Harvard Pilgrim HealthCare Medical Policy

Varicose Vein Procedures

STRIDEsm (HMO) MEDICARE ADVANTAGE

Subject: Varicose Vein Procedures

Background:

Chronic venous insufficiency (CVI), or Chronic Venous Disease (CVD). Is due to abnormally high pressure in the venous system, which normally has low pressure. This high pressure is caused by venous blood not properly getting out of the leg, either due to obstruction (such as a deep venous thrombosis) or refluxing blood flow due to incompetent vein valves. Varicose veins are dilated, tortuous veins under the surface of the skin which are commonly found in legs.

While exact cause of varicose veins is unknown, factors commonly associated with increased risk of developing varicose veins include family history, age, and obesity., While many individuals with varicose veins are symptom free, some may experience pain or complications from varicose veins and require a medical intervention. Most common symptoms include heaviness, aching, swelling, throbbing, and itching.

In many individuals experiencing symptoms as result of varicose veins, wearing specially fitted elastic stockings is appropriate treatment. Varicose veins are abnormally enlarged and tortuous vessels that result when veins become incompetent, and this failure allows blood to flow in a retrograde direction (reflux). Varicose veins are most often noted on the back of the calf or on the inside of the leg between the groin and ankle but can occur anywhere on the extremity.

Chronic venous disease is commonly stratified using the CEAP (Clinical, Etiology, Anatomy, Pathophysiology) classification, of which the Clinical (C) grade is most commonly used, and grades venous disease based on the presence of dilated veins, (C2) edema, (C3) skin changes, (C4a and b) for ulceration (C5 healed ulcer, C6 open ulcer).

Authorization:

Prior authorization from Harvard Pilgrim StrideSM (HMO) Medicare Advantage is required for the following interventional treatments for varicose veins:

• Ambulatory Phlebectomy (Stab or Hook Phlebectomy)
• Endovenous Laser Ablation (EVLA)
• Endovenous Radiofrequency Ablation [EFRA]
• Sclerotherapy
• Subfascial Endoscopic Perforator Surgery (SEPS)
• Transilluminated Powered Phlebectomy (TIPP)

Policy and Coverage Criteria:

Harvard Pilgrim StrideSM (HMO) Medicare Advantage considers the treatment of varicose veins as reasonable and medically necessary for eligible members with symptoms of significantly diseased vessels of the lower extremities that have not resolved after an appropriate course of conservative therapy.

Covered services must be:

• Reasonable and medically necessary based on the member’s condition, complexity of requested service(s),and accepted standards of clinical practice;
• An essential part of active treatment of the member’s medical condition;

HPHC Medical Policy

Public Domain

Page 1 of 9

Varicose Vein Procedures VA06MAY22P

Harvard Pilgrim StrideSM (HMO) policies are based on medical science and relevant information including current Medicare coverage (including National and Local Coverage Determinations), Harvard Pilgrim medical policies, and Harvard Pilgrim StrideSM (HMO) Medicare Advantage Plan materials. These policies are intended to provide benefit coverage information and guidelines specific to the Harvard Pilgrim StrideSM (HMO) Medicare Advantage Plan.

Providers are responsible for reviewing the CMS Medicare Coverage Center guidance; in the event that there is a conflict between this document and the CMS Medicare Coverage Center guidance, the CMS Medicare Coverage Center guidance will control.

• Ordered under a plan of care established and reviewed regularly by the attending physician caring for the member; and
• Furnished by provider(s) with appropriate state licensure, and (if indicated) accreditation/certification from an appropriate accrediting organization.

General Eligibility Criteria:

Harvard Pilgrim StrideSM (HMO) Medicare Advantage considers interventional treatment for symptomatic varicose veins as reasonable and medically necessary when medical record documentation confirms ALL the following:

• The member has symptomatic varicose veins evidenced by ANY of the following:
  • Significant pain and/or edema that impairs mobility and interferes with activities of daily living
  • Stasis dermatitis
  • Bleeding from a varicosity associated with diseased vessels of the lower extremity or extremities
  • Non-healing stasis ulcer of the lower leg
  • Recurrent episodes of superficial phlebitis
  • Refractory dependent edema; AND
• Symptoms of significantly diseased vessels of the lower extremities persist after at least 6 weeks of conservative therapy including the following components (as indicated):
  • Weight reduction (if overweight)
  • Regular exercise
  • Periodic leg elevation
  • Use of appropriate compressive bandages or prescription generated, pressure gradient compression stockings (> 20-30 mm Hg)
  • NSAIDs unless contraindicated or not tolerated; AND
• Duplex ultrasound of the deep and superficial venous system (performed while patient is standing) confirms ANY of the following:
  • Reflux >1 second, and venous diameter ≥ 3 mm in an axial vein connected to symptomatic varicose veins, leg ulcer, or area of lipodermatosclerosis;
  • Nonaxial varicose vein(s) with diameter ≥ 3mm (by physical exam or ultrasound);
  • “Pathologic” perforating veins (i.e., outward flow of >500 msec duration, with a diameter of >3.5mm) located beneath or associated with the ulcer bed, and no post thrombotic deep system incompetence. (Ultrasound documented competency, or confirmation of successful ablation/removal of axial veins is required. ); AND
• Relevant Procedure-Specific Criteria (below) are met.

Procedure-Specific Criteria:

Harvard Pilgrim StrideSM (HMO) Medicare Advantage considers the following procedures or combination of procedures as reasonable and medically necessary when General Eligibility Criteria above are met:

1. Ambulatory Phlebectomy
   • ANY of the following: e AAGSV with reflux >1 second and venous diameter > 3 mm; OR e Symptomatic secondary varicosities in the same vein field, in conjunction with, or after a successful main axial superficial vein ablation/removal performed within the past year
2. Endovenous Laser Ablation (EVLA)
   • Criteria 1 AND 2 are met: e Patient's anatomy and clinical condition is amenable to the proposed treatment, including ALL the following:

HPHC Medical Policy Public Domain Page 2 of 9 Varicose Vein Procedures VA06MAY22P

Harvard Pilgrim StrideSM (HMO) policies are based on medical science and relevant information including current Medicare coverage (including National and Local Coverage Determinations), Harvard Pilgrim medical policies, and Harvard Pilgrim StrideSM (HMO) Medicare Advantage Plan materials. These policies are intended to provide benefit coverage information and guidelines specific to the Harvard Pilgrim StrideSM (HMO) Medicare Advantage Plan.

Providers are responsible for reviewing the CMS Medicare Coverage Center guidance; in the event that there is a conflict between this document and the CMS Medicare Coverage Center guidance, the CMS Medicare Coverage Center guidance will control.

Procedure-Specific Criteria:

• Not authorized for patients with obliteration of deep venous system, allergy to the sclerosant, or hypercoagulable state.
• Absence of aneurysm in the target segment;
• Maximum vein diameter of 30 mm;
• Absence of thrombosis or vein tortuosity which would impair catheter advancement:
• Absence of significant peripheral arterial diseases.
• EITHER of the following:
  • Reflux >1 second and venous diameter > 3 mm in GSV, SSV, or AAGSV; OR
  • Pathologic perforator vein directly associated with a venous ulcer

• Endovenous Radiofrequency Ablation (RFA) Coverage limited to patients with no significant peripheral artery disease.
• Criteria 1 AND 2 are met:
• Patient's anatomy and clinical condition is amenable to the proposed treatment including ALL the following:
  • Absence of aneurysm in the target segment;
  • Maximum vein diameter of 20 mm; AND
  • Absence of thrombosis or vein tortuosity, which would impair catheter advancement.
• EITHER of the following:
  • Reflux >1 second and venous diameter > 3 mm in GSV, SSV, or AAGSV; OR
  • Pathologic perforator vein directly associated with a venous ulcer

• Ligation and Stripping Not covered for patients with severe distal arterial occlusive disease, obliteration of deep venous system, allergy to the sclerosant, or hypercoagulable state.
• ALL the following:
  • Reflux >1 second;
  • Venous diameter > 3 mm in GSV, SSV, or AAGSV

• Sclerotherapy Not covered for patients with severe distal arterial occlusive disease, obliteration of deep venous system, allergy to the sclerosant, or hypercoagulable state.
• EITHER of the following:
  • Symptomatic secondary varicosities in vessels less than 4 mm in diameter (in the same vein field), in conjunction with, or after, successful main axial superficial vein ablation/removal performed within the past year;
  • Pathologic perforator vein directly associated with a venous ulcer (Sclerotherapy usually performed with Duplex guidance)

• Subfascial Interruption or Subfascial Endoscopic Perforator Vein Surgery (SEPS)
• Transilluminated Powered
• ANY of the following:

HPHC Medical Policy

Public Domain

Page 3 of 9 Varicose Vein Procedures VA06MAY22P

Harvard Pilgrim StrideSM (HMO) policies are based on medical science and relevant information including current Medicare coverage (including National and Local Coverage Determinations), Harvard Pilgrim medical policies, and Harvard Pilgrim StrideSM (HMO) Medicare Advantage Plan materials. These policies are intended to provide benefit coverage information and guidelines specific to the Harvard Pilgrim StrideSM (HMO) Medicare Advantage Plan.

• Phlebectomy (TIPP)
• AAGSV with reflux >1 second and venous diameter > 3 mm; OR
• Symptomatic secondary varicosities (in the same vein field) in conjunction with, or after a successful main axial superficial vein ablation/removal performed within the past year. (TIPP authorized for remaining veins >3mm in size)

Exclusions:

Harvard Pilgrim StrideSM (HMO) Medicare Advantage considers varicose vein procedures as not medically necessary for all other indications.

Exclusions:

In addition, HPHC does not cover:

• Interventional treatment of symptomatic varicosities without documentation of a failed six-week trial of conservative therapy
• Sclerotherapy for cosmetic purposes
• Experimental and/or investigational treatments
• Reinjection following recanalization or failure of vein closure without recurrent signs or symptoms
• Sclerotherapy of the saphenous vein at its junction with the deep system
• Non-compressive sclerotherapy
• Compressive sclerotherapy for large, extensive or truncal varicosities
• Sclerotherapy, ligation and/or stripping of varicose veins, or endovenous ablation therapy for patients with severe distal arterial occlusive disease; obliteration of deep venous system; an allergy to the sclerosant or a hypercoagulable state
• Any interventional treatment that uses equipment or sclerosants not approved for such purposes by the FDA
• Endovenous ablation therapy in the presence of thrombosis or venous tortuosity which would impair catheter advancement
• Treatment of spider veins/telangiectasias for cosmetic purposes
• Interventional treatment of asymptomatic varicosities for cosmetic purposes
• Interventional treatment for varicose veins that develop or worsen during pregnancy