Treatment of Varicose Veins of the Lower Extremity

Clinical Medical Policy Department Clinical Affairs Division

Treatment of varicose veins of the lower extremity [For the list of services and procedures that need preauthorization, please refer to www.mcs.com.pr go to “Comunicados a Proveedores”, and click “Cartas Circulares”.]

Medical Policy: MP-SU-07-11 Original Effective Date: September 29, 2011 Revised: August 24, 2020 Next Revision: August, 2021

This policy applies to products subscribed by the following corporations, MCS Life Insurance Company (Commercial), and MCS Advantage, Inc. (Classicare) and Medical Card System, Inc., provider’s contract; unless specific contract limitations, exclusions or exceptions apply. Please refer to the member’s benefit certification language for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply subject to the aforementioned exceptions. For MCS Advantage (Classicare) lines of business (LOB) refer to CMS-First Coast Service Options, Local Coverage Determination (LCD) for Treatment of varicose veins of the lower extremity (L33762).

DESCRIPTION

Varicose veins are a manifestation of chronic venous disease (CVD) caused by ambulatory venous hypertension.

Varicose veins are superficially located, dilated, tortuous, veins of the lower extremities. They are usually caused by insufficiency, or valvular reflux, of the valvular apparatus (primary disease), or as a result of previous thrombosis or trauma (secondary disease). These dilated superficial veins of the lower limbs are considered pathologic when they are 5 mm or greater in diameter or sometimes 3 mm or greater in diameter when measured in the upright position and have greater than 500 milliseconds of reflux by duplex scan. CVD can cause clinically significant pain and result in a decrease in quality of life and even disability which may necessitate treatment which would be considered reasonable and necessary.

CVD is progressive, and over time may progress to secondary skin changes (edema, lipodermatosclerosis, and ulceration), which is referred to as chronic venous insufficiency (CVI). CVD and CVI can be further complicated by superficial thrombophlebitis and variceal hemorrhage.

Chronic venous disease refers to a wide spectrum of morphologic (i.e., venous dilation) and/or functional abnormalities (e.g., venous reflux) of long duration. Vein related problems may or may not be symptomatic and include a wide range of clinical signs that vary from minimal superficial venous dilation to chronic skin changes with ulceration.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 1 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 1 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

Varicose veins (CEAP category 2) are dilated, elongated, tortuous, subcutaneous veins of 3 millimeters or greater in diameter. They may involve the saphenous veins (great or small), saphenous tributaries veins, or non-saphenous superficial leg veins.

Visibly dilated lower extremity veins (i.e., telangiectasias, reticular veins, or varicose veins) may be indicative of underlying venous reflux, especially when are associated with symptoms like (aching, swelling, heaviness). However, dilated veins can occur in the absence of symptoms or reflux and are often a source of significant distress to the patient, even in the absence of symptoms.

Some of the treatments used for treatment of the varicose veins of the lower extremity are described below: 1. Thermal ablation of superficial and perforating veins is a technique performed with endovenous radiofrequency ablation (RFA) or endovenous laser ablation (EVLA). These techniques are minimally invasive alternatives to high ligation and saphenous vein stripping (HL/S) and can be performed in an office/outpatient setting using local anesthesia and typically require no or minimal sedation. Thermal ablation is only a treatment option for sufficiently straight superficial vein segments that will allow passage of the device. Endovenous radiofrequency ablation (RFA) and endovenous laser ablation (EVLA) have the same purpose, that is, to damage the endothelium of the vein resulting in fibrosis and occlusion of a vein segment to eliminate reflux. There is sufficient evidence of the effectiveness of thermal ablation procedures for the primary treatment of the great saphenous vein (GSV) and/or saphenous veins and their tributaries (SSV), and incompetent accessory saphenous veins.

2. Surgical ligation and stripping is the traditional treatment of varicose veins in the lower legs where it includes a surgical procedure called high ligation and saphenous vein stripping (HL/S), which had been the gold standard of treatment; and its primary goal is removal of refluxing veins and improvement of symptoms. HL/S is typically a three-step process performed in the following manner: first, controlling reflux by proximal ligating of an incompetent vein; then, stripping a vein segment (usually the GSV or SSV) or removing of an incompetent long axial vein segment (usually the saphenous vein) from circulation through incisions in the groin and lower in the leg. The third step is removing tributaries via stab phlebectomies or sclerotherapy, either at the time of ligation or subsequent to the ligation.

3. Phlebectomy (Stab phlebectomy also referred to as stab avulsion, phlebectomy, ambulatory stab phlebectomy, or microphlebectomy) is a surgical treatment involving the removal of varicose veins through small “stab” 1 - 2 mm incisions in the skin overlying the vein. The vein is

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 2 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 2 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

hooked and brought to the surface at each incision site to release it from the surrounding tissues and to sever any connections to other veins.

4. Subfascial endoscopic perforator surgery (SEPS) is a treatment option of incompetent perforator veins in patients with advanced chronic venous insufficiency (e.g., venous ulcer, active or healed) when conservative management has failed. The overall goal of SEPS in treating chronic venous ulcers is to interrupt the incompetent perforating veins in order to decrease reflux and pressure in areas above the ankle. The Clinical Practice Guidelines of the Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) has determined that current studies do not support treatment of perforator veins in patients with simple varicose veins. Pathologic perforating veins include those with outward flow of ≥ 500 ms, with a diameter of ≥ 3.5 mm, located beneath or contiguous to a healed or open venous ulcer (CEAP class C5 - C6).

5. Sclerotherapy is another minimally invasive treatment modality. Sclerotherapy is the injection of a chemical (FDA-approved sclerosing agent) into a varicose or incompetent vein to achieve endoluminal fibrosis and obstruction. Sclerotherapy (liquid or foam) is performed for signs and symptoms of refluxing veins and can be used as an adjunct to surgical or ablative therapy (radiofrequency or laser). Evidence supports sclerotherapy is limited to the treatment of residual or recurrent varicose tributary veins following control of reflux in the GSV/SSV either by surgical ligation or endovenous thermal ablation.

COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate member certificate and subscriber agreement contract for applicable diagnostic imaging, DME, laboratory, machine tests, benefits, and coverage.

VARICOSE VEIN TERMINOLOGY RELEVANT TO THIS MEDICAL POLICY:

Varicose veins are visible distended superficial veins > 3mm with venous incompetence. Not all require treatment, and some treatment is cosmetic. Spider veins are intradermal venules of < 1 mm, also known as telangiectasia or thread veins. Reticular veins are subdermal veins of 1 - 3 mm in diameter. Superficial veins include truncal (GSV/SSV) and accessory/tributary veins in the subcutaneous tissue. Perforator veins are the veins that link the superficial and deep veins. Deep veins are located deep to the muscular fascia, such as the common femoral vein.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 3 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 3 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

CONDITIONS FOR COVERAGE:

1. The evaluations of a patient with lower extremity venous incompetence and its advanced consequences—edema and skin changes—should include the assessment of history and physical examination including the Classification of Venous Disease (CEAP classification) and revised Venous Clinical Severity Score (VCSS). A duplex ultrasound scan of the deep and superficial venous systems must support the examination findings.

2. For patients with C2 disease and VCSS score > 6, or patients with C3 - C6 disease, proposed interventions for a 90-day episode of care should be addressed in the treatment plan.

Note: A plan of care is required for all patients receiving treatment per the indications of this Medical Policy. Procedures will only be considered covered (reasonable and necessary) if the patient meets the criteria for the procedure as outlined in this Medical Policy, and the intervention is addressed and supported in the plan of care.

Note: Please refer to Appendix 1 for the Classification of Venous Disease and Appendix 2 for the Venous Clinical Severity Score (VCSS).

INDICATIONS

I. For MCS Advantage (Classicare) lines of business (LOB) refer to CMS - First Coast Service Options, Local Coverage Determination (LCD) for Treatment of varicose veins of the lower extremity (L33762).

II. For Commercial Line of Business (LOB):

A. Endovenous Radiofrequency and Laser Ablation: Medical Card System Inc. (MCS) will consider Endovenous Radiofrequency and Laser Ablation for the treatment of symptomatic Great Saphenous Vein (GSV), Small Saphenous Vein (SSV), or Accessory Saphenous Veins medically necessary when the following criteria are met:

1. A three (3) to six (6) months trial of conservative therapy including support hose, leg elevation or weight reduction when appropriate;

2. For C2 - Simple varicose veins (3 mm or larger) patients:

 The plan of care must include a duplex scan report demonstrating saphenous vein reflux (at least 500 ms); and

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 4 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 4 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

 A Great Saphenous Vein (GSV) has a diameter of at least 5 mm and the Small Saphenous Vein (SSV) has a diameter of at least 3 mm; and

 The signs and symptoms (e.g., persistent pain, swelling, itching, burning) must significantly interfere with activities of daily living or quality of life; and

 Exceed a VCSS score of 6 or have a VCSS < 6 with documentation of the failure of compression therapy.

3. For (C3 - C6) (See Appendix 1) - patients:

 The plan of care should also include a duplex ultrasound scan report demonstrating saphenous vein reflux (at least 500 ms); and

 A Great Saphenous Vein (GSV) has a diameter of at least 5 mm and the Small Saphenous Vein (SSV) has diameter of at least 3 mm; and

 Documentation must include signs such as skin thickening and discoloration, superficial phlebitis, edema, variceal hemorrhage, and ulceration.

 If perforator vein treatment is a consideration, the plan of care must also include evidence of perforator venous insufficiency (outward flow of at least 500 ms) measured by recent duplex ultrasonography report, perforator vein size of 3.5 mm or greater, and documentation in office notes and recent duplex ultrasound study that the perforating vein lies beneath or contiguous to a healed or active venous stasis ulcer (unless the deep veins are obstructed).

In addition to the above conditions, the following must be present:

1. Absence of aneurysm in the target segment,

2. Maximum vein diameter of >2.5 cm for ERFA or laser ablation

3. Absence of thrombosis or vein tortuosity, which would impair catheter advancement

4. Absence of significant peripheral artery disease

B. Surgical ligation and stripping: Medical Card System Inc. (MCS) will consider Surgical ligation and stripping for the treatment of symptomatic Great Saphenous Vein (GSV), Small Saphenous Vein (SSV), or Accessory Saphenous Veins medically necessary when the following criteria are met:

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 5 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 5 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

1. Surgical ligation and stripping (HL/S) will be Perform in a three-step process: first, controlling reflux by proximal ligating of an incompetent vein; then, stripping a vein segment (usually the GSV or SSV) or removing of an incompetent long axial vein segment (usually the saphenous vein) from circulation through incisions in the groin and lower in the leg. The third step is removing tributaries via stab phlebotomies or sclerotherapy, either at the time of ligation or subsequent to the ligation.

2. Phlebectomy of the distal branch varicosities in the lower leg without elimination of proximal axial venous insufficiency will not be reasonable and necessary without a clear explanation in the plan of care.

C. Phlebectomy: Medical Card System Inc. (MCS) will consider Phlebectomy (Stab phlebectomy also referred to as stab avulsion, phlebectomy, ambulatory stab phlebectomy, or microphlebectomy) for the treatment of symptomatic Great Saphenous Vein (GSV), Small Saphenous Vein (SSV), Accessory Saphenous Veins, or perforator veins 2.5 mm or greater in diameter medically necessary when the following criteria are met:

1. Phlebectomy is an adjunctive procedure and may be covered for patients with symptomatic varicose tributary veins for those with C2 and VCSS >6, or C2 and VCSS <6 with documentation of the failure of compression therapy, or patients with C3-C6 disease, ideally at the same time or following surgical or thermal ablation treatment of the saphenous veins, as outlined in the plan of care that addresses the episode of care.

D. Subfascial endoscopic perforator surgery (SEPS): Medical Card System Inc. (MCS) will consider Subfascial endoscopic perforator surgery (SEPS) for the treatment option of incompetent perforator veins in patients with advanced chronic venous insufficiency (e.g., venous ulcer, active or healed) when conservative management has failed. The following criteria must be met: The overall goal of Subfascial endoscopic perforator surgery (SEPS) in treating chronic venous ulcers is to interrupt the incompetent perforating veins in order to decrease reflux and pressure in areas above the ankle. SEPS for the treatment of C1-C4 is not covered. The Clinical Practice Guidelines of the Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) has determined that current studies do not support treatment of perforator veins in patients with simple varicose veins.

1. Pathologic perforating veins include those with outward flow of ≥ 500 ms, with a diameter of ≥ 3.5 mm, located beneath or contiguous to a healed or open venous ulcer (CEAP class C5 - C6).

E. For Sclerotherapy: Medical Card System Inc. (MCS) will consider liquid or foam Sclerotherapy (endovenous chemical ablation) medically necessary like adjunctive treatment when the following medical criteria are met:

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 6 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 6 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

1. Sclerotherapy (liquid or foam) will be performed for signs and symptoms of refluxing veins and can be used as an adjunct to surgical or ablative therapy (radiofrequency or laser). Evidence supports sclerotherapy is limited to the treatment of residual or recurrent varicose tributary veins following control of reflux in the GSV/SSV either by surgical ligation or endovenous thermal ablation.

2. Sclerotherapy will be consider as an adjunctive procedure and covered for patients with symptomatic varicose tributary veins for those with C2 and VCSS > 6, or C2 and VCSS <6 with documentation of the failure of compression therapy, or patients with C3-C6 disease and ideally at the same time or following surgical or thermal ablation treatment of the saphenous veins, as outlined in the plan of care that addresses the episode of care.

3. If endothermal ablation is unsuitable, image-guided foam sclerotherapy for tributary vein can be a consideration if clinically significant reflux is documented and addressed in the plan of care.

LIMITATIONS

1. If it determined on review that the varicose veins were asymptomatic, the claim will be denied as a non-covered (cosmetic) procedure.

2. Isolated injections for the treatment of telangiectasia and reticular veins less than 3mm in diameter are considered cosmetic and do not meet the Medicare reasonable and necessary threshold for coverage.

3. Duplex scanning will be considered medically necessary when used to initially determine the extent and mapping of the varicose veins and identify the location of incompetence. Additional studies in the absence of new or recurrent symptoms during the 90-day episode of care may result in prepayment medical review.

4. It is not expected that phlebectomy on the same vein will be performed on the same day as endovenous radiofrequency and laser ablation or surgery.

5. Phlebectomy of the distal branch varicosities in the lower leg without elimination of proximal axial venous insufficiency is not reasonable and necessary without a clear explanation in the plan of care.

6. Transilluminated powered phlebectomy (TriVex) should be billed as a phlebectomy and can be covered if it meets indications as outlined for phlebectomy.

7. Thermal ablation includes the necessary ultrasound imaging for any additional procedures done with the thermal ablation. Thermal ablation of the same leg on different days (utilizing two base

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 7 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 7 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

codes on separate days vs. a base code with an add-on code) for C2 staging and standard axial treatment of GSV and/or SSV would not be allowed unless the procedure note clearly documents why the procedure had to be split.

8. Subfascial endoscopic perforator surgery (SEPS) for the treatment of C1 - C4 is not covered.

9. Local anesthesia and minimal to no sedation is the standard of care. Monitored Anesthesia Care (MAC) or moderate (conscious) sedation needs clear support in the medical record based on patient clinical presentation/characteristics and may be subject to prepayment review.

10. Photothermal sclerosis (also referred to as an intense pulsed light source, e.g., the PhotoDerm VascuLight, VeinLase), transdermal laser treatment, and mechanochemical ablation (MOCA) (Clarivein) do not meet the Medicare reasonable and necessary threshold for coverage.

11. Ultrasound technologists and therapists do not qualify to surgically treat varicose veins.

12. Additional studies in the absence of new or recurrent symptoms during the 90-day episode of care may result in prepayment medical review.

13. The treatment of C1 disease (spider telangiectasia and their feeding reticular veins) is considered cosmetic, and therefore, not reasonable and necessary for the purposes of Medicare coverage.

14. Device/sclerosant combination procedures without a unique CPT code are described by CPT code 37799. The sclerosant is included in the procedure. Coverage is limited to the ‘sclerotherapy’ indications in this Medical Policy.

CONTRAINDICATIONS

1. Pregnancy or Nursing*. Note3*= Secondary to concerns related to anesthetic drug use and related to vein or heated blood effluent which may pass through the placenta to the fetus.

2. Acute superficial or deep venous thrombosis and/or thromboembolism.

3. Moderate to severe peripheral artery disease.

4. Advance generalized systemic disease.

5. Joint disease that interferes with mobility and/or inability to adequately ambulate after the procedure.

6. Diabetes.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 8 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 8 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

7. Very large veins.

8. Liver dysfunction or local anesthetic allergy limiting local anesthetic agent use.

9. Severe uncorrectable coagulopathy, intrinsic or iatrogenic.

10. Severe hypercoagulopathy syndromes.

11. Inability to wear compression stocking secondary to inadequate arterial circulation, hypersensitivity to the compressive materials, or musculoskeletal or neurologic limitations to donning the stocking itself.

12. Sciatic vein reflux.

13. Nerve stimulator.

TRAINING AND QUALIFICATIONS:

A qualified physician for this service/procedure is defined as follows:

1. Training and expertise must have been acquired within the framework of an accredited residency (general or vascular surgery, radiology, cardiology) and/or fellowship program in the applicable specialty/subspecialty in the United States or must reflect equivalent education, training, and expertise endorsed by an academic institution in the United States or by the applicable specialty/subspecialty society in the United States.

2. The accuracy of non-invasive diagnostic studies depends on the knowledge, skill and experience of the technologist and the physician performing the interpretation of the study. Consequently, the technologist and the physician must maintain proof of training and experience. All non- invasive vascular diagnostic studies must be: a. Performed by a qualified physician; or

b. Performed under the general supervision of a qualified physician or technologist who has demonstrated minimum entry level competency by being credentialed in vascular technology, and/or

c. Performed in a laboratory accredited in vascular technology.

Examples of certification in vascular technology for non-physician personnel include:  Registered Vascular Technologist (RVT) credential.  Registered Vascular Specialist (RVS) credential.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 9 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 9 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

These credentials must be provided by nationally recognized credentialing organizations such as:  The American Registry of Diagnostic Medical Sonographers (ARDMS) which provides Registered Diagnostic Medical Sonographer(RDMS), Registered Vascular Technologist (RVT), and Registered Physician in Vascular Interpretation (RPVI) credentials.  The Cardiovascular Credentialing International (CCI) which provides RVS credential.

Appropriate, nationally recognized laboratory accreditation bodies include:  Intersocietal Accreditation Commission (IAC), formerly Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL).  American College of Radiology (ACR).

3. Nonphysician practitioners (NPP) have a defined scope of practice per state licensure. A NPP under the supervision of a qualified physician for the intra service aspects of sclerotherapy (standard or foam) and/or phlebectomy must be able to demonstrate education and training in the intervention.

Note4: General Supervision means the procedure is furnished under the physician’s overall direction and control, but the physician’s presence is not required during the performance of the procedure. Under general supervision, the training of the non-physician personnel who actually performs the diagnostic procedure and the maintenance of the necessary equipment and supplies are the continuing responsibility of the physician.

DOCUMENTATION REQUIREMENTS:

PLAN OF CARE:

For the purposes of this Policy, any reference to plan of care signifies a 90-day episode of care that begins with the first date of service of procedures outlined in this policy. The plan of care is based on the treating physician’s assessment with CEAP and VCSS classification including the date(s) of exam and diagnostic evaluation. The minimum evaluation that must be documented includes history, physical exam, and a formal venous duplex ultrasound scan.

The initial plan of care is expected to address all sites of clinically significant axial or non-axial reflux along with a description of the specific procedure(s) to be used in a 90-day episode of care consistent with the CEAP and Venous Clinical Severity Score (VCSS) classification and supporting clinical and diagnostic data. Again, for patients with C2 disease and a VCSS score < 6, the initial plan of care must include at least a failure of a 90-day course of compression therapy before a new 90 day episode of care.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 10 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 10 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

For C2 patients with VCSS < 6, documentation of the failure of compression therapy (graduated compression stockings (15-20 mmHg)) is required for consideration of ablations, as outlined below.

The following must be documented in the patient’s medical record and made available to the Medical Examiner upon request:

 Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.

 The initial work up plan/ plan of care is based on the treating physician’s assessment and includes the date(s) of exam and diagnostic evaluation. The minimum evaluation that must be documented includes history, physical exam, basic CEAP classification, VCSS score, and venous duplex scan;

 Once the initial work up plan is completed, the plan of care should outline interventions for 90 days;

 Failure of at least a 90-day course of compression therapy as described in the Indications section of the Medical Policy must be documented for C2 patients with VCSS < 6;

 Exclusion of other causes of leg pain, ulceration, and edema;

 Performance of duplex scanning used to confirm the presence, location, and size of incompetent veins;

 Imaging including 2D and spectral analysis comprising the venous duplex scan;

 All other requirements of medical necessity outlined in the Indications and Limitations sections of this Policy.

CODING INFORMATION CPT® Codes (List may not be all inclusive) CPT Codes DESCRIPTION 36470 Injection of sclerosant; single incompetent vein (other than telangiectasia) 36471 Injection of sclerosant; multiple incompetent veins (other than telangiectasia), same leg 36475* Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 11 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 11 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

guidance and monitoring percutaneous , radiofrequency: first vein treated +36476 Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; subsequent vein(s) treated in a single extremity, each through separate access sites (list separately in addition to code for primary procedure) 36478* Endovenous ablation therapy of incompetent vein, extremity , inclusive of all imaging guidance and monitoring, percutaneous, laser, first vein treated +36479 Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, laser; subsequent vein(s) treated in a single extremity, each through separate access sites (list separately in addition to code for primary procedure) 36482 Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (eg, cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring, percutaneous; first vein treated 36483 Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (eg, cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring, percutaneous; subsequent vein(s) treated in a single extremity, each through separate access sites (list separately in addition to code for primary procedure) 37500 Vascular endoscopy, surgical, with ligation of perforator veins, subfascial (seps)

37700 Ligation and division of long saphenous vein at saphenofemoral junction, or distal interruptions

37718 Ligation, division, and stripping, short saphenous vein

37722 Ligation, division, and stripping, long (greater) saphenous veins from saphenofemoral junction to knee or below

37735 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 lower leg, with excision of deep fascia

37765 Stab phlebectomy of varicose veins, 1 extremity; 10-20 stab incisions

37766 Stab phlebectomy of varicose veins, 1 extremity; more than 20 incisions

37780 Ligation and division of short saphenous vein at saphenopopliteal junction (separate procedure)

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 12 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 12 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

37785 Ligation, division, and/or excision of varicose vein cluster(s), 1 leg

37799 Unlisted procedure, vascular surgery

93970 Duplex scan of extremity veins including responses to compression and other maneuvers; complete bilateral study

93971 Duplex scan of extremity veins including responses to compression and other maneuvers; unilateral or limited study

Current Procedural Terminology (CPT®) 2020 American Medical Association: Chicago, IL.

Note: Claims data analysis demonstrating persistent outlier code utilization (frequent use of the base code for thermal ablation [CPT code 36475 for RFA or 36478 for EVLA]) in a single episode of care may be subject to prepayment review.

HCPCS® CODES (List may not be all inclusive) HCPCS® CODES DESCRIPTION N/A N/A 2020 HCPCS LEVEL II Professional Edition® (American Medical Association).

ICD-10 Codes (List may not be all inclusive) ICD-10-Codes DESCRIPTION I83.001 Varicose veins of unspecified lower extremity with ulcer of thigh I83.002 Varicose veins of unspecified lower extremity with ulcer of calf I83.003 Varicose veins of unspecified lower extremity with ulcer of ankle I83.004 Varicose veins of unspecified lower extremity with ulcer of heel and midfoot I83.005 Varicose veins of unspecified lower extremity with ulcer other part of foot I83.008 Varicose veins of unspecified lower extremity with ulcer other part of lower leg I83.009 Varicose veins of unspecified lower extremity with ulcer of unspecified site I83.011 Varicose veins of right lower extremity with ulcer of thigh I83.012 Varicose veins of right lower extremity with ulcer of calf I83.013 Varicose veins of right lower extremity with ulcer of ankle I83.014 Varicose veins of right lower extremity with ulcer of heel and midfoot I83.015 Varicose veins of right lower extremity with ulcer other part of foot I83.018 Varicose veins of right lower extremity with ulcer other part of lower leg I83.019 Varicose veins of right lower extremity with ulcer of unspecified site I83.021 Varicose veins of left lower extremity with ulcer of thigh I83.022 Varicose veins of left lower extremity with ulcer of calf I83.023 Varicose veins of left lower extremity with ulcer of ankle

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 13 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 13 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

I83.024 Varicose veins of left lower extremity with ulcer of heel and midfoot I83.025 Varicose veins of left lower extremity with ulcer other part of foot I83.028 Varicose veins of left lower extremity with ulcer other part of lower leg I83.029 Varicose veins of left lower extremity with ulcer of unspecified site I83.10 Varicose veins of unspecified lower extremity with inflammation I83.11 Varicose veins of right lower extremity with inflammation I83.12 Varicose veins of left lower extremity with inflammation I83.201 Varicose veins of unspecified lower extremity with both ulcer of thigh and inflammation I83.202 Varicose veins of unspecified lower extremity with both ulcer of calf and inflammation I83.203 Varicose veins of unspecified lower extremity with both ulcer of ankle and inflammation I83.204 Varicose veins of unspecified lower extremity with both ulcer of heel and midfoot and inflammation I83.205 Varicose veins of unspecified lower extremity with both ulcer other part of foot and inflammation I83.208 Varicose veins of unspecified lower extremity with both ulcer of other part of lower extremity and inflammation I83.209 Varicose veins of unspecified lower extremity with both ulcer of unspecified site and inflammation I83.211 Varicose veins of right lower extremity with both ulcer of thigh and inflammation I83.212 Varicose veins of right lower extremity with both ulcer of calf and inflammation I83.213 Varicose veins of right lower extremity with both ulcer of ankle and inflammation I83.214 Varicose veins of right lower extremity with both ulcer of heel and midfoot and inflammation I83.215 Varicose veins of right lower extremity with both ulcer other part of foot and inflammation I83.218 Varicose veins of right lower extremity with both ulcer of other part of lower extremity and inflammation I83.219 Varicose veins of right lower extremity with both ulcer of unspecified site and inflammation I83.221 Varicose veins of left lower extremity with both ulcer of thigh and inflammation I83.222 Varicose veins of left lower extremity with both ulcer of calf and inflammation I83.223 Varicose veins of left lower extremity with both ulcer of ankle and inflammation I83.224 Varicose veins of left lower extremity with both ulcer of heel and midfoot and inflammation

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 14 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 14 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

I83.225 Varicose veins of left lower extremity with both ulcer other part of foot and inflammation I83.228 Varicose veins of left lower extremity with both ulcer of other part of lower extremity and inflammation I83.229 Varicose veins of left lower extremity with both ulcer of unspecified site and inflammation I83.811 Varicose veins of right lower extremities with pain I83.812 Varicose veins of left lower extremities with pain I83.813 Varicose veins of bilateral lower extremities with pain I83.891 Varicose veins of right lower extremity with other complications I83.892 Varicose veins of left lower extremity with other complications I83.893 Varicose veins of bilateral lower extremities with other complications I87.2 Venous insufficiency (chronic) (peripheral) R60.0 Localized Edema

REFERENCES

1. American College of Phlebology. (2016 Feb 03). Treatment of Superficial Venous Disease of the Lower Leg. Accessed July 10, 2020. Available at URL Address: https://www.myavls.org/assets/pdf/SuperficialVenousDiseaseGuidelinesPMS313-02.03.16.pdf or https://www.myavls.org/member-resources/clinical-guidelines.html

2. Centers for Medicare & Medicaid Services. (First Coast Service Options, Inc.). Local Coverage Article (LCA) Billing and Coding: Treatment of varicose veins of the lower extremity (A57781). Original Effective Date: 10/03/2018. Revision Effective Date: 07/01/2020. Accessed August 17, 2020. Available at URL address: https://www.cms.gov/medicare-coverage- database/details/article- details.aspx?articleId=57781&ver=7&LCDId=33762&CntrctrSelected=371*1&Cntrctr=371&s=46 &DocType=Active&bc=AAgAAAQAgAAA&

3. Centers for Medicare & Medicaid Services. (First Coast Service Options, Inc.). Local Coverage Determination (LCD) for Treatment of varicose veins of the lower extremity (L33762). Original Effective Date: 10/01/2015. Revision Effective Date: for Services performed on or after 11/27/2019. Accessed July 10, 2020. Available at URL address: https://www.cms.gov/medicare- coverage-database/details/lcd-

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 15 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 15 All Rights Reserved®

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details.aspx?LCDId=33762&ver=41&CntrctrSelected=371*1&Cntrctr=371&s=46&DocType=Activ e&bc=AAgAAAQAgAAA&

4. E. Rabe, F. X. Breu, A. Cavezzi, P. Coleridge Smith, A. Frullini, J. L. Gillet, J. J. Guex, C. Hamel- Desnos, P. Kern, B. Partsch, et al. (2014, Jul). European guidelines for sclerotherapy in chronic venous disorders. Phlebology. 29(6): 338–354. Doi: 10.1177/0268355513483280. Accessed July 10, 2020. Available at URL Address: http://journals.sagepub.com/pb- assets/cmscontent/PHL/PHL-EuropeanGuidelinesForSclerotherapy.pdf

5. Gloviczki, Peter et al. (2011, May). 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. 53(5 Suppl): 2S - 48S. Doi: 10.1016/j.jvs.2011.01.079. Accessed July 10, 2020. Available at URL Address: http://www.jvascsurg.org/article/S0741- 5214(11)00327-2/fulltext

6. Khilnani et al. (2010, January) Multi- society consensus quality improvement guidelines for the treatment of lower extremity superficial venous insufficiency with endovenous thermal ablation from the society of interventional radiology, Cardiovascular Interventional Radiological Society of Europe, American College of Phlebology, and Canadian Interventional Radiology Association. J Vasc Interven Radiol 2010; 21: 14 - 31. Accessed July 10, 2020. Available at URL Address: https://www.jvir.org/article/S1051-0443(09)00131-6/abstract

7. Khilnani et al. (2020) Varicose Vein Treatment with Endovenous Laser Therapy. Medscape. Updated Jun 01, 2020. Accessed July 10, 2020. Available at URL Address: http://emedicine.medscape.com/article/1815850-overview

8. Kuyumcu, G., Salazar, G. M., Prabhakar, A. M., & Ganguli, S. (2016). Minimally invasive treatments for perforator vein insufficiency. Cardiovascular Diagnosis and Therapy, 6(6), 593– 598. Accessed July 10, 2020. Available at URL Address: http://doi.org/10.21037/cdt.2016.11.12

9. National Institute for Health and Clinical Excellence (NICE). (2013 Feb). Ultrasound-guided foam sclerotherapy for varicose veins Interventional procedures guidance [IPG440] Published date: February 2013. Accessed July 10, 2020. Available at URL Address: https://www.nice.org.uk/guidance/ipg440

10. National Institute for Health and Clinical Excellence (NICE). (May 2004). Subfascial endoscopic perforator vein surgery Interventional procedures guidance [IPG59] Published date: May 2004. Accessed July 10, 2020. Available at URL Address: https://www.nice.org.uk/guidance/ipg59

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 16 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 16 All Rights Reserved®

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11. Paula Corabian, Christa Harstall. (2004, May). Alberta Heritage Foundation for Medical Research Sclerotherapy for leg varicose veins. IP-19 Information Paper. Accessed July 10, 2020. Available at URL Address: https://www.ihe.ca/publications/sclerotherapy-for-leg-varicose-veins

12. Uptodate. Alguire, P. C, MD, FACP; Scovell, S. MD, FACS. (2020) Overview and Management of Lower extremity chronic venous disease. Literature review current through: July 2020. Last updated: Jan 14, 2020. Accessed July 10, 2020. Available at URL address: https://www.uptodate.com/contents/overview-and-management-of-lower-extremity-chronic- venous-disease

13. Uptodate. Alguire, P. C.; MD, FACS; Mathes, B. M. MD, FACP, FAAD. (2020) Medical management of lower extremity chronic venous disease. Literature review current through: July 2020. Last updated: April 22, 2020. Accessed July 10, 2020. Available at URL address: http://www.uptodate.com/contents/medical-management-of-lower-extremity-chronic-venous- disease

14. Uptodate. Eidt, J. F. MD. ; Mills, J. L. Sr, MD. (2020) Open Surgical Techniques for lower extremity vein Ablation. Literature review current through: July 2020. Last updated: January 28, 2019. Accessed July 10, 2020. Available at URL address: http://www.uptodate.com/contents/open-surgical-techniques-for-lower-extremity-vein- ablation

15. Uptodate. IHnat D. M. (2020) Endovenous laser ablation for the treatment of lower extremity chronic venous disease. Literature review current through: July 2020. This topic last updated: July 16, 2019. Accessed July 10, 2020. Available at URL Address: https://www.uptodate.com/contents/endovenous-laser-ablation-for-the-treatment-of-lower- extremity-chronic-venous- disease?source=search_result&search=Endovenous+laser+ablation+for+the+treatment+of+lowe r+extremity+chronic+venous+disease&selectedTitle=1~150

16. Uptodate. Scovel, S. MD, FACS. (2020) Radiofrequency Ablation for the treatment of lower extremity chronic venous disease. Literature review current through: July 2020. This topic last updated: December 02, 2019. Accessed July 10, 2020. Available at URL address: http://www.uptodate.com/contents/radiofrequency-ablation-for-the-treatment-of-lower- extremity-chronic-venous-disease

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 17 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 17 All Rights Reserved®

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POLICY HISTORY

DATE ACTION COMMENT September 29, 2011 Origination of Policy November 7, 2012 Revised References updated. To the Coding Information: Deleted CPT Code 76942 and ICD-9 Code 448.1. September 24, 2013 Reviewed References updated.  References #6 to #9 were added to the Medical Policy January 29, 2014 Revised References #6 to #9 was reviewed with the information contained in this medical policy and “UpToDate”.  To the indications section: Indication #6 was added.  To the contraindications section: Contraindications #6, 7 were added. February 21,2014 Revised To the Coding section: A new ICD-10 Codes (Preview Draft) section was added to the policy. September 15, 2014 Revised References updated. To the contraindications section:  The word “Nursing” was added to the contraindication #1.  New contraindications 1, 5, 8, 9, 10, 11, 12, 13 and note1 were added to the policy. To the References section:  New References (#7, 8) were added to the Policy.

November 23, 2015 Revised To the coding section:  Eliminate ICD-9 codes since they are no longer valid for diagnosis classification.  Add new section of ICD-10 codes which are the valid diagnosis classification system since October 1, 2015. September 16, 2016 Revised To the Tittle:  Endovenous Radiofrequency and Laser Ablation for Treatment of Varicose Veins of the Lower Extremity

 The Initial Statement for Classicare Coverage was moved to the First part of the Indications:  “For MCS Advantage (Classicare) lines of business (LOB) refer to CMS- First Coast Service Options, Local Coverage Determination (LCD) for Treatment of varicose veins of the lower extremity (L33762).” To the Description Section: Some Information was deleted for the description Section:  Varicose veins are caused by venous insufficiency as a result of valve reflux (incompetence). The venous insufficiency results in dilated, tortuous, superficial vessels that protrude from the skin of the lower extremities (CMS, L29403, 2012).

 Vein related problems may or may not be symptomatic, and include a wide range of clinical signs that vary from minimal superficial venous dilation to chronic skin changes with ulceration. Chronic venous disease refers to a wide spectrum of morphologic (i.e., venous dilation) and /or functional abnormalities (e.g., venous reflux) of long duration (Alguire, Scovell, et al, 2016).

Some New information was added to this Section:  Chronic venous disease refers to a wide spectrum of morphologic (ie, venous dilation) and/or functional abnormalities (e.g., venous reflux) of long duration. Vein related problems may or may not be symptomatic and include a wide range of clinical signs that vary from minimal superficial venous dilation to chronic skin changes with ulceration.

 Varicose veins (CEAP category 2) are dilated, elongated, tortuous,

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 18 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 18 All Rights Reserved®

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subcutaneous veins of 3 millimeters or greater in diameter. They may involve the saphenous veins (great or small), saphenous tributaries veins, or nonsaphenous superficial leg veins.

 Visibly dilated lower extremity veins (i.e., telangiectasia, reticular veins, or varicose veins) may be indicative of underlying venous reflux, especially when are associated with symptoms like (aching, swelling, heaviness). However, dilated veins can occur in the absence of symptoms or reflux and are often a source of significant distress to the patient, even in the absence of symptoms.

To the Coverage Section:  New Conditions for Coverage Section was added to the Policy.

To the Indications Section:  The Initial Statement for Classicare Coverage was moved to the First part of the Indications: “For MCS Advantage (Classicare) lines of business (LOB) refer to CMS-First Coast Service Options, Local Coverage Determination (LCD) for Treatment of varicose veins of the lower extremity (L33762).”

 Phrase “varicosities of the lesser or greater saphenous vein” was deleted and adapted to the New LCD with the New Phrase “Great Saphenous Vein (GSV), Small Saphenous Vein (SSV), or Accessory Saphenous Veins” in the Commercial Line of Business.

To the Indications:  To the Indication #1: This Information was deleted for restructured the indications according to the information contained in the New LCD (L33762).

 New Indications #2 and #3 were added to the Policy.

 The Additional Conditions Included in the LCD was retired from this Policy by MAC decision.

To the Limitations Section:

 Limitations #2 and #3 were restructured.

 New Limitations from #4 to #11 were added to the Policy.

New Training and Qualifications Section was added to the Policy.

New Documentation Requirements Section was added to the Policy.

To the Coding Section:  The following ICD-10 Codes were Deleted from Our Policy: I78.0, I78.8, I78.9, I80.00, I80.01, I80.02, I80.03, I80.10, I80.201, I80.202, I80.203, I80.209, I80.229, I80.239, I80.299, I83.819, I83.899, I87.011, I87.012, I87.013, I87.019, I87.021, I87.022, I87.023, I87.029, I87.031, I87.032, I87.033, I87.039, I87.091, I87.092, I87.093, I87.099, I87.9, Z41.1, I78.0, I78.8, I78.9, I80.00, I80.01, I80.02, I80.03, I80.10, I80.11, I80.12, I80.13, I80.201, I80.202, I80.203, I80.209, I80.221, I80.222, I80.223, I80.229,

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 19 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 19 All Rights Reserved®

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I80.231, I80.232, I80.233, I80.239, I80.291, I80.292, I80.293, I80.299, I80.3, I83.001, I83.002, I83.003, I83.004, I83.005, I83.008, I83.009, I83.011, I83.012, I83.013, I83.014, I83.015, I83.018, I83.019, I83.021, I83.022, I83.023, I83.024, I83.025, I83.028, I83.029, I83.10, I83.11, I83.12, I83.201, I83.202, I83.203, I83.204, I83.205, I83.208, I83.209, I83.211, I83.212, I83.213, I83.214, I83.215, I83.218, I83.219, I83.221, I83.222, I83.223, I83.224, I83.225, I83.228, I83.229, I83.811, I83.812, I83.813, I83.819, I83.891, I83.892, I83.893, I83.899, I87.011, I87.012, I87.013, I87.019, I87.021, I87.022, I87.023, I87.029, I87.031, I87.032, I87.033, I87.039, I87.091, I87.092, I87.093, I87.099, I87.9 and Z41.1.

The Following ICD-10 Code was added to Our Policy:  R60.0 Localized Edema

To the References Section:

 References #2, 3, 4, and 5 were added to the Policy.

 New References #8 and 12 were added to the Policy.

Appendix 1 was added to the Policy. July 26, 2018 Revised To the Description Section:  New Information was added to the Policy from: The traditional treatment of varicose veins in the lower legs includes a surgical procedure called high ligation and saphenous vein stripping, which had been the gold standard of treatment; and its primary goal is removal of refluxing veins and improvement of symptoms. This treatment is typically a three- step process: first, controlling reflux by proximal ligating of an incompetent vein; then, stripping a vein segment (usually the GSV or SSV) or removing of an incompetent long axial vein segment (usually the saphenous vein) from circulation through incisions in the groin and lower in the leg. The third step is removing tributaries via stab phlebectomies or sclerotherapy, either at the time of ligation or subsequent to the ligation.

Stab phlebectomy also referred to as stab avulsion, phlebectomy, ambulatory stab phlebectomy, or microphlebectomy is a surgical treatment involving the removal of varicose veins through small “stab” 1 - 2 mm incisions in the skin overlying the vein. The vein is hooked and brought to the surface at each incision site to release it from the surrounding tissues and to sever any connections to other veins.

Subfascial endoscopic perforator surgery (SEPS) is a treatment option of incompetent perforator veins in patients with advanced chronic venous insufficiency (e.g., venous ulcer, active or healed) when conservative management has failed. The overall goal of SEPS in treating chronic venous ulcers is to interrupt the incompetent perforating veins in order to decrease reflux and pressure in areas above the ankle.

Sclerotherapy is another minimally invasive treatment modality. Sclerotherapy is the injection of a chemical (FDA-approved sclerosing agent) into a varicose or incompetent vein to achieve endoluminal fibrosis and obstruction. Sclerotherapy (liquid or foam) is performed for signs and symptoms of refluxing veins and can be used as an adjunct to surgical or ablative therapy

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 20 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 20 All Rights Reserved®

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(radiofrequency or laser).

To the Indications Section:  New Indications Letters B, C, D, and E.

To the Contraindications Section: New Contraindications #14, 15 and 16 were added to the Policy.

To the Coding Section:  To the CPT Codes Section: The following CPTs Codes were added to the Policy: 36470, 36471, 36482, 36483, 37500, 37718, 37722, 37735, 37765, 37766, 37780, 37785, 93970, and 93971.

To the References Section:  New Reference #1 was added to the Policy.

October 10, 2018 Revised To the Appendix Section: Venous clinical severity score Information was added to the Policy.

To the References Section:  New References #3, 4, 7, 8, 9. 10 and 12 were added to the Policy. October 16, 2018 Mac Approval August 19, 2019 Revised To the Indications Section:  To the Endovenous Radiofrequency and Laser Ablation: Maximun Vein diameter of the veins was changed from 20mm to >2.5 cm in the #2 above conditions.

 To the Subfascial endoscopic perforator surgery (SEPS): To the #1 Sign “>” was corrected to “≥”.

To the Limitations Section:  Phrase “or surgery” was added to the Limitation #4.  New Limitation #15 was added to the Policy.

To the Training and Qualifications Section:  New Accreditation #3 was added to this section.  New Note4 was added to this section.

To the Coding Information Section:  To the CPT Codes Section: New CPT codes 37700 and 37799 were added to the Policy.

To the References Section: The following References were deleted from this Policy: #10 and 11. August 24 2020. Revised To the Limitation Section:  Sentence “Intraoperative ultrasound guidance is not separately reimbursable” was deleted from this Policy. Information was not included in the LCA A57781.  Limitation #9 was deleted from this Policy. Instruction for Code 76937.  New Phrase “In this Medical Policy” was added to the Limitation #15.

To the Training and Qualifications Section:  Phrases “Registered Diagnostic Medical Sonographer” and “Registered Vascular Technologist” were added to the Training

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 21 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 21 All Rights Reserved®

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and Qualifications “2C”.

 New Information for the Medical Record was added from the LCA A57781: Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.

To the Coding Information Section:  To the CPT Code Section: New Note Code Review was added for CPT Code 36475 and 36478 from the information contained in the Utilization Guidelines Section at the LCA A57781: Note: Claims data analysis demonstrating persistent outlier code utilization (frequent use of the base code for thermal ablation [CPT code 36475 for RFA or 36478 for EVLA]) in a single episode of care may be subject to prepayment review.

To the ICD-10 Code Section:  The following ICD-10 Codes were deleted from this Policy: I80.11, I80.12, I80.13, I80.221, I80. 222, I80.223, I80.231, I80.232, I80.233, I80.291, I80.292, I80.293, and I80.3.

To the References Section: New Reference #2 was added to the Policy.

This document is for informational purposes only. It is not an authorization, certification, explanation of benefits, or contract. Receipt of benefits is subject to satisfaction of all terms and conditions of coverage. Eligibility and benefit coverage are determined in accordance with the terms of the member’s plan in effect as of the date services are rendered. Medical Card System, Inc., (MCS) medical policies are developed with the assistance of medical professionals and are based upon a review of published and unpublished information including, but not limited to, current medical literature, guidelines published by public health and health research agencies, and community medical practices in the treatment and diagnosis of disease. Because medical practice, information, and technology are constantly changing, Medical Card System, Inc., (MCS) reserves the right to review and update its medical policies at its discretion. Medical Card System, Inc.; (MCS) medical policies are intended to serve as a resource to the plan. They are not intended to limit the plan’s ability to interpret plan language as deemed appropriate. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment they choose to provide.

Appendix 1:

Classification for chronic venous disorders (CVD and CVI)

The CEAP classification for chronic venous disorders was developed by an international committee that classifies venous disease according to the clinical severity (C), etiology (E), anatomy (A), and pathophysiology (P) to improve the accuracy of the diagnosis.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 22 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 22 All Rights Reserved®

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The CEAP classification includes the following elements:

Clinical Classification and Description: C0 - No visible or palpable signs of venous disease C1 - Telangiectasies or reticular veins less than 3 mm C2 - Simple varicose veins (3 mm or larger) C3 - Ankle edema of venous origin (not foot edema) C4a - Skin pigmentation or eczema C4b - Lipodermatosclerosis or atrophie blanche C5 - Healed venous ulcer C6 - Open venous ulcer S - Symptomatic, including ache, pain, tightness, skin irritation, heaviness, muscle cramps, and other complaints attributable to venous dysfunction A - Asymptomatic

Etiologic Classification: Ec - Congenital Ep - Primary Es - Secondary (post-thrombotic) En - No venous cause identified

Anatomic Classification: As - Superficial veins Ap - Perforator veins Ad - Deep veins An - No venous location identified

Pathophysiologic Classification: Pr - Reflux Po - Obstruction Pr, o - Reflux and obstruction Pn - No venous pathophysiology identifiable

Appendix 2

VENOUS CLINICAL SEVERITY SCORE: - FOR EACH LEG, PLEASE REVIEW EACH ITEM (SYMPTOM AND SIGN) THAT IS LISTED BELOW.

1. Pain or other discomfort (i.e., aching, heaviness, fatigue, soreness, burning): The clinician describes the 4 categories of leg pain or discomfort that are outlined below to the patient and asks the patient to choose, separately for each leg, the category that best describes the pain or discomfort the patient experiences.

None = 0: None.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 23 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 23 All Rights Reserved®

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Mild = 1: Occasional pain or discomfort that does not restrict daily activities.

Moderate = 2: Daily pain or discomfort that interferes with, but does not prevent, regular daily activities.

Severe = 3: Daily pain or discomfort that limits most regular daily activities.

2. Varicose Veins: The clinician examines the patient’s legs and, separately for each leg, chooses the category that best describes the patient’s superficial veins. The standing position is used for varicose vein assessment. Veins must be ≥ 3 mm in diameter to qualify as “varicose veins.”

None = 0: None.

Mild = 1: Few, scattered, varicosities that are confined to branch veins or clusters. Includes “corona phlebectatica” (ankle flare), defined as > 5 blue telangiectases at the inner or sometimes the outer edge of the foot.

Moderate = 2: Multiple varicosities that are confined to the calf or the thigh.

Severe = 3: Multiple varicosities that involve both the calf and the thigh.

3. Venous Edema: The clinician examines the patient’s legs and, separately for each leg, chooses the category that best describes the patient’s pattern of leg edema. The clinician’s examination may be supplemented by asking the patient about the extent of leg edema that is experienced.

None = 0: None.

Mild = 1: Edema that is limited to the foot and ankle.

Moderate = 2: Edema that extends above the ankle but below the knee.

Severe = 3: Edema that extends to the knee or above.

4. Skin Pigmentation: The clinician examines the patient’s legs and, separately for each leg, chooses the category that best describes the patient’s skin pigmentation. Pigmentation refers to color changes of venous origin and not secondary to other chronic diseases (i.e., vasculitis purpura).

None = 0: None, or focal pigmentation that is confined to the skin over varicose veins.

Mild = 1: Pigmentation that is limited to the perimalleolar area.

Moderate = 2: Diffuse pigmentation that involves the lower third of the calf.

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Severe = 3: Diffuse pigmentation that involves more than the lower third of the calf.

5. Inflammation: The clinician examines the patient’s legs and, separately for each leg, chooses the category that best describes the patient’s skin inflammation. Inflammation refers to erythema, cellulitis, venous eczema, or dermatitis, rather than just recent pigmentation.

None = 0: None.

Mild = 1: Inflammation that is limited to the perimalleolar area.

Moderate = 2: Inflammation that involves the lower third of the calf.

Severe = 3: Inflammation that involves more than the lower third of the calf.

6. Induration: The clinician examines the patient’s legs and, separately for each leg, chooses the category that best describes the patient’s skin induration. Induration refers to skin and subcutaneous changes such as chronic edema with fibrosis, hypodermitis, white atrophy, and lipodermatosclerosis.

None = 0: None.

Mild = 1: Induration that is limited to the perimalleolar area.

Moderate = 2: Induration that involves the lower third of the calf.

Severe = 3: Induration that involves more than the lower third of the calf.

7. Active Ulcer Number: The clinician examines the patient’s legs and, separately for each leg, chooses the category that best describes the number of active ulcers.

None = 0: None.

Mild = 1: 1 Ulcer.

Moderate = 2: 2 Ulcers.

Severe = 3: ≥ 3 Ulcers.

8. Active Ulcer Duration: If there is at least 1 active ulcer, the clinician describes the 4 categories of ulcer duration that are outlined below to the patient and asks the patient to choose, separately for each leg, the category that best describes the duration of the longest unhealed ulcer.

None = 0: No active ulcers.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 25 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 25 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

Mild = 1: Ulceration present for < 3 mo.

Moderate = 2: Ulceration present for 3 - 12 mo.

Severe = 3: Ulceration present for > 12 mo.

9. Active Ulcer Size: If there is at least 1 active ulcer, the clinician examines the patient’s legs, and separately for each leg, chooses the category that best describes the size of the largest active ulcer.

None = 0: No active ulcer.

Mild = 1: Ulcer < 2 cm in diameter.

Moderate = 2: Ulcer 2 - 6 cm in diameter.

Severe = 3: Ulcer > 6 cm in diameter.

10. Use of Compression Therapy: Choose the level of compliance with medical compression therapy.

None = 0: Not used.

Mild = 1: Intermittent use.

Moderate = 2: Wears stockings most days.

Severe = 3: Full compliance: stockings.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 26 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 26 All Rights Reserved®