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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-35000-01

Original Effective Date: 11/15/11

Reviewed: 09/25/14

Revised: 01/01/17

Subject: Diagnosis and Treatment of Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position
Statement
Billing/Coding Reimbursement Program
Exceptions
Definitions Related
Guidelines
           
Other References Updates     Previous Information
           

DESCRIPTION:

Multiple sclerosis (MS) is generally considered a chronic inflammatory demyelinating disease of the central nervous system (brain, spinal cord, optic nerve) felt to be triggered by an autoimmune response to myelin.

However, due in part to the periventricular tendency of the lesions of multiple sclerosis, chronic cerebrospinal venous insufficiency (CCSVI) has also been considered. An animal model for MS was developed by injecting obstructing agents into the venous sinuses. This etiology and treatment approach for MS had not been actively pursued for many years. Recent reports by a European researcher have renewed interest in this topic.

The core foundation of this vascular theory is that there is abnormal venous drainage from the brain due to outflow obstruction in the draining jugular vein and/or azygos veins. This abnormal venous drainage, which is characterized by special ultrasound criteria is said to cause intracerebral flow disturbance or outflow problems that lead to periventricular deposits. In the CCSVI theory, these deposits have a similarity to the iron deposits seen around the veins in the legs in patients with chronic deep vein thrombosis. Those studying this theory have promoted balloon dilatation, with or without stenting, to treat the outflow problems, thereby curing CCSVI and by the same token alleviating MS complaints. Correction of CCSVI may be referred to as the “liberation procedure.”

POSITION STATEMENT:

The diagnosis and treatment of chronic cerebrospinal venous insufficiency (CCSVI) of individuals with multiple sclerosis and the treatment of CCSVI in individuals with multiple sclerosis is considered experimental or investigational, as there is insufficient clinical evidence published in the peer-reviewed literature that supports the safety and efficacy of these services. A relationship between CCSVI and multiple sclerosis has not been established with certainty and the effects on outcomes of multiple sclerosis are unknown.

BILLING/CODING INFORMATION:

There is no specific code describing CCSVI or liberation therapy for treating multiple sclerosis.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Azygos veins: any of a system of three veins which drain the thoracic wall and much of the abdominal wall and which form a collateral circulation when either the inferior or superior vena cava is obstructed; especially: a vein that receives blood from the right half of the thoracic and abdominal walls, ascends along the right side of the spinal column, and empties into the superior vena cava.

Demyelinating: causing or characterized by the loss or destruction of myelin.

Multiple sclerosis: a demyelinating disease marked by patches of hardened tissue in the brain or the spinal cord and associated especially with partial or complete paralysis and jerking muscle tremor.

Myelin: makes up an insulating covering that surrounds an axon (part of a nerve).

Periventricular: situated or occurring around a ventricle, especially of the brain.

RELATED GUIDELINES:

None

OTHER:

Other terms describing this therapy:

Angioplasty, transluminal balloon venous, multiple sclerosis
Liberation procedure
Liberation therapy
Multiple sclerosis
Transluminal balloon angioplasty, venous, multiple sclerosis
Venous ultrasonography, multiple sclerosis

REFERENCES:

  1. Benedict RH(1), Weinstock-Guttmam B, Marr K, Valnarov V, Kennedy C, Carl E, Brooks C, Hojnacki D, Zivadinov R. Chronic cerebrospinal venous insufficiency is not associated with cognitive impairment in multiple sclerosis. BMC Med. 2013 Jul 18;11:167.
  2. Blue Cross BlueShield Association Medical Policy Reference Manual 8.01.56 Diagnosis and Treatment of Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis (05/22/14).
  3. Canadian Institutes for Health Research (CIHR). Systematic reviews of the evidence regarding chronic cerebral spinal venous insufficiency (CCSVI) and multiple sclerosis - Summary of the First Report for CIHR Expert Panel. Laupacis A, Lillie E, Dueck A, Aviv R, Straus S, Perrier L, Burton J, Thorpe K, Feasby T, Spears J. 09/23/11.
  4. Cardiovascular and Interventional Radiological Society of Europe (CIRSE) commentary on the treatment of CCSVI. Accessed 08/11/14.
  5. ClinicalTrials.gov:
  1. Dome H, Zaidat OO, Fliorella D, et al. Chronic cerebrospinal venous insufficiency and the doubtful promise of an endovascular treatment for multiple sclerosis. J NeuroIntervent Surg 2010;2:309-311.
  2. ECRI Health Technology Forecast News Brief. Angioplasty still under study for MS treatment (04/30/2012).
  3. Fox RJ, Rae-Grant A. Chronic cerebrospinal venous insufficiency: have we found the cause and cure of MS? Neurology 2011 Apr 13.
  4. Goodin DS, Frohman EM, Garmany GP Jr, Halper J, Likosky WH, Lublin FD, Silberberg DH, Stuart WH, van den Noort S. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology 2002 Jan 22;58(2):169-78 (Guideline updated by ECRI Institute on March 17, 2010).
  5. Lanzillo R, Mancini M, Liuzzi R, Di Donato O, Salvatore E, Maglio V, Vacca G, Amato L, D'Anna G, Brunetti A, Brescia Morra V. Chronic cerebrospinal venous insufficiency in multiple sclerosis: a highly prevalent age-dependent phenomenon. BMC Neurol. 2013 Feb 13;13:20.
  6. Laupacis A, Slutsky AS. Endovascular treatment for multiple sclerosis: The intersection of science, policy and the public. Open Med. 2010;4(4):e197-9.
  7. Laupacis A, Lillie E, Dueck A, Aviv R, Straus S, Perrier L, Burton J, Thorpe K, Feasby T, Spears J. Association between chronic cerebrospinal venous insufficiency and multiple sclerosis: a meta-analysis. CMAJ 10/03/11, doi: 10.1503/cmaj.111074.
  8. Leone MA, Raymkulova O, Naldi P, Lochner P, Bolamperti L, Coppo L, Stecco A, Liboni W. Chronic Cerebrospinal Venous Insufficiency Is Not Associated with Multiple Sclerosis and Its Severity: A Blind-Verified Study. PLoS One. 2013; 8(2): e56031. Published online Feb 13, 2013.
  9. Mayer CA, Pfeilschifter W, Lorenz MW, Nedelmann M, Bechmann I, Steinmetz H,Ziemann U. The perfect crime? CCSVI not leaving a trace in MS. J Neurol Neurosurg Psychiatry. 2011 Apr;82(4):436-40. Epub 2011 Feb 4.
  10. National Guideline Clearinghouse NGC-10315. Summary of evidence-based guideline: complementary and alternative medicine in multiple sclerosis. Report of the Guideline Development Subcommittee of the American Academy of Neurology. 2014
  11. National Institute for Health and Clinical Excellence (NICE). Percutaneous venoplasty for chronic cerebrospinal venous insufficiency for multiple sclerosis. NICE interventional procedure guidance 420. March 2012.
  12. Pullman D, Zarzeczny A, Picard A. Media, politics and science policy: MS and evidence from the CCSVI Trenches. BMC Med Ethics. 2013 Feb 12;14:6. doi: 10.1186/1472-6939-14-6.
  13. Reekers JA, Lee MJ, Belli AM et al. Cardiovascular and Interventional Radiological Society of Europe commentary on the treatment of chronic cerebrospinal venous insufficiency. Cardiovasc Intervent Radiol 2011; 34(1):1-2.
  14. Rynor B. Canadian trials to examine "liberation procedure" for multiple sclerosis. CMAJ. 2010 Jun 15;182(9):E403-4.
  15. The Society for Interventional Radiology (SIR) position statement on the association of CCSVI with MS and the efficacy of endovascular treatments. Accessed 08/11/14.
  16. U.S. Food and Drug Administration (FDA). FDA issues alert on potential dangers of unproven treatment for multiple sclerosis. FDA News. Silver Spring, MD: FDA; May 10, 2012.
  17. Vedantham S, Benenati JF, Kundu S et al. 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(9):1335-7.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 09/25/14.

GUIDELINE UPDATE INFORMATION:

11/15/11

New Medical Coverage Guideline.

10/15/12

Annual review; position statement unchanged, references updated.

10/15/13

Annual review; position statement unchanged; Program Exceptions section updated; references updated.

10/15/14

Annual review with literature search; position statement unchanged; references updated.

01/01/17

Annual CPT/HCPCS update. Revised BIlling/Coding Information section.

Date Printed: June 26, 2017: 11:41 AM