing GSV obliteration with temperature-controlled
radiofrequency ablation (RFO).
Success was reported for 95% of limbs in the RFO group and 100% of limbs in the SandL group. In
16.3% RFO limbs, a scan after the procedure showed flow in the proximal GSV. Five of these
segments had reflux in the open segment. At one week two closed, and an additional segment
closed at three weeks. In no cases did flow reappear after complete occlusion of the GSV.


Mandavia (2015)
RFO groups had shorter recovery times and better global and pain scores than the SandL
group.
There are significant early advantages to endovascular obliteration of the GSV compared
with conventional vein stripping.
Key points:

Brittenden (2014)
Cost-effectiveness analysis of eight popular varicose vein treatment options) in terms of
quality adjusted life year..
 Treatment was more cost effective than conservative management options including
compression stockings.
 Endovenous treatment is most cost effective option including ELVA and RFA compared
to compression and surgical treatment.
Key points:



Randomized trial with 798 patients comparing results of foam sclerotherapy, laser
endovenous treatment, and surgical stripping.
Efficacy of treatment options similar, lower rate of complications in laser group.
Foam sclerotherapy produced slightly worse quality of life scores (P=0.006) and was
less successful at complete ablation of saphenous vein.
Policy Update:
Amerihealth Caritas found one randomized controlled study comparing treatments on cost effectiveness
study of vascular surgery (Brittenden 2014, Mandavia 2015). These studies confirm current practice
guidelines and would not change current policy.
Glossary
Ablation — The removal of tissue, a part of the body, or an abnormal growth, usually by cutting.
Ambulatory phlebectomy — A surgical technique to remove superficial varicosities, usually involving an
instrument that pierces the skin adjacent to the varicosity, hooks under it and pulls the varicosity from the
skin. Also known as avulsions, hook avulsion, stab avulsion or micro-extraction phlebectomy.
Avulsion — A surgical technique to remove superficial varicosities.
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Chronic venous insufficiency (CVI) – A disorder in which veins fail to pump blood back to the heart
appropriately causing varicose veins, skin ulcers, and superficial or deep vein thrombosis in the legs.
Crossectomy — Division of a truncal vein and ligation of tributaries.
Doppler ultrasound — A device utilizing Doppler ultrasound that permits color-coded visualization of
blood flow in the superficial, perforating and deep veins, as well as gray-scale imaging of the veins and
surrounding tissue. It can also be used to image blood flow in arteries.
Duplex — A device utilizing Doppler ultrasound that permits color-coded visualization of blood flow in the
superficial, perforating and deep veins, as well as gray-scale imaging of the veins and surrounding tissue.
Endothermal — A specialized form of endovenous treatment that ablates via thermal damage to the inner
lumen of the vein.
Endovenous — Indicates within the vein.
Foam sclerotherapy — Sclerotherapy using a sclerosant that has been mixed with a gas to make a foam.
Endovenous thermal ablation — Also called laser therapy endovenous alser ablation therapy (EVLAT)) is a
newer technique that uses a laser or high-frequency radio waves to create intense local heat in the varicose
vein or incompetent vein to close vein with minimal damage.
Great saphenous vein (GSV) — Previously also called the long saphenous vein, is a large, subcutaneous,
superficial vein of the leg. It is the longest vein in the body running along the length of the leg.
Laser ablation — An endothermal ablation technique that uses laser energy to cause venous ablation and
closure by raising the temperature of the inner lumen of the vein.
Ligation — A surgical technique where veins are tied off proximally; this usually results in atrophy of the
vein.
Liquid sclerotherapy — Sclerotherapy using a liquid sclerosant.
Phlebectomy — A surgical technique to remove superficial varicosities, usually involving an instrument that
pierces the skin adjacent to the varicosity, hooks under it and pulls the varicosity from the skin. Also known
as avulsion, hook avulsion or ambulatory phlebectomy.
Radiofrequency ablation — An endothermal ablation technique that uses radio wave electromagnetic
energy to cause venous ablation and closure by raising the temperature of the inner lumen of the vein.
Sclerotherapy — The injection of chemical substances into a truncal or tributary vein, that causes closure of
the vein.
13
Spider veins/dermal telangiectasias — Are a localized collection of distended blood capillary vessels which
may be obliterated through various procedures, such as laser photocoagulation or sclerotherapy.
Stripping — A surgical technique of truncal vein removal, where the vein is stripped from surrounding
tissues and removed.
Transilluminated powered phlebectomy (TIPP) — Transilluminated powered phlebectomy performed with
an illuminator and a motorized resector aiming to reduce the risk associated with stab avulsion.
Ultrasound-guided sclerotherapy — The injection of a sclerosing agent into a vein guided by real-time
ultrasound imaging.
Vein ligation and stripping — A surgical approach to the treatment of varicose veins. Also called
phlebectomy.
References
Professional society guidelines/other:
American College of Phlebology (ACP website). ACP Patient Information for Vein Treatment (Varicose and
Spider). 2008. http://phlebology.org/patientinfo/index.html. Accessed August 5, 2015.
ECRI Institute. Hotline Response [database online]. Plymouth Meeting (PA): ECRI Institute; Endovenous
radiofrequency ablation (VNUS Closure System) for the treatment of varicose veins. 2008, Aug 8.
http://www.ecri.org. Accessed August 7, 2015.
ECRI Institute. Endovenous Radio-frequency Ablation (VNUS Closure System) for the Treatment of Varicose
Veins. Plymouth Meeting (PA): ECRI Institute; 2006 August 24. (Evidence Report Issue No. 138).
http://www.ecri.org. Accessed August 7, 2015.
ECRI Institute. Endovenous Laser Ablation of the Greater Saphenous Vein. Plymouth Meeting (PA): ECRI
Institute; 2004, December 30. (Evidence Report Issue No. 121). http://www.ecri.org. Accessed August 7,
2015.
ECRI Institute. Transilluminated powered phlebectomy (TIPP) for varicose veins [Emerging Technology
Evidence Report]. Plymouth Meeting (PA): ECRI Institute; 2008, April 8. http://www.ecri.org. Accessed
August 7, 2015.
Hayes Directory, Endovenous Laser Therapy for Varicose Veins due to Great Saphenous Vein Reflux.
February 6, 2009.
Hayes Directory, Ultrasound-Guided Foam Sclerotherapy (UGFS) for Varicose Veins, November 4, 2011.
14
National Institute for Clinical Excellence (NICE). Endovenous laser treatment of the long saphenous vein.
Guidance. Issued 2004b Mar 4. Accessed August 7, 2015.
http://www.nice.org.uk/guidance/ipg52/resources/ipg052-endovenous-laser-treatment-of-the-longsaphenous-vein-information-for-people-considering-the-procedure-and-for-the-public2.
National Institute for Clinical Excellence (NICE). Endovenous mechanicochemical ablation for varicose
veins. Guidance issued January 2013. Accessed August 7, 2015. http://guidance.nice.org.uk/IPG435.
National Institute for Clinical Excellence (NICE). Radiofrequency ablation of varicose veins. Guidance. Issued
September 2003. Accessed August 7, 2015. https://www.nice.org.uk/Guidance/IPG8.
National Institute for Clinical Excellence (NICE). Subfascial endoscopic perforator surgery, Guidance. Issued
2004c June. Accessed August 7, 2015. https://www.nice.org.uk/guidance/ipg59/resources/interventionalprocedure-consultation-document-subfascial-endoscopic-perforator-vein-surgery-seps.
National Institute for Clinical Excellence (NICE). Transilluminated powered phlebectomy for varicose veins,
Guidance. Issued 2004a Jan. Accessed August 7, 2015. https://www.nice.org.uk/Guidance/IPG37.
National Institute for Clinical Excellence (NICE). Ultrasound guided foam sclerotherapy for varicose veins.
Guidance. Issued June 2006. Re-issued May 2007. Accessed August 7, 2015.
https://www.nice.org.uk/Guidance/IPG440.
Proebstle TM, Alm J, Göckeritz O, et al. European Closure Fast Clinical Study Group. Three-year European
follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein
with or without treatment of calf varicosities. J Vasc Surg. 2011 Jul;54(1):146-52. Epub 2011 Mar 24.
Society of Interventional Radiology (SIR) [website]. Position Statement. Endovenous Ablation. December
2003. http://www.sirweb.org/clinical/cpg/SIR_venous_ablation_statement_final_Dec03.pdf.
Accessed August 4, 2015.
Peer-reviewed references:
Bellmunt-Montoya S, Escribano JM, Dilme J, Martinex-Zapata MJ. Cochrane Peripheral Vascular Disease
Group, CHIVA method for the treatment of chronic venous insufficiency, Published Online: 3 JUL
2013Assessed as up-to-date: 22 DEC 2012 DOI: 10. 1002/14651858.CD009648.pub2.
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009648.pub2/abstract. Accessed August 4, 2015.
Bergan J. Sclerotherapy: a truly minimally invasive technique. Perspect Vasc Surg Endovasc Ther.
2008; 20(1): 70 –72.
Bergan JJ, et al. Surgical and endovascular treatment of lower extremity venous insufficiency. J Vasc Interv
Radio.. 2002; 13(6): 563 – 568.
15
Brittenden J, Cotton SC, Elders A, et al. A randomized trial comparing treatments for varicose veins. N Engl J
Med. 2014; 371(13): 1218 – 1227.
Cheshire N, Elias SM, Keagy B, Kolvenbach R, Leahy AL, Marston W, Pannier-Fischer F, Rabe E, Spitz GA.
Powered phlebectomy (TriVex) in treatment of varicose veins. Ann Vasc Surg. 2002 Jul; 16(4): 488 – 494.
Chetter IC, Mylankal KJ, Hughes H, Fitridge R. Randomized clinical trial comparing multiple stab incision
phlebectomy and transilluminated powered phlebectomy for varicose veins. Br J Surg. 2006 Feb; 93(2): 169
– -174.
Disselhoff BC, der Kinderen DJ, Kelder JC, Moll FL. Randomized clinical trial comparing endovenous laser
ablation of the great Saphenous vein with and without ligation of the sapheno-femoral junction: 2-year
results. Eur J Vasc Endovasc Surg. 2008 Dec; 36(6): 713 – 718.
Disselhoff BC, der Kinderen DJ, Kelder JC, Moll FL. Randomized clinical trial comparing endovenous laser
with cryostripping for great saphenous varicose veins. Br J Surg. 2008 Oct; 95(10): 1232 – 1238.
Disselhoff BC, der Kinderen DJ, Kelder JC, Moll FL. Five-year results of a randomized clinical trial comparing
endovenous laser ablation with cryostripping for great saphenous varicose veins. Br J Surg. 2011 Aug; 98(8):
1107 – 1011. doi: 10.1002/bjs.7542.
Eklöf B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner RL, et al., American Venous Forum
International Ad Hoc Committee for Revision of the CEAP Classification. Revision of the CEAP classification
for chronic venous disorders: consensus statement. J Vasc Surg. 2004 Dec; 40(6): 1248 – 1252.
Fischer R, Chandler JG, Stenger D, Puhan MA, De Maeseneer MG, Schimmelpfennig L. Patient
characteristics and physician-determined variables affecting saphenofemoral reflux recurrence after
ligation and stripping of the great saphenous vein. J Vasc Surg. 2006; 43(1): 81.
Franz RW, Knapp ED. Transilluminated Powered Phlebectomy Surgery for Varicose Veins: A Review of 339
Consecutive Patients. Ann Vasc Surg. 2008 September 5.
Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner
MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for
Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic
venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous
Forum. J Vasc Surg. 2011 May; 53(5 Suppl): 2S-48S.
Hingorani AP, et al. Deep venous thrombosis after radiofrequency ablation of greater saphenous vein: a
word of caution. Journal of Vascular Surgery 2004; 40(3): 500 – -504.
16
Kim JW, Han JW, Jung SY, Lim MS, Jung JP, Cho JW. Outcome of transilluminated powered phlebectomy for
varicose vein: review of 299 patients (447 limbs). Surg Today. 2012 March 6.
Lurie F, et al. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure)
versus ligation and stripping in a selected patient population (EVOLVeS Study). J Vasc Surg. 2003; 38(2):207
– 214.
Menyhei G, Gyevnár Z, Arató E, Kelemen O, Kollár L . Conventional stripping versus cryostripping: a
prospective randomised trial to compare improvement in quality of life and complications. Eur J Vasc
Endovasc Surg. 2008 Feb; 35(2): 218 – 223.
Merchant RF, DePalma RG, Kabnick LS. Endovascular obliteration of saphenous reflux: a multicenter study. J
Vasc Surg. 2002; 35(6): 1190 – 1196.
McDonagh B, Sorenson S, Gray C, Huntley DE, Putterman P, King T, et al. Clinical spectrum of recurrent
postoperative varicose veins and efficacy of sclerotherapy management using the compass technique.
Phlebology. 2003; 18: 173 –1786.
Nesbitt C, Eifell RKG, Coyne P, Badri H, Bhattacharya V, Stansby G. Endovenous ablation (radiofrequency
and laser) and foam sclerotherapy versus conventional surgery for great saphenous vein varices. Cochrane
Database of Systematic Reviews 2011, Issue 10. Art. No.: CD005624. DOI:
10.1002/14651858.CD005624.pub2
Rasmussen LH, Bjoern L, Lawaetz M, et al. Randomized trial comparing endovenous laser ablation of the
great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results. J
Vasc Surg. 2007; 46(2): 308 –315.
Sadick NS. Commentary: Closure of the greater saphenous vein with endoluminal radiofrequency thermal
heating of the vein wall in combination with ambulatory phlebectomy: Preliminary 6-month follow-up.
Dermatol Surg. 2000; 26(5): 456.
Tisi PV, Beverley CA. Injection sclerotherapy for varicose veins. Cochrane Database of Systematic Reviews
2002 ;( 1):CD001732.
Shingler S, Robertson L, Boghossian S, Stewart M, Compression stockings for the initial treatment of
varicose veins in patients without venous ulceration, Published Online: 9 DEC 2013Assessed as up-to-date:
20 AUG 2013DOI: 10.1002/14651858.CD008819.pub3.
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008819.pub3/abstract. Accessed August 4, 2015.
Wright D, Gobin JP, Bradbury AW, Coleridge-Smith P, Spoelstra H, Berridge C, et al. Varisolve® polidocanol
microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of
trunk vein incompetence: European randomized controlled trial. Phlebology. 2006; 21(4): 180 – 190.
17
Clinical trials:
Searched clinicaltrials.gov on August 4, 2015, using terms varicose veins treatment | Open Studies.
Corporacion Parc Tauli. Compairison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficiency.
In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). January 2012 – June 2016
[cited 2015 August 04]. https://clinicaltrials.gov/ct2/show/NCT02454452. NLM Identifier: NCT02454452
Maastricht University Medical Center. Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical
Surgical Stripping Study. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US).
January 2012 – June 2016 [cited 2015 August 04]. https://clinicaltrials.gov/ct2/show/NCT02304146. NLM
Identifier: NCT02304146
University Hospital, Linkoeping. Lower Limb Venous Insufficiency and the Effect of Radiofrequency
Treatment Versus Open Surgery. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of
Medicine (US). January 2012 – June 2016 [cited 2015 August 04].
https://clinicaltrials.gov/ct2/show/NCT02397226. NLM Identifier: NCT02397226
Additional resource information on clinical trials is at http://clinicaltrials.gov/info/resources.
CMS National Coverage Determinations (NCDs):
No NCDs for varicose vein treatments identified as of the writing of this policy.
Local Coverage Determinations (LCDs):
No LCDs for varicose vein treatments identified as of the writing this policy.
Commonly submitted codes
Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not
an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill in
accordance with those manuals.
CPT Code
36475
36476
36478
Description
Endovenous ablation therapy of incompetent vein, extremity, includes of all
imaging guidance and monitoring, percutaneous, radiofrequency, first vein
treated.
Second and subsequent veins treated in a single extremity, each through
separate access sites.
Endovenous ablation therapy of an incompetent vein, extremity, inclusive of all
imaging guidance and monitoring, percutaneous, laser; first vein treated.
Comment
Add-on code
18
36479
37735
37760
37761
Second and subsequent veins treated in a single extremity; each through
separate access sites,
Ligation and division and complete stripping of long or short saphenous veins
with radical excision of ulcer and skin graft and/or interruption of
communicating veins of the lower leg, with excision of deep fascia.
Ligation of perforator veins, subfascial, radical (Linton type), including skin
graft, when performed, open, one leg.
Ligation of perforator vein(s), subfascial, open, including ultrasound guidance
when performed; one leg.
37765
Stab phlebectomy of varicose veins, one extremity; 10-20 stab incisions.
37766
Stab phlebectomy of varicose veins, 1 extremity; more than 20 stab incisions.
37780
Ligation and division of short saphenous vein at saphenopopliteal junction.
37785
Ligation, division, and/or excision of varicose vein cluster(1), one leg.
ICD-9 Code
454.0
454.1
454.9
454.2
454.8
Description
Add-on code
Comment
Varicose veins, lower extremities, with ulcer.
Varicose veins, lower extremities, with inflammation.
Varicose veins, asymptomatic.
Varicose veins, lower extremities, with ulcer and inflammation.
Varicose veins, lower extremities, with other complication.
ICD-10 Code
Description
Comment
HCPCS Level
II
Description
Comment
19