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LCD Reference Article Response To Comments Article

Response to Comments: Varicose Veins of Lower Extremity, Treatment of

A55704

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Source Article ID
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Article ID
A55704
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Article Title
Response to Comments: Varicose Veins of Lower Extremity, Treatment of
Article Type
Response to Comments
Original Effective Date
01/01/2018
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As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the LCD for Varicose Veins of Lower Extremity, Treatment of. The official notice period for the final LCD begins on November 16, 2017 and the final determination will become effective on January 1, 2018.

Response To Comments

Number Comment Response
1

A coalition of specialty societies (Society of Vascular Surgery (SVS), American college of Phlebology (ACP), Society for Cardiovascular Angiography and Interventions (SCAI), and Society of Interventional Radiology (SIR)), as well as a number of individual practicing clinicians, endorsed coverage for treatment with Varithena for its FDA-approved indication. The coalition noted: “Randomized trials have demonstrated improvements in disease specific and generic QOL that is durable to three years. Varithena has been assigned CPT codes by the CPT Editorial Committee that will be effective in January 2018. It has also been through the RUC committees and CMS recently proposed reimbursement levels for these planned CPT codes. Recommendation: Coverage for treatment with Varithena for its FDA-approved indications beginning January 2018.”

NGS agrees. Several other wording changes recommended by the coalition also flow from this change and will not be separately addressed.

 
2

The specialty coalition referred to in #1 also recommended coverage for treatment with Venaseal for its FDA-approved indication. The coalition noted: “In its US pivotal trial that served as the basis for its approval, it was as effective as RF ablation in closing the GSV and resulted in identical improvements in disease specific and generic QOL that are durable to three years. The six month and one year data are published and the three year follow up data has been presented and is in a submitted manuscript at this point. Venaseal has been assigned CPT codes by the CPT Editorial Committee that will be effective in January 2018. It has also been through the RUC committees and CMS recently proposed reimbursement levels for these planned CPT codes. Recommendation: Coverage for treatment with Varithena for its FDA-approved indications beginning January 2018."

NGS agrees.
3

The specialty coalition referred to in #1 recommended the “once per leg” endovenous ablation limitation be expanded to two and limited to patients with C2-C4a disease. They argue that: “While we agree with the principle that in most patients with C2, C3 and C4a venous disease only a single saphenous vein ablation is required to achieve a clinically relevant improvement, realistically this is not true in all patients. There is a small subset of patients that will require ablation of 2 or rarely 3 saphenous (great saphenous, accessory saphenous, small saphenous) veins per limb to achieve acceptable improvement, but these should be in the minority of patients. In contrast, it is important to recognize that in patients with advanced venous disease (C4b, C5, or C6), ablation of a second or third vein may be necessary to prevent progression to ulceration, recurrence of ulceration, or delayed ulcer healing.  Unfortunately, chronic venous disease is a progressive disorder that can result in another saphenous vein developing reflux despite optimal primary therapy. In patients with recurrent symptoms and signs of significant venous disease attributable to new saphenous reflux, ablation of additional veins may be required again. Finally, we must not forget that clinical failure rates of 3-5% with endovenous ablation have been published. If symptoms persist in patients with a clinical failure and the failure is related to saphenous veins that are refluxing, the patient may require re-intervention.”

NGS agrees.
4

The specialty coalition referred to in #1 recommended referring to the lesser saphenous vein as the small saphenous vein to be consistent with the most recent nomenclature standard.

NGS agrees.
5

The specialty coalition referred to in #1 recommended coverage of endovenous treatment of anterior accessory GSV (AA-GSV) reflux. They note: “reflux in the anterior accessory GSV (AA-GSV) has been demonstrated to be associated with similar symptoms to those that are found with GSV reflux and as measured by QOL tools, and result in similar morbidity. Since the AAGSV represents a congenital variation of the GSV, historically many veins treated and labeled as the GSV were likely the AA GSV Endovenous ablation of the anterior accessory GSV and the thigh extension of the small saphenous vein are recommended in symptomatic patients with reflux in these veins by the ACP Clinical Practice Guidelines and the most recent AVF/SVS Guidelines.”

NGS agrees.
6

The specialty coalition referred to in #1 recommended eliminating the coverage limitation: “Surgery, endovenous ablation, or sclerotherapy are typically not performed for varicose veins that develop or worsen during pregnancy because most will spontaneously resolve or improve after delivery”, since “pregnancy and the immediate post-partum period is not a concern for Medicare beneficiaries.”

NGS disagrees. Medicare also covers the disabled which may include younger beneficiaries.
7

The specialty coalition referred to in #1 recommended eliminating the limitation of endovenous ablation to a maximum vein diameter of 20mm. They state: “Laser and radiofrequency ablation of saphenous veins can be routinely performed for very large veins and the old arbitrary criteria established in early clinical trials are not valid limits for vein size. Proper tumescent anesthetic technique and catheter technique afford adequate vein wall contact with the thermal source. It is far less traumatic to the patient to treat these large saphenous veins with thermal ablation than with stripping.”

NGS agrees.
8

The specialty coalition referred to in #1 recommended eliminating the statement: “Sclerotherapy, ligation and/or stripping of varicose veins, or endovenous ablation therapy are not covered for patients with severe distal arterial occlusive disease; obliteration of deep venous system; an allergy to the sclerosant; or a hypercoagulable state.” They state that: “Severe arterial occlusive disease takes many forms and is not always a contraindication to treatment of a severe venous problem. Clinical practice guidelines describe the selection of patients with combined arterial and venous disease who may require venous treatments. “Obliteration of the deep venous system” can be quite variable. Again guidelines assist physicians in selection patients with certain types of deep venous occlusion for superficial venous treatment. Consequently, this provision likely will result in denial of necessary care for some patients who have certain degrees of deep venous obstruction from previous venous thrombosis who can be safely treated for severe venous insufficiency. Hypercoagulable state refers to the presence of a tendency to excessive clotting. There is a large spectrum of severity that is encompassed by this term from a relatively small risk of thrombosis to those associated with high risk of clotting. Clinical judgment for which patients would benefit from treatment involves a complex risk benefit assessment that is challenging for any LCD policy to attempt to address. Such decision-making is best assisted with the use of the clinical practice guidelines.”

NGS partially agrees and have qualified the limitation to be “generally not covered.”
9

The manufacturer of ClariVein (Vascular Insights) requested changing the phrase “coverage is only for FDA devices specifically approved for these procedures” to “coverage is only for devices approved or cleared by the FDA for use in the peripheral vasculature.” They state: “The reference to ‘FDA devices’ is unclear, as is the reference to ‘these’ procedures, without further explanation as to what procedures may qualify and what devices may be covered. Since devices may be cleared or approved by FDA for a variety of uses and clinical locations—either specific to the saphenous veins or more broadly to other locations within the peripheral vasculature—we believe the prior language could be applied to deny coverage for endovenous ablation procedures even if a device (like ClariVein) is being used to treat an anatomical target consistent with its FDA-cleared indication.”

NGS generally agrees and have changed the wording to: “Coverage is only for devices with FDA approval or clearance consistent with saphenous ablation and used according to its approved instructions for use (IFU).”
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Associated Documents

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Medicare BPM Ch 15.50.2
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