Local Coverage Determination (LCD)

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

L35028

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Proposed LCD
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Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L35028
Original ICD-9 LCD ID
Not Applicable
LCD Title
Venous Angioplasty with or without Stent Placement for the Treatment of Chronic Cerebrospinal Venous Insufficiency
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 11/14/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A

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Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):
Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Section 1862(a)(7) excludes routine physical examinations, unless otherwise covered by statute.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Indications:

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. Unfortunately, MS is associated with frequent spontaneous exacerbations of signs and symptoms. Thus it is very difficult to determine whether any change in medical condition is due to a treatment, or merely represents a normal fluctuation of the disease process. The literature currently 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 internal jugular veins as well as the azygos 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.

Limitations:

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) for any of the jugular veins, azygos veins, or other thoracic veins is considered investigational and not medically necessary for the treatment of multiple sclerosis and not covered by Medicare.

Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

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N/A

Revenue Codes

Code Description

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N/A

CPT/HCPCS Codes

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N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

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Group 1 Codes:

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Additional ICD-10 Information

General Information

Associated Information
N/A
Sources of Information
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Bibliography

This bibliography presents those sources that were obtained during the development of this policy. National Government Services is not responsible for the continuing viability of Web site addresses listed below.

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

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.

Vedantham S, Benenati JF, Kundu S, Black CM, Murphy KJ, Cardella JF. 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, et al. Rationale and preliminary results of endovascular treatment of multiple sclerosis, the liberation procedure. http://www.direct-ms.org/sites/default/files/Zamboni%20CCVI%20treatment%20liberation%2009.pdf

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. doi:10.1136/jnnp.2008.157164

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
11/14/2019 R3

Consistent with Change Request 10901, all coding information, National coverage provisions, and Associated Information (Documentation Requirements, Utilization Guidelines) have been removed from the LCD and placed in the related Billing and Coding Article, A56845. There has been no change in coverage with this LCD revision.

  • Revisions Due To Code Removal
01/01/2017 R2 Based on the 2017 annual HCPCS update, CPT codes 35460, 35476 and 75978 have been deleted and replaced with 37248 and 37249.
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2015 R1 LCD updated to reflect administrative changes.
  • Provider Education/Guidance
N/A

Associated Documents

Attachments
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Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
11/08/2019 11/14/2019 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • Multiple sclerosis

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