VARICOSE VEIN PROCEDURES - Health Plan of Nevada
VARICOSE VEIN PROCEDURES - Health Plan of Nevada
VARICOSE VEIN PROCEDURES - Health Plan of Nevada
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Protocol: SUR037<br />
Effective Date: September 12, 2011<br />
<strong>VARICOSE</strong> <strong>VEIN</strong> <strong>PROCEDURES</strong><br />
Table <strong>of</strong> Contents<br />
Page<br />
COMMERCIAL INDICATIONS FOR COVERAGE............................................................................. 1<br />
MEDICARE & MEDICAID COVERAGE RATIONALE...................................................................... 4<br />
BACKGROUND ...................................................................................................................................... 8<br />
CLINICAL EVIDENCE........................................................................................................................... 8<br />
U.S. FOOD AND DRUG ADMINISTRATION (FDA)........................................................................ 10<br />
APPLICABLE CODES FOR COMMERCIAL COVERAGE .............................................................. 10<br />
APPLICABLE CODES FOR MEDICARE & MEDICAID COVERAGE ........................................... 11<br />
REFERENCES ....................................................................................................................................... 13<br />
QUESTIONNAIRE ................................................................................................................................ 15<br />
PROTOCOL HISTORY/REVISION INFORMATION ........................................................................ 16<br />
INSTRUCTIONS FOR USE<br />
This protocol provides assistance in interpreting United<strong>Health</strong>care benefit plans. When deciding<br />
coverage, the enrollee specific document must be referenced. The terms <strong>of</strong> an enrollee's document<br />
(e.g., Certificate <strong>of</strong> Coverage (COC) or Evidence <strong>of</strong> Coverage (EOC) may differ greatly. In the event<br />
<strong>of</strong> a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first<br />
identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage<br />
prior to use <strong>of</strong> this Protocol. Other Protocols, Policies and Coverage Determination Guidelines may<br />
apply. United<strong>Health</strong>care reserves the right, in its sole discretion, to modify its Protocols, Policies and<br />
Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute<br />
medical advice.<br />
COMMERCIAL INDICATIONS FOR COVERAGE<br />
Required Documentation:<br />
The decision regarding whether the requested procedure will be covered as reconstructive or excluded<br />
from coverage as cosmetic will require review <strong>of</strong> ALL <strong>of</strong> the following required clinical<br />
information/documentation:<br />
A. Contemporaneous physician <strong>of</strong>fice notes with the history <strong>of</strong> the medical condition(s)<br />
requiring treatment or surgical intervention. This documentation must include ALL <strong>of</strong><br />
the following:<br />
1. The patient has venous insufficiency and valvular reflux that is consistent with<br />
the nature <strong>of</strong> the complaint that results in a functional deficit that is recurrent<br />
or persistent in nature AND<br />
2. The condition is causing the functional impairment (include the nature <strong>of</strong> the<br />
impairment)<br />
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B. A written report, signed by the physician who interpreted the duplex ultrasonography<br />
with the patient in a standing or reverse Trendelenburg position that demonstrates<br />
reflux, duration <strong>of</strong> reflux and documentation <strong>of</strong> vein size. Hand-held ultrasound is<br />
insufficient for these purposes.<br />
C. For those members with pain and discomfort as their only complaint, a completed<br />
questionnaire addressing the degree and severity <strong>of</strong> the pain (refer to page 15 for a copy<br />
<strong>of</strong> the questionnaire)<br />
D. Documentation in physician <strong>of</strong>fice notes <strong>of</strong> skin changes, dermatitis, or ulceration <strong>of</strong><br />
veins that account for the functional impairment.<br />
E. Treatment plan that must include proposed procedures and the expected outcome for the<br />
improvement <strong>of</strong> the functional deficit.<br />
ADDITIONAL INFORMATION: All required documentation must be submitted and approved<br />
through the standard precertification process.<br />
Criteria for a Coverage Determination as Reconstructive:<br />
REVIEW NOTE: Each <strong>of</strong> the requested surgical excisions or catheter entry points should be reviewed<br />
independently for coverage.<br />
A. Varicose vein ablation (surgical excision, radi<strong>of</strong>requency ablation or endovenous laser ablation) <strong>of</strong><br />
the great saphenous vein, small saphenous vein or principle branches (posterior accessory vein,<br />
anterior accessory vein and the cephalad extension <strong>of</strong> the small saphenous vein (vein <strong>of</strong> Giacomini)) is<br />
considered reconstructive when ALL <strong>of</strong> the following criteria are present:<br />
1. Condition is caused by venous insufficiency.<br />
2. Vein size by ultrasound<br />
a. If the planned ablation involves the great saphenous vein, the vein must be 5.5 mm or<br />
greater in diameter, as measured by duplex ultrasonography<br />
b. If the planned ablation involves the small saphenous vein, the vein must measure 5 mm<br />
or greater just below the saphenopopliteal junction.<br />
c. If the planned ablation involves the named principle branches, the vein must measure 5<br />
mm or greater.<br />
d. If there is either bleeding or ulceration from the varicose vein in question that has<br />
moderate or severe reflux as noted below, the vein sizes <strong>of</strong> lower diameters will be<br />
accepted.<br />
3. Documentation in a signed report <strong>of</strong> duration <strong>of</strong> reflux, as measured by duplex<br />
ultrasonography, in the standing or reverse Trendelenburg position that meets the following<br />
parameters:<br />
a. Greater than or equal to 500 milliseconds (ms) for the great saphenous, small saphenous<br />
or principle branches.<br />
b. Perforating veins > 350 ms<br />
c. Some duplex ultrasound readings will describe this as moderate to severe reflux which<br />
will be acceptable.<br />
4. Member must have one <strong>of</strong> the following functional impairments:<br />
a. Skin ulceration OR<br />
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. Documented episode(s) <strong>of</strong> frank bleeding <strong>of</strong> the varicose vein due to erosion <strong>of</strong> or<br />
trauma to the skin OR<br />
c. Documented history <strong>of</strong> superficial thrombophlebitis OR<br />
d. Documented venous stasis dermatitis OR<br />
e. Moderate or severe pain and/or limitation <strong>of</strong> activities as indicated by answers to the<br />
following questions (the following questions are applicable to 4e only):<br />
B. Ablation <strong>of</strong> perforator veins is considered reconstructive when the following criteria are<br />
present:<br />
1. Evidence <strong>of</strong> perforator venous insufficiency measured by duplex<br />
ultrasonography report (see criteria above) and<br />
2. Perforator vein size is 3.5mm or greater and<br />
3. Documentation in <strong>of</strong>fice notes <strong>of</strong> venous stasis ulceration(s) due to the<br />
insufficiency.<br />
C. Endovenous ablation (radi<strong>of</strong>requency or laser) <strong>of</strong> either reticular or telangiectatic veins is not<br />
considered reconstructive.<br />
High Ligation Procedures:<br />
For Commercial members, services can only be performed by surgeons and radiologists.<br />
Ligation <strong>of</strong> the greater saphenous vein at the saphen<strong>of</strong>emoral junction, as a stand-alone procedure, is<br />
not medically necessary for treating venous reflux. Ligation performed without stripping or ablation<br />
is associated with high long-term recurrence rates due to neovascularization.<br />
Ligation <strong>of</strong> the small saphenous vein at the saphenopopliteal junction, as a stand-alone procedure, is<br />
not medically necessary for treating venous reflux. Ligation performed without stripping or ablation<br />
is associated with high long-term recurrence rates due to increased risk <strong>of</strong> neovascularization.<br />
Ligation at the saphen<strong>of</strong>emoral junction, as a stand-alone procedure, is medically necessary, when<br />
used in patients with ascending superficial thrombophlebitis, to prevent the propagation <strong>of</strong> an active<br />
clot from the superficial system to the deep venous system.<br />
Ligation at the saphen<strong>of</strong>emoral junction, as an adjunct to radi<strong>of</strong>requency ablation or endovenous<br />
laser ablation <strong>of</strong> the main saphenous veins, is not medically necessary.<br />
Policy History Revision Information<br />
Published clinical evidence has not demonstrated that the addition <strong>of</strong> saphen<strong>of</strong>emoral ligation to<br />
endovenous ablation procedures provides an additive benefit in resolving venous reflux or preventing<br />
varicose vein recurrence. Endovenous ablation is a clinically effective therapy for treating venous<br />
reflux. Adding ligation to the procedure adds clinical risk without adding clinical benefit.<br />
ADDITIONAL INFORMATION:<br />
Please refer to:<br />
• The enrollee’s COC or specific plan documents,<br />
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• Coverage Determination Guideline, if one, for specific requirements for Reconstructive criteria<br />
MEDICARE & MEDICAID COVERAGE RATIONALE<br />
Medicare does not have a National Coverage Determination for Varicose Vein Procedures.<br />
There is a Local Coverage Determination for <strong>Nevada</strong> for Treatment <strong>of</strong> Varicose Veins <strong>of</strong> the Lower<br />
Extremity. The Local Coverage Determination is as follows:<br />
Indications and Limitations <strong>of</strong> Coverage and/or Medical Necessity<br />
Abstract<br />
Varicose veins are caused by venous insufficiency as a result <strong>of</strong> valve reflux (incompetence). The<br />
venous insufficiency results in dilated, tortuous, superficial vessels that protrude from the skin <strong>of</strong> the<br />
lower extremities. Spider veins (telangiectases) are dilated capillary veins that are most <strong>of</strong>ten treated<br />
for cosmetic purposes. Treatment <strong>of</strong> telangiectases (36468) is not covered by Medicare.<br />
Ligation and stripping <strong>of</strong> varicose veins is a treatment option that aims to eliminate reflux at the<br />
saphen<strong>of</strong>emoral junction. Some consider this the treatment <strong>of</strong> choice for moderate to large<br />
symptomatic varicose veins, ligation and stripping <strong>of</strong> the saphenous vein, has the lowest failure rate.<br />
Sclerotherapy, injecting sclerosing solutions directly into the abnormal veins, is an alternative<br />
occasionally selected for the treatment <strong>of</strong> varicose veins without significant saphen<strong>of</strong>emoral or<br />
saphenopopliteal incompetence. However, it is not considered to be as reliable and effective as surgical<br />
ligation and stripping.<br />
Sclerotherapy for cosmetic purposes is not considered medically necessary. Sclerotherapy is<br />
considered medically necessary for the treatment <strong>of</strong> small to medium sized vessels (generally less<br />
than 4 mm in diameter.) Sclerotherapy is not considered medically necessary for vessels larger than 5<br />
mm in diameter.<br />
Foam sclerotherapy <strong>of</strong> the saphenous vein at its junction with the deep venous system has been<br />
proposed as an alternative to ligation or saphenectomy, but its efficacy lacks significant scientific<br />
evidence to support its widespread use.<br />
Sclerotherapy <strong>of</strong> the saphenous vein at its junction with the deep system is not a covered procedure.<br />
Non-compressive sclerotherapy involves injection <strong>of</strong> a sclerosant into a vein without the application<br />
<strong>of</strong> a compressive dressing. Because it is not effective in producing long-term obliteration <strong>of</strong> the<br />
incompetent veins, noncompressive sclerotherapy is not covered by Medicare.<br />
Compressive sclerotherapy is the injection <strong>of</strong> the sclerosant into an empty vein (elevated limb)<br />
followed by application <strong>of</strong> a compressive bandage or dressing. This is the most commonly performed<br />
sclerotherapy procedure for varicose veins <strong>of</strong> the lower extremity. Compressive sclerotherapy is<br />
indicated for local small to medium symptomatic varices, isolated incompetent perforators, or<br />
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ecurrence <strong>of</strong> symptomatic varices after adequate surgical removal <strong>of</strong> varices. It is not considered an<br />
appropriate option for large, extensive or truncal varicosities.<br />
High ligation and compression sclerotherapy refers to ligation <strong>of</strong> a truncal junction (saphen<strong>of</strong>emoral<br />
or saphenopopliteal) followed by compressive sclerotherapy <strong>of</strong> one or more veins.<br />
Endovenous radi<strong>of</strong>requency ablation (ERFA) and laser ablation are minimally invasive<br />
alternatives to vein ligation and stripping. Endovenous radi<strong>of</strong>requency ablation is FDA-approved for<br />
treatment <strong>of</strong> the greater saphenous vein, perforators and tributary veins. Endovenous laser ablation is<br />
FDA-approved for the treatment <strong>of</strong> varicose veins and varicosities associated with superficial reflux <strong>of</strong><br />
the greater saphenous vein.<br />
Stab phlebectomy or ambulatory phlebectomy may be considered medically necessary for<br />
treatment <strong>of</strong> patients who meet the medical necessity criteria listed below for varicose vein treatment<br />
whose symptoms and functional problems are attributable only to the secondary smaller vessels. Stab<br />
phlebectomy <strong>of</strong> the same vein performed on the same day as endovenous radi<strong>of</strong>requency or laser<br />
ablation may be covered if the criteria for reasonable and necessary service are met and<br />
documentation in the chart supports the medical necessity.<br />
Indications:<br />
Medicare will consider interventional treatment <strong>of</strong> varicose veins (sclerotherapy, ligation with or<br />
without stripping, and endovenous radi<strong>of</strong>requency or laser ablation) medically necessary if the patient<br />
remains symptomatic after a 6-8 week trial <strong>of</strong> conservative therapy. Based on recent literature<br />
combination therapy (the use <strong>of</strong> compression and surgery) has been shown to decrease 12 month ulcer<br />
recurrence rates and therefore may be considered in patients with chronic venous ulcers. Components<br />
<strong>of</strong> the conservative therapy include, but are not limited to:<br />
weight reduction,<br />
a daily exercise plan,<br />
periodic leg elevation, and<br />
the use <strong>of</strong> graduated compression stockings.<br />
The conservative therapy must be documented in the medical record. Conservative treatment may slow<br />
down progression <strong>of</strong> disease or may demonstrate (if symptoms reduced) that treating the disease may<br />
eliminate the symptoms.<br />
The patient is considered symptomatic if any <strong>of</strong> the following signs and symptoms <strong>of</strong> significantly<br />
diseased vessels <strong>of</strong> the lower extremities are documented in the medical record:<br />
stasis ulcer <strong>of</strong> the lower leg, as above,<br />
significant pain and/or significant edema that interferes with activities <strong>of</strong> daily living,<br />
bleeding associated with the diseased vessels <strong>of</strong> the lower extremities,<br />
recurrent episodes <strong>of</strong> superficial phlebitis,<br />
stasis dermatitis, or<br />
refractory dependent edema.<br />
Additional indications and limitations are discussed according to type <strong>of</strong> treatment.<br />
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In addition to the requirement for failure <strong>of</strong> a 6-8 week trial <strong>of</strong> conservative treatment and the<br />
symptoms described above, coverage <strong>of</strong> endovenous ablation therapy is limited to patients with:<br />
laser ablation <strong>of</strong> veins with a vein diameter less than or equal to 20mm, or<br />
ERFA for a vein diameter less than or equal to 12mm, or<br />
absence <strong>of</strong> thrombosis or vein tortuosity, which would impair catheter advancement, and<br />
absence <strong>of</strong> significant peripheral artery disease.<br />
Radi<strong>of</strong>requency/laser ablation is covered only for treatment <strong>of</strong> the lesser or greater saphenous veins<br />
and selected tributaries to improve symptoms attributable to saphen<strong>of</strong>emoral or saphenopopliteal<br />
reflux. Coverage is only for FDA devices specifically approved for these procedures.<br />
Limitations:<br />
Duplex ultrasound is <strong>of</strong>ten used in conjunction with other non-invasive physiologic testing to define<br />
the anatomy and physiology <strong>of</strong> the varicose vein network prior to injection or surgical intervention.<br />
There is adequate evidence that the pre-procedural ultrasound is helpful, and Medicare will cover a<br />
pre-procedure Duplex scan (93970 or 93971) used in conjunction with other non-invasive physiologic<br />
testing (93965) to determine the extent and configuration <strong>of</strong> the varicosities. This A/B MAC expects<br />
that these studies will be performed by the provider planning to provide the therapy. This A/B MAC<br />
will allow this study once per provider or provider group. Clinical experience supports the use <strong>of</strong><br />
ultrasound during the sclerotherapy procedure, and evidence shows that the outcomes may be<br />
improved and complication rates may be minimized when ultrasound guidance is used.<br />
Medicare will cover intraoperative ultrasonic guidance in situations when it is medically necessary.<br />
Medicare includes payment for the intraoperative ultrasound in the payment for the ERFA and laser<br />
ablation procedures.<br />
A postoperative ultrasound will be covered if the test is reasonable and necessary for the diagnosis and<br />
treatment <strong>of</strong> a complication.<br />
Cosmetic surgery is statutorily excluded from coverage by Medicare. The following interventional<br />
treatments are considered to be cosmetic and are denied as not medically necessary:<br />
Interventional treatment <strong>of</strong> asymptomatic varicosities.<br />
Treatment <strong>of</strong> telangiectases (36468).<br />
Sclerotherapy for cosmetic purposes.<br />
Medicare cannot cover services which are not reasonable and necessary for the treatment <strong>of</strong> illness<br />
or injury or to improve the functioning <strong>of</strong> a malformed body member. The following interventional<br />
treatments are not considered medically reasonable or necessary and are denied as such:<br />
Interventional treatment <strong>of</strong> symptomatic varicosities without documentation <strong>of</strong> a failed 6-8<br />
week trial <strong>of</strong> conservative therapy in patients without chronic venous ulcers.<br />
Sclerotherapy for vessels larger than 5 mm in diameter.<br />
Reinjection following recanalization or failure <strong>of</strong> vein closure without recurrent signs or<br />
symptoms.<br />
Sclerotherapy <strong>of</strong> the saphenous vein at its junction with the deep venous system.<br />
Varicose Vein Procedures Page 6 <strong>of</strong> 16
Noncompressive sclerotherapy.<br />
Compressive sclerotherapy for large, extensive or truncal varicosities.<br />
Sclerotherapy, ligation and/or stripping <strong>of</strong> varicose veins, or endovenous ablation therapy are<br />
not covered for pregnant women, patients on anticoagulant therapy, or patients with the<br />
inability to tolerate compressive bandages or stockings; severe distal arterial occlusive disease;<br />
obliteration <strong>of</strong> deep venous system; an allergy to the sclerosant; or a hypercoaguable state.<br />
Any interventional treatment that uses equipment not approved for such purposes by the FDA.<br />
Laser ablation <strong>of</strong> veins with a diameter less than or equal to 20mm and ERFA for vein diameter<br />
less than or equal to 12mm.<br />
Endovenous ablation therapy in the presence <strong>of</strong> thrombosis or venous tortuosity which would<br />
impair catheter advancement.<br />
Documentation Requirements<br />
The patient's medical record must contain documentation that fully supports the medical necessity for<br />
services included within this LCD. This documentation includes, but is not limited to, relevant medical<br />
history, physical examination, and results <strong>of</strong> pertinent diagnostic tests or procedures.<br />
The patient's medical record must document the following:<br />
history and physical findings supporting a diagnosis <strong>of</strong> symptomatic varicose veins<br />
failure <strong>of</strong> an adequate trial <strong>of</strong> conservative treatment as described in the "Indications" section <strong>of</strong><br />
this LCD<br />
exclusion <strong>of</strong> other causes <strong>of</strong> edema, ulceration and pain in the limbs<br />
performance <strong>of</strong> appropriate tests to confirm the presence and location <strong>of</strong> incompetent<br />
perforating veins<br />
location and number <strong>of</strong> varicosities, level <strong>of</strong> incompetence <strong>of</strong> the vein and the veins involved<br />
and<br />
necessity <strong>of</strong> utilizing ultrasound guidance, if used.<br />
The medical record must also include pre-treatment photographs <strong>of</strong> the varicose veins for which claims<br />
for sclerotherapy are submitted to Medicare. These photographs must be made available to the A/B<br />
MAC upon request for review.<br />
Utilization Guidelines<br />
Coverage for podiatrists is limited by scope <strong>of</strong> practice specific to the state in which the service is<br />
provided.<br />
Medicare recognizes that multiple injections are needed to perform sclerotherapy and that responses<br />
differ due to the anatomical site being treated. Medicare would not expect to see the following when<br />
performing sclerotherapy:<br />
<br />
<br />
More than three sclerotherapy sessions for each leg.<br />
Only one sclerotherapy service per treatment session should be reported for either leg,<br />
regardless <strong>of</strong> how many veins are treated per session.<br />
Patients are not expected to require ablation <strong>of</strong> the saphenous vein by radi<strong>of</strong>requency or laser more<br />
Varicose Vein Procedures Page 7 <strong>of</strong> 16
than once for either leg.<br />
A duplex ultrasound examination will be allowed when performed within 1 week (preferably within 72<br />
hours) <strong>of</strong> ERFA to check for any evidence <strong>of</strong> thrombus extension from the saphen<strong>of</strong>emoral junction<br />
into the deep system.<br />
For Medicare and Medicaid Determinations Related to States Outside <strong>of</strong> <strong>Nevada</strong>:<br />
Please review Local Coverage Determinations that apply to other states outside <strong>of</strong> <strong>Nevada</strong>.<br />
http://www.cms.hhs.gov/mcd/search<br />
Important Note: Please also review local carrier Web sites in addition to the Medicare Coverage<br />
database on the Centers for Medicare and Medicaid Services’ Website.<br />
BACKGROUND<br />
Varicose veins are enlarged veins that are swollen and raised above the surface <strong>of</strong> the skin. They can<br />
be dark purple or blue, and look twisted and bulging. Varicose veins are commonly found on the backs<br />
<strong>of</strong> the calves or on the inside <strong>of</strong> the leg. Veins have one-way valves that help keep blood flowing<br />
towards the heart. When the valves become weak or damaged and do not close properly, blood can<br />
back up and pool in the veins causing them to get larger. The resulting condition is known as venous<br />
insufficiency or venous reflux. Varicose veins may lead to complications such as pain, blood clots or<br />
skin ulcers.<br />
Varicose veins are treated with lifestyle changes and medical procedures done either to remove the<br />
veins or to close them. Sclerotherapy uses a liquid chemical to close <strong>of</strong>f a varicose vein. Endovenous<br />
ablation therapy uses lasers or radi<strong>of</strong>requency energy to create heat to close <strong>of</strong>f a varicose vein. Vein<br />
stripping and ligation involves tying shut and removing the veins through small cuts in the skin<br />
(National Heart, Lung and Blood Institute 2009).<br />
CLINICAL EVIDENCE<br />
O’Hare et al. (2008) conducted a multicenter, prospective cohort study <strong>of</strong> patients undergoing small<br />
saphenous vein surgery (SSV). Patients were evaluated at six weeks and one year after surgery. A<br />
total <strong>of</strong> 204 legs were reviewed at one year; 67 had small saphenous varicose vein stripping, 116 had<br />
saphenopopliteal junction (SPJ) disconnection only and the remainder had miscellaneous procedures.<br />
The incidence <strong>of</strong> visible recurrent varicosities at one year was lower after SSV stripping than after<br />
disconnection only, although this did not reach statistical significance. The rate <strong>of</strong> SPJ incompetence<br />
detected by duplex at one year was significantly lower in patients who underwent SSV stripping than<br />
in those who did not.<br />
In a literature review <strong>of</strong> long-term results following high ligation supplemented by sclerotherapy,<br />
Recek (2004) found that ligation <strong>of</strong> the saphen<strong>of</strong>emoral junction alone provokes a higher recurrence<br />
rate in comparison with high ligation and stripping. The hemodynamic improvement achieved<br />
Varicose Vein Procedures Page 8 <strong>of</strong> 16
immediately after high ligation deteriorates progressively during the follow-up owing to recurrent<br />
reflux.<br />
Winterborn et al. (2004) conducted an 11 year follow-up study on the Jones et al. patient group. A<br />
cumulative total <strong>of</strong> 83 legs had developed clinically recurrent varicose veins by 11 years (62%). There<br />
was no statistically significant difference between the ligation-only and the stripping groups.<br />
Reoperation was required for 20 <strong>of</strong> 69 legs that underwent ligation alone compared with 7 <strong>of</strong> 64 legs<br />
that had additional long saphenous vein stripping. Freedom from reoperation at 11 years was 70% after<br />
ligation, compared with 86% after stripping. The presence <strong>of</strong> neovascularization, an incompetent<br />
superficial vessel in the thigh or an incompetent saphen<strong>of</strong>emoral junction on duplex imaging at 2 years<br />
postoperatively increased the risk <strong>of</strong> a patient's developing clinically recurrent veins. Results from the<br />
study indicate that stripping the long saphenous vein is recommended as part <strong>of</strong> routine varicose vein<br />
surgery as it reduces the risk <strong>of</strong> reoperation after 11 years, although it did not reduce the rate <strong>of</strong> visible<br />
recurrent veins.<br />
Dwerryhouse et al. (1999) designed as a 5-year follow-up study on the Jones et al. patient group. 78<br />
patients (110 legs) underwent clinical review and duplex scan imaging. Sixty-five patients remained<br />
pleased with the results <strong>of</strong> their surgery (35 <strong>of</strong> 39 stripped vs. 30 <strong>of</strong> 39 ligated). Reoperation for<br />
recurrence was necessary for three <strong>of</strong> 52 <strong>of</strong> the legs that underwent stripping vs. 12 <strong>of</strong> 58 ligated legs.<br />
Neovascularization at the saphen<strong>of</strong>emoral junction was responsible for 10 <strong>of</strong> 12 recurrent veins that<br />
underwent reoperation and also was the cause <strong>of</strong> recurrent saphen<strong>of</strong>emoral incompetence in 12 <strong>of</strong> 52<br />
stripped veins vs. 30 <strong>of</strong> 58 ligated legs. The authors concluded that stripping reduced the risk <strong>of</strong><br />
reoperation by two thirds after 5 years and should be routine for primary long saphenous varicose<br />
veins.<br />
Jones et al. (1996) conducted a randomized controlled trial <strong>of</strong> one hundred patients (133 legs) to<br />
determine whether routine stripping <strong>of</strong> the long saphenous vein reduced recurrence after varicose vein<br />
surgery. A two year follow-up in 81 patients (113 legs) showed that 89% <strong>of</strong> patients remained satisfied<br />
with the results <strong>of</strong> their surgery, though 35% had recurrent veins on clinical examination. Recurrence<br />
was reduced in patients who had their long saphenous vein stripped. Neovascularization was detected<br />
in 52% <strong>of</strong> limbs and was the most common cause <strong>of</strong> recurrence.<br />
Rutgers et al. (1994) conducted a prospective randomized study comparing stripping and local<br />
avulsions with high ligation <strong>of</strong> the saphen<strong>of</strong>emoral junction combined with sclerotherapy for the<br />
treatment <strong>of</strong> greater saphenous vein insufficiency. Of 156 consecutive patients, 89 legs were randomly<br />
allocated to stripping and 92 to high ligation. Patients were followed-up at 3 months and 1, 2, and 3<br />
years after treatment. At 3 years, 69 limbs in the stripping group (78%) and 73 limbs in the ligation<br />
group (79%) were available to follow-up. The authors found that clinical and Doppler ultrasound<br />
evidence <strong>of</strong> reverse flow in the saphenous vein was significantly less after stripping.<br />
Eighty-nine legs with long saphenous vein (LSV) reflux and saphen<strong>of</strong>emoral junction incompetence<br />
were treated by saphen<strong>of</strong>emoral ligation and multiple avulsions. Patients were randomized to undergo<br />
additional stripping <strong>of</strong> the LSV (n = 43) or no additional treatment (n = 46). At a median <strong>of</strong> 21 months<br />
after surgery, more patients were free <strong>of</strong> recurrence when the LSV had been stripped compared with<br />
saphen<strong>of</strong>emoral ligation alone. The authors concluded that the addition <strong>of</strong> LSV stripping to<br />
saphen<strong>of</strong>emoral ligation and multiple avulsions results in a better overall outcome (Sarin, 1994).<br />
Varicose Vein Procedures Page 9 <strong>of</strong> 16
During endovenous ablation procedures, radi<strong>of</strong>requency or laser energy is applied to heat the vein,<br />
causing the vessel to close and eventually be absorbed by the body. This technique achieves the same<br />
effect as saphen<strong>of</strong>emoral or saphenopopliteal ligation and stripping. Adding ligation <strong>of</strong> the main trunk<br />
to the procedure has not been shown to provide an additive benefit in resolving venous reflux or<br />
preventing varicose vein recurrence.<br />
In a systematic review, Darwood and Gough found that adjunctive saphen<strong>of</strong>emoral ligation is not<br />
necessary to achieve success with endovenous laser therapy <strong>of</strong> the greater saphenous vein (Darwood,<br />
2009). Similarly, a randomized controlled trial conducted by Disselh<strong>of</strong>f et al. (2008) found that the<br />
addition <strong>of</strong> saphen<strong>of</strong>emoral ligation to endovenous ablation made no difference to the short-term<br />
outcome <strong>of</strong> varicose vein treatment. Further studies with larger patient populations are needed to<br />
establish the superiority <strong>of</strong> adjunctive saphen<strong>of</strong>emoral ligation in improving long-term outcomes.<br />
Theivacumar et al. (2007) also found that saphen<strong>of</strong>emoral ligation following endovenous laser ablation<br />
was unnecessary. Persistent non-refluxing greater saphenous vein tributaries at the saphen<strong>of</strong>emoral<br />
junction did not have an adverse impact on clinical outcome 1 year after successful endovenous laser<br />
ablation <strong>of</strong> the greater saphenous vein.<br />
Pr<strong>of</strong>essional Societies<br />
No specialty society recommendations related to the policy were identified at this time.<br />
U.S. FOOD AND DRUG ADMINISTRATION (FDA)<br />
Vein ligation surgery is a procedure and therefore not subject to FDA regulation.<br />
APPLICABLE CODES FOR COMMERCIAL COVERAGE<br />
The codes listed in this policy are for reference purposes only. Listing <strong>of</strong> a service or device code in<br />
this policy does not imply that the service described by this code is a covered or non-covered health<br />
service. Coverage is determined by the benefit document. This list <strong>of</strong> codes may not be all inclusive.<br />
CPT ® Codes for Vein<br />
Procedures<br />
36475<br />
36476<br />
Description<br />
Endovenous ablation therapy <strong>of</strong> incompetent vein, extremity, inclusive <strong>of</strong> all<br />
imaging guidance and monitoring, percutaneous, radi<strong>of</strong>requency; first vein<br />
treated<br />
Endovenous ablation therapy <strong>of</strong> incompetent vein, extremity, inclusive <strong>of</strong> all<br />
imaging guidance and monitoring, percutaneous, radi<strong>of</strong>requency; second and<br />
subsequent veins treated in a single extremity, each through separate access<br />
sites (List separately in addition to code for primary procedure)<br />
36478 Endovenous ablation therapy <strong>of</strong> incompetent vein, extremity, inclusive <strong>of</strong> all<br />
imaging guidance and monitoring, percutaneous, laser; first vein treated<br />
36479 Endovenous ablation therapy <strong>of</strong> incompetent vein, extremity, inclusive <strong>of</strong> all<br />
Varicose Vein Procedures Page 10 <strong>of</strong> 16
37700<br />
imaging guidance and monitoring, percutaneous, laser; second and<br />
subsequent veins treated in a single extremity, each through separate access<br />
sites (List separately in addition to code for primary procedure)<br />
Ligation and division <strong>of</strong> long saphenous vein at saphen<strong>of</strong>emoral junction, or<br />
distal interruptions<br />
37718 Ligation, division, and stripping, short saphenous vein<br />
37722 Ligation, division, and stripping, long (greater) saphenous veins from<br />
saphen<strong>of</strong>emoral junction to knee or below<br />
Ligation and division <strong>of</strong> short saphenous vein at saphenopopliteal junction<br />
37780<br />
(separate procedure).<br />
CPT ® is a registered trademark <strong>of</strong> the American Medical Association.<br />
NOTE: CPT Code 37799 should be used to report “Trivex Procedure”<br />
APPLICABLE CODES FOR MEDICARE & MEDICAID COVERAGE<br />
The codes listed in this policy are for reference purposes only. Listing <strong>of</strong> a service or device code in<br />
this policy does not imply that the service described by this code is a covered or non-covered health<br />
service. Coverage is determined by the benefit document. This list <strong>of</strong> codes may not be all inclusive.<br />
CPT ® Codes for Vein Description<br />
Procedures<br />
36470 Injection <strong>of</strong> sclerosing solution; single vein<br />
36471 Injection <strong>of</strong> sclerosing solution; multiple veins, same leg<br />
Endovenous ablation therapy <strong>of</strong> incompetent vein, extremity, inclusive <strong>of</strong> all<br />
36475 imaging guidance and monitoring, percutaneous, radi<strong>of</strong>requency; first vein<br />
treated<br />
Endovenous ablation therapy <strong>of</strong> incompetent vein, extremity, inclusive <strong>of</strong> all<br />
imaging guidance and monitoring, percutaneous, radi<strong>of</strong>requency; second and<br />
36476<br />
subsequent veins treated in a single extremity, each through separate access<br />
sites (List separately in addition to code for primary procedure)<br />
Endovenous ablation therapy <strong>of</strong> incompetent vein, extremity, inclusive <strong>of</strong> all<br />
36478<br />
imaging guidance and monitoring, percutaneous, laser; first vein treated<br />
Endovenous ablation therapy <strong>of</strong> incompetent vein, extremity, inclusive <strong>of</strong> all<br />
imaging guidance and monitoring, percutaneous, laser; second and<br />
36479<br />
subsequent veins treated in a single extremity, each through separate access<br />
sites (List separately in addition to code for primary procedure)<br />
Ligation and division <strong>of</strong> long saphenous vein at saphen<strong>of</strong>emoral junction, or<br />
37700<br />
distal interruptions<br />
37718 Ligation, division, and stripping, short saphenous vein<br />
Ligation, division, and stripping, long (greater) saphenous veins from<br />
37722<br />
saphen<strong>of</strong>emoral junction to knee or below<br />
Varicose Vein Procedures Page 11 <strong>of</strong> 16
37735<br />
Ligation and division and complete stripping <strong>of</strong> long or short saphenous veins<br />
with radical excision <strong>of</strong> ulcer and skin graft and/or interruption <strong>of</strong><br />
communicating veins <strong>of</strong> lower leg, with excision <strong>of</strong> deep fascia<br />
37760<br />
Ligation <strong>of</strong> perforator veins, subfacsial, radical (linton type), including skin<br />
graft, when performed, open, 1 leg<br />
37761<br />
Ligation <strong>of</strong> perforator vein(s). subfascial, open, including ultrasound<br />
guidance, when performed, 1 leg<br />
37765 Stab phlebectomy <strong>of</strong> varicose veins, 1 extremity; 10-20 stab incisions<br />
37766 Stab phlebectomy <strong>of</strong> varicose veins, 1 extremity; more than 20 incisions<br />
37780<br />
Ligation and division <strong>of</strong> short saphenous vein at saphenopopliteal junction<br />
(separate procedure)<br />
37785 Ligation; division, and/or excision <strong>of</strong> varicose vein cluster(s), 1 leg<br />
37799 Unlisted procedure, vascular surgery<br />
76942<br />
Ultrasonic guidance for needle placement (e.g., biopsy, aspiration, injection,<br />
localization device), imaging supervision and interpretation<br />
Noninvasive physiologic studies <strong>of</strong> extremity veins, complete bilateral study<br />
93965 (e.g., Doppler waveform analysis with responses to compression and other<br />
maneuvers, phleborheography, impedance plethysmography)<br />
93970<br />
Duplex scan <strong>of</strong> extremity veins including responses to compression and other<br />
maneuvers; complete bilateral study<br />
93971<br />
Duplex scan <strong>of</strong> extremity veins including responses to compression and other<br />
maneuvers; unilateral or limited study<br />
CPT ® is a registered trademark <strong>of</strong> the American Medical Association.<br />
NOTE: CPT Code 37799 should be used to report “Trivex Procedure”<br />
ICD-9 Codes That Description<br />
Support Medical<br />
Necessity<br />
451.0 Phlebitis and thrombophlebitis <strong>of</strong> superficial vessels <strong>of</strong> lower extremities<br />
451.11 Phlebitis and thrombophlebitis <strong>of</strong> femoral vein (deep) (superficial)<br />
451.2 Phlebitis and thrombophlebitis <strong>of</strong> lower extremities, unspecified<br />
459.10 Postphlebitic syndrome without complications<br />
459.11 Postphlebitic syndrome with ulcer<br />
459.12 Postphlebitic syndrome with inflammation<br />
459.13 Postphlebitic syndrome with ulcer and inflammation<br />
459.19 Postphlebitic syndrome with other complication<br />
459.31 Chronic venous hypertension with ulcer<br />
459.32 Chronic venous hypertension with inflammation<br />
459.33 Chronic venous hypertension with ulcer and inflammation<br />
Varicose Vein Procedures Page 12 <strong>of</strong> 16
ICD-9 Codes that DO Description<br />
NOT Support<br />
Medical Necessity<br />
448.0 Hereditary hemorrhagic telangiectasia (spider veins)<br />
448.1 Nevus non-neoplastic<br />
448.9 Other and unspecified capillary diseases<br />
454.0 Varicose veins <strong>of</strong> lower extremities with ulcer<br />
454.1 Varicose veins <strong>of</strong> lower extremities with inflammation<br />
454.2 Varicose veins <strong>of</strong> lower extremities with ulcer and inflammation<br />
454.8 Varicose veins <strong>of</strong> the lower extremities with other complications<br />
459.81 Unspecified venous (peripheral) insufficiency<br />
NOTE: CPT codes 36470, 36471, 36475, 36476, 36478, 36479, 37700, 37718, 37722, 37735, 37760, 37761,<br />
37765, 37766, 37780, 37785 and 37799 (when used to report "Trivex Procedure"), submitted for any <strong>of</strong> the<br />
previous three ICD-9-CM codes will be denied for lack <strong>of</strong> medical necessity:<br />
REFERENCES<br />
Allan PL. Role <strong>of</strong> ultrasound in the assessment <strong>of</strong> chronic venous insufficiency. Ultrasound Q. 2001<br />
Mar;17(1):3-10.<br />
Darwood RJ, Gough MJ. Endovenous laser treatment for uncomplicated varicose veins. Phlebology.<br />
2009;24 Suppl 1:50-61.<br />
Disselh<strong>of</strong>f BC, der Kinderen DJ, Kelder JC, Moll FL. Randomized clinical trial comparing<br />
endovenous laser ablation <strong>of</strong> the great saphenous vein with and without ligation <strong>of</strong> the saphen<strong>of</strong>emoral<br />
junction: 2-year results. Eur J Vasc Endovasc Surg. 2008 Dec;36(6):713-8.<br />
Dwerryhouse S, Davies B, Harradine K, Earnshaw JJ. Stripping the long saphenous vein reduces the<br />
rate <strong>of</strong> reoperation for recurrent varicose veins: five-year results <strong>of</strong> a randomized trial. J Vasc Surg.<br />
1999 Apr;29(4):589-92.<br />
ECRI. <strong>Health</strong> Technology Assessment Information Service (HTAIS) Custom Hotline Report. Surgical<br />
Ligation and Stripping <strong>of</strong> Varicose Veins. July 2004.<br />
Ekl<strong>of</strong> B, Rutherford RB, Bergan JJ, et al. Revision <strong>of</strong> the CEAP classification <strong>of</strong> chronic venous<br />
disorders: Consensus statement. Journal <strong>of</strong> Vascular Surgery. 2004; 40:1248-1252.<br />
Intersocietal Commission for the Accreditation <strong>of</strong> Vascular Laboratories (ICAVL). 2007 ICAVL<br />
Standards. Part II: Vascular Laboratory Operations – Peripheral Venous. Available at:<br />
http://www.icavl.org/icavl/pdfs/venous2007.pdf<br />
Jones L, Braithwaite BD, Selwyn D, et al. Neovascularisation is the principal cause <strong>of</strong> varicose vein<br />
recurrence: results <strong>of</strong> a randomised trial <strong>of</strong> stripping the long saphenous vein. Eur J Vasc Endovasc<br />
Surg. 1996 Nov;12(4):442-5.<br />
Varicose Vein Procedures Page 13 <strong>of</strong> 16
Labropoulos N, Tiongson J Definition <strong>of</strong> venous reflux in lower-extremity veins Journal <strong>of</strong> Vascular<br />
Surgery October 2003 Volume 38, Number 4.<br />
Milliman Care Guidelines® Ambulatory Care 14th Edition, 2010. Saphenous Vein Ablation, Laser:<br />
ACG: A-0425 (AC). Available at: http://careweb.careguidelines.com/ed14/<br />
Milliman Care Guidelines® Ambulatory Care 14th Edition, 2010. Saphenous Vein Ablation,<br />
Radi<strong>of</strong>requency: ACG: A-0174 (AC). Available at: http://careweb.careguidelines.com/ed14/<br />
Milliman Care Guidelines® Ambulatory Care 14th Edition, 2010. Saphenous Vein Stripping: ACG: A-<br />
0172 (AC). Available at: http://careweb.careguidelines.com/ed14/<br />
Milliman Care Guidelines® Ambulatory Care 14th Edition, 2010. Duplex (Doppler) Scan, Lower<br />
Extremity, Venous: ACG: A-0119 (AC). Available at: http://careweb.careguidelines.com/ed14/<br />
National Heart, Lung and Blood Institute (NHLBI) website. Varicose veins. January 2009. Available<br />
at: http://www.nhlbi.nih.gov/health/dci/Diseases/vv/vv_whatis.html. Accessed April 7, 2010.<br />
O'Hare JL, Vandenbroeck CP, Whitman B, et al. A prospective evaluation <strong>of</strong> the outcome after small<br />
saphenous varicose vein surgery with one-year follow-up. J Vasc Surg. 2008 Sep;48(3):669-73;<br />
discussion 674.<br />
Recek C. Saphen<strong>of</strong>emoral junction ligation supplemented by postoperative sclerotherapy: a review <strong>of</strong><br />
long-term clinical and hemodynamic results. Vasc Endovascular Surg. 2004 Nov- Dec;38(6):533-40.<br />
Rutgers PH, Kitslaar PJ. Randomized trial <strong>of</strong> stripping versus high ligation combined with<br />
sclerotherapy in the treatment <strong>of</strong> the incompetent greater saphenous vein. Am J Surg. 1994<br />
Oct;168(4):311-5.<br />
Sarin S, Scurr JH, Coleridge Smith PD. Stripping <strong>of</strong> the long saphenous vein in the treatment <strong>of</strong><br />
primary varicose veins. Br J Surg. 1994 Oct;81(10):1455-8.<br />
Theivacumar NS, Dellagrammaticas D, Beale RJ, et al. Fate and clinical significance <strong>of</strong><br />
saphen<strong>of</strong>emoral junction tributaries following endovenous laser ablation <strong>of</strong> great saphenous vein. Br J<br />
Surg. 2007 Jun;94(6):722-5.<br />
Winterborn, RJ, et al. (2004). Causes <strong>of</strong> varicose vein recurrence: late results <strong>of</strong> a randomized<br />
controlled trial <strong>of</strong> stripping the long saphenous vein. J Vasc Surgery. 40(4): 634-9.<br />
Saphenous Trunk Eur J Vasc Endovasc Surg 28, 595–599 (2004) doi:10.1016/j.ejvs.2004.07.021,<br />
available online at http://www.sciencedirect.com<br />
Varicose Vein Procedures Page 14 <strong>of</strong> 16
QUESTIONNAIRE<br />
QUESTIONNAIRE<br />
1) Do the patient’s daily activities require prolonged periods <strong>of</strong> standing?<br />
If yes, what activity requires prolonged periods <strong>of</strong> standing?<br />
_______________________________________________________________________<br />
If yes, how many times during the day does the patient have to sit or take a break due to<br />
aching, cramping, burning, itching or swelling in the lower extremities?<br />
Never (0) Once per day (1) 2 – 3 times per day (2) 4 or more times per day (3)<br />
2) Does the patient take over-the-counter medications (e.g., aspirin, ibupr<strong>of</strong>en, other NSAIDS or a<br />
similar type <strong>of</strong> medication) or prescription medications for aching, cramping, burning or swelling <strong>of</strong> the<br />
lower extremities?<br />
If yes, what is the medication and dosage?<br />
_______________________________________________________________________<br />
If yes, how many days in a two week period <strong>of</strong> time did the patient take the medication?<br />
0 - 2 days (0) 3 - 4 days (1) 5 - 6 days (2) 7 or more days (3)<br />
Scale:<br />
0 =no symptoms<br />
1=mild<br />
2=moderate<br />
3=severe<br />
(If the member has a moderate or severe rating for either question #1 or question #2, he/she would<br />
meet the criteria)<br />
Varicose Vein Procedures Page 15 <strong>of</strong> 16
PROTOCOL HISTORY/REVISION INFORMATION<br />
Date<br />
07/28/2011<br />
03/24/2011<br />
01/28/2011<br />
11/2010<br />
07/13/2010<br />
04/23/2010<br />
07/24/2009<br />
Action/Description<br />
Corporate Medical Affairs Committee<br />
The foregoing <strong>Health</strong> <strong>Plan</strong> <strong>of</strong> <strong>Nevada</strong>/Sierra <strong>Health</strong> & Life Operations protocol has been adopted from<br />
an existing United<strong>Health</strong>care coverage determination guideline that was researched, developed and<br />
approved by the United<strong>Health</strong>care Coverage Determination Committee.<br />
Varicose Vein Procedures Page 16 <strong>of</strong> 16