DRAFT Local Coverage Determination for Venous Angioplasty with or without Stent Placement for the Treatment of Chronic Cerebrospinal Venous Insufficiency (DL32452)

Contractor Information

Contractor Name
Wisconsin Physicians Service Insurance Corporation
Contractor Number
00951, 00952, 00953, 00954, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402, 52280
Contractor Type
Carrier - MAC - FI

LCD Information

Document Information
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LCD ID Number
DL32452

LCD Title
Venous Angioplasty with or without Stent Placement for the Treatment of Chronic Cerebrospinal Venous Insufficiency

Contractor's Determination Number
CV-041

AMA CPT/ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Primary Geographic Jurisdiction


Oversight Region



Original Determination Effective Date


Original Determination Ending Date


Revision Effective Date


Revision Ending Date


CMS National Coverage Policy

Indications and Limitations of Coverage and/or Medical Necessity
Discussion

Multiple Sclerosis (MS)
MS is an autoimmune disease of the central nervous system. In MS, inflammation of nervous tissue causes the loss of myelin, a fatty material that acts as a protective insulation for the nerve fibers in the brain and spinal cord. This demyelination leaves multiple areas of hard scarred tissue (plaques) along the covering of the nerve cells. Another characteristic of MS is the destruction of axons, which are the long filaments that carry electric impulses away from a nerve cell. The demyelination and axon destruction disrupts the ability of the nerves to conduct electrical impulses to and from the brain, and produces the various symptoms.

Chronic cerebrospinal venous insufficiency (CCSVI)
Recent information suggests that obstruction to venous flow or inadequate venous valves in the great veins in the neck, thorax and abdomen may cause insufficient drainage and damaging backflow into the cerebral and spinal cord circulations.
Chronic cerebrospinal venous insufficiency (CCSVI) has been described as follows in multiple sclerosis (MS) patients. CCSVI is characterized by impaired brain venous drainage due to outflow obstruction in the extracranial venous system, mostly related to anomalies in the internal jugular and azygos veins. The current CCSVI diagnosis is based on Doppler sonography of extracranial and transcranial venous hemodynamics where there has been documentation of stenotic and occlusive lesions in the azygos and internal jugular veins in patients with MS. The literature is inconclusive on whether CCSVI is a clinically important factor in the development and/or progression of MS

Treatment of CCSVI with balloon angioplasty and or stent placement
Venous angioplasty (with or without stent placement) is currently under investigation as a method to improve blood flow in chronic cerebrospinal venous insufficiency (CCSVI). The hypothesis is that symptoms of MS might improve with this treatment. The literature however, is inconclusive on whether balloon angioplasty and/or stent placement are clinically effective in treating patients with MS.

Endovascular treatment for CCSVI is typically performed from common femoral vein access. Initially a venogram is performed so that images can be obtained. A small catheter is inserted and advanced into the right and left IJVs as well as the AZY vein. If the venogram indicates a vein is stenosed then angioplasty is performed. Another venogram is done post angioplasty to confirm that the stenosis was successfully corrected. If the venous angioplasty results in no change or worsening of the stenosis, then stent placement is considered. Individuals who receive a stent typically are placed on anticoagulants for at least three months.

Coverage
The evidence is inconclusive as to whether CCSVI impacts multiple sclerosis and therefore if treatment with angioplasty would impact the disease. Therefore, venous angioplasty (with or without stent placement) is considered investigational and not medically necessary for the treatment of multiple sclerosis and not covered by Medicare.


Coding Information

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Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

011x Hospital Inpatient (Including Medicare Part A)
012x Hospital Inpatient (Medicare Part B only)
013x Hospital Outpatient
018x Hospital - Swing Beds
021x Skilled Nursing - Inpatient (Including Medicare Part A)
022x Skilled Nursing - Inpatient (Medicare Part B only)
023x Skilled Nursing - Outpatient
028x Skilled Nursing - Swing Beds
072x Clinic - Hospital Based or Independent Renal Dialysis Center
085x Critical Access Hospital

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

Revenue codes only apply to providers who bill these services to the fiscal intermediary or Part A MAC. Revenue codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC.

Please note that not all revenue codes apply to every type of bill code. Providers are encouraged to refer to the FISS revenue code file for allowable bill types. Similarly, not all revenue codes apply to each CPT/HCPCS code. Providers are encouraged to refer to the FISS HCPCS file for allowable revenue codes.

All revenue codes billed on the inpatient claim for the dates of service in question may be subject to review.

0320 Radiology - Diagnostic - General Classification
0329 Radiology - Diagnostic - Other Radiology - Diagnostic
0360 Operating Room Services - General Classification
0361 Operating Room Services - Minor Surgery
0369 Operating Room Services - Other OR Services
0450 Emergency Room - General Classification
0490 Ambulatory Surgical Care - General Classification
0520 Free-Standing Clinic - General Classification
0521 Free-Standing Clinic - Clinic Visit by Member to RHC/FQHC
0920 Other Diagnostic Services - General Classification
0929 Other Diagnostic Services - Other Diagnostic Service
0960 Professional Fees - General Classification
0981 Professional Fees - Emergency Room Services
0982 Professional Fees - Outpatient Services
0983 Professional Fees - Clinic

CPT/HCPCS Codes

35460TRANSLUMINAL BALLOON ANGIOPLASTY, OPEN; VENOUS
35476TRANSLUMINAL BALLOON ANGIOPLASTY, PERCUTANEOUS; VENOUS
75978TRANSLUMINAL BALLOON ANGIOPLASTY, VENOUS (EG, SUBCLAVIAN STENOSIS), RADIOLOGICAL SUPERVISION AND INTERPRETATION

ICD-9 Codes that Support Medical Necessity

NA
XX000Not Applicable

Diagnoses that Support Medical Necessity
NA
ICD-9 Codes that DO NOT Support Medical Necessity
Note: ICD-9 codes must be coded to the highest level of specificity
340 MULTIPLE SCLEROSIS

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

General Information

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Documentations Requirements
CPT codes 35460, 35476 and 35478 are used for many other conditions than the one expressed in this policy

Appendices

Utilization Guidelines

Sources of Information and Basis for Decision
Suresh Vedantham, MD, FSIR, James F. Benenati, MD, FSIR, Sanjoy Kundu, MD, FSIR, Carl M. Black, MD, Kieran J. Murphy, MD, FSIR, and John F. Cardella, MD, FSIR; Interventional Endovascular Management of Chronic Cerebrospinal Venous Insufficiency in Patients with Multiple Sclerosis: A Position Statement by the Society of Interventional Radiology, Endorsed by the Canadian Interventional Radiology Association; J Vasc Interv Radiol 2010; 21:1335–1337

Zamboni P., Galeotti R., Menegatti E., Malagoni A.M., Mascoli F., Dall'Ara S., Bartolomei I., Salvi F.; Rationale and preliminary results of endovascular treatment of multiple sclerosis. the liberation procedure.

Zamboni P., Galeotti R., Menegatti E., et al.; Chronic cerebrospinal venous insufficiency
in patients with multiple sclerosis; J Neurol Neurosurg Psychiatry 2009 80: 392-399 originally published online December 5, 2008

Simka M, Kostecki J, Zaniewski M, Majewski E, Hartel M. Extracranial Doppler sonographic criteria of chronic cerebrospinal venous insufficiency in the patients with multiple sclerosis. Int Angiol 2010; 29:109–114

Al-Omari MH, Rousan LA.; Internal jugular vein morphology and hemodynamics in patients with multiple sclerosis.; Int Angiol 2010; 29:115–120.

Advisory Committee Meeting Notes
Meeting Date:
Wisconsin 01/27/2012
Illinois 01/25/2012
Michigan 02/01/2012
Minnesota 02/02/2012
J5: Iowa, Kansas, Missouri, Nebraska 02/02/2012

Open LCD meeting Date:
01/12/2012

*- An asterisk indicates a revision to that section of the policy.

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the MAC contractor this policy was developed in cooperation with advisory groups which include representatives from various specialties, and adapted for the purpose of converting to MAC jurisdiction.



Start Date of Comment Period
02/02/2012
End Date of Comment Period
03/14/2012
Start Date of Notice Period

Revision History Number
Revision History Explanation

Reason for Change
Related Documents
This LCD has no Related Documents.

LCD Attachments
There are no attachments for this LCD.

Draft Contact
Kenneth Bussan
WPS Medicare
1717 W. Broadway
Madison, WI 53701-1787
policycomments@wpsic.com

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Page Last Updated: Thursday, 05-Jan-2012 08:08:46 CST