Subject:
Placement of Iliac Vein Stent
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Placement of a mesh tube into the iliac vein is intended to restore blood flow and maintain patency in a narrowed or collapsed iliac vein. Stent placement may be performed following an angioplasty or as an alternative to angioplasty.
According to UpToDate, May-Thurner syndrome (or iliac vein compression syndrome) is an anatomic variant resulting in the compression of the left common iliac vein between the overlying right common iliac artery and the underlying fifth lumbar vertebra. It is commonly seen in women between ages of 20 and 50. With partial venous obstruction, the condition can be asymptomatic. However, in patients with hemodynamically significant compression of the left common iliac vein, it has been associated with unprovoked left iliofemoral deep vein thrombosis (DVT) or chronic venous insufficiency. Episodes of DVT may be recurrent and/or poorly responsive to treatment with anticoagulation alone, and may require catheter-directed thrombolysis, venous angioplasty and/or intravascular stenting, especially in those with limb-threatening thrombosis.
Policy:
(NOTE: Effective July 15, 2019, Horizon Blue Cross Blue Shield of New Jersey (“Horizon BCBSNJ”) contracted with TurningPoint Healthcare Solutions, LLC (TurningPoint) to manage our Surgical and Implantable Device Management Program (“the Program”). TurningPoint conducts Prior Authorization and Medical Necessity Determination reviews of certain cardiac services to be provided to members included in the scope of the Program. The scope of the program includes members enrolled in the Horizon BCBSNJ plans for the effective dates noted below.
For services rendered July 15, 2019 and after, the Program includes members enrolled in Horizon BCBSNJ Fully Insured plans.
For services to be rendered January 20, 2020 and after, the Program will also include members enrolled in New Jersey State Health Benefits Program (SHBP)/School Employees’ Health Benefits Program (SEHBP) plans.
Please note that this policy’s criteria and guidelines only apply to members enrolled in plans that DO NOT participate in the Program. Visit our TurningPoint webpage for instructions on accessing the policy criteria and guidelines that TurningPoint will follow as they conduct PA/MND reviews as part of the Program. You may also call TurningPoint at 1-833-436-4083, Monday through Friday between 8 a.m. and 5 p.m., Eastern Time to request policy content.
For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
1. Placement of an Iliac vein stent is considered medically necessary for members with moderate-severe May-Thurner syndrome (iliac vein compression syndrome):
a. unilateral leg swelling and pain; AND
b. demonstration of the venous stenotic lesion in an appropriate anatomic location with noninvasive venous imaging (computed tomography [CT] venography, magnetic resonance [MR] venography), or invasive venous imaging (catheter-based venography or intravascular ultrasound); AND
c. skin changes (hyperpigmentation, venous eczema, lipodermatosclerosis, venous ulceration) associated with moderate-severe chronic venous insufficiency; AND
d. history of deep vein thrombosis (DVT) or post thrombotic syndrome (PTS); AND
e. member has failed at least 3 months of conservative management with compression stockings and leg elevation.
2. All other indications for iliac vein stent placement are considered investigational.
Medicare Coverage:
Placement of an Iliac Vein Stent is covered when NCD 20.7, LCD L35084 and Article A56365 criteria are met.
Additionally, per Local Coverage Determination (LCD):Endovenous Stenting (L37893), effective 5/20/19, Endovenous stents may be placed for individuals with severely symptomatic venous obstructions due to any of the following:
1. Iliac vein compression syndrome also known as May-Thurner or Cockett syndrome
2. Iliocaval obstruction
3. Iliofemoral obstruction for individuals with venous leg ulceration(s) not relieved by conservative therapies and compression. Progression of symptoms may lead to Phlegmasia Cerulea Dolens (PCD), acute inferior vena cava (IVC) thrombosis, and rapid thrombus extension despite anticoagulation as well as anatomically extensive DVT affecting the common femoral and/or iliac vein, or post-thrombotic stenosis with ankle edema of venous origin (i.e., minimum CEAP score 3)
4. Superior or Inferior Vena Caval Thrombosis including Superior Vena Cava syndrome
5. Post-thrombotic syndrome (PTS)
6. As an adjunct to catheter-directed thrombolysis for acute femoroiliocaval deep vein thrombosis when post thrombolysis imaging identifies symptomatic residual stenosis
7. Post radiation venous stenosis
8. Symptomatic post-traumatic venous stenosis including those resulting from central venous catheters or transvenous device (e.g., pacemakers, defibrillators,) pacemaker leads or a history of abdominal and/or pelvic surgery.
9. Salvage of thrombosed or stenotic symptomatic or limited function arteriovenous dialysis access fistulae or grafts with compromised venous outflow, failed angioplasty rapid restenosis, or vessel perforation. This may include treatment of trapping a life threatening thrombus, an aneurysm or pseudoaneurysm that threatens the viability of the AV fistula or graft, or the treatment of a hemodialysis vascular access rupture that cannot be controlled through balloon tamponade.
10. Thrombotic obstruction of major hepatic veins (Budd-Chiari syndrome)
11. Transvenous decompression of portosystemic shunts
12. Post-operative stenosis or venous narrowing due to repair of congenital cardiac disease, e.g. sinus venosus Atrial Septal Defect (ASD), discordant atrioventricular connection status post Mustard or Senning repair of Transposition of the Great Arteries (TGA).
13. Pulmonary vein stenosis resulting from congenital malformation, extrinsic compression, sequelae of radiofrequency ablation (RFA), lung transplantation, or status post repair of Total Anomalous Pulmonary Vein Return (TAPVR)
The placement of a stent in a vein for which there is no objective-related symptom or limitation of function is considered to be preventive and, therefore, not covered.
Required Documentation:
Pre- and post-deployment intervention images must be obtained and made available upon request. Documentation should include the nature of the obstruction, position of the device and, when appropriate, the effect of the device on target or nontarget vessels. Medical record documentation must list guide catheter used, as well as stent type, diameter and length.
The following are considered not reasonable and necessary and therefore will be denied:
· Endovenous stents are contraindicated in patients with an existing contraindication to anticoagulation or thrombolytic therapy or those with an uncorrectable coagulopathy.
· Use of stents without U.S. FDA approval designation will be considered not medically necessary.
· Stenting of popliteal or tibial veins.
· Venous stenosis less than or equal to 50% of diameter of vein.
The placement of a stent in a vein for which there is no objective-related symptom or limitation of function is considered to be preventive and, therefore, not covered by Medicare.
For additional information and eligibility, refer to the NCD, LCDs and Articles below:
National Coverage Determination (NCD) for Percutaneous Transluminal Angioplasty (PTA) (20.7). Available to be accessed at CMS National Coverage Determinations (NCDs) Alphabetical Index search page: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx.
Local Coverage Determination (LCD): Endovenous Stenting (L37893) and Local Coverage Article: Billing and Coding: Endovenous Stenting (A56414). Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00024370.
Local Coverage Determination (LCD): Non-Coronary Vascular Stents (L35084). Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00024370.
Local Coverage Article: Billing and Coding: Non-Coronary Vascular Stents (A56365). Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00024370.
Local Coverage Article: Billing and Coding: Endovenous Stenting (A56414). Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00024370
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Placement of Iliac Vein Stent
Iliac Vein Stent Placement
Iliac Vein Stenting
Stenting, Iliac Vein
Stent Placement, Iliac Vein
References:
1. Mousa A. May-Thurner syndrome. In: UpToDate, Eidt JF (Ed), UpToDate, Waltham, MA. (Accessed on February 7, 2019.)
2. Murphy EH, Black SA. Avoiding Misuse and Overuse of Iliac Vein Stenting for Chronic Venous Disease. Endovascular Today. 2018 July;17(7):74-76.
3. Akers DL, Jr., Creado B, Hewitt RL. Iliac vein compression syndrome: Case report and review of the literature. J Vasc Surg. 1996;24:477-481.
4. Kogel H. Regarding ’Iliac vein compression syndrome: Case report and review of the literature’. J Vasc Surg. 1997;26(4):721-722.
5. Akesson H, Lindh M, Ivancev K, et al. Venous stents in chronic iliac vein occlusions. Eur J Vasc Endovasc Surg. 1997;13(3):334-336.
6. Broholm R, Baekgaard N, Just SR, Jorgensen M. Endovascular treatment of chronic iliac vein obstruction in patients with venous claudication. Ugeskr Laeger. 2007 Apr 23 2007;169(17):1564-1568.
7. Funatsu A, Shibata K, Yamamoto R, et al. [Initial and long term outcomes of stent implantation for iliac compression syndrome]. J Cardiol. 2007 Dec 2007;50(6):371-377.
8. Mussa FF, Peden EK, Zhou W, Lin PH, Lumsden AB, Bush RL. Iliac vein stenting for chronic venous insufficiency. Tex Heart Inst J. 2007 2007;34(1):60-66.
9. Neglen P. Chronic Venous Obstruction: Diagnostic Considerations and Therapeutic Role of Percutaneous Iliac Stenting. 2007.
10. Lou WS, Gu JP, He X, et al. Endovascular treatment for iliac vein compression syndrome: A comparison between the presence and absence of secondary thrombosis. Korean J Radiol. 2009;10(2):135-143.
11. Bi Y, Yu Z, Chen H, et al. Long-term outcome and quality of life in patients with iliac vein compression syndrome after endovascular treatment. Phlebology. 2019 Jan [Epub ahead of print].
12. Jayarai A, Buck W, Knight A, et al. Impact of degree of stenosis in May-Thurner syndrome on iliac vein stenting. J Vasc Surg Venous Lymphat Disord. 2018 Dec [Epub ahead of print].
13. Funatsu A, Anzai H, Komiyama K, et al. Stent implantation for May-Thurner syndrome with acute deep venous thrombosis: acute and long-term results from the ATOMIC (AcTive stenting for May-Thurner Iliac Compression syndrome) registry.Cardiovasc Interv Ther. 2018 Jun [Epub ahead of print].
14. Sedhai TR, Golamari R, Salei A, et al. May-Thurner Syndrome. Am J Med Sci. 2018 May;355(5):510-514.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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